0A4F4F9BD490A749D5437F821CF06DF1
FDA: Guideline for Good Clinical Practice
https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0030056
http://leaux.net/URLS/ConvertAPI Text Files/872362A4EEB06B087150403D643D6836.en.txt
Examining the file media/Synopses/872362A4EEB06B087150403D643D6836.html:
This file was generated: 2020-08-23 05:52:58
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / vulnerable
Searching for indicator vulnerable:
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p.(None): 13.Adverse Drug Reaction (ADR): All noxious and unexpected response to a medicinal product. An adverse drug reaction should be
p.(None): reasonably related to the use of the investigational product(s).
p.(None): 14.Adverse Event (AE): Any untoward medical occurrence in a clinical investigation subject administered an investigational product
p.(None): and which does not necessarily have a causal relationship with the use of the investigational product(s).
p.(None): 15.Blinding/Masking: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-
p.(None): blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor,
p.(None): and, in some cases, data analyst(s) being unaware of the treatment assignment(s).
p.(None):
p.(None): Article 4
p.(None): Clinical trials should be conducted in accordance with the ethical principles of the Declaration of Helsinki.
p.(None): Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual
p.(None): trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks and inconveniences.
p.(None): The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of
p.(None): science and society.
p.(None): The Ethics Committee should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials
p.(None): that may include vulnerable subjects.
p.(None):
p.(None): Article 5
p.(None): The investigator should obtain the informed consent form freely given by the subjects prior to the beginning of the trial.
p.(None): The investigator, or a person designated by the investigator, should fully inform the subject of all pertinent aspects of the trial,
p.(None): including the contents of the informed consent form and the documentations approved by the Ethics Committee. The investigator, or
p.(None): designated person, should ensure the content of inform consent form and other trial-related documentations are well understood,
p.(None): signed and dated by the subject.
p.(None): For the consent mentioned in the preceding two paragraphs, where the subject is incompetent, the consent should be performed by
p.(None): his or her legal representative; where the subject is of limited legal capacity, consent should be obtained from his or her legal
p.(None): representative; where the subject who is neither incompetent nor of limited legal capacity, yet is unable to give consent due to
p.(None): insanity or the absence of discernment, the consent could be given by the person legally acceptable for making decisions on behalf of
p.(None): the subject.
...
Health / Drug Usage
Searching for indicator drug:
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p.(None): persons with no medical professions, whose responsibility is to ensure the protection of the rights, safety and well-being of human
p.(None): subjects involved in a trial.
p.(None): 6.Institution/Trial Site: A medical institution where clinical trials are conducted.
p.(None): 7.Investigator: A person responsible for the conduct of the clinical trial at a trial site.
p.(None): 8.Sponsor: An individual, company, institution, or organization which takes responsibility for the initiation and management of a
p.(None): clinical trial.
p.(None): 9.Contract Research Organization (CRO): A person or an organization (commercial, academic, or other) contracted by the sponsor to
p.(None): perform one or more of a sponsor's trial-related duties and functions.
p.(None): 10.Investigational Product: A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical
p.(None): trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the
p.(None): approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
p.(None): 11.Protocol: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial.
p.(None): The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced
p.(None): documents.
p.(None): 12.Investigator's Brochure (IB): A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to
p.(None): the study of the investigational product(s) in human subjects.
p.(None): 13.Adverse Drug Reaction (ADR): All noxious and unexpected response to a medicinal product. An adverse drug reaction should be
p.(None): reasonably related to the use of the investigational product(s).
p.(None): 14.Adverse Event (AE): Any untoward medical occurrence in a clinical investigation subject administered an investigational product
p.(None): and which does not necessarily have a causal relationship with the use of the investigational product(s).
p.(None): 15.Blinding/Masking: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-
p.(None): blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor,
p.(None): and, in some cases, data analyst(s) being unaware of the treatment assignment(s).
p.(None):
p.(None): Article 4
p.(None): Clinical trials should be conducted in accordance with the ethical principles of the Declaration of Helsinki.
p.(None): Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual
p.(None): trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks and inconveniences.
p.(None): The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of
p.(None): science and society.
p.(None): The Ethics Committee should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials
p.(None): that may include vulnerable subjects.
p.(None):
p.(None): Article 5
p.(None): The investigator should obtain the informed consent form freely given by the subjects prior to the beginning of the trial.
...
p.(None): The monitor, auditor, the Ethics Committee, or the Competent Authority, can request for direct access to all trial-related records.
p.(None): However, prior to access to the subject’s personal identity information, confirmation of the subject’s written consent is required.
p.(None):
p.(None): Article 104
p.(None): The Competent Authority may request the investigator to submit written reports to the institution, elaborating the trial status.
p.(None): The investigator and the institution should submit written summaries of the trial status to the Ethics Committee annually. If necessary,
p.(None): the Ethics Committee may request to shorten the interval of the routine reports.
p.(None):
p.(None): Article 105
p.(None): The investigator shall promptly provide written reports to the sponsor, the Ethics Committee and the Competent Authority on any
p.(None): situation significantly affecting the conduct of the trial, and/or increasing the risk to subjects.
p.(None):
p.(None): Article 106
p.(None): The investigator shall immediately report any serious adverse events to the sponsor, and shall provide detailed, written reports as
p.(None): soon as possible. The investigator shall immediately report any suspected unexpected serious adverse drug reactions to the Ethics
p.(None): Committee. However, those SAEs that the protocol or other document identifies as not needing immediate reporting shall not apply.
p.(None): The sponsor shall report any suspected unexpected serious adverse reactions that are fatal or life-threatening to the Competent
p.(None): Authority or the contracted organization within 7 days after being aware of the event, and shall provide detailed written documents
p.(None): within 15 days after being aware of the event.
p.(None): The sponsor shall report all the other suspected unexpected serious adverse reactions to the Competent Authority or the contracted
p.(None): organization and provide detailed written documents within 15 days after being aware of the event.
p.(None): The subjects’ identity should be coded in the oral and written reports mentioned in paragraph 1 that should not reveal subjects’
p.(None): names, ID numbers, addresses, or any other information which may reveal subject’s personal identity.
p.(None): The serious adverse events and serious adverse drug reactions are defined and announced by the Competent Authority.
p.(None):
p.(None): Article 107
p.(None): When adverse events or laboratory abnormalities are identified as critical to safety evaluations, the investigator should report to the
p.(None): sponsor within the time periods specified by the sponsor in the protocol.
p.(None):
p.(None): Article 108
p.(None): For reported deaths, the sponsor, the Ethics Committee, and the Competent Authority may request the investigator to provide
p.(None): autopsy reports, terminal medical reports and any additional information.
p.(None):
p.(None): Article 109
p.(None): The sponsor shall promptly notify all investigator(s), institution(s) and the Competent Authority for any of the following situations:
p.(None): 1.New findings that could affect adversely the safety of subjects.
p.(None): 2.New findings that impact the conduct of the trial.
p.(None): 3.New findings that alter the Ethics Committee's approval to continue the trial.
p.(None):
p.(None): Article 110
p.(None): The sponsor shall submit the latest safety reports to the Competent Authority.
p.(None):
p.(None): Article 111
p.(None): Upon the trial is completed or prematurely terminated, the investigator and the institution shall provide the sponsor and the
p.(None): Competent Authority with any reports required, and provide the Ethics Committee with a summary of the trial’s outcome.
...
Searching for indicator influence:
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p.(None): his or her legal representative; where the subject is of limited legal capacity, consent should be obtained from his or her legal
p.(None): representative; where the subject who is neither incompetent nor of limited legal capacity, yet is unable to give consent due to
p.(None): insanity or the absence of discernment, the consent could be given by the person legally acceptable for making decisions on behalf of
p.(None): the subject.
p.(None): The person legally acceptable for making decisions on behalf of the subject refers to the subject’s spouse and cohabiting families.
p.(None):
p.(None): Article 6
p.(None): During and following a subject's participation in a trial, the investigator and the institution should ensure that adequate medical care is
p.(None): provided to a subject for any adverse events related to the trial. The investigator should inform a subject when medical care is
p.(None): needed for intercurrent illness(es) of which the investigator becomes aware.
p.(None):
p.(None): Article 7
p.(None): The investigator should inform the subject's primary physician about the subject's participation in the trial if the subject has a primary
p.(None): physician and if the subject agrees to the primary physician being informed.
p.(None):
p.(None): Article 8
p.(None): Neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate in a trial.
p.(None): During the trial, neither the investigator, nor the trial staff, should coerce or unduly influence a subject to continue the trial.
p.(None):
p.(None): Article 9
p.(None): A subject is entitled to withdraw from a clinical trial at any time without giving reason(s).
p.(None): Under the circumstances referred to in the preceding paragraph, the investigator should make a reasonable effort to ascertain the
p.(None): reason(s) while fully respecting the subject's rights and will.
p.(None):
p.(None): Article 10
p.(None): In the aspect of amount and method of payment to subjects, the sponsor should not impose coercion or undue influences on the trial
p.(None): subjects.
p.(None): Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject, except when the
p.(None): payment is a small amount.
p.(None): Information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, should be
p.(None): clearly stated in the written informed consent form and any other written information to be provided to subjects. The way payment will
p.(None): be prorated should be specified.
p.(None):
p.(None): Article 11
p.(None): Identities and records of the subjects that are related to the trial should be kept confidential.
p.(None):
p.(None): Article 12
p.(None): Clinical trials should be scientifically based, and the protocol should be clearly defined and detailed.
p.(None):
p.(None): Article 13
p.(None): No trials shall be conducted without approval from an Ethics Committee.
p.(None): After reviewing the informed consent form, protocol and all other relevant documents, the Ethics Committee can approve the
p.(None): institution to conduct the clinical trial.
...
Health / Physically Disabled
Searching for indicator illness:
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p.(None): designated person, should ensure the content of inform consent form and other trial-related documentations are well understood,
p.(None): signed and dated by the subject.
p.(None): For the consent mentioned in the preceding two paragraphs, where the subject is incompetent, the consent should be performed by
p.(None): his or her legal representative; where the subject is of limited legal capacity, consent should be obtained from his or her legal
p.(None): representative; where the subject who is neither incompetent nor of limited legal capacity, yet is unable to give consent due to
p.(None): insanity or the absence of discernment, the consent could be given by the person legally acceptable for making decisions on behalf of
p.(None): the subject.
p.(None): The person legally acceptable for making decisions on behalf of the subject refers to the subject’s spouse and cohabiting families.
p.(None):
p.(None): Article 6
p.(None): During and following a subject's participation in a trial, the investigator and the institution should ensure that adequate medical care is
p.(None): provided to a subject for any adverse events related to the trial. The investigator should inform a subject when medical care is
p.(None): needed for intercurrent illness(es) of which the investigator becomes aware.
p.(None):
p.(None): Article 7
p.(None): The investigator should inform the subject's primary physician about the subject's participation in the trial if the subject has a primary
p.(None): physician and if the subject agrees to the primary physician being informed.
p.(None):
p.(None): Article 8
p.(None): Neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate in a trial.
p.(None): During the trial, neither the investigator, nor the trial staff, should coerce or unduly influence a subject to continue the trial.
p.(None):
p.(None): Article 9
p.(None): A subject is entitled to withdraw from a clinical trial at any time without giving reason(s).
p.(None): Under the circumstances referred to in the preceding paragraph, the investigator should make a reasonable effort to ascertain the
p.(None): reason(s) while fully respecting the subject's rights and will.
p.(None):
p.(None): Article 10
p.(None): In the aspect of amount and method of payment to subjects, the sponsor should not impose coercion or undue influences on the trial
p.(None): subjects.
p.(None): Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject, except when the
p.(None): payment is a small amount.
p.(None): Information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, should be
...
Health / Terminally Ill
Searching for indicator terminal:
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p.(None): The sponsor shall report any suspected unexpected serious adverse reactions that are fatal or life-threatening to the Competent
p.(None): Authority or the contracted organization within 7 days after being aware of the event, and shall provide detailed written documents
p.(None): within 15 days after being aware of the event.
p.(None): The sponsor shall report all the other suspected unexpected serious adverse reactions to the Competent Authority or the contracted
p.(None): organization and provide detailed written documents within 15 days after being aware of the event.
p.(None): The subjects’ identity should be coded in the oral and written reports mentioned in paragraph 1 that should not reveal subjects’
p.(None): names, ID numbers, addresses, or any other information which may reveal subject’s personal identity.
p.(None): The serious adverse events and serious adverse drug reactions are defined and announced by the Competent Authority.
p.(None):
p.(None): Article 107
p.(None): When adverse events or laboratory abnormalities are identified as critical to safety evaluations, the investigator should report to the
p.(None): sponsor within the time periods specified by the sponsor in the protocol.
p.(None):
p.(None): Article 108
p.(None): For reported deaths, the sponsor, the Ethics Committee, and the Competent Authority may request the investigator to provide
p.(None): autopsy reports, terminal medical reports and any additional information.
p.(None):
p.(None): Article 109
p.(None): The sponsor shall promptly notify all investigator(s), institution(s) and the Competent Authority for any of the following situations:
p.(None): 1.New findings that could affect adversely the safety of subjects.
p.(None): 2.New findings that impact the conduct of the trial.
p.(None): 3.New findings that alter the Ethics Committee's approval to continue the trial.
p.(None):
p.(None): Article 110
p.(None): The sponsor shall submit the latest safety reports to the Competent Authority.
p.(None):
p.(None): Article 111
p.(None): Upon the trial is completed or prematurely terminated, the investigator and the institution shall provide the sponsor and the
p.(None): Competent Authority with any reports required, and provide the Ethics Committee with a summary of the trial’s outcome.
p.(None): Under the circumstances referred to in the preceding paragraph, the sponsor shall provide the Competent Authority with a complete
p.(None): and detailed clinical trial report.
p.(None): The format of the clinical trial reports referred to in the preceding paragraph is announced by the Competent Authority.
p.(None):
p.(None): IV. Suspension and Termination of a Trial
p.(None):
p.(None): Article 112
p.(None): If the trial is suspended or terminated, the investigator and the institution shall promptly inform the trial subjects, should assure
p.(None): appropriate therapy and follow-up for the subjects.
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): The informed consent form and any other written information to be provided to subjects shall include explanations of the following:
p.(None): 1.That the trial involves research.
p.(None): 2.The purpose of the trial.
p.(None): 3.The trial treatment(s) and the probability for random assignment to each treatment.
p.(None): 4.The trial procedures to be followed, including all invasive procedures.
p.(None): 5.The subject's responsibilities.
p.(None): 6.Those aspects of the trial that are experimental.
p.(None): 7.The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant.
p.(None): 8.The reasonably expected benefits.
p.(None): 9.The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits
p.(None): and risks.
p.(None): 10.The compensation and/or treatment available to the subject in the event of trial-related injury.
p.(None): 11.The anticipated prorated payment, if any, to the subject for participating in the trial.
p.(None): 12.The anticipated expenses, if any, to the subject for participating in the trial.
p.(None): 13.That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at
p.(None): any time, without penalty or loss of benefits to which the subject is otherwise entitled.
p.(None): 14.That the monitor(s), the auditor(s), the Ethics Committee, and the Competent Authority will be granted direct access to the
p.(None): subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the
p.(None): subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the
p.(None): subject is authorizing such access.
p.(None): 15.That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations,
p.(None): will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential.
p.(None): 16.That the subject or the subject's legally acceptable representative will be informed in a timely manner if information becomes
p.(None): available that may be relevant to the subject's willingness to continue participation in the trial.
p.(None): 17.The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to contact in the event
p.(None): of trial-related injury.
p.(None): 18.The foreseeable circumstances and/or reasons under which the subject's participation in the trial may be terminated.
p.(None): 19.The expected duration of the subject's participation in the trial.
p.(None): 20.The approximate number of subjects involved in the trial.
p.(None):
p.(None): Article 23
p.(None): Prior to participation in the trial, the subject or the subject's legally acceptable representative shall receive a copy of the signed and
p.(None): dated informed consent form and any other written information provided to the subjects. The clinical trials intended for treating
p.(None): emergency cases when prior consent is not possible are exceptional.
p.(None): During a subject’s participation in the trial, the subject or the subject’s legally acceptable representative shall receive a copy of the
p.(None): signed and dated consent form updates and a copy of any amendments to the written information provided to subjects.
p.(None):
p.(None): Article 24
...
p.(None): The IDMC should have written operating procedures and maintain written records of all its meetings.
p.(None):
p.(None): Article 45
p.(None): The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related
p.(None): medical questions or problems. If necessary, outside consultant(s) may be appointed for this purpose.
p.(None):
p.(None): Article 46
p.(None): Prior to initiating a trial, the sponsor should define, establish, and allocate all trial-related duties and functions.
p.(None):
p.(None): Article 47
p.(None): The sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator and the institution against
p.(None): claims arising from the trial, except for claims that arise from malpractice and/or negligence.
p.(None):
p.(None): Article 48
p.(None): When the investigator, the institution or any trial staff fails to comply with the protocol or this Regulations, the sponsor should adopt
p.(None): immediate measures to ensure the compliance.
p.(None): While the investigator or the institution does not adopt the measures referred to in the preceding paragraph, the sponsor should take
p.(None): action in accordance with Article 116.
p.(None):
p.(None): II. Quality Assurance and Quality Control
p.(None):
p.(None): Article 49
p.(None): The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to
p.(None): ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, this
p.(None): Regulations, and the applicable regulatory requirement(s).
p.(None):
p.(None): Article 50
p.(None): The sponsor is responsible for securing agreement from all involved parties to ensure direct access to all trial related sites, source
p.(None): data/ documents, and reports for the purpose of monitoring and auditing by the sponsor, and inspection by the Competent Authority.
p.(None):
p.(None): Article 51
p.(None): Agreements, made by the sponsor with the investigator, the institution and any other parties involved with the clinical trial, should be
p.(None): in writing, as part of the protocol or in a separate agreement.
p.(None):
p.(None): Article 52
p.(None): The sponsor should utilize appropriately qualified individual to design the protocol, produce case report forms (CRFs), plan the
p.(None): analysis, and prepare interim and final clinical trial reports.
p.(None):
p.(None): III. Data Handling and Record Keeping
p.(None):
p.(None): Article 53
p.(None): Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed
p.(None): correctly.
p.(None):
p.(None): Article 54
p.(None): The sponsor should utilize appropriately qualified individuals to be responsible for the following work:
p.(None): 1.to supervise the overall conduct of the trial,
p.(None): 2.to handle the data and to verify the data,
p.(None): 3.to conduct the statistical analyses, and to prepare the trial reports.
p.(None):
p.(None): Article 55
p.(None): When using electronic trial data handling or remote electronic trial data systems, the sponsor should:
p.(None): 1.Ensure and document that the electronic data processing system(s) conforms to the sponsor’s established requirements for
p.(None): completeness, accuracy, reliability, and consistent intended performance (i.e. validation).
p.(None): 2.Follow and maintain SOPs for using these systems.
p.(None): 3.Ensure that the systems are designed to permit data changes in such a way that the data changes are documented and that there
p.(None): is no deletion of entered data (i.e. maintain an audit trail, data trail, edit trail).
p.(None): 4.Maintain a security system that prevents unauthorized access to the data.
p.(None): 5.Maintain a list of the individuals who are authorized to make data changes.
p.(None): 6.Maintain adequate backup of the data.
p.(None): 7.Safeguard the blinding.
p.(None):
p.(None): Article 56
p.(None): If data are transformed during processing, it should always be possible to compare the original data and observations with the
p.(None): processed data.
p.(None):
p.(None): Article 57
p.(None): The sponsor should use an unambiguous subject identification code that allows identification of all the data reported for each subject.
p.(None):
p.(None): Article 58
p.(None): The sponsor, or other owners of the data, shall retain all of the sponsor-specific essential documents pertaining to the trial for at least
p.(None): 2 years after approval of the marketing application of the investigational product(s) in Taiwan. However, these documents shall be
p.(None): retained for a longer period if required by other applicable regulatory requirements.
p.(None):
p.(None): Article 59
p.(None): If the sponsor discontinues the clinical development of an investigational product, the sponsor should notify all the trial investigators,
p.(None): institutions and the Competent Authority.
p.(None): Under the preceding circumstance, the sponsor shall maintain all sponsor-specific essential documents for at least 2 years after
p.(None): formal discontinuation. However, these documents shall be retained for a longer period if required by other applicable regulatory
p.(None): requirements.
p.(None):
p.(None): Article 60
p.(None): Any transfer of ownership of the data shall be reported to the Competent Authority.
p.(None):
p.(None): Article 61
p.(None): The sponsor should inform the investigator(s) and the institution(s) in writing of the need for record retention. When the trial related
...
p.(None):
p.(None): VI. Audit
p.(None):
p.(None): Article 80
p.(None): A sponsor's audit should be independent of and separate from routine monitoring or quality control functions. The purpose of auditing
p.(None): is to evaluate trial conduct and compliance with the protocol, SOPs, this Regulations, and the applicable regulatory requirements.
p.(None):
p.(None): Article 81
p.(None): Selection and qualification of auditors should comply with:
p.(None): 1.The sponsor should appoint individuals, who are independent of the clinical trials and data capture systems, to conduct audits.
p.(None): 2.The sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly. An auditor’s
p.(None): qualifications should be documented.
p.(None):
p.(None): Article 82
p.(None): The auditing procedures should comply with:
p.(None): 1.The auditing procedures is conducted in accordance with the sponsor's written procedures on what to audit, how to audit, the
p.(None): frequency of audits, and the form and content of audit reports.
p.(None): 2.The sponsor's audit plan and procedures for a trial audit should be guided by the importance of the trial, the number of subjects in
p.(None): the trial, the type and complexity of the trial, the level of risks to the trial subjects, and any identified problem(s).
p.(None): 3.The observations and findings of the auditor(s) should be documented in writing.
p.(None): 4.To preserve the independence and value of the audit function, the Competent Authority should not routinely request the audit
p.(None): reports, except when evidence of serious non-compliance with this Regulations exists, or in the course of legal proceedings, the
p.(None): Competent Authority may seek access to an audit report on a case by case basis.
p.(None): 5.The sponsor should provide an audit certificate.
p.(None):
p.(None): Chapter VI Application and Assessment of Clinical Trials
p.(None):
p.(None): Article 83
p.(None): For applying for a clinical trial approval, an application form and the following documents are needed to submit:
p.(None): 1.Protocol;
p.(None): 2.Informed Consent From;
p.(None): 3.Advertisement on subject recruitment or any other documents regarding the recruitment procedures;
p.(None): 4.All written information to be provided to subjects;
p.(None): 5.Investigator’s Brochure;
p.(None): 6.Currently available safety data on the investigational product(s);
p.(None): 7.Descriptions of the payments and compensations to trials subjects;
p.(None): 8.The investigator’s current curriculum vitae or any other documents supported his/her qualifications;
p.(None): 9.Other essential documents specified by the Ethics Committee.
p.(None):
p.(None): Article 84
p.(None): The Ethics Committee shall review a proposed clinical trial within one month and make a decision for one of the four review results:
p.(None): 1.Approval;
p.(None): 2.Reassessment after modification;
p.(None): 3.Disapproval;
p.(None): 4.Termination or suspension of any prior approval trials.
p.(None):
p.(None): Article 85
p.(None): The review decision should be made in writing and include the following contents:
p.(None): 1.The title of the trial;
p.(None): 2.The institution and the investigator;
p.(None): 3.The reviewed documents and the version numbers;
p.(None): 4.The review results and reasons;
p.(None): 5.Year, Month and date.
p.(None):
p.(None): Article 86
...
p.(None): The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs
p.(None): and in all required reports.
p.(None):
p.(None): Article 99
p.(None): Data reported on the CRF should be consistent with the source documents. The discrepancies should be explained.
p.(None):
p.(None): Article 100
p.(None): Any change or correction to a CRF should be dated, initialed, and explained and should not obscure the original entry.
p.(None): The preceding regulation applies to both written and electronic changes or corrections.
p.(None): The investigator should designate a person to document changes or corrections in CRF. All changes or corrections should be
p.(None): endorsed by the investigator.
p.(None): The investigator should retain records of the changes and corrections.
p.(None):
p.(None): Article 101
p.(None): The investigator and the institution should pay sufficient attention to properly maintain all the important trial documents, and take
p.(None): measures to prevent accidental or premature destruction of these documents.
p.(None): The documents referred to in the preceding paragraph shall be retained until at least 2 years after approval of the marketing
p.(None): application of the investigational product(s) in Taiwan. However, these documents shall be retained for a longer period if required by
p.(None): other applicable regulatory requirements.
p.(None):
p.(None): Article 102
p.(None): The financial aspects of the trial should be documented in an agreement between the sponsor and the institution or the investigator.
p.(None):
p.(None): Article 103
p.(None): The monitor, auditor, the Ethics Committee, or the Competent Authority, can request for direct access to all trial-related records.
p.(None): However, prior to access to the subject’s personal identity information, confirmation of the subject’s written consent is required.
p.(None):
p.(None): Article 104
p.(None): The Competent Authority may request the investigator to submit written reports to the institution, elaborating the trial status.
p.(None): The investigator and the institution should submit written summaries of the trial status to the Ethics Committee annually. If necessary,
p.(None): the Ethics Committee may request to shorten the interval of the routine reports.
p.(None):
p.(None): Article 105
p.(None): The investigator shall promptly provide written reports to the sponsor, the Ethics Committee and the Competent Authority on any
p.(None): situation significantly affecting the conduct of the trial, and/or increasing the risk to subjects.
p.(None):
p.(None): Article 106
p.(None): The investigator shall immediately report any serious adverse events to the sponsor, and shall provide detailed, written reports as
p.(None): soon as possible. The investigator shall immediately report any suspected unexpected serious adverse drug reactions to the Ethics
p.(None): Committee. However, those SAEs that the protocol or other document identifies as not needing immediate reporting shall not apply.
p.(None): The sponsor shall report any suspected unexpected serious adverse reactions that are fatal or life-threatening to the Competent
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.(None): that the information were accurately explained by the investigator or designated person, and were fully understood by the subject or
p.(None): the subject's legally acceptable representative.
p.(None): Under the circumstances referred to in paragraph 1, the subject or the subject’s legally acceptable representative shall still sign and
p.(None): date the informed consent form. Finger print is an acceptable substitute for signature.
p.(None): After finishing the work described in paragraph 2, the impartial witness attests that informed consent was freely given by the subject
p.(None): or the subject’s legally acceptable representative by signing and dating the informed consent form.
p.(None): Trial staff shall not acts as the impartial witness.
p.(None):
p.(None): Article 22
p.(None): The informed consent form and any other written information to be provided to subjects shall include explanations of the following:
p.(None): 1.That the trial involves research.
p.(None): 2.The purpose of the trial.
p.(None): 3.The trial treatment(s) and the probability for random assignment to each treatment.
p.(None): 4.The trial procedures to be followed, including all invasive procedures.
p.(None): 5.The subject's responsibilities.
p.(None): 6.Those aspects of the trial that are experimental.
p.(None): 7.The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant.
p.(None): 8.The reasonably expected benefits.
p.(None): 9.The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits
p.(None): and risks.
p.(None): 10.The compensation and/or treatment available to the subject in the event of trial-related injury.
p.(None): 11.The anticipated prorated payment, if any, to the subject for participating in the trial.
p.(None): 12.The anticipated expenses, if any, to the subject for participating in the trial.
p.(None): 13.That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at
p.(None): any time, without penalty or loss of benefits to which the subject is otherwise entitled.
p.(None): 14.That the monitor(s), the auditor(s), the Ethics Committee, and the Competent Authority will be granted direct access to the
p.(None): subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the
p.(None): subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the
p.(None): subject is authorizing such access.
p.(None): 15.That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations,
p.(None): will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential.
...
Social / Infant
Searching for indicator infant:
(return to top)
p.(None): that the information were accurately explained by the investigator or designated person, and were fully understood by the subject or
p.(None): the subject's legally acceptable representative.
p.(None): Under the circumstances referred to in paragraph 1, the subject or the subject’s legally acceptable representative shall still sign and
p.(None): date the informed consent form. Finger print is an acceptable substitute for signature.
p.(None): After finishing the work described in paragraph 2, the impartial witness attests that informed consent was freely given by the subject
p.(None): or the subject’s legally acceptable representative by signing and dating the informed consent form.
p.(None): Trial staff shall not acts as the impartial witness.
p.(None):
p.(None): Article 22
p.(None): The informed consent form and any other written information to be provided to subjects shall include explanations of the following:
p.(None): 1.That the trial involves research.
p.(None): 2.The purpose of the trial.
p.(None): 3.The trial treatment(s) and the probability for random assignment to each treatment.
p.(None): 4.The trial procedures to be followed, including all invasive procedures.
p.(None): 5.The subject's responsibilities.
p.(None): 6.Those aspects of the trial that are experimental.
p.(None): 7.The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant.
p.(None): 8.The reasonably expected benefits.
p.(None): 9.The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits
p.(None): and risks.
p.(None): 10.The compensation and/or treatment available to the subject in the event of trial-related injury.
p.(None): 11.The anticipated prorated payment, if any, to the subject for participating in the trial.
p.(None): 12.The anticipated expenses, if any, to the subject for participating in the trial.
p.(None): 13.That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at
p.(None): any time, without penalty or loss of benefits to which the subject is otherwise entitled.
p.(None): 14.That the monitor(s), the auditor(s), the Ethics Committee, and the Competent Authority will be granted direct access to the
p.(None): subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the
p.(None): subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the
p.(None): subject is authorizing such access.
p.(None): 15.That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations,
p.(None): will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential.
p.(None): 16.That the subject or the subject's legally acceptable representative will be informed in a timely manner if information becomes
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.(None):
p.(None): Chapter II Protection of Trial Subjects
p.(None):
p.(None): Article 16
p.(None): Prior to the beginning of the trial, the investigator shall obtain the approval from the Ethics Committee for the informed consent form
p.(None): and any other written information to be provided to subjects.
p.(None): The approval referred to in the preceding paragraph should be made in writing.
p.(None):
p.(None): Article 17
p.(None): The informed consent form and any other written information to be provided to subjects should be revised whenever important new
p.(None): information becomes available that may be relevant to the subject’s consent. The subject or the subject’s legally acceptable
p.(None): representative should be informed in a timely manner if new information becomes available.
p.(None): Any revised informed consent form, and written information shall be approved by the Ethics Committee in advance of use; For those
p.(None): clinical trials which are approved by the Competent Authority, the revised documents shall be resubmitted for approval.
p.(None): The communication and approval referred to in preceding paragraph1 and paragraph 2 should be made in writing.
p.(None):
p.(None): Article 18
p.(None): None of the informed consent form and any other written information to be provided to subjects shall contain any language that
p.(None): causes the subject or the subject's legally acceptable representative to waive or to appear to waive any legal rights, or that releases
p.(None): or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence.
p.(None): Statements in contradiction to the rules specified in the preceding paragraph are invalid.
p.(None):
p.(None): Article 19
p.(None): The language used in the oral and written information about the trial, including the informed consent form, should be as non-technical
p.(None): as practical and should be understandable to the subject or the subject's legally acceptable representative and the impartial witness,
p.(None): where applicable.
p.(None):
p.(None): Article 20
p.(None): Prior to a subject’s participation in the trial, the informed consent form shall be signed and personally dated by the subject or by the
p.(None): subject's legally acceptable representative.
p.(None): Before informed consent may be obtained, the investigator, or a person designated by the investigator, should provide the subject or
p.(None): the subject's legally acceptable representative ample time and opportunity to inquire about details of the trial and to decide whether or
p.(None): not to participate in the trial.
p.(None): All questions about the trial should be answered to the satisfaction of the subject or the subject's legally acceptable representative.
p.(None): Informed consent forms shall be signed by all parties mentioned in paragraph 2.
p.(None): In clinical trials of emergency cases, prior consent of the subject or the subject’s legally representatives could be waived only when
p.(None): the emergency procedures are well described in the protocol. While consent of the subject or the subject's legally acceptable
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.(None): perform one or more of a sponsor's trial-related duties and functions.
p.(None): 10.Investigational Product: A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical
p.(None): trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the
p.(None): approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
p.(None): 11.Protocol: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial.
p.(None): The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced
p.(None): documents.
p.(None): 12.Investigator's Brochure (IB): A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to
p.(None): the study of the investigational product(s) in human subjects.
p.(None): 13.Adverse Drug Reaction (ADR): All noxious and unexpected response to a medicinal product. An adverse drug reaction should be
p.(None): reasonably related to the use of the investigational product(s).
p.(None): 14.Adverse Event (AE): Any untoward medical occurrence in a clinical investigation subject administered an investigational product
p.(None): and which does not necessarily have a causal relationship with the use of the investigational product(s).
p.(None): 15.Blinding/Masking: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-
p.(None): blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor,
p.(None): and, in some cases, data analyst(s) being unaware of the treatment assignment(s).
p.(None):
p.(None): Article 4
p.(None): Clinical trials should be conducted in accordance with the ethical principles of the Declaration of Helsinki.
p.(None): Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual
p.(None): trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks and inconveniences.
p.(None): The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of
p.(None): science and society.
p.(None): The Ethics Committee should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials
p.(None): that may include vulnerable subjects.
p.(None):
p.(None): Article 5
p.(None): The investigator should obtain the informed consent form freely given by the subjects prior to the beginning of the trial.
p.(None): The investigator, or a person designated by the investigator, should fully inform the subject of all pertinent aspects of the trial,
p.(None): including the contents of the informed consent form and the documentations approved by the Ethics Committee. The investigator, or
...
Social / Presence of Coercion
Searching for indicator coerce:
(return to top)
p.(None): his or her legal representative; where the subject is of limited legal capacity, consent should be obtained from his or her legal
p.(None): representative; where the subject who is neither incompetent nor of limited legal capacity, yet is unable to give consent due to
p.(None): insanity or the absence of discernment, the consent could be given by the person legally acceptable for making decisions on behalf of
p.(None): the subject.
p.(None): The person legally acceptable for making decisions on behalf of the subject refers to the subject’s spouse and cohabiting families.
p.(None):
p.(None): Article 6
p.(None): During and following a subject's participation in a trial, the investigator and the institution should ensure that adequate medical care is
p.(None): provided to a subject for any adverse events related to the trial. The investigator should inform a subject when medical care is
p.(None): needed for intercurrent illness(es) of which the investigator becomes aware.
p.(None):
p.(None): Article 7
p.(None): The investigator should inform the subject's primary physician about the subject's participation in the trial if the subject has a primary
p.(None): physician and if the subject agrees to the primary physician being informed.
p.(None):
p.(None): Article 8
p.(None): Neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate in a trial.
p.(None): During the trial, neither the investigator, nor the trial staff, should coerce or unduly influence a subject to continue the trial.
p.(None):
p.(None): Article 9
p.(None): A subject is entitled to withdraw from a clinical trial at any time without giving reason(s).
p.(None): Under the circumstances referred to in the preceding paragraph, the investigator should make a reasonable effort to ascertain the
p.(None): reason(s) while fully respecting the subject's rights and will.
p.(None):
p.(None): Article 10
p.(None): In the aspect of amount and method of payment to subjects, the sponsor should not impose coercion or undue influences on the trial
p.(None): subjects.
p.(None): Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject, except when the
p.(None): payment is a small amount.
p.(None): Information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, should be
p.(None): clearly stated in the written informed consent form and any other written information to be provided to subjects. The way payment will
p.(None): be prorated should be specified.
p.(None):
p.(None): Article 11
p.(None): Identities and records of the subjects that are related to the trial should be kept confidential.
p.(None):
p.(None): Article 12
p.(None): Clinical trials should be scientifically based, and the protocol should be clearly defined and detailed.
p.(None):
p.(None): Article 13
p.(None): No trials shall be conducted without approval from an Ethics Committee.
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.(None): Search SEARCH
p.(None):
p.(None): : Location Home > Law > Article Content
p.(None): P
p.(None):
p.(None): Article Content
p.(None):
p.(None):
p.(None):
p.(None): Title Regulations for Good Clinical Practice CH
p.(None): Amended Date 2014-10-23
p.(None): Category Ministry of Health and Welfare
p.(None):
p.(None):
p.(None): Article Content Chapter Article No Search Content Search Legislative History
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Chapter I General Provisions
p.(None):
p.(None): Article 1
p.(None): This Regulations are enacted pursuant to Paragraph 2, Article 42 of the Pharmaceutical Affairs Act.
p.(None):
p.(None): Article 2
p.(None): The Competent Authority as referred to herein means the Ministry of Health and Welfare.
p.(None):
p.(None): Article 3
p.(None): Terms used in this Regulations are defined as follows:
p.(None): 1.Clinical Trial: Any investigation in human subjects intended to discover or verify the clinical, pharmacological or other
p.(None): pharmaceutical effects of an investigational product(s).
p.(None): 2.Nonclinical Study: Biomedical studies not performed on human subjects.
p.(None): 3.Subject/Trial Subject: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a
p.(None): control.
p.(None): 4.Informed Consent Form: A written documentation signed and dated by a subject who voluntarily confirms his or her willingness to
p.(None): participate in a particular trial, after having been informed and understand all aspects of the trial that are relevant to the subject's
p.(None): decision to participate.
...
Social / education
Searching for indicator education:
(return to top)
p.(None): Under the circumstances referred to in the preceding paragraph, the investigator should make a reasonable effort to ascertain the
p.(None): reason(s) while fully respecting the subject's rights and will.
p.(None):
p.(None): Article 10
p.(None): In the aspect of amount and method of payment to subjects, the sponsor should not impose coercion or undue influences on the trial
p.(None): subjects.
p.(None): Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject, except when the
p.(None): payment is a small amount.
p.(None): Information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, should be
p.(None): clearly stated in the written informed consent form and any other written information to be provided to subjects. The way payment will
p.(None): be prorated should be specified.
p.(None):
p.(None): Article 11
p.(None): Identities and records of the subjects that are related to the trial should be kept confidential.
p.(None):
p.(None): Article 12
p.(None): Clinical trials should be scientifically based, and the protocol should be clearly defined and detailed.
p.(None):
p.(None): Article 13
p.(None): No trials shall be conducted without approval from an Ethics Committee.
p.(None): After reviewing the informed consent form, protocol and all other relevant documents, the Ethics Committee can approve the
p.(None): institution to conduct the clinical trial.
p.(None):
p.(None): Article 14
p.(None): All trial staff should have qualified education, training and working experiences to assume their responsibilities in the trial.
p.(None):
p.(None): Article 15
p.(None): All clinical trial documents should be recorded and retained.
p.(None):
p.(None): Chapter II Protection of Trial Subjects
p.(None):
p.(None): Article 16
p.(None): Prior to the beginning of the trial, the investigator shall obtain the approval from the Ethics Committee for the informed consent form
p.(None): and any other written information to be provided to subjects.
p.(None): The approval referred to in the preceding paragraph should be made in writing.
p.(None):
p.(None): Article 17
p.(None): The informed consent form and any other written information to be provided to subjects should be revised whenever important new
p.(None): information becomes available that may be relevant to the subject’s consent. The subject or the subject’s legally acceptable
p.(None): representative should be informed in a timely manner if new information becomes available.
p.(None): Any revised informed consent form, and written information shall be approved by the Ethics Committee in advance of use; For those
p.(None): clinical trials which are approved by the Competent Authority, the revised documents shall be resubmitted for approval.
p.(None): The communication and approval referred to in preceding paragraph1 and paragraph 2 should be made in writing.
p.(None):
p.(None): Article 18
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.(None): The impartial witness should read the informed consent form and any other written information to be provided to subjects and attests
p.(None): that the information were accurately explained by the investigator or designated person, and were fully understood by the subject or
p.(None): the subject's legally acceptable representative.
p.(None): Under the circumstances referred to in paragraph 1, the subject or the subject’s legally acceptable representative shall still sign and
p.(None): date the informed consent form. Finger print is an acceptable substitute for signature.
p.(None): After finishing the work described in paragraph 2, the impartial witness attests that informed consent was freely given by the subject
p.(None): or the subject’s legally acceptable representative by signing and dating the informed consent form.
p.(None): Trial staff shall not acts as the impartial witness.
p.(None):
p.(None): Article 22
p.(None): The informed consent form and any other written information to be provided to subjects shall include explanations of the following:
p.(None): 1.That the trial involves research.
p.(None): 2.The purpose of the trial.
p.(None): 3.The trial treatment(s) and the probability for random assignment to each treatment.
p.(None): 4.The trial procedures to be followed, including all invasive procedures.
p.(None): 5.The subject's responsibilities.
p.(None): 6.Those aspects of the trial that are experimental.
p.(None): 7.The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant.
p.(None): 8.The reasonably expected benefits.
p.(None): 9.The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits
p.(None): and risks.
p.(None): 10.The compensation and/or treatment available to the subject in the event of trial-related injury.
p.(None): 11.The anticipated prorated payment, if any, to the subject for participating in the trial.
p.(None): 12.The anticipated expenses, if any, to the subject for participating in the trial.
p.(None): 13.That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at
p.(None): any time, without penalty or loss of benefits to which the subject is otherwise entitled.
p.(None): 14.That the monitor(s), the auditor(s), the Ethics Committee, and the Competent Authority will be granted direct access to the
p.(None): subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the
p.(None): subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the
p.(None): subject is authorizing such access.
p.(None): 15.That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations,
p.(None): will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): disease or condition for which the investigational product is intended. Subjects in these trials shall be particularly closely monitored
p.(None): and shall be withdrawn if they appear to be unduly distressed.
p.(None):
p.(None): Chapter III Ethics Committee
p.(None):
p.(None): Article 25
p.(None): For the purpose of clinical trials review, an institution shall establish an Ethics Committee consisting of members, with the
p.(None): qualifications and experiences to review and evaluate the science, medical aspects and ethics of the proposed trial.
p.(None): The Ethics Committee should include at least five members, with at least one member with non-scientific background, and at least
p.(None): one member who is independent of the institution.
p.(None): The Ethics Committee should perform its functions according to written operating procedures, should maintain written records of its
p.(None): activities and minutes of its meetings.
p.(None): The constitution and operation should be in compliance with the regulations stipulated by the Competent Authority.
p.(None):
p.(None): Article 26
p.(None): The Ethics Committee should make its decision in accordance with the regulations specified in the paragraph 4 of the preceding
p.(None): Article.
p.(None):
p.(None): Article 27
p.(None): Members who do not participate in the Ethics Committee review and discussion should not vote or provide their opinion.
p.(None):
p.(None): Article 28
p.(None): The investigator may provide information on any aspect of the trial, but should not participate in the deliberations, decision or vote of
p.(None): the Ethics Committee.
p.(None): The Ethics Committee may invite nonmembers with expertise in special areas for assistance.
p.(None):
p.(None): Article 29
p.(None): The Ethics Committee should retain written procedures, membership lists, lists of occupations/affiliations of members, submitted
p.(None): documents, minutes of meetings, correspondence and any other relevant records for a period of at least 3 years after completion of
p.(None): the trial and make them available upon request from the Competent Authority.
p.(None): The Ethics Committee may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and
p.(None): membership lists. Upon requests, the Ethics Committee shall not reject.
p.(None):
p.(None): Chapter IV Investigator
p.(None):
p.(None): Article 30
p.(None): The investigator(s) shall meet all the qualifications and abilities specified by the Competent Authority, and shall have experiences for
p.(None): the proper conduct of the trial.
p.(None):
p.(None): Article 31
p.(None): The investigator should be thoroughly familiar with the appropriate use of the investigational product(s), as described in the protocol,
p.(None): in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor.
p.(None):
p.(None): Article 32
...
General/Other / Natural Hazards
Searching for indicator hazard:
(return to top)
p.(None):
p.(None): Article 87
p.(None): The Ethics Committee should depend on the degree of risk to human subjects, conduct continuing review of each ongoing trial at
p.(None): appropriate interval.
p.(None): The preceding continuing review shall be conducted at least once a year.
p.(None):
p.(None): Article 88
p.(None): A clinical trial is to be carried out with the consent of the subject’s legally acceptable representative, the Ethics Committee should
p.(None): ensure that the proposed protocol and other document(s) adequately addresses relevant ethical concerns.
p.(None):
p.(None): Chapter VII Conduction of Clinical Trials
p.(None):
p.(None): I. Clinical Trial Protocol
p.(None):
p.(None): Article 89
p.(None): The investigator and the institution should conduct the trial in compliance with the protocol agreed to by the sponsor, by the Ethics
p.(None): Committee and by the Competent Authority. The investigator, the institution and the sponsor should sign the protocol, or an
p.(None): alternative contract, to confirm agreement.
p.(None):
p.(None): Article 90
p.(None): The investigator should not implement any deviation, or changes of the protocol without agreement by the sponsor and prior approval
p.(None): from the Ethics Committee, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s)
p.(None): involves only administrative aspects of the trial.
p.(None): For a deviation, or a change of, the protocol implemented to eliminate an immediate hazard(s) to trial subjects, the investigator should
p.(None): submit the implemented deviation or change, the reasons for it, or the proposed protocol amendment(s) to the Ethics Committee and
p.(None): the sponsor, and to the Competent Authority if the trials are approved by the Competent Authority.
p.(None):
p.(None): Article 91
p.(None): The investigator, or person designated by the investigator, should document and explain any deviation from the protocol.
p.(None):
p.(None): II. Investigational Products
p.(None):
p.(None): Article 92
p.(None): The investigator or the institution should be responsible for the accountability and storage of the investigational product(s).
p.(None): The investigator or the institution may assign some or all of the duties for investigational product(s) accountability and storage at the
p.(None): trial site(s) to designated pharmacists or other appropriate individuals.
p.(None):
p.(None): Article 93
p.(None): The investigator, the institution and the designated pharmacist or other appropriate individual should maintain following records:
p.(None): 1.Records of the product's delivery to the trial site;
p.(None): 2.The inventory at the site;
p.(None): 3.The use of the investigational product(s) by subjects;
p.(None): 4.The return to the sponsor or alternative disposition of unused investigational product(s).
p.(None): The preceding records should include dates, quantities, batch/serial numbers, expiration dates, and the unique code numbers
p.(None): assigned to the investigational product(s) and trial subjects.
p.(None): The investigator should maintain records that document adequately that the subjects were provided the doses specified by the
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None): causes the subject or the subject's legally acceptable representative to waive or to appear to waive any legal rights, or that releases
p.(None): or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence.
p.(None): Statements in contradiction to the rules specified in the preceding paragraph are invalid.
p.(None):
p.(None): Article 19
p.(None): The language used in the oral and written information about the trial, including the informed consent form, should be as non-technical
p.(None): as practical and should be understandable to the subject or the subject's legally acceptable representative and the impartial witness,
p.(None): where applicable.
p.(None):
p.(None): Article 20
p.(None): Prior to a subject’s participation in the trial, the informed consent form shall be signed and personally dated by the subject or by the
p.(None): subject's legally acceptable representative.
p.(None): Before informed consent may be obtained, the investigator, or a person designated by the investigator, should provide the subject or
p.(None): the subject's legally acceptable representative ample time and opportunity to inquire about details of the trial and to decide whether or
p.(None): not to participate in the trial.
p.(None): All questions about the trial should be answered to the satisfaction of the subject or the subject's legally acceptable representative.
p.(None): Informed consent forms shall be signed by all parties mentioned in paragraph 2.
p.(None): In clinical trials of emergency cases, prior consent of the subject or the subject’s legally representatives could be waived only when
p.(None): the emergency procedures are well described in the protocol. While consent of the subject or the subject's legally acceptable
p.(None): representative is possible, the consent shall be obtained immediately.
p.(None):
p.(None): Article 21
p.(None): If the subject or the subject's legally acceptable representative is unable to read, an impartial witness shall be present during the
p.(None): entire informed consent discussion.
p.(None): The impartial witness should read the informed consent form and any other written information to be provided to subjects and attests
p.(None): that the information were accurately explained by the investigator or designated person, and were fully understood by the subject or
p.(None): the subject's legally acceptable representative.
p.(None): Under the circumstances referred to in paragraph 1, the subject or the subject’s legally acceptable representative shall still sign and
p.(None): date the informed consent form. Finger print is an acceptable substitute for signature.
p.(None): After finishing the work described in paragraph 2, the impartial witness attests that informed consent was freely given by the subject
p.(None): or the subject’s legally acceptable representative by signing and dating the informed consent form.
p.(None): Trial staff shall not acts as the impartial witness.
p.(None):
p.(None): Article 22
p.(None): The informed consent form and any other written information to be provided to subjects shall include explanations of the following:
...
p.(None): subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the
p.(None): subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the
p.(None): subject is authorizing such access.
p.(None): 15.That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations,
p.(None): will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential.
p.(None): 16.That the subject or the subject's legally acceptable representative will be informed in a timely manner if information becomes
p.(None): available that may be relevant to the subject's willingness to continue participation in the trial.
p.(None): 17.The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to contact in the event
p.(None): of trial-related injury.
p.(None): 18.The foreseeable circumstances and/or reasons under which the subject's participation in the trial may be terminated.
p.(None): 19.The expected duration of the subject's participation in the trial.
p.(None): 20.The approximate number of subjects involved in the trial.
p.(None):
p.(None): Article 23
p.(None): Prior to participation in the trial, the subject or the subject's legally acceptable representative shall receive a copy of the signed and
p.(None): dated informed consent form and any other written information provided to the subjects. The clinical trials intended for treating
p.(None): emergency cases when prior consent is not possible are exceptional.
p.(None): During a subject’s participation in the trial, the subject or the subject’s legally acceptable representative shall receive a copy of the
p.(None): signed and dated consent form updates and a copy of any amendments to the written information provided to subjects.
p.(None):
p.(None): Article 24
p.(None): The subject’s legally acceptable representative can not represent the subject to provide consent to participate in non-therapeutic
p.(None): trials, except for those non-therapeutic trials with the following conditions are fulfilled:
p.(None): 1.The objectives of the trial can not be met by means of a trial in subjects who can give informed consent personally.
p.(None): 2.The foreseeable risks to the subjects are low.
p.(None): 3.The negative impact on the subject’s well-being is minimized and low.
p.(None): 4.The trial is not prohibited by law.
p.(None): 5.The written approval of the Ethics Committee.
p.(None): Under the exceptional circumstances referred to in the preceding paragraph, those trials shall be conducted in patients having a
p.(None): disease or condition for which the investigational product is intended. Subjects in these trials shall be particularly closely monitored
p.(None): and shall be withdrawn if they appear to be unduly distressed.
p.(None):
p.(None): Chapter III Ethics Committee
p.(None):
p.(None): Article 25
...
p.(None):
p.(None): IV. Management of Investigational Product(s)
p.(None):
p.(None): Article 62
p.(None): When planning trials, the sponsor should ensure that sufficient safety and efficacy data from nonclinical studies and/or clinical trials
p.(None): are available to support human exposure by the route, at the dosages, for the duration, and in the trial population to be studied.
p.(None):
p.(None): Article 63
p.(None): The sponsor should update the Investigator's Brochure as significant new information becomes available.
p.(None):
p.(None): Article 64
p.(None): The characters of the investigational product(s), including active comparator(s) and placebo should be appropriate to the stage of
p.(None): development of the product(s).The manufacturing, handling and storage of the investigational product(s) shall comply with the GMP.
p.(None): The labeling and codes should protect the blinding design.
p.(None):
p.(None): Article 65
p.(None): The sponsor should determine, for the investigational product(s), acceptable storage temperatures, storage conditions, storage times,
p.(None): reconstitution fluids and procedures, and devices for product infusion, and should inform monitors, investigators, pharmacists,
p.(None): storage managers and any other involved parties.
p.(None):
p.(None): Article 66
p.(None): The investigational product(s) should be packaged to prevent contamination and unacceptable deterioration during transport and
p.(None): storage.
p.(None):
p.(None): Article 67
p.(None): In blinded trials, the coding system for the investigational product(s) should include a mechanism that permits rapid identification of
p.(None): the product(s) in case of a medical emergency, but does not permit undetectable breaks of the blinding.
p.(None): Article 68
p.(None): If significant formulation changes are made in the investigational or comparator product(s) during the course of clinical development,
p.(None): studies about whether the new formulated product(s) significantly alter the stability, dissolution rate, bioavailability and other
p.(None): pharmacokinetic profile of the product(s) should be completed prior to the use of the new formulation in clinical trials.
p.(None):
p.(None): Article 69
p.(None): The sponsor should not supply an investigator and an institution with the investigational product(s) before the trial is approved.
p.(None):
p.(None): Article 70
p.(None): The sponsor should ensure that written procedures include:
p.(None): 1.The instructions that the investigator and the institution should follow for the handling and storage of investigational product(s).
p.(None): 2.Procedures about handling, storage, dispensing, retrieval of unused product from subjects, and return of unused investigational
p.(None): product(s) to the sponsor.
p.(None):
p.(None): Article 71
p.(None): In the aspect of the handling of investigational product(s), the sponsor should:
p.(None): 1.Ensure timely delivery of investigational product(s) to the investigator(s).
p.(None): 2.Maintain records that document shipment, receipt, disposition, return, and destruction of the investigational product(s).
p.(None): 3.Follow and maintain a system for retrieving investigational products and documenting this retrieval.
p.(None): 4.Follow and maintain a system for the disposition of unused investigational product(s) and for the documentation of this disposition.
p.(None): 5.Ensure that the investigational product(s) are stable over the period of use.
p.(None): 6.Maintain sufficient quantities of the investigational product(s) used in the trials to reconfirm specifications if necessary.
...
General/Other / Relationship to Authority
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p.(None): Search SEARCH
p.(None):
p.(None): : Location Home > Law > Article Content
p.(None): P
p.(None):
p.(None): Article Content
p.(None):
p.(None):
p.(None):
p.(None): Title Regulations for Good Clinical Practice CH
p.(None): Amended Date 2014-10-23
p.(None): Category Ministry of Health and Welfare
p.(None):
p.(None):
p.(None): Article Content Chapter Article No Search Content Search Legislative History
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Chapter I General Provisions
p.(None):
p.(None): Article 1
p.(None): This Regulations are enacted pursuant to Paragraph 2, Article 42 of the Pharmaceutical Affairs Act.
p.(None):
p.(None): Article 2
p.(None): The Competent Authority as referred to herein means the Ministry of Health and Welfare.
p.(None):
p.(None): Article 3
p.(None): Terms used in this Regulations are defined as follows:
p.(None): 1.Clinical Trial: Any investigation in human subjects intended to discover or verify the clinical, pharmacological or other
p.(None): pharmaceutical effects of an investigational product(s).
p.(None): 2.Nonclinical Study: Biomedical studies not performed on human subjects.
p.(None): 3.Subject/Trial Subject: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a
p.(None): control.
p.(None): 4.Informed Consent Form: A written documentation signed and dated by a subject who voluntarily confirms his or her willingness to
p.(None): participate in a particular trial, after having been informed and understand all aspects of the trial that are relevant to the subject's
p.(None): decision to participate.
p.(None): 5.Ethics Committee/ Institutional Review Board (IRB): An independent committee constituted of medical professionals and impartial
p.(None): persons with no medical professions, whose responsibility is to ensure the protection of the rights, safety and well-being of human
p.(None): subjects involved in a trial.
p.(None): 6.Institution/Trial Site: A medical institution where clinical trials are conducted.
p.(None): 7.Investigator: A person responsible for the conduct of the clinical trial at a trial site.
p.(None): 8.Sponsor: An individual, company, institution, or organization which takes responsibility for the initiation and management of a
p.(None): clinical trial.
...
p.(None): institution to conduct the clinical trial.
p.(None):
p.(None): Article 14
p.(None): All trial staff should have qualified education, training and working experiences to assume their responsibilities in the trial.
p.(None):
p.(None): Article 15
p.(None): All clinical trial documents should be recorded and retained.
p.(None):
p.(None): Chapter II Protection of Trial Subjects
p.(None):
p.(None): Article 16
p.(None): Prior to the beginning of the trial, the investigator shall obtain the approval from the Ethics Committee for the informed consent form
p.(None): and any other written information to be provided to subjects.
p.(None): The approval referred to in the preceding paragraph should be made in writing.
p.(None):
p.(None): Article 17
p.(None): The informed consent form and any other written information to be provided to subjects should be revised whenever important new
p.(None): information becomes available that may be relevant to the subject’s consent. The subject or the subject’s legally acceptable
p.(None): representative should be informed in a timely manner if new information becomes available.
p.(None): Any revised informed consent form, and written information shall be approved by the Ethics Committee in advance of use; For those
p.(None): clinical trials which are approved by the Competent Authority, the revised documents shall be resubmitted for approval.
p.(None): The communication and approval referred to in preceding paragraph1 and paragraph 2 should be made in writing.
p.(None):
p.(None): Article 18
p.(None): None of the informed consent form and any other written information to be provided to subjects shall contain any language that
p.(None): causes the subject or the subject's legally acceptable representative to waive or to appear to waive any legal rights, or that releases
p.(None): or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence.
p.(None): Statements in contradiction to the rules specified in the preceding paragraph are invalid.
p.(None):
p.(None): Article 19
p.(None): The language used in the oral and written information about the trial, including the informed consent form, should be as non-technical
p.(None): as practical and should be understandable to the subject or the subject's legally acceptable representative and the impartial witness,
p.(None): where applicable.
p.(None):
p.(None): Article 20
p.(None): Prior to a subject’s participation in the trial, the informed consent form shall be signed and personally dated by the subject or by the
p.(None): subject's legally acceptable representative.
p.(None): Before informed consent may be obtained, the investigator, or a person designated by the investigator, should provide the subject or
p.(None): the subject's legally acceptable representative ample time and opportunity to inquire about details of the trial and to decide whether or
...
p.(None): Trial staff shall not acts as the impartial witness.
p.(None):
p.(None): Article 22
p.(None): The informed consent form and any other written information to be provided to subjects shall include explanations of the following:
p.(None): 1.That the trial involves research.
p.(None): 2.The purpose of the trial.
p.(None): 3.The trial treatment(s) and the probability for random assignment to each treatment.
p.(None): 4.The trial procedures to be followed, including all invasive procedures.
p.(None): 5.The subject's responsibilities.
p.(None): 6.Those aspects of the trial that are experimental.
p.(None): 7.The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant.
p.(None): 8.The reasonably expected benefits.
p.(None): 9.The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits
p.(None): and risks.
p.(None): 10.The compensation and/or treatment available to the subject in the event of trial-related injury.
p.(None): 11.The anticipated prorated payment, if any, to the subject for participating in the trial.
p.(None): 12.The anticipated expenses, if any, to the subject for participating in the trial.
p.(None): 13.That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at
p.(None): any time, without penalty or loss of benefits to which the subject is otherwise entitled.
p.(None): 14.That the monitor(s), the auditor(s), the Ethics Committee, and the Competent Authority will be granted direct access to the
p.(None): subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the
p.(None): subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the
p.(None): subject is authorizing such access.
p.(None): 15.That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations,
p.(None): will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential.
p.(None): 16.That the subject or the subject's legally acceptable representative will be informed in a timely manner if information becomes
p.(None): available that may be relevant to the subject's willingness to continue participation in the trial.
p.(None): 17.The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to contact in the event
p.(None): of trial-related injury.
p.(None): 18.The foreseeable circumstances and/or reasons under which the subject's participation in the trial may be terminated.
p.(None): 19.The expected duration of the subject's participation in the trial.
p.(None): 20.The approximate number of subjects involved in the trial.
p.(None):
p.(None): Article 23
p.(None): Prior to participation in the trial, the subject or the subject's legally acceptable representative shall receive a copy of the signed and
p.(None): dated informed consent form and any other written information provided to the subjects. The clinical trials intended for treating
...
p.(None): 2.The foreseeable risks to the subjects are low.
p.(None): 3.The negative impact on the subject’s well-being is minimized and low.
p.(None): 4.The trial is not prohibited by law.
p.(None): 5.The written approval of the Ethics Committee.
p.(None): Under the exceptional circumstances referred to in the preceding paragraph, those trials shall be conducted in patients having a
p.(None): disease or condition for which the investigational product is intended. Subjects in these trials shall be particularly closely monitored
p.(None): and shall be withdrawn if they appear to be unduly distressed.
p.(None):
p.(None): Chapter III Ethics Committee
p.(None):
p.(None): Article 25
p.(None): For the purpose of clinical trials review, an institution shall establish an Ethics Committee consisting of members, with the
p.(None): qualifications and experiences to review and evaluate the science, medical aspects and ethics of the proposed trial.
p.(None): The Ethics Committee should include at least five members, with at least one member with non-scientific background, and at least
p.(None): one member who is independent of the institution.
p.(None): The Ethics Committee should perform its functions according to written operating procedures, should maintain written records of its
p.(None): activities and minutes of its meetings.
p.(None): The constitution and operation should be in compliance with the regulations stipulated by the Competent Authority.
p.(None):
p.(None): Article 26
p.(None): The Ethics Committee should make its decision in accordance with the regulations specified in the paragraph 4 of the preceding
p.(None): Article.
p.(None):
p.(None): Article 27
p.(None): Members who do not participate in the Ethics Committee review and discussion should not vote or provide their opinion.
p.(None):
p.(None): Article 28
p.(None): The investigator may provide information on any aspect of the trial, but should not participate in the deliberations, decision or vote of
p.(None): the Ethics Committee.
p.(None): The Ethics Committee may invite nonmembers with expertise in special areas for assistance.
p.(None):
p.(None): Article 29
p.(None): The Ethics Committee should retain written procedures, membership lists, lists of occupations/affiliations of members, submitted
p.(None): documents, minutes of meetings, correspondence and any other relevant records for a period of at least 3 years after completion of
p.(None): the trial and make them available upon request from the Competent Authority.
p.(None): The Ethics Committee may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and
p.(None): membership lists. Upon requests, the Ethics Committee shall not reject.
p.(None):
p.(None): Chapter IV Investigator
p.(None):
p.(None): Article 30
p.(None): The investigator(s) shall meet all the qualifications and abilities specified by the Competent Authority, and shall have experiences for
p.(None): the proper conduct of the trial.
p.(None):
p.(None): Article 31
p.(None): The investigator should be thoroughly familiar with the appropriate use of the investigational product(s), as described in the protocol,
p.(None): in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor.
p.(None):
p.(None): Article 32
p.(None): The investigator shall be aware of, and shall comply with, this Regulations and the applicable regulatory requirements.
p.(None):
p.(None): Article 33
p.(None): The investigator and the institution shall permit monitoring and auditing by the sponsor, and inspection by the Competent Authority or
p.(None): the delegated agencies.
p.(None):
p.(None): Article 34
p.(None): The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-
p.(None): related duties.
p.(None):
p.(None): Article 35
p.(None): The investigator should be able to demonstrate a potential for recruiting the required number of suitable subjects within the agreed
p.(None): recruitment period.
p.(None):
p.(None): Article 36
p.(None): The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period.
p.(None):
p.(None): Article 37
p.(None): The investigator should have available an adequate number of qualified staff and adequate facilities to conduct the trial properly and
p.(None): safely.
p.(None):
p.(None): Article 38
p.(None): The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational
p.(None): product(s), and their trial-related duties and functions.
p.(None):
p.(None): Article 39
p.(None): If the protocol and Investigator's Brochure are updated during the trial, the investigator and the institution shall supply a copy of the
p.(None): updated ones to the Ethics Committee.
p.(None):
p.(None): Chapter V Sponsor
p.(None):
p.(None): I. General Rules
p.(None):
p.(None): Article 40
p.(None): The sponsor is responsible for selecting the investigator(s).
p.(None):
p.(None): Article 41
p.(None): Before entering an agreement with an investigator and an institution to conduct a trial, the sponsor should provide the investigator(s)
p.(None): and the institution(s) with the protocol and an up-to-date Investigator's Brochure, and should provide sufficient time for the
p.(None): investigator to review the protocol and the information provided.
p.(None):
...
p.(None): medical questions or problems. If necessary, outside consultant(s) may be appointed for this purpose.
p.(None):
p.(None): Article 46
p.(None): Prior to initiating a trial, the sponsor should define, establish, and allocate all trial-related duties and functions.
p.(None):
p.(None): Article 47
p.(None): The sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator and the institution against
p.(None): claims arising from the trial, except for claims that arise from malpractice and/or negligence.
p.(None):
p.(None): Article 48
p.(None): When the investigator, the institution or any trial staff fails to comply with the protocol or this Regulations, the sponsor should adopt
p.(None): immediate measures to ensure the compliance.
p.(None): While the investigator or the institution does not adopt the measures referred to in the preceding paragraph, the sponsor should take
p.(None): action in accordance with Article 116.
p.(None):
p.(None): II. Quality Assurance and Quality Control
p.(None):
p.(None): Article 49
p.(None): The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to
p.(None): ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, this
p.(None): Regulations, and the applicable regulatory requirement(s).
p.(None):
p.(None): Article 50
p.(None): The sponsor is responsible for securing agreement from all involved parties to ensure direct access to all trial related sites, source
p.(None): data/ documents, and reports for the purpose of monitoring and auditing by the sponsor, and inspection by the Competent Authority.
p.(None):
p.(None): Article 51
p.(None): Agreements, made by the sponsor with the investigator, the institution and any other parties involved with the clinical trial, should be
p.(None): in writing, as part of the protocol or in a separate agreement.
p.(None):
p.(None): Article 52
p.(None): The sponsor should utilize appropriately qualified individual to design the protocol, produce case report forms (CRFs), plan the
p.(None): analysis, and prepare interim and final clinical trial reports.
p.(None):
p.(None): III. Data Handling and Record Keeping
p.(None):
p.(None): Article 53
p.(None): Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed
p.(None): correctly.
p.(None):
p.(None): Article 54
p.(None): The sponsor should utilize appropriately qualified individuals to be responsible for the following work:
p.(None): 1.to supervise the overall conduct of the trial,
p.(None): 2.to handle the data and to verify the data,
p.(None): 3.to conduct the statistical analyses, and to prepare the trial reports.
p.(None):
p.(None): Article 55
p.(None): When using electronic trial data handling or remote electronic trial data systems, the sponsor should:
p.(None): 1.Ensure and document that the electronic data processing system(s) conforms to the sponsor’s established requirements for
p.(None): completeness, accuracy, reliability, and consistent intended performance (i.e. validation).
p.(None): 2.Follow and maintain SOPs for using these systems.
p.(None): 3.Ensure that the systems are designed to permit data changes in such a way that the data changes are documented and that there
p.(None): is no deletion of entered data (i.e. maintain an audit trail, data trail, edit trail).
p.(None): 4.Maintain a security system that prevents unauthorized access to the data.
p.(None): 5.Maintain a list of the individuals who are authorized to make data changes.
p.(None): 6.Maintain adequate backup of the data.
p.(None): 7.Safeguard the blinding.
p.(None):
p.(None): Article 56
p.(None): If data are transformed during processing, it should always be possible to compare the original data and observations with the
p.(None): processed data.
p.(None):
p.(None): Article 57
p.(None): The sponsor should use an unambiguous subject identification code that allows identification of all the data reported for each subject.
p.(None):
p.(None): Article 58
p.(None): The sponsor, or other owners of the data, shall retain all of the sponsor-specific essential documents pertaining to the trial for at least
p.(None): 2 years after approval of the marketing application of the investigational product(s) in Taiwan. However, these documents shall be
p.(None): retained for a longer period if required by other applicable regulatory requirements.
p.(None):
p.(None): Article 59
p.(None): If the sponsor discontinues the clinical development of an investigational product, the sponsor should notify all the trial investigators,
p.(None): institutions and the Competent Authority.
p.(None): Under the preceding circumstance, the sponsor shall maintain all sponsor-specific essential documents for at least 2 years after
p.(None): formal discontinuation. However, these documents shall be retained for a longer period if required by other applicable regulatory
p.(None): requirements.
p.(None):
p.(None): Article 60
p.(None): Any transfer of ownership of the data shall be reported to the Competent Authority.
p.(None):
p.(None): Article 61
p.(None): The sponsor should inform the investigator(s) and the institution(s) in writing of the need for record retention. When the trial related
p.(None): records are no longer needed, the sponsor should notify the investigator(s) and the institution(s) in writing.
p.(None):
p.(None): IV. Management of Investigational Product(s)
p.(None):
p.(None): Article 62
p.(None): When planning trials, the sponsor should ensure that sufficient safety and efficacy data from nonclinical studies and/or clinical trials
p.(None): are available to support human exposure by the route, at the dosages, for the duration, and in the trial population to be studied.
p.(None):
p.(None): Article 63
p.(None): The sponsor should update the Investigator's Brochure as significant new information becomes available.
p.(None):
p.(None): Article 64
p.(None): The characters of the investigational product(s), including active comparator(s) and placebo should be appropriate to the stage of
p.(None): development of the product(s).The manufacturing, handling and storage of the investigational product(s) shall comply with the GMP.
p.(None): The labeling and codes should protect the blinding design.
p.(None):
p.(None): Article 65
p.(None): The sponsor should determine, for the investigational product(s), acceptable storage temperatures, storage conditions, storage times,
p.(None): reconstitution fluids and procedures, and devices for product infusion, and should inform monitors, investigators, pharmacists,
p.(None): storage managers and any other involved parties.
p.(None):
p.(None): Article 66
p.(None): The investigational product(s) should be packaged to prevent contamination and unacceptable deterioration during transport and
p.(None): storage.
p.(None):
p.(None): Article 67
...
p.(None): findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken and actions recommended to secure compliance.
p.(None): 4.The sponsor should designate representatives to record, review and follow-up of the monitoring report.
p.(None):
p.(None): VI. Audit
p.(None):
p.(None): Article 80
p.(None): A sponsor's audit should be independent of and separate from routine monitoring or quality control functions. The purpose of auditing
p.(None): is to evaluate trial conduct and compliance with the protocol, SOPs, this Regulations, and the applicable regulatory requirements.
p.(None):
p.(None): Article 81
p.(None): Selection and qualification of auditors should comply with:
p.(None): 1.The sponsor should appoint individuals, who are independent of the clinical trials and data capture systems, to conduct audits.
p.(None): 2.The sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly. An auditor’s
p.(None): qualifications should be documented.
p.(None):
p.(None): Article 82
p.(None): The auditing procedures should comply with:
p.(None): 1.The auditing procedures is conducted in accordance with the sponsor's written procedures on what to audit, how to audit, the
p.(None): frequency of audits, and the form and content of audit reports.
p.(None): 2.The sponsor's audit plan and procedures for a trial audit should be guided by the importance of the trial, the number of subjects in
p.(None): the trial, the type and complexity of the trial, the level of risks to the trial subjects, and any identified problem(s).
p.(None): 3.The observations and findings of the auditor(s) should be documented in writing.
p.(None): 4.To preserve the independence and value of the audit function, the Competent Authority should not routinely request the audit
p.(None): reports, except when evidence of serious non-compliance with this Regulations exists, or in the course of legal proceedings, the
p.(None): Competent Authority may seek access to an audit report on a case by case basis.
p.(None): 5.The sponsor should provide an audit certificate.
p.(None):
p.(None): Chapter VI Application and Assessment of Clinical Trials
p.(None):
p.(None): Article 83
p.(None): For applying for a clinical trial approval, an application form and the following documents are needed to submit:
p.(None): 1.Protocol;
p.(None): 2.Informed Consent From;
p.(None): 3.Advertisement on subject recruitment or any other documents regarding the recruitment procedures;
p.(None): 4.All written information to be provided to subjects;
p.(None): 5.Investigator’s Brochure;
p.(None): 6.Currently available safety data on the investigational product(s);
p.(None): 7.Descriptions of the payments and compensations to trials subjects;
p.(None): 8.The investigator’s current curriculum vitae or any other documents supported his/her qualifications;
p.(None): 9.Other essential documents specified by the Ethics Committee.
p.(None):
p.(None): Article 84
p.(None): The Ethics Committee shall review a proposed clinical trial within one month and make a decision for one of the four review results:
p.(None): 1.Approval;
p.(None): 2.Reassessment after modification;
p.(None): 3.Disapproval;
p.(None): 4.Termination or suspension of any prior approval trials.
p.(None):
p.(None): Article 85
p.(None): The review decision should be made in writing and include the following contents:
p.(None): 1.The title of the trial;
p.(None): 2.The institution and the investigator;
p.(None): 3.The reviewed documents and the version numbers;
p.(None): 4.The review results and reasons;
p.(None): 5.Year, Month and date.
p.(None):
p.(None): Article 86
p.(None): The Ethics Committee should review the qualifications, curriculum vitae and any other relevant documentation of the investigator.
p.(None):
p.(None): Article 87
p.(None): The Ethics Committee should depend on the degree of risk to human subjects, conduct continuing review of each ongoing trial at
p.(None): appropriate interval.
p.(None): The preceding continuing review shall be conducted at least once a year.
p.(None):
p.(None): Article 88
p.(None): A clinical trial is to be carried out with the consent of the subject’s legally acceptable representative, the Ethics Committee should
p.(None): ensure that the proposed protocol and other document(s) adequately addresses relevant ethical concerns.
p.(None):
p.(None): Chapter VII Conduction of Clinical Trials
p.(None):
p.(None): I. Clinical Trial Protocol
p.(None):
p.(None): Article 89
p.(None): The investigator and the institution should conduct the trial in compliance with the protocol agreed to by the sponsor, by the Ethics
p.(None): Committee and by the Competent Authority. The investigator, the institution and the sponsor should sign the protocol, or an
p.(None): alternative contract, to confirm agreement.
p.(None):
p.(None): Article 90
p.(None): The investigator should not implement any deviation, or changes of the protocol without agreement by the sponsor and prior approval
p.(None): from the Ethics Committee, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s)
p.(None): involves only administrative aspects of the trial.
p.(None): For a deviation, or a change of, the protocol implemented to eliminate an immediate hazard(s) to trial subjects, the investigator should
p.(None): submit the implemented deviation or change, the reasons for it, or the proposed protocol amendment(s) to the Ethics Committee and
p.(None): the sponsor, and to the Competent Authority if the trials are approved by the Competent Authority.
p.(None):
p.(None): Article 91
p.(None): The investigator, or person designated by the investigator, should document and explain any deviation from the protocol.
p.(None):
p.(None): II. Investigational Products
p.(None):
p.(None): Article 92
p.(None): The investigator or the institution should be responsible for the accountability and storage of the investigational product(s).
p.(None): The investigator or the institution may assign some or all of the duties for investigational product(s) accountability and storage at the
p.(None): trial site(s) to designated pharmacists or other appropriate individuals.
p.(None):
p.(None): Article 93
p.(None): The investigator, the institution and the designated pharmacist or other appropriate individual should maintain following records:
p.(None): 1.Records of the product's delivery to the trial site;
p.(None): 2.The inventory at the site;
p.(None): 3.The use of the investigational product(s) by subjects;
p.(None): 4.The return to the sponsor or alternative disposition of unused investigational product(s).
p.(None): The preceding records should include dates, quantities, batch/serial numbers, expiration dates, and the unique code numbers
p.(None): assigned to the investigational product(s) and trial subjects.
p.(None): The investigator should maintain records that document adequately that the subjects were provided the doses specified by the
p.(None): protocol and reconcile all investigational product(s) received from the sponsor.
p.(None):
p.(None): Article 94
p.(None): The investigational product(s) should be stored as specified by the sponsor and in accordance with applicable regulatory
p.(None): requirement(s).
p.(None): Article 95
p.(None): The investigational product(s) should be used only in the approved protocol.
p.(None):
p.(None): Article 96
...
p.(None):
p.(None): III. Records and Reports
p.(None):
p.(None): Article 98
p.(None): The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs
p.(None): and in all required reports.
p.(None):
p.(None): Article 99
p.(None): Data reported on the CRF should be consistent with the source documents. The discrepancies should be explained.
p.(None):
p.(None): Article 100
p.(None): Any change or correction to a CRF should be dated, initialed, and explained and should not obscure the original entry.
p.(None): The preceding regulation applies to both written and electronic changes or corrections.
p.(None): The investigator should designate a person to document changes or corrections in CRF. All changes or corrections should be
p.(None): endorsed by the investigator.
p.(None): The investigator should retain records of the changes and corrections.
p.(None):
p.(None): Article 101
p.(None): The investigator and the institution should pay sufficient attention to properly maintain all the important trial documents, and take
p.(None): measures to prevent accidental or premature destruction of these documents.
p.(None): The documents referred to in the preceding paragraph shall be retained until at least 2 years after approval of the marketing
p.(None): application of the investigational product(s) in Taiwan. However, these documents shall be retained for a longer period if required by
p.(None): other applicable regulatory requirements.
p.(None):
p.(None): Article 102
p.(None): The financial aspects of the trial should be documented in an agreement between the sponsor and the institution or the investigator.
p.(None):
p.(None): Article 103
p.(None): The monitor, auditor, the Ethics Committee, or the Competent Authority, can request for direct access to all trial-related records.
p.(None): However, prior to access to the subject’s personal identity information, confirmation of the subject’s written consent is required.
p.(None):
p.(None): Article 104
p.(None): The Competent Authority may request the investigator to submit written reports to the institution, elaborating the trial status.
p.(None): The investigator and the institution should submit written summaries of the trial status to the Ethics Committee annually. If necessary,
p.(None): the Ethics Committee may request to shorten the interval of the routine reports.
p.(None):
p.(None): Article 105
p.(None): The investigator shall promptly provide written reports to the sponsor, the Ethics Committee and the Competent Authority on any
p.(None): situation significantly affecting the conduct of the trial, and/or increasing the risk to subjects.
p.(None):
p.(None): Article 106
p.(None): The investigator shall immediately report any serious adverse events to the sponsor, and shall provide detailed, written reports as
p.(None): soon as possible. The investigator shall immediately report any suspected unexpected serious adverse drug reactions to the Ethics
p.(None): Committee. However, those SAEs that the protocol or other document identifies as not needing immediate reporting shall not apply.
p.(None): The sponsor shall report any suspected unexpected serious adverse reactions that are fatal or life-threatening to the Competent
p.(None): Authority or the contracted organization within 7 days after being aware of the event, and shall provide detailed written documents
p.(None): within 15 days after being aware of the event.
p.(None): The sponsor shall report all the other suspected unexpected serious adverse reactions to the Competent Authority or the contracted
p.(None): organization and provide detailed written documents within 15 days after being aware of the event.
p.(None): The subjects’ identity should be coded in the oral and written reports mentioned in paragraph 1 that should not reveal subjects’
p.(None): names, ID numbers, addresses, or any other information which may reveal subject’s personal identity.
p.(None): The serious adverse events and serious adverse drug reactions are defined and announced by the Competent Authority.
p.(None):
p.(None): Article 107
p.(None): When adverse events or laboratory abnormalities are identified as critical to safety evaluations, the investigator should report to the
p.(None): sponsor within the time periods specified by the sponsor in the protocol.
p.(None):
p.(None): Article 108
p.(None): For reported deaths, the sponsor, the Ethics Committee, and the Competent Authority may request the investigator to provide
p.(None): autopsy reports, terminal medical reports and any additional information.
p.(None):
p.(None): Article 109
p.(None): The sponsor shall promptly notify all investigator(s), institution(s) and the Competent Authority for any of the following situations:
p.(None): 1.New findings that could affect adversely the safety of subjects.
p.(None): 2.New findings that impact the conduct of the trial.
p.(None): 3.New findings that alter the Ethics Committee's approval to continue the trial.
p.(None):
p.(None): Article 110
p.(None): The sponsor shall submit the latest safety reports to the Competent Authority.
p.(None):
p.(None): Article 111
p.(None): Upon the trial is completed or prematurely terminated, the investigator and the institution shall provide the sponsor and the
p.(None): Competent Authority with any reports required, and provide the Ethics Committee with a summary of the trial’s outcome.
p.(None): Under the circumstances referred to in the preceding paragraph, the sponsor shall provide the Competent Authority with a complete
p.(None): and detailed clinical trial report.
p.(None): The format of the clinical trial reports referred to in the preceding paragraph is announced by the Competent Authority.
p.(None):
p.(None): IV. Suspension and Termination of a Trial
p.(None):
p.(None): Article 112
p.(None): If the trial is suspended or terminated, the investigator and the institution shall promptly inform the trial subjects, should assure
p.(None): appropriate therapy and follow-up for the subjects.
p.(None): Under the circumstances referred to in the preceding paragraph, the investigator and the institution shall inform the Competent
p.(None): Authority of the reasons for suspension or termination of the trial in writing.
p.(None):
p.(None): Article 113
p.(None): If the investigator suspended or terminated a trial without prior agreement of the sponsor, the investigator and the institution shall
p.(None): promptly inform the sponsor and the Ethics Committee, and provide detailed written reports.
p.(None):
p.(None): Article 114
p.(None): If the sponsor suspended or terminated a trial, the sponsor shall promptly inform the investigators, the institutions, the Ethics
p.(None): Committee, and the Competent Authority and the reason(s) for the termination or suspension, and provide detailed written reports.
p.(None):
p.(None): Article 115
p.(None): If the Ethics Committee terminated or suspended a trial, the investigator and the institution shall promptly inform the sponsor, and
p.(None): provide the detailed written reports.
p.(None):
p.(None): Article 116
p.(None): If the investigator or the institution seriously or repeatedly violates the protocol, the sponsor should stop the investigator or the
p.(None): institution from conducting the trial and promptly notify the Competent Authority.
p.(None):
p.(None): V. Multicenter Trials
p.(None): Article 117
p.(None): When conducting a multicenter trial, all investigators should conduct the trial in compliance with the protocol agreed to by the sponsor
p.(None): and approved by the Competent Authority, and by the Ethics Committee.
p.(None):
p.(None): Article 118
p.(None): When conducting a multicenter trial, for those investigators who are collecting additional data according to the protocol, the sponsor
p.(None): should provide supplemental CRFs that are designed to capture the additional data.
p.(None):
p.(None): Article 119
p.(None): The coordination approaches and responsibilities of the investigator(s) and the other participating investigators should be
p.(None): documented in writing prior to the start of a multicenter trial.
p.(None):
p.(None): Article 120
p.(None): When conducting a multicenter trial, all investigators should comply with a uniform set of standards for the assessment of clinical and
p.(None): laboratory findings, and on completing the CRFs.
p.(None):
p.(None): Article 121
p.(None): When conducting a multicenter trial, the sponsor should facilitate communication between all investigators.
p.(None):
p.(None): Chapter VIII Supplemental Provisions
p.(None):
p.(None): Article 122
p.(None): For clinical trials initiated in accordance with the original Guideline for Good Clinical Practice prior to the implementation of this
p.(None): Regulations, this Regulations shall be applied after taking effect.
p.(None):
p.(None): Article 123
p.(None): This Regulations shall take effect immediately upon the date of promulgation hereof.
p.(None):
p.(None):
p.(None): NOTE
p.(None): This English version of the Regulations for Good Clinical Practice is provided for reference purposes only. In the event of any
p.(None): inconsistency between the Chinese original and the English translation, the former shall prevail.
p.(None):
p.(None):
p.(None):
p.(None): News Law Convention
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.(None): pharmaceutical effects of an investigational product(s).
p.(None): 2.Nonclinical Study: Biomedical studies not performed on human subjects.
p.(None): 3.Subject/Trial Subject: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a
p.(None): control.
p.(None): 4.Informed Consent Form: A written documentation signed and dated by a subject who voluntarily confirms his or her willingness to
p.(None): participate in a particular trial, after having been informed and understand all aspects of the trial that are relevant to the subject's
p.(None): decision to participate.
p.(None): 5.Ethics Committee/ Institutional Review Board (IRB): An independent committee constituted of medical professionals and impartial
p.(None): persons with no medical professions, whose responsibility is to ensure the protection of the rights, safety and well-being of human
p.(None): subjects involved in a trial.
p.(None): 6.Institution/Trial Site: A medical institution where clinical trials are conducted.
p.(None): 7.Investigator: A person responsible for the conduct of the clinical trial at a trial site.
p.(None): 8.Sponsor: An individual, company, institution, or organization which takes responsibility for the initiation and management of a
p.(None): clinical trial.
p.(None): 9.Contract Research Organization (CRO): A person or an organization (commercial, academic, or other) contracted by the sponsor to
p.(None): perform one or more of a sponsor's trial-related duties and functions.
p.(None): 10.Investigational Product: A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical
p.(None): trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the
p.(None): approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
p.(None): 11.Protocol: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial.
p.(None): The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced
p.(None): documents.
p.(None): 12.Investigator's Brochure (IB): A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to
p.(None): the study of the investigational product(s) in human subjects.
p.(None): 13.Adverse Drug Reaction (ADR): All noxious and unexpected response to a medicinal product. An adverse drug reaction should be
p.(None): reasonably related to the use of the investigational product(s).
p.(None): 14.Adverse Event (AE): Any untoward medical occurrence in a clinical investigation subject administered an investigational product
p.(None): and which does not necessarily have a causal relationship with the use of the investigational product(s).
p.(None): 15.Blinding/Masking: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-
p.(None): blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor,
p.(None): and, in some cases, data analyst(s) being unaware of the treatment assignment(s).
p.(None):
p.(None): Article 4
...
p.(None): retained for a longer period if required by other applicable regulatory requirements.
p.(None):
p.(None): Article 59
p.(None): If the sponsor discontinues the clinical development of an investigational product, the sponsor should notify all the trial investigators,
p.(None): institutions and the Competent Authority.
p.(None): Under the preceding circumstance, the sponsor shall maintain all sponsor-specific essential documents for at least 2 years after
p.(None): formal discontinuation. However, these documents shall be retained for a longer period if required by other applicable regulatory
p.(None): requirements.
p.(None):
p.(None): Article 60
p.(None): Any transfer of ownership of the data shall be reported to the Competent Authority.
p.(None):
p.(None): Article 61
p.(None): The sponsor should inform the investigator(s) and the institution(s) in writing of the need for record retention. When the trial related
p.(None): records are no longer needed, the sponsor should notify the investigator(s) and the institution(s) in writing.
p.(None):
p.(None): IV. Management of Investigational Product(s)
p.(None):
p.(None): Article 62
p.(None): When planning trials, the sponsor should ensure that sufficient safety and efficacy data from nonclinical studies and/or clinical trials
p.(None): are available to support human exposure by the route, at the dosages, for the duration, and in the trial population to be studied.
p.(None):
p.(None): Article 63
p.(None): The sponsor should update the Investigator's Brochure as significant new information becomes available.
p.(None):
p.(None): Article 64
p.(None): The characters of the investigational product(s), including active comparator(s) and placebo should be appropriate to the stage of
p.(None): development of the product(s).The manufacturing, handling and storage of the investigational product(s) shall comply with the GMP.
p.(None): The labeling and codes should protect the blinding design.
p.(None):
p.(None): Article 65
p.(None): The sponsor should determine, for the investigational product(s), acceptable storage temperatures, storage conditions, storage times,
p.(None): reconstitution fluids and procedures, and devices for product infusion, and should inform monitors, investigators, pharmacists,
p.(None): storage managers and any other involved parties.
p.(None):
p.(None): Article 66
p.(None): The investigational product(s) should be packaged to prevent contamination and unacceptable deterioration during transport and
p.(None): storage.
p.(None):
p.(None): Article 67
p.(None): In blinded trials, the coding system for the investigational product(s) should include a mechanism that permits rapid identification of
p.(None): the product(s) in case of a medical emergency, but does not permit undetectable breaks of the blinding.
p.(None): Article 68
p.(None): If significant formulation changes are made in the investigational or comparator product(s) during the course of clinical development,
p.(None): studies about whether the new formulated product(s) significantly alter the stability, dissolution rate, bioavailability and other
p.(None): pharmacokinetic profile of the product(s) should be completed prior to the use of the new formulation in clinical trials.
p.(None):
p.(None): Article 69
p.(None): The sponsor should not supply an investigator and an institution with the investigational product(s) before the trial is approved.
p.(None):
p.(None): Article 70
p.(None): The sponsor should ensure that written procedures include:
...
Orphaned Trigger Words
p.(None): recruitment period.
p.(None):
p.(None): Article 36
p.(None): The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period.
p.(None):
p.(None): Article 37
p.(None): The investigator should have available an adequate number of qualified staff and adequate facilities to conduct the trial properly and
p.(None): safely.
p.(None):
p.(None): Article 38
p.(None): The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational
p.(None): product(s), and their trial-related duties and functions.
p.(None):
p.(None): Article 39
p.(None): If the protocol and Investigator's Brochure are updated during the trial, the investigator and the institution shall supply a copy of the
p.(None): updated ones to the Ethics Committee.
p.(None):
p.(None): Chapter V Sponsor
p.(None):
p.(None): I. General Rules
p.(None):
p.(None): Article 40
p.(None): The sponsor is responsible for selecting the investigator(s).
p.(None):
p.(None): Article 41
p.(None): Before entering an agreement with an investigator and an institution to conduct a trial, the sponsor should provide the investigator(s)
p.(None): and the institution(s) with the protocol and an up-to-date Investigator's Brochure, and should provide sufficient time for the
p.(None): investigator to review the protocol and the information provided.
p.(None):
p.(None): Article 42
p.(None): The sponsor should obtain the investigator's and the institution's agreement:
p.(None): 1.to conduct the trial in compliance with this Regulations and the applicable regulatory requirement(s), and with the protocol agreed to
p.(None): by the sponsor and given approval by the Ethics Committee;
p.(None): 2.to comply with procedures for data recording and reporting;
p.(None): 3.to permit monitoring, auditing and inspection;
p.(None): 4.to retain the essential documents that the investigator and the institution should file within the time period sponsor specified.
p.(None): The sponsor, the investigator and the institution should sign the protocol, or an alternative document, to confirm this agreement.
p.(None):
p.(None): Article 43
p.(None): A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO.
p.(None): The ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.
p.(None): The delegation referred to in the preceding paragraph should be made in writing.
p.(None): Within the scope of the transferred duties and obligations referred to paragraph 1, CRO shall apply mutatis mutandis to the relevant
p.(None): provisions of the sponsor in this Regulations.
p.(None):
p.(None): Article 44
p.(None): The sponsor may consider establishing an independent data-monitoring committee (IDMC) to assess the progress of a clinical trial,
p.(None): including the safety data and the critical efficacy endpoints at intervals.
p.(None): The IDMC can recommend to the sponsor whether to continue, modify, or stop a trial.
p.(None): The IDMC should have written operating procedures and maintain written records of all its meetings.
p.(None):
p.(None): Article 45
p.(None): The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related
p.(None): medical questions or problems. If necessary, outside consultant(s) may be appointed for this purpose.
p.(None):
p.(None): Article 46
p.(None): Prior to initiating a trial, the sponsor should define, establish, and allocate all trial-related duties and functions.
p.(None):
p.(None): Article 47
...
p.(None): 5.Ensure that the investigational product(s) are stable over the period of use.
p.(None): 6.Maintain sufficient quantities of the investigational product(s) used in the trials to reconfirm specifications if necessary.
p.(None): 7.Maintain records of batch sample analyses and characteristics.
p.(None): For samples referred to in item 6 and item 7 for extending storage permits, samples should be retained either until the analyses of the
p.(None): trial data are complete or as required by the applicable regulatory requirement(s), whichever represents the longer retention period.
p.(None):
p.(None): Article 72
p.(None): The sponsor is responsible for the ongoing safety evaluation of the investigational product(s).
p.(None):
p.(None): V. Monitoring
p.(None):
p.(None): Article 73
p.(None): The sponsor should ensure the trial is conducted under appropriate monitoring.
p.(None):
p.(None): Article 74
p.(None): The purposes of trial monitoring are to verify that:
p.(None): 1.The rights and well-being of human subjects are protected.
p.(None): 2.The reported trial data are accurate, complete, and verifiable from source documents.
p.(None): 3.The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with this Regulations, and with the
p.(None): applicable regulatory requirement(s).
p.(None):
p.(None): Article 75
p.(None): Selection and qualifications of monitors should comply with:
p.(None): 1.Monitors should be appointed by the sponsor.
p.(None): 2.Monitors should be appropriately trained, and should have the scientific and clinical knowledge needed to monitor the trial
p.(None): adequately.
p.(None): 3.A monitor’s qualifications should be documented.
p.(None): 4.Monitors should be thoroughly familiar with the investigational product(s), the protocol, informed consent form and any other written
p.(None): information to be provided to subjects, the sponsor’s SOPs, this Regulations, and the applicable regulatory requirement(s).
p.(None):
p.(None): Article 76
p.(None): The sponsor should determine the appropriate scope and nature of monitoring. The determination of the scope and nature of
p.(None): monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, scale, and endpoints of
p.(None): the trial.
p.(None): On-site monitoring should be conducted before, during, and after the trial. However, the sponsor may increase some monitoring
p.(None): procedures such as investigators’ training or meetings.
p.(None): Statistically controlled sampling can be an acceptable method for monitor(s) to select the data to be verified.
p.(None):
p.(None): Article 77
p.(None): The monitor(s) should carry out the following activities in accordance with the sponsor’s requirements to ensure that the trial is
p.(None): conducted and documented properly:
p.(None): 1.Acting as the main line of communication between the sponsor and the investigator.
p.(None): 2.Verifying that the investigator has adequate qualifications and resources and remain adequate throughout the trial period.
p.(None): 3.Verifying trial staff and the facilities, including laboratories, equipment, are adequate, safely and properly to conduct the trial and
p.(None): remain adequate throughout the trial period.
p.(None): 4.Verifying, for the investigational product(s):
p.(None): (1)That storage times and conditions are complies with the requirement(s), and that supplies are sufficient throughout the trial.
p.(None): (2)That the investigational product(s) are supplied only to subjects who are eligible to receive it and at the protocol specified dose(s).
p.(None): (3)That subjects are provided with necessary instruction on properly using, handling, storing, and returning the investigational
p.(None): product(s).
p.(None): (4)That the receipt, use, and return of the investigational product(s) at the trial sites are controlled and documented adequately.
p.(None): (5)That the disposition of unused investigational product(s) at the trial sites complies with applicable regulatory requirement(s) and is
p.(None): in accordance with the sponsor.
p.(None): 5.Verifying that the investigator follows the approved protocol and amendment(s).
p.(None): 6.Verifying that informed consent was obtained before each subject's participation in the trial.
p.(None): 7.Ensuring that the investigator receives the current Investigator's Brochure, all documents, and all trial supplies needed to conduct
p.(None): the trial properly.
p.(None): 8.Ensuring that the investigator and the investigator's trial staff are adequately informed about the trial details.
p.(None): 9.Verifying that the investigator and the investigator's trial staff are performing the specified trial functions, in accordance with the
p.(None): protocol and any other written agreement between the sponsor and the investigator and the institution, and have not delegated these
p.(None): functions to unauthorized individuals.
p.(None): 10.Verifying that the investigator is enrolling only eligible subjects.
p.(None): 11.Reporting the subject recruitment rate.
p.(None): 12.Verifying that source data, documents and other trial records are accurate, complete, and maintained.
p.(None): 13.Verifying that the investigator provides all the required reports, notifications, applications, and submissions, and that these
p.(None): documents are accurate, complete, timely, legible, dated, and identify the trial.
p.(None): 14.Checking the accuracy and completeness of the CRF entries, source documents, files and other trial-related records against each
p.(None): other. The monitor specifically should verify that:
p.(None): (1)The data required by the protocol are reported accurately on the CRFs and are consistent with the source documents.
p.(None): (2)Any dose or therapy modifications are well documented for each of the trial subjects.
p.(None): (3)Adverse events, concomitant medications and intercurrent illnesses are reported in accordance with the protocol on the CRFs.
p.(None): (4)Visits that the subjects fail to make, tests that are not conducted, and examinations that are not performed are clearly reported as
p.(None): such on the CRFs.
...
p.(None): When conducting a multicenter trial, all investigators should comply with a uniform set of standards for the assessment of clinical and
p.(None): laboratory findings, and on completing the CRFs.
p.(None):
p.(None): Article 121
p.(None): When conducting a multicenter trial, the sponsor should facilitate communication between all investigators.
p.(None):
p.(None): Chapter VIII Supplemental Provisions
p.(None):
p.(None): Article 122
p.(None): For clinical trials initiated in accordance with the original Guideline for Good Clinical Practice prior to the implementation of this
p.(None): Regulations, this Regulations shall be applied after taking effect.
p.(None):
p.(None): Article 123
p.(None): This Regulations shall take effect immediately upon the date of promulgation hereof.
p.(None):
p.(None):
p.(None): NOTE
p.(None): This English version of the Regulations for Good Clinical Practice is provided for reference purposes only. In the event of any
p.(None): inconsistency between the Chinese original and the English translation, the former shall prevail.
p.(None):
p.(None):
p.(None):
p.(None): News Law Convention
p.(None): Searching Justices of the Constitutional Court
p.(None):
p.(None):
p.(None): E-PAPER
p.(None): enter your email address
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p.(None): This website does not provide legal counseling service, please contact with related public offices for more information.
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p.(None): │ Government Website Open Information Announcement │ Declaration on Privacy Right Protection │ Information Security Policy │ EMail │
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...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| coerce | Presence of Coercion |
| drug | Drug Usage |
| education | education |
| embryo | embryo |
| emergency | Public Emergency |
| fetus | Fetus/Neonate |
| hazard | Natural Hazards |
| home | Property Ownership |
| illness | Physically Disabled |
| infant | Infant |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| opinion | philosophical differences/differences of opinion |
| placebo | participants in a control group |
| single | Marital Status |
| terminal | Terminally Ill |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['influence'] |
| influence | ['drug'] |
Trigger Words
capacity
coercion
consent
ethics
justice
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input