4D3B7B391183C231934F85202FEF7C32
National Ethical Guidelines for Health and Health-Related Research, Pages 108-118 (2017):
http://www.pcrp.org.ph/pdf/GuidelinesversionLR.PDF
http://leaux.net/URLS/ConvertAPI Text Files/A7064B14E7736745B58E26CE213DABD4.en.txt
Examining the file media/Synopses/A7064B14E7736745B58E26CE213DABD4.html:
This file was generated: 2020-05-31 04:17:09
| 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
Health / Drug Usage
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p.000002:
p.000002: GUIDELINE
p.000002: Regulation of Clinical Trials in the
p.000002: Philippines
p.000002: CLINTCALTRtAL UNIT
p.000002: POLICY PLANNING ANDADYOCACY DIVISION FOOD AND DRUG ADMINISTRATION
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p.000002: TABLE OF CONTENTS
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p.000002:
p.000002: CONTENTS: PAGES
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p.000002:
p.000002: FDA CIRCULAR 2012-007 1-10
p.000002: CLINICAL TRIAL APPLICATION FORM 11-12
p.000002: PERMIT FOR ERB/ERC REVIEW 13
p.000002: FDA CLINICAL TRIAL ASSESSMENT FORM 14-19
p.000002: APPROVAL TO CONDUCT CLINICAL TRIAL 20
p.000002: LIST OF ACCREDITED INSTITUTIONS AND SOPs 21-38
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p.000002:
p.000002:
p.000002: GUIDELINES ON THE REGULATION OF CLINICAL TRIALS V. 1.0
p.000002: 2
p.000002:
p.000002: FDA CIRCULAR 2012-007
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: June 7, 2012
p.000002:
p.000002:
p.000002: FDA Circular No. 2012-007
p.000002:
p.000002:
p.000002: SUBJECT: Recognition of Ethical Review Board/Committee (ERB/ERC) For Purposes of the Conduct of Clinical Trials on
p.000002: Investigational Medicinal Products in the Philippines and for Other Purposes
p.000002:
p.000002:
p.000002:
p.000002: I. RATIONALE AND BACKGROUND
p.000002:
p.000002: The Philippines: An Emerging Destination for Global Clinical Trials
p.000002: In recent years there has been an increase in the number of clinical trials in the Philippines. Of the 10 countries in
...
p.000001: To require mandatory ethical and technical reviews by accredited independent review committees of experts in
p.000001: accordance with existing national regulations (PNHRS Ethics Guidelines) as well as Good Clinical Practice (GCP ICH-E6
p.000001: 1996) guidelines and any supplements and amendments thereof, which are hereby adopted.
p.000001: To require mandatory inclusion for all clinical trials (Phases I, II, III and IV) in the Philippine Clinical Trials
p.000001: Registry (http://registry.healthresearch.ph).
p.000001: III. COVERAGE AND SCOPE
p.000001: This Circular covers the recognition of ERB/ERCs to serve as ethical and technical reviewers for clinical trial
p.000001: applications and is for the compliance is for the compliance of the sponsor companies, Clinical Research Organizations
p.000001: (CROs), and Ethical Review Board/Committees (ERB/ERCs).
p.000001: This regulation covers Phase I, II, III and IV clinical trials of investigational medicinal products defined as any
p.000001: substance or combinationof substances presented as having properties for treating or preventing disease in human
p.000001: beings; or any substance or combination of substances which may be used in or administered to human beings either with
p.000001: a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or
p.000001: metabolic action, or to making a medical diagnosis. Investigational medicinal products cover new chemical
p.000001: entities under the investigational phase of drug development as well as existing drug preparations already in the
p.000001: market seeking approval for new or additional indications.
p.000001: IV. DECLARATION OF POLICIES
p.000001: Pursuant to the mandates provided under the 1987 Constitution to protect and promote the right to health of the people,
p.000001: Republic Act 3720, as amended by Executive Order 175, otherwise known as the “Food, Drugs and Devices, and Cosmetics
p.000001: Act”, to adopt measures that ensure the purity and safety of foods and cosmetics, and, in addition to purity and
p.000001: safety, the efficacy and quality of drugs and devices in the country and as reiterated by Republic Act No. 9711 or the
p.000001: “The Food and Drug Administration (FDA) Act of 2009,” the adoption of the International Conference on Harmonization
p.000001: Guideline for Good Clinical Practice or ICH GCP (E6) in the review, approval and regulation of clinical trials not only
p.000001: for vaccines but for all pharmaceutical products as may be applicable or supported by local guidelines as expressed
p.000001: under Administrative Order 47-a, series of 2001 entitled Rules and Regulations on the Registration, Including Approval
p.000001: and Conduct of Clinical Trials and Lot or Batch Release Certification of Vaccines and Biologic Products is hereby
p.000001: reiterated.
p.000001: This circular strengthens the technical and ethical review through the use of independent ethical and technical panels
p.000001: that have been audited and accredited by Philippine Health Research Ethics Board (PHREB), the national body constituted
p.000001: under the Philippine National Health Research System (PNHRS)under the Department of Science and Technology (DOST) to
p.000001: ensure that ERB/ERCs comply with international and national standards in the performance of their function. In keeping
p.000001: with international standards to safeguard the quality of research and protect the public from the negative effects of
p.000001: biased reporting and publication, clinical trials are hereby mandatorily required to be posted on the clinical trials
p.000001: registry established under the mandate of PNHRS.
p.000001:
p.000001: A. FDA Recognition of PHREB-Accredited IRBs to Serve as Ethical and Technical Reviewers for Clinical Trial
p.000001: Applications
p.000001: The FDA recognizes the following IRBs/ERCs of institutions based on the recommendation of the PHREB:
p.000001: 1. University of the Philippines Manila –National Institutes of Health (UPM-NIH)
...
p.000006: 4. FDA will be in close coordination with the ERB/ERCs during the process and will be provided information on the
p.000006: progress of the review and all pertinent matters of the review.
p.000006: 5. The FDA will give the final decision to approve or deny an application based on the recommendation,
p.000006: submitted in written format, emanating from the ERB/ERC review. A document granting approval for the conduct
p.000006: of a clinical trial based on the completed technical and ethical review by the ERB/ERC will be issued by the FDA to the
p.000006: study sponsor.
p.000006: C. Mandatory inclusion of clinical trials in the Philippine Clinical Trial Registry
p.000006: All clinical trials are required to be uploaded in the Philippine Clinical Trial Registry. It is the responsibility
p.000006: of the study sponsor to upload information related to the clinical trial it is conducting to the Registry
p.000006: (http://registry.healthresearch.ph) 30 days after the application to conduct the clinical trial has been granted.
p.000006: Figure 3
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p.000007: 7
p.000007: FDA AUGUST 31, 2012
p.000007:
p.000007: D. Access to medicines for use in clinical trials using the Import Permit
p.000007: The FDA, as mandated by law, grants approval to all locally manufactured and imported drug products seeking entry
p.000007: into the Philippine market by the issuance of a Certificate of Product Registration (CPR). Only such drug
p.000007: products with CPRs are allowed to be imported and sold in the country. For purposes of clinical trials use, medicines
p.000007: not registered by the FDA can be accessed by an Import Permit. In addition to drug products, the Import Permit allows
p.000007: the inclusion of ancillary supplies such as laboratory kits, reagents, and other materials to be used for the clinical
p.000007: trial concerned to be imported.
p.000007: The procedure to secure an Import Permit will be defined by FDA based on what capacity is available at its disposal.
p.000007: Specifically, it is currently done under the existing practice of securing permits using a manual system but may, in
p.000007: the futureand pending ongoing feasibility studies, utilize a computerized online system such as the National Single
p.000007: Window (NSW).
p.000007: 1. The Import Permit authorizes the importation ofdrug products and materials for purposes of clinical trials
p.000007: provided that the clinical trials protocol has been reviewed and ascertained to comply with acceptable ethical and
p.000007: technical standards by a duly-accredited Institutional Review Board and granted the approval to proceed by the FDA.
p.000007: 2. The following can apply for the Import Permit:
p.000007: a. Principal investigator
p.000007: b. Authorized representative of the Study sponsor (registered pharmaceutical company with permanent address
p.000007: in the Philippines
p.000007: c. CRO, with permanent Philippine address, representing the sponsor through a letter of authorization
p.000007: 3. To secure an Import Permit, the application must be supported by the FDA document attesting to the approval of
p.000007: the clinical trials to proceed based on compliance to ethical and technical requirements as ascertained by
p.000007: the ERB/ERC.
p.000007: 4. Under the existing FDA system, the Import Permit will be issued by PSD with the cooperation of the Regulation
p.000007: Division I which has linkage with the Bureau of Customs in this regard.
p.000007:
p.000007: E. Inspections of clinical trials:
p.000007: FDA shall conduct random inspections on the clinical trial sites to monitor complianceto the approved study protocol
p.000007: and monitoring plan of the sponsor. It shall specifically look into adherence to the GCP:
p.000007:
p.000007: F. Safety Reporting
p.000007: Reporting must be consistent with ICH Topic E2A- Clinical Data Management: Definitions and
p.000007: Standards for Safety Reporting.
p.000007: 1. Suspected Unexpected Serious Adverse Drugs Reactions (SUSARs)
p.000007:
p.000007: a. Fatal or Life-Threatening Unexpected ADRs
p.000007: All adverse drug reactions (ADRs) that are both serious and unexpected are subject to expedited reporting. Fatal
p.000007: (deaths) or life-threatening, serious unexpected ADRs occurring in clinical trials, onsite or offsite (for
p.000007: multi-site studies) should be reported. The FDA should be notified (landline/mobile phone, facsimile transmission,
p.000007: email or written letter) as soon as possible but no later than 7 calendar days after first knowledge by the
p.000007: sponsor that a case qualifies, followed by a complete report as soon as possible within 8 additional calendar days. The
p.000007: CIOMS-I form has been a widely accepted standard for expedited adverse event reporting
p.000007:
p.000007: GUIDELINES ON THE REGULATION OF CLINICAL TRIALS V. 1.0
p.000008: 8
p.000008:
p.000008: b. All Other Unexpected Serious ADRs
p.000008: Serious, unexpected reactions (ADRs) that are not fatal or life-threatening, whether onsite or offsite, must be filed
p.000008: as soon as possible but no later than 15 calendar days after first knowledge by the sponsor that the case meets the
p.000008: minimum criteria for expedited reporting.
p.000008: 2. ExpectedAdverse Drug Reactions
p.000008: a. Serious adverse drug reactions which are expected based on information from Investigator’s
p.000008: Brochure will be reported in the regular progress report and final report.
p.000008:
p.000008: b. Adverse drug reactions which are not serious will also be reported in the regular progress report
p.000008: and final report.
p.000008:
p.000008: G. Termination of Clinical Trial and Sanctions
p.000008: For the effective implementation of this Circular, this Office shall order the termination of an on-going clinical
p.000008: trial without need of a hearing should the result of random trial sites inspections reveal any major violation(s),
p.000008: notifying only the concerned establishment of such termination. Other sanction(s) to concerned entities shall be
p.000008: imposed respectively under the following instances of violations and the table below:
p.000008: 1. The result of the random clinical trial sites inspections shall have the following categories:
p.000008: a. No violation - No objectionable conditions or practices were found during the inspection, or the significance
p.000008: of the documented objectionable conditions found does not justify further FDA action (from USFDA). Compliant to GCP
p.000008: rules and approved protocol
p.000008: b. Minor violations - Regulatory violations uncovered during the inspection are few and do not seriously impact
p.000008: subject safety or data integrity.
p.000008: c. Major violations-The regulatory violation(s) uncovered is/are significant/serious and/or numerous, and
p.000008: the scope, severity, or pattern of violation(s) support a finding that:
p.000008: 1) Subjects under the care of the investigator would be or have been exposed to an
p.000008: unreasonable and significant risk of illness or injury.
p.000008: 2) Subjects’ rights would be or have been seriously compromised. OR
p.000008: 3) Data integrity or reliability is or has been compromised.
p.000008: 4) Non disclosure of conflict of interest by the investigator and other members of the trial
p.000008: team
p.000008: 5) Failure to get an informed consent is a major violation
p.000008:
p.000008: Any pharmaceutical product the clinical trial of which has been ordered terminated by FDA shall be a ground for the
p.000008: invalidation of data for drug registration purposes and accordingly disapproval of subsequent application for product
p.000008: registration pursuant to Paragraphs (1) or (6), Item B, Section 4, Article I, Book II of the Implementing Rules and
p.000008: Regulations of Republic Act No. 9711 on ground that application requirements does not meet the required technical
p.000008: requirements or appropriate standards, or such other analogous grounds or causes as determined by the FDA.
p.000008: 2. Disciplinary actions shall be imposed on the following after finalizing the Inspection Report by
p.000008: the Legal Division of the FDA.
p.000008:
p.000008:
p.000008:
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p.000009: FDA AUGUST 31, 2012
p.000009:
p.000009: Entity/Individual
p.000009: Researcher
p.000009:
p.000009:
p.000009: Sponsor
p.000009: Ethics Review Committee The FDA shall recommend appropriate action to the PHREB based on inspection findings.
p.000009: Minor Violation(s)
p.000009: Warning, re-inspection
p.000009:
p.000009:
p.000009: Warning, re-inspection Warning, re-inspection
p.000009: Major Violation(s)
p.000009: Suspension from conduct of
p.000009: researches from (range in months or years) depending on the type
p.000009: and degree of violation Termination of trial, invalidation of
p.000009: data for drug registration purposes Suspension from the conduct
p.000009: of reviews for (range in months/ years) depending on the type and degree of violation
p.000009: H. Archiving and Database Management
p.000009: All original and latest approved versions of CT protocols, IB, Informed Consent, ERC proof of approval,
p.000009: summary of amendments, and final CT report including summary of safety reports shall be recorded, filed and archived by
p.000009: the clinical unit of the FDA.
p.000009: Stored files shall be accessed only by duly authorized personsand shall be stored and disposed thereafter in a manner
p.000009: as may be provided by existing laws, rules and regulations. Disposal of files shall be in coordination with the
p.000009: Records Section of the Administrative Division which shall seek approval from the National Archives of the Philippines.
p.000009:
p.000009: VI. SUPERVISION AND OVERSIGHT
p.000009: The Policy Planning and Advocacy Division (PPAD) shall supervise and provide technical guidance in the implementation
p.000009: of this Circular. The Clinical Trial Management staff shall prepare and submit quarterly reports to the Chief of the
p.000009: PPAD on the status of implementation, issues and problems and proposed solutions.
p.000009: Likewise, the PPAD shall provide the FDA MANCOM an annual report on the implementation of this Circular.
p.000009:
p.000009: In pursuit of good governance and transparency the PPAD shall organize and convene regular meetings with
p.000009: concerned partners and networks to provide updates and reports on the implementation or any matter concerning this
p.000009: Circular.
p.000009:
p.000009: VII. SEPARABILITY AND REPEALING CLAUSE
p.000009: In the event that a rule, section, paragraph, sentence, clause or words of this Circular is declared invalid for any
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p.000002:
p.000002: II. OBJECTIVES
p.000002: In addition to the objectives laid down in the Rules and Regulations implementing Republic Act No. 9711, this Order is
p.000002: hereby formulated to:
p.000002: To accord due protection to human subjects of clinical trials and ensure the generation of research
p.000002: findings of strong scientific merit, FDA grants recognition and empowersselected institution-based
p.000002:
p.000002:
p.000001: 1
p.000001: FDA AUGUST 31, 2012
p.000001:
p.000001: Ethical Review Board/Committees (ERB/ERCs)undertaketheethical and technical evaluation of clinical trials for
p.000001: the purpose of recommending, to the FDA, the approval of such studies for conduct in the Philippines.
p.000001: To require mandatory ethical and technical reviews by accredited independent review committees of experts in
p.000001: accordance with existing national regulations (PNHRS Ethics Guidelines) as well as Good Clinical Practice (GCP ICH-E6
p.000001: 1996) guidelines and any supplements and amendments thereof, which are hereby adopted.
p.000001: To require mandatory inclusion for all clinical trials (Phases I, II, III and IV) in the Philippine Clinical Trials
p.000001: Registry (http://registry.healthresearch.ph).
p.000001: III. COVERAGE AND SCOPE
p.000001: This Circular covers the recognition of ERB/ERCs to serve as ethical and technical reviewers for clinical trial
p.000001: applications and is for the compliance is for the compliance of the sponsor companies, Clinical Research Organizations
p.000001: (CROs), and Ethical Review Board/Committees (ERB/ERCs).
p.000001: This regulation covers Phase I, II, III and IV clinical trials of investigational medicinal products defined as any
p.000001: substance or combinationof substances presented as having properties for treating or preventing disease in human
p.000001: beings; or any substance or combination of substances which may be used in or administered to human beings either with
p.000001: a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or
p.000001: metabolic action, or to making a medical diagnosis. Investigational medicinal products cover new chemical
p.000001: entities under the investigational phase of drug development as well as existing drug preparations already in the
p.000001: market seeking approval for new or additional indications.
p.000001: IV. DECLARATION OF POLICIES
p.000001: Pursuant to the mandates provided under the 1987 Constitution to protect and promote the right to health of the people,
p.000001: Republic Act 3720, as amended by Executive Order 175, otherwise known as the “Food, Drugs and Devices, and Cosmetics
p.000001: Act”, to adopt measures that ensure the purity and safety of foods and cosmetics, and, in addition to purity and
p.000001: safety, the efficacy and quality of drugs and devices in the country and as reiterated by Republic Act No. 9711 or the
p.000001: “The Food and Drug Administration (FDA) Act of 2009,” the adoption of the International Conference on Harmonization
p.000001: Guideline for Good Clinical Practice or ICH GCP (E6) in the review, approval and regulation of clinical trials not only
p.000001: for vaccines but for all pharmaceutical products as may be applicable or supported by local guidelines as expressed
...
Health / Healthy People
Searching for indicator volunteers:
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p.000002: 2
p.000002:
p.000002: FDA CIRCULAR 2012-007
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: June 7, 2012
p.000002:
p.000002:
p.000002: FDA Circular No. 2012-007
p.000002:
p.000002:
p.000002: SUBJECT: Recognition of Ethical Review Board/Committee (ERB/ERC) For Purposes of the Conduct of Clinical Trials on
p.000002: Investigational Medicinal Products in the Philippines and for Other Purposes
p.000002:
p.000002:
p.000002:
p.000002: I. RATIONALE AND BACKGROUND
p.000002:
p.000002: The Philippines: An Emerging Destination for Global Clinical Trials
p.000002: In recent years there has been an increase in the number of clinical trials in the Philippines. Of the 10 countries in
p.000002: Southeast Asia, the Philippines ranks third in terms of the number of clinical trials (US NIH, http://
p.000002: clinicaltrials.gov/ct2/search/browse?brwse=locn_cat_SE, Accessed on May 19, 2012).Based on the 2009 report by the
p.000002: European Medicines Agency, the Philippines is ranked as number 8 among the top 10 countries worldwide with a high
p.000002: annual growth rate of 30.9 % in clinical trials. Clinical trials emanating from the European Union increased from 2 in
p.000002: 2005 to 25 in 2008 with a corresponding increase in the number of trial participants from 67 to 3,042 respectively.
p.000002: Likewise, trials emanating from the US increased from 3 in 2000 to 363 in 2009. The Philippines currently ranks third
p.000002: in Southeast Asia with 528 ongoing global trials, after Thailand with 1094, and Singapore with 958
p.000002: (www.clinicaltrials.gov, accessed on June 5, 2012). FDA received 396 clinical trial
p.000002: applications in 2009; 339 in 2010, and 335 in 2011.
p.000002: As recruitment for volunteers become more intense with the anticipated increase in clinical studies and
p.000002: given the vulnerabilities of the majority of our people because of poor health, economic status, abuse or poor
p.000002: orientation and lack of awareness of their rights, there is an urgent need to improve regulatory function and promote
p.000002: cooperation between DOH-FDA and other quasi-regulatory agencies suchas the Philippine Health Research Ethics Board
p.000002: (PHREB) of the Philippines National Research Health System (PNHRS) to better ensure that every Filipino
p.000002: patient who volunteers to participate in clinical research studies is accorded due protection as embodied in the
p.000002: Philippine Constitution.
p.000002: As part of the quest to attain a higher level of competitiveness for the country, there is a need to find a more
p.000002: efficient system that should be benchmarked with global models.
p.000002:
p.000002: II. OBJECTIVES
p.000002: In addition to the objectives laid down in the Rules and Regulations implementing Republic Act No. 9711, this Order is
p.000002: hereby formulated to:
p.000002: To accord due protection to human subjects of clinical trials and ensure the generation of research
p.000002: findings of strong scientific merit, FDA grants recognition and empowersselected institution-based
p.000002:
p.000002:
p.000001: 1
p.000001: FDA AUGUST 31, 2012
p.000001:
p.000001: Ethical Review Board/Committees (ERB/ERCs)undertaketheethical and technical evaluation of clinical trials for
p.000001: the purpose of recommending, to the FDA, the approval of such studies for conduct in the Philippines.
p.000001: To require mandatory ethical and technical reviews by accredited independent review committees of experts in
p.000001: accordance with existing national regulations (PNHRS Ethics Guidelines) as well as Good Clinical Practice (GCP ICH-E6
p.000001: 1996) guidelines and any supplements and amendments thereof, which are hereby adopted.
p.000001: To require mandatory inclusion for all clinical trials (Phases I, II, III and IV) in the Philippine Clinical Trials
p.000001: Registry (http://registry.healthresearch.ph).
p.000001: III. COVERAGE AND SCOPE
p.000001: This Circular covers the recognition of ERB/ERCs to serve as ethical and technical reviewers for clinical trial
...
Health / Physically Disabled
Searching for indicator illness:
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p.000008: Brochure will be reported in the regular progress report and final report.
p.000008:
p.000008: b. Adverse drug reactions which are not serious will also be reported in the regular progress report
p.000008: and final report.
p.000008:
p.000008: G. Termination of Clinical Trial and Sanctions
p.000008: For the effective implementation of this Circular, this Office shall order the termination of an on-going clinical
p.000008: trial without need of a hearing should the result of random trial sites inspections reveal any major violation(s),
p.000008: notifying only the concerned establishment of such termination. Other sanction(s) to concerned entities shall be
p.000008: imposed respectively under the following instances of violations and the table below:
p.000008: 1. The result of the random clinical trial sites inspections shall have the following categories:
p.000008: a. No violation - No objectionable conditions or practices were found during the inspection, or the significance
p.000008: of the documented objectionable conditions found does not justify further FDA action (from USFDA). Compliant to GCP
p.000008: rules and approved protocol
p.000008: b. Minor violations - Regulatory violations uncovered during the inspection are few and do not seriously impact
p.000008: subject safety or data integrity.
p.000008: c. Major violations-The regulatory violation(s) uncovered is/are significant/serious and/or numerous, and
p.000008: the scope, severity, or pattern of violation(s) support a finding that:
p.000008: 1) Subjects under the care of the investigator would be or have been exposed to an
p.000008: unreasonable and significant risk of illness or injury.
p.000008: 2) Subjects’ rights would be or have been seriously compromised. OR
p.000008: 3) Data integrity or reliability is or has been compromised.
p.000008: 4) Non disclosure of conflict of interest by the investigator and other members of the trial
p.000008: team
p.000008: 5) Failure to get an informed consent is a major violation
p.000008:
p.000008: Any pharmaceutical product the clinical trial of which has been ordered terminated by FDA shall be a ground for the
p.000008: invalidation of data for drug registration purposes and accordingly disapproval of subsequent application for product
p.000008: registration pursuant to Paragraphs (1) or (6), Item B, Section 4, Article I, Book II of the Implementing Rules and
p.000008: Regulations of Republic Act No. 9711 on ground that application requirements does not meet the required technical
p.000008: requirements or appropriate standards, or such other analogous grounds or causes as determined by the FDA.
p.000008: 2. Disciplinary actions shall be imposed on the following after finalizing the Inspection Report by
p.000008: the Legal Division of the FDA.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009: FDA AUGUST 31, 2012
p.000009:
p.000009: Entity/Individual
p.000009: Researcher
p.000009:
p.000009:
p.000009: Sponsor
p.000009: Ethics Review Committee The FDA shall recommend appropriate action to the PHREB based on inspection findings.
p.000009: Minor Violation(s)
p.000009: Warning, re-inspection
p.000009:
p.000009:
p.000009: Warning, re-inspection Warning, re-inspection
p.000009: Major Violation(s)
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Social / Access to Social Goods
Searching for indicator access:
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p.000005: the FDA in close coordination with the ERB/ERCs.
p.000005:
p.000005: B. Ethical/Technical Review of Applications for Clinical Trials by ERB/ERC
p.000005: The FDA will accredit the ERB/ERCs of institutions based on the recommendation of the PHREB and the list will be
p.000005: subject to updating based on PHREB’s continuing accreditation of institutions. Guidance on the filing, review and
p.000005: approval process must be guided by the following:
p.000005: 1. Approvals of study proposals will be guided by the highest ethical and technical standards.
p.000005: 2. As shown in Figure 3, the initial step entails the submission of an application to the FDA which will issue the
p.000005: Permit for the ethical and technical review of the clinical trial protocol to be done by an accredited
p.000005: ERB/ERC.Accreditation is based on the recommendation of PHREB which conducts audits to assess the capability of
p.000005: ERB/ERCs all over the Philippines.
p.000005: 3. The accredited ERB/ERCs should be guided by the following conditions:
p.000005: a. Fees to be charged per project as fee for technical and ethical review by the ERB/ERC will be standardized at
p.000005: THIRTY THOUSAND PESOS. This amount will be subject to regular review every two years.
p.000005: GUIDELINES ON THE REGULATION OF CLINICAL TRIALS V. 1.0
p.000006: 6
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p.000006: b. The timeline for the review from acceptance to completion should not exceed 60 days.
p.000006: c. The institutions will ensure that the individuals who will conduct the review process must have established
p.000006: competence in their areas of specializations and properly disclose conflicts of interest. Participation in the review
p.000006: process, by its nature, grants access to privileged information and thus, is subject to exercising confidentiality on
p.000006: the details of the documents submitted for review by the study sponsor. Reviewers and the study sponsor must adhere to
p.000006: a strict code of ethical conduct that ensures independence of reviewers and objectivity as basis for decisions.
p.000006: 4. FDA will be in close coordination with the ERB/ERCs during the process and will be provided information on the
p.000006: progress of the review and all pertinent matters of the review.
p.000006: 5. The FDA will give the final decision to approve or deny an application based on the recommendation,
p.000006: submitted in written format, emanating from the ERB/ERC review. A document granting approval for the conduct
p.000006: of a clinical trial based on the completed technical and ethical review by the ERB/ERC will be issued by the FDA to the
p.000006: study sponsor.
p.000006: C. Mandatory inclusion of clinical trials in the Philippine Clinical Trial Registry
p.000006: All clinical trials are required to be uploaded in the Philippine Clinical Trial Registry. It is the responsibility
p.000006: of the study sponsor to upload information related to the clinical trial it is conducting to the Registry
p.000006: (http://registry.healthresearch.ph) 30 days after the application to conduct the clinical trial has been granted.
p.000006: Figure 3
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p.000007: FDA AUGUST 31, 2012
p.000007:
p.000007: D. Access to medicines for use in clinical trials using the Import Permit
p.000007: The FDA, as mandated by law, grants approval to all locally manufactured and imported drug products seeking entry
p.000007: into the Philippine market by the issuance of a Certificate of Product Registration (CPR). Only such drug
p.000007: products with CPRs are allowed to be imported and sold in the country. For purposes of clinical trials use, medicines
p.000007: not registered by the FDA can be accessed by an Import Permit. In addition to drug products, the Import Permit allows
p.000007: the inclusion of ancillary supplies such as laboratory kits, reagents, and other materials to be used for the clinical
p.000007: trial concerned to be imported.
p.000007: The procedure to secure an Import Permit will be defined by FDA based on what capacity is available at its disposal.
p.000007: Specifically, it is currently done under the existing practice of securing permits using a manual system but may, in
p.000007: the futureand pending ongoing feasibility studies, utilize a computerized online system such as the National Single
p.000007: Window (NSW).
p.000007: 1. The Import Permit authorizes the importation ofdrug products and materials for purposes of clinical trials
p.000007: provided that the clinical trials protocol has been reviewed and ascertained to comply with acceptable ethical and
p.000007: technical standards by a duly-accredited Institutional Review Board and granted the approval to proceed by the FDA.
p.000007: 2. The following can apply for the Import Permit:
p.000007: a. Principal investigator
...
p.000022: 3.2.3 Stability Data (storage conditions)
p.000022: 3.2.4 Manufacturing Data & Formulation
p.000022: 3.2.5 Product labeling (coded & labeled: blinding)
p.000022:
p.000022: 1.3 PART C: Investigator’s Brochure (Efficacy and Safety Data)
p.000022:
p.000022: 1.3.1 Safety Data
p.000022: 3.3.1a Non-Clinical Studies
p.000022: 3.3.1b Pharmacology; PK/PD studies 3.3.1c Toxicology Studies
p.000022: 3.3.1d Marketing Experience, Periodic Safety Update Reports (PSUR), product status if marketed abroad
p.000022: 3.3.1e Risks and ADR anticipated
p.000022:
p.000022: 1.3.2 Efficacy Data
p.000022: 3.3.2a PK/PD Data in human subjects 3.3.2b In-house preliminary data
p.000022: 3.3.2c Summaries of clinical trial studies conducted (Phase I, II, III)
p.000022: 3.3.2d Published clinical data
p.000022:
p.000022: 3 The following are required to be submitted for the regulatory review at DLSHSI:
p.000022: 3.3 One (1) electronic copy (compact disc) of Parts A and C.
p.000022: 3.4 Four (4) hard copies of Parts A and C
p.000022: 3.5 One (1) hard copy of Part B
p.000022: 3.6 Clinical Trial Reference Number from FDA
p.000022: 3.7 Permit for Regulatory Review from FDA
p.000022: 3.8 Check payment for Regulatory Review
p.000022:
p.000022: 4 The check payment must be payable to De La Salle Health Sciences Institute in the amount of Thirty Thousand Pesos
p.000022: (PhP 30,000.00 – not subject to tax). The review process will commence only upon receipt of the full
p.000022: payment for regulatory review. You will be provided with an Official Receipt and a Regulatory Review Receipt
p.000022: Form by the Project Coordinator.
p.000022:
p.000022: 5 A tracking system that is secure yet accessible to FDA and the study sponsor will be used to monitor the status of
p.000022: the screening process. To have access to this tracking system, the sponsor should provide the project coordinator with
p.000022: an e-mail address of their designated contact person. We will also inform you through text, email, or telephone call.
p.000022:
p.000022: 5.1 If applicable or necessary, an Interim Recommendation from DLSHSI IRB/ERB will be communicated to the FDA and the
p.000022: Study Sponsor within thirty (30) days from the start of the review process. The study sponsor should respond to DLSHSI
p.000022: IRB/ERB within two (2) weeks upon receipt of the Interim Recommendation.
p.000022:
p.000022:
p.000023: 23
p.000023: FDA AUGUST 31, 2012
p.000023:
p.000023: 5.2 A final recommendation from the DLSHSI IRB/ERB will be communicated to the FDA within sixty
p.000023: (60) days from the start of the review process.
p.000023:
p.000023:
p.000023: For further inquiries, please contact:
p.000023:
p.000023: Mr. Andrew C. Casipi
p.000023: Project Coordinator for Clinical Trials Mobile No: 09207316391 or 09166194617
p.000023: Telefax: (046) 481-8000 local 4000 e-mail: casipi_andrew@yahoo.com
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p.000023: GUIDELINES ON THE REGULATION OF CLINICAL TRIALS V. 1.0
p.000024: 24
p.000024:
p.000024: RESEARCH INSTITUTE FOR TROPICAL MEDICINE
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Social / Marital Status
Searching for indicator single:
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p.000006:
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p.000007: 7
p.000007: FDA AUGUST 31, 2012
p.000007:
p.000007: D. Access to medicines for use in clinical trials using the Import Permit
p.000007: The FDA, as mandated by law, grants approval to all locally manufactured and imported drug products seeking entry
p.000007: into the Philippine market by the issuance of a Certificate of Product Registration (CPR). Only such drug
p.000007: products with CPRs are allowed to be imported and sold in the country. For purposes of clinical trials use, medicines
p.000007: not registered by the FDA can be accessed by an Import Permit. In addition to drug products, the Import Permit allows
p.000007: the inclusion of ancillary supplies such as laboratory kits, reagents, and other materials to be used for the clinical
p.000007: trial concerned to be imported.
p.000007: The procedure to secure an Import Permit will be defined by FDA based on what capacity is available at its disposal.
p.000007: Specifically, it is currently done under the existing practice of securing permits using a manual system but may, in
p.000007: the futureand pending ongoing feasibility studies, utilize a computerized online system such as the National Single
p.000007: Window (NSW).
p.000007: 1. The Import Permit authorizes the importation ofdrug products and materials for purposes of clinical trials
p.000007: provided that the clinical trials protocol has been reviewed and ascertained to comply with acceptable ethical and
p.000007: technical standards by a duly-accredited Institutional Review Board and granted the approval to proceed by the FDA.
p.000007: 2. The following can apply for the Import Permit:
p.000007: a. Principal investigator
p.000007: b. Authorized representative of the Study sponsor (registered pharmaceutical company with permanent address
p.000007: in the Philippines
p.000007: c. CRO, with permanent Philippine address, representing the sponsor through a letter of authorization
p.000007: 3. To secure an Import Permit, the application must be supported by the FDA document attesting to the approval of
p.000007: the clinical trials to proceed based on compliance to ethical and technical requirements as ascertained by
p.000007: the ERB/ERC.
p.000007: 4. Under the existing FDA system, the Import Permit will be issued by PSD with the cooperation of the Regulation
p.000007: Division I which has linkage with the Bureau of Customs in this regard.
p.000007:
p.000007: E. Inspections of clinical trials:
p.000007: FDA shall conduct random inspections on the clinical trial sites to monitor complianceto the approved study protocol
p.000007: and monitoring plan of the sponsor. It shall specifically look into adherence to the GCP:
p.000007:
p.000007: F. Safety Reporting
p.000007: Reporting must be consistent with ICH Topic E2A- Clinical Data Management: Definitions and
p.000007: Standards for Safety Reporting.
p.000007: 1. Suspected Unexpected Serious Adverse Drugs Reactions (SUSARs)
p.000007:
p.000007: a. Fatal or Life-Threatening Unexpected ADRs
...
Social / Police Officer
Searching for indicator officer:
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p.000025: It covers the actions done from the time of submission of documents for IERB review by the sponsor to the IERB
p.000025: Secretariat to the return of same regulatory review documents to the FDA-PPAD.
p.000025:
p.000025: 3. Responsibility
p.000025:
p.000025: Secretariat – receives the initial protocol package and payment for the protocol review PPAD – sends the notification
p.000025: letter to the PHC IERB
p.000025: Sponsor – submits protocol package and payment for protocol review to PHC IERB IERB – evaluates the protocol and sends
p.000025: report and recommendations to FDA-PPAD
p.000025:
p.000025: 4. Policy
p.000025:
p.000025: 4.1 The PHC IERB shall receive permit letter regarding a protocol for regulatory review from
p.000025: FDA-PPAD.
p.000025:
p.000025: 4.2 The sponsor shall submit a protocol package to the PHC IERB.
p.000025:
p.000025: 4.3 Requirements for protocol submission can be accessed from the IERB Secretariat or through email
p.000025: (irbphc@gmail.com). The protocol package will be send by FDA to IERB.
p.000025:
p.000025: 4.4 The sponsor shall pay PHC-IERB an amount of P30,000.00 for every protocol review.
p.000025: 4.4.1 The sponsor shall give payment to PHC cashier for PHC IERB protocol review.
p.000025: 4.4.2 A copy of official receipt shall be forwarded to the IERB secretariat.
p.000025:
p.000025: 4.5 The Chairman shall invite an independent consultant for non-cardiology and non- pulmonary
p.000025: protocol.
p.000025:
p.000025: 4.6 The Board Secretary shall document all meetings regarding review of all protocols including decisions and
p.000025: recommendations to the FDA-PPAD.
p.000025:
p.000025: 4.7 The Chairman shall designate the secretariat to be the liaison officer to the Task Force and
p.000025: FDA-PPAD.
p.000025:
p.000025: GUIDELINES ON THE REGULATION OF CLINICAL TRIALS V. 1.0
p.000026: 26
p.000026:
p.000026: Department / Division
p.000026: INSTITUTIONAL ETHICS REVIEW BOARD
p.000026: Page Number P/P Number
p.000026: Date Reviewed
p.000026: Page 2 of 8
p.000026: PHC-IERB-01-31-00
p.000026:
p.000026: PHILIPPINE HEART CENTER
p.000026:
p.000026: QUALITY MANUAL
p.000026: 5 Procedure
p.000026: Title
p.000026: 3.6
p.000026: MANAGEMENT OF PROTOCOL SUBMITTED BY FDA-PPAD
p.000026:
p.000026:
p.000026: Registration Date Effective Date
p.000026:
p.000026:
p.000026: 9 July 2012
p.000026: 16 July 2012
p.000026:
p.000026: 5.1 Receipt of the protocol package The Secretariat:
p.000026: 5.1.1 receives the notification from FDA-PPAD
p.000026: 5.1.2 receives ten (10) copies of the initial protocol package with Initial IERB Application Form -
p.000026: PHC-IERB-03-21-01
p.000026: 5.1.3 stamps “RECEIVED” on the protocol package and signs the document receipt form
p.000026: 5.1.4 encodes the accession number of the protocol package to the assigned FDA-PPAD database.
p.000026:
p.000026: 5.2 Management of the protocol package The Secretariat:
p.000026: 5.2.1 Prepares copies of the protocol package for distribution to the reviewers.
p.000026:
p.000026: 5.3 Conduct of Full Board Review
p.000026: 5.3.1 The IERB Chairman schedules the protocol review
p.000026: 5.3.2 The IERB evaluates the protocol as a full board review in an en banc meeting.
p.000026: 5.3.3 The IERB makes a decision and gives recommendations to the FDA- PPAD.
p.000026: 5.3.4 The IERB members sign the IERB’s decision form.
p.000026:
p.000026: 5.4 Communication of recommendation to FDA -PPAD
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Social / Trade Union Membership
Searching for indicator union:
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p.000002: FDA CLINICAL TRIAL ASSESSMENT FORM 14-19
p.000002: APPROVAL TO CONDUCT CLINICAL TRIAL 20
p.000002: LIST OF ACCREDITED INSTITUTIONS AND SOPs 21-38
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p.000002: GUIDELINES ON THE REGULATION OF CLINICAL TRIALS V. 1.0
p.000002: 2
p.000002:
p.000002: FDA CIRCULAR 2012-007
p.000002:
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p.000002:
p.000002: June 7, 2012
p.000002:
p.000002:
p.000002: FDA Circular No. 2012-007
p.000002:
p.000002:
p.000002: SUBJECT: Recognition of Ethical Review Board/Committee (ERB/ERC) For Purposes of the Conduct of Clinical Trials on
p.000002: Investigational Medicinal Products in the Philippines and for Other Purposes
p.000002:
p.000002:
p.000002:
p.000002: I. RATIONALE AND BACKGROUND
p.000002:
p.000002: The Philippines: An Emerging Destination for Global Clinical Trials
p.000002: In recent years there has been an increase in the number of clinical trials in the Philippines. Of the 10 countries in
p.000002: Southeast Asia, the Philippines ranks third in terms of the number of clinical trials (US NIH, http://
p.000002: clinicaltrials.gov/ct2/search/browse?brwse=locn_cat_SE, Accessed on May 19, 2012).Based on the 2009 report by the
p.000002: European Medicines Agency, the Philippines is ranked as number 8 among the top 10 countries worldwide with a high
p.000002: annual growth rate of 30.9 % in clinical trials. Clinical trials emanating from the European Union increased from 2 in
p.000002: 2005 to 25 in 2008 with a corresponding increase in the number of trial participants from 67 to 3,042 respectively.
p.000002: Likewise, trials emanating from the US increased from 3 in 2000 to 363 in 2009. The Philippines currently ranks third
p.000002: in Southeast Asia with 528 ongoing global trials, after Thailand with 1094, and Singapore with 958
p.000002: (www.clinicaltrials.gov, accessed on June 5, 2012). FDA received 396 clinical trial
p.000002: applications in 2009; 339 in 2010, and 335 in 2011.
p.000002: As recruitment for volunteers become more intense with the anticipated increase in clinical studies and
p.000002: given the vulnerabilities of the majority of our people because of poor health, economic status, abuse or poor
p.000002: orientation and lack of awareness of their rights, there is an urgent need to improve regulatory function and promote
p.000002: cooperation between DOH-FDA and other quasi-regulatory agencies suchas the Philippine Health Research Ethics Board
p.000002: (PHREB) of the Philippines National Research Health System (PNHRS) to better ensure that every Filipino
p.000002: patient who volunteers to participate in clinical research studies is accorded due protection as embodied in the
p.000002: Philippine Constitution.
p.000002: As part of the quest to attain a higher level of competitiveness for the country, there is a need to find a more
p.000002: efficient system that should be benchmarked with global models.
p.000002:
...
Social / Victim of Abuse
Searching for indicator abuse:
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p.000002: Investigational Medicinal Products in the Philippines and for Other Purposes
p.000002:
p.000002:
p.000002:
p.000002: I. RATIONALE AND BACKGROUND
p.000002:
p.000002: The Philippines: An Emerging Destination for Global Clinical Trials
p.000002: In recent years there has been an increase in the number of clinical trials in the Philippines. Of the 10 countries in
p.000002: Southeast Asia, the Philippines ranks third in terms of the number of clinical trials (US NIH, http://
p.000002: clinicaltrials.gov/ct2/search/browse?brwse=locn_cat_SE, Accessed on May 19, 2012).Based on the 2009 report by the
p.000002: European Medicines Agency, the Philippines is ranked as number 8 among the top 10 countries worldwide with a high
p.000002: annual growth rate of 30.9 % in clinical trials. Clinical trials emanating from the European Union increased from 2 in
p.000002: 2005 to 25 in 2008 with a corresponding increase in the number of trial participants from 67 to 3,042 respectively.
p.000002: Likewise, trials emanating from the US increased from 3 in 2000 to 363 in 2009. The Philippines currently ranks third
p.000002: in Southeast Asia with 528 ongoing global trials, after Thailand with 1094, and Singapore with 958
p.000002: (www.clinicaltrials.gov, accessed on June 5, 2012). FDA received 396 clinical trial
p.000002: applications in 2009; 339 in 2010, and 335 in 2011.
p.000002: As recruitment for volunteers become more intense with the anticipated increase in clinical studies and
p.000002: given the vulnerabilities of the majority of our people because of poor health, economic status, abuse or poor
p.000002: orientation and lack of awareness of their rights, there is an urgent need to improve regulatory function and promote
p.000002: cooperation between DOH-FDA and other quasi-regulatory agencies suchas the Philippine Health Research Ethics Board
p.000002: (PHREB) of the Philippines National Research Health System (PNHRS) to better ensure that every Filipino
p.000002: patient who volunteers to participate in clinical research studies is accorded due protection as embodied in the
p.000002: Philippine Constitution.
p.000002: As part of the quest to attain a higher level of competitiveness for the country, there is a need to find a more
p.000002: efficient system that should be benchmarked with global models.
p.000002:
p.000002: II. OBJECTIVES
p.000002: In addition to the objectives laid down in the Rules and Regulations implementing Republic Act No. 9711, this Order is
p.000002: hereby formulated to:
p.000002: To accord due protection to human subjects of clinical trials and ensure the generation of research
p.000002: findings of strong scientific merit, FDA grants recognition and empowersselected institution-based
p.000002:
p.000002:
p.000001: 1
p.000001: FDA AUGUST 31, 2012
p.000001:
p.000001: Ethical Review Board/Committees (ERB/ERCs)undertaketheethical and technical evaluation of clinical trials for
p.000001: the purpose of recommending, to the FDA, the approval of such studies for conduct in the Philippines.
p.000001: To require mandatory ethical and technical reviews by accredited independent review committees of experts in
...
Social / Youth/Minors
Searching for indicator minor:
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p.000008:
p.000008: b. All Other Unexpected Serious ADRs
p.000008: Serious, unexpected reactions (ADRs) that are not fatal or life-threatening, whether onsite or offsite, must be filed
p.000008: as soon as possible but no later than 15 calendar days after first knowledge by the sponsor that the case meets the
p.000008: minimum criteria for expedited reporting.
p.000008: 2. ExpectedAdverse Drug Reactions
p.000008: a. Serious adverse drug reactions which are expected based on information from Investigator’s
p.000008: Brochure will be reported in the regular progress report and final report.
p.000008:
p.000008: b. Adverse drug reactions which are not serious will also be reported in the regular progress report
p.000008: and final report.
p.000008:
p.000008: G. Termination of Clinical Trial and Sanctions
p.000008: For the effective implementation of this Circular, this Office shall order the termination of an on-going clinical
p.000008: trial without need of a hearing should the result of random trial sites inspections reveal any major violation(s),
p.000008: notifying only the concerned establishment of such termination. Other sanction(s) to concerned entities shall be
p.000008: imposed respectively under the following instances of violations and the table below:
p.000008: 1. The result of the random clinical trial sites inspections shall have the following categories:
p.000008: a. No violation - No objectionable conditions or practices were found during the inspection, or the significance
p.000008: of the documented objectionable conditions found does not justify further FDA action (from USFDA). Compliant to GCP
p.000008: rules and approved protocol
p.000008: b. Minor violations - Regulatory violations uncovered during the inspection are few and do not seriously impact
p.000008: subject safety or data integrity.
p.000008: c. Major violations-The regulatory violation(s) uncovered is/are significant/serious and/or numerous, and
p.000008: the scope, severity, or pattern of violation(s) support a finding that:
p.000008: 1) Subjects under the care of the investigator would be or have been exposed to an
p.000008: unreasonable and significant risk of illness or injury.
p.000008: 2) Subjects’ rights would be or have been seriously compromised. OR
p.000008: 3) Data integrity or reliability is or has been compromised.
p.000008: 4) Non disclosure of conflict of interest by the investigator and other members of the trial
p.000008: team
p.000008: 5) Failure to get an informed consent is a major violation
p.000008:
p.000008: Any pharmaceutical product the clinical trial of which has been ordered terminated by FDA shall be a ground for the
p.000008: invalidation of data for drug registration purposes and accordingly disapproval of subsequent application for product
p.000008: registration pursuant to Paragraphs (1) or (6), Item B, Section 4, Article I, Book II of the Implementing Rules and
p.000008: Regulations of Republic Act No. 9711 on ground that application requirements does not meet the required technical
p.000008: requirements or appropriate standards, or such other analogous grounds or causes as determined by the FDA.
p.000008: 2. Disciplinary actions shall be imposed on the following after finalizing the Inspection Report by
p.000008: the Legal Division of the FDA.
p.000008:
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p.000009: 9
p.000009: FDA AUGUST 31, 2012
p.000009:
p.000009: Entity/Individual
p.000009: Researcher
p.000009:
p.000009:
p.000009: Sponsor
p.000009: Ethics Review Committee The FDA shall recommend appropriate action to the PHREB based on inspection findings.
p.000009: Minor Violation(s)
p.000009: Warning, re-inspection
p.000009:
p.000009:
p.000009: Warning, re-inspection Warning, re-inspection
p.000009: Major Violation(s)
p.000009: Suspension from conduct of
p.000009: researches from (range in months or years) depending on the type
p.000009: and degree of violation Termination of trial, invalidation of
p.000009: data for drug registration purposes Suspension from the conduct
p.000009: of reviews for (range in months/ years) depending on the type and degree of violation
p.000009: H. Archiving and Database Management
p.000009: All original and latest approved versions of CT protocols, IB, Informed Consent, ERC proof of approval,
p.000009: summary of amendments, and final CT report including summary of safety reports shall be recorded, filed and archived by
p.000009: the clinical unit of the FDA.
p.000009: Stored files shall be accessed only by duly authorized personsand shall be stored and disposed thereafter in a manner
p.000009: as may be provided by existing laws, rules and regulations. Disposal of files shall be in coordination with the
p.000009: Records Section of the Administrative Division which shall seek approval from the National Archives of the Philippines.
p.000009:
p.000009: VI. SUPERVISION AND OVERSIGHT
p.000009: The Policy Planning and Advocacy Division (PPAD) shall supervise and provide technical guidance in the implementation
p.000009: of this Circular. The Clinical Trial Management staff shall prepare and submit quarterly reports to the Chief of the
p.000009: PPAD on the status of implementation, issues and problems and proposed solutions.
p.000009: Likewise, the PPAD shall provide the FDA MANCOM an annual report on the implementation of this Circular.
p.000009:
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p.000002:
p.000002:
p.000002: SUBJECT: Recognition of Ethical Review Board/Committee (ERB/ERC) For Purposes of the Conduct of Clinical Trials on
p.000002: Investigational Medicinal Products in the Philippines and for Other Purposes
p.000002:
p.000002:
p.000002:
p.000002: I. RATIONALE AND BACKGROUND
p.000002:
p.000002: The Philippines: An Emerging Destination for Global Clinical Trials
p.000002: In recent years there has been an increase in the number of clinical trials in the Philippines. Of the 10 countries in
p.000002: Southeast Asia, the Philippines ranks third in terms of the number of clinical trials (US NIH, http://
p.000002: clinicaltrials.gov/ct2/search/browse?brwse=locn_cat_SE, Accessed on May 19, 2012).Based on the 2009 report by the
p.000002: European Medicines Agency, the Philippines is ranked as number 8 among the top 10 countries worldwide with a high
p.000002: annual growth rate of 30.9 % in clinical trials. Clinical trials emanating from the European Union increased from 2 in
p.000002: 2005 to 25 in 2008 with a corresponding increase in the number of trial participants from 67 to 3,042 respectively.
p.000002: Likewise, trials emanating from the US increased from 3 in 2000 to 363 in 2009. The Philippines currently ranks third
p.000002: in Southeast Asia with 528 ongoing global trials, after Thailand with 1094, and Singapore with 958
p.000002: (www.clinicaltrials.gov, accessed on June 5, 2012). FDA received 396 clinical trial
p.000002: applications in 2009; 339 in 2010, and 335 in 2011.
p.000002: As recruitment for volunteers become more intense with the anticipated increase in clinical studies and
p.000002: given the vulnerabilities of the majority of our people because of poor health, economic status, abuse or poor
p.000002: orientation and lack of awareness of their rights, there is an urgent need to improve regulatory function and promote
p.000002: cooperation between DOH-FDA and other quasi-regulatory agencies suchas the Philippine Health Research Ethics Board
p.000002: (PHREB) of the Philippines National Research Health System (PNHRS) to better ensure that every Filipino
p.000002: patient who volunteers to participate in clinical research studies is accorded due protection as embodied in the
p.000002: Philippine Constitution.
p.000002: As part of the quest to attain a higher level of competitiveness for the country, there is a need to find a more
p.000002: efficient system that should be benchmarked with global models.
p.000002:
p.000002: II. OBJECTIVES
p.000002: In addition to the objectives laid down in the Rules and Regulations implementing Republic Act No. 9711, this Order is
p.000002: hereby formulated to:
p.000002: To accord due protection to human subjects of clinical trials and ensure the generation of research
p.000002: findings of strong scientific merit, FDA grants recognition and empowersselected institution-based
p.000002:
p.000002:
p.000001: 1
p.000001: FDA AUGUST 31, 2012
p.000001:
p.000001: Ethical Review Board/Committees (ERB/ERCs)undertaketheethical and technical evaluation of clinical trials for
p.000001: the purpose of recommending, to the FDA, the approval of such studies for conduct in the Philippines.
p.000001: To require mandatory ethical and technical reviews by accredited independent review committees of experts in
...
Orphaned Trigger Words
p.000001: A. FDA Recognition of PHREB-Accredited IRBs to Serve as Ethical and Technical Reviewers for Clinical Trial
p.000001: Applications
p.000001: The FDA recognizes the following IRBs/ERCs of institutions based on the recommendation of the PHREB:
p.000001: 1. University of the Philippines Manila –National Institutes of Health (UPM-NIH)
p.000001: 2. De La Salle University Health Sciences Institute
p.000001: 3. St. Luke’s Medical Center for Clinical Trials
p.000001:
p.000001:
p.000001: GUIDELINES ON THE REGULATION OF CLINICAL TRIALS V. 1.0
p.000002: 2
p.000002:
p.000002: The list will be subject to updating based on PHREB’s continuing accreditation of institutions and compliance with
p.000002: other requirements of FDA.
p.000002: As shown in Figure 1, the ERB/ERCs will submit recommendations to the FDAfor the approval or denial of clinical trial
p.000002: protocols subjected to review. FDA, after due deliberation will renderthe decision for approval or denial.
p.000002:
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p.000002:
p.000002:
p.000002: Figure 1
p.000002: Approval Process for Clinical Trial Applications
p.000002:
p.000002: The FDA will also coordinate with the ERB/ERCs as well as the PHREB on all matters related to the applications under
p.000002: review to resolve whatever issues will arise.
p.000002:
p.000002: B. Mandatory FDA Approval for All Phase I to IV Clinical Trials
p.000002: All clinical studies, from Phase I to IV, including amendment(s) thereto, require mandatory approval from the FDA to
p.000002: ensure that clinical trials intended to be conducted in the country that involve the recruitment of Filipinos as
p.000002: volunteer subjects conform to the highest ethical and technical standards of clinical research. Approval will be based
p.000002: on results of the evaluation that will be carried out by accredited ERB/ERBs.
p.000002:
p.000002: V. IMPLEMENTATION GUIDELINES
p.000002:
p.000002: A. In line with the recognition of accredited ERB/ERCs, the Policy Planning and Advocacy Division (PPAD) of the FDA
p.000002: is mainly responsible for providing supervision and oversight (VI. Supervision and Oversight) in the regulation of
p.000002: clinical trials. The Clinical Trial Management Unit under PPAD will be:
p.000002:
p.000002:
p.000003: 3
p.000003: FDA AUGUST 31, 2012
p.000003:
p.000003: 1. Responsible for handling the filing of the application, issuance of the Clinical Trial Reference No. and “Permit
p.000003: for ERB/ERC Review” and approval to conduct clinical trials. PPAD is also responsible for handling amendments to the
p.000003: clinical trial protocols that must be approved by the FDA Director.
p.000003: 2. Responsible for coordinating with the ERB/ERCs on matters relevant to the conduct of the ethical and technical
p.000003: review of clinical trial protocols.
p.000003: 3. Coordinating with PSD who will conduct the review of Part B- Pharmaceutical Data and the issuance of the Import
p.000003: Permit.In addition, PPAD must ascertain that the Regulation Division I beproperly informed of Import Permit issuances
p.000003: to facilitate processing with the Bureau of Customs.
p.000003: 4. Receiving and acting on amendments and other changes to the clinical trial protocol and coordinating
p.000003: closely with ERB/ERCs
p.000003: 5. Monitoring compliance to mandatory requirement for participation in the Philippines Clinical Trial Registry
p.000003: 6. PPAD will be responsible for conducting on-site inspections of clinical trials; it is imperative that capacity for
p.000003: this be developed as soon as possible.
p.000003: 7. Coordinating with the FDA ADR Unit which is mainly responsible for receiving, analyzing and reporting on Safety
p.000003: Reporting
p.000003: 8. Responsible for maintaining data on statistics and formulating reports for submission regularly to the FDA
p.000003: Director.
p.000003:
p.000003:
p.000003: B. The Product Services Division is responsible for evaluating the pharmaceutical data of new
p.000003: pharmaceutical products to ascertain that Chemistry, Manufacturing and Controls (CMC) and Good Manufacturing Practice
p.000003: (GMP) standards are met to ascertain the safety of the product for use by clinical trial subjects. Furthermore, PSD
p.000003: is also responsible for issuing the Import Permit. The review of pharmaceutical data must be accomplished within a
p.000003: reasonably efficient timeframe not to exceed thirty (30) calendar days from receipt thereof from PPAD, and issuance of
p.000003: the Import Permit not to exceed seven (7) working days from receipt of application.
p.000003:
p.000003: C. The ADR Unit will be the unit responsible for receiving and analyzing reports on Adverse Events.
p.000003:
p.000003: D. FDA reserves the right to terminate any clinical trial found to be violative of existing regulations or deviates
p.000003: from the approved protocol and monitoring plan.
p.000003:
p.000003: E. Submission of Application to the FDA
p.000003: 1. Applicant company files applications to the FDA which will set one day of the week, schedule subject to
p.000003: announcement, for receiving applications from eight (8) in the morning to three (3) in the afternoon.
p.000003:
p.000003: 2. Steps in the filing:
p.000003: a. File application to PPAD-PAICS for assessment
p.000003: b. Go to Accounting Section for validation of Order of Payment
p.000003: c. Go to Cashier Section to pay the fee and secure an Official Receipt (OR)
p.000003: d. Return to PPAD-PAICS, present OR and secure Clinical Trial Reference Number. Submit documents and receive
p.000003: “Permit for ERB/ERC Review” which will signal the accredited ERB/ERCs to conduct the ethical and technical review.
p.000003: 3. Documents to be submitted will include those in Parts A, B and C and such other documents or
p.000003: data as hereinafter be required by FDA to ascertain safety, efficacy and quality of the products
p.000003:
p.000003:
p.000003: GUIDELINES ON THE REGULATION OF CLINICAL TRIALS V. 1.0
p.000004: 4
p.000004:
p.000004: that will be subject to clinical study.
p.000004: a. PART A: Clinical Trial Protocol and other Pertinent Documents
p.000004: o Name and dosage form of product
p.000004: o Title and aim of the trial
p.000004: o Description of the trial design
p.000004: o Description of the subjects
p.000004: o Treatment profile
p.000004: o Operational aspects
p.000004: o Adverse events
p.000004: o Evaluation of results
p.000004: o Informed consent form, Case Report Form and Patient Information Sheet
p.000004: o Resumes of Principal and other Investigators
p.000004: o For multi-center studies, a list of Principal Investigators (and CVs) including trial sites
p.000004: b. PART B: Pharmaceutical Data
p.000004: To ascertain the quality and safety of the IPand to protect clinical trial subjects, FDA needs to ensure that the IP’s
p.000004: CMC and manufacturing process is in compliance with acceptable standards (GMP).
p.000004: o GMP statement from manufacturing/Certificate from Regulatory Body
p.000004: o Certificate of Analysis
p.000004: o Stability Data (storage conditions)
p.000004: o Manufacturing Data & Formulation
p.000004: o Product labeling (coded & labeled: blinding)
p.000004: c. PART C: Investigator’s Brochure (Efficacy and Safety Data)
p.000004: Safety Data:
p.000004: o Non-Clinical Studies
p.000004: o Pharmacology; PK/PD studies
p.000004: o Toxicology Studies
p.000004: o Marketing Experience, Periodic Safety Update Reports (PSUR), product status if marketed abroad
p.000004: o Risks and ADR anticipated
p.000004: Efficacy Data
p.000004: o PK/PD Data in human subjects
p.000004: o In-house preliminary data
p.000004: o Summaries of clinical trial studies conducted (Phase I, II, III)
p.000004: o Published clinical data
p.000004:
p.000004:
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p.000005: 5
p.000005: FDA AUGUST 31, 2012
p.000005:
p.000005: 4. Submission of documents:
p.000005: Documents may be submitted as hardcopy or electronic file based on preference of FDA and
p.000005: ERB/ERC.
p.000005: Figure 2 below shows algorithm of submission of application to the FDA.
p.000005: Figure2
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p.000019:
p.000019: GUIDELINES ON THE REGULATION OF CLINICAL TRIALS V. 1.0
p.000020: 20
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020: LIST OF ACCREDITED INSTITUTIONS AS OF JULY 2012 AND THEIR
p.000020: STANDARD OPERATING PROCEDURES OF ACCREDITED INSTITUTIONS
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020: ACCREDITED INSTITUTIONS
p.000020: 1. De La Salle Health Sciences Institute
p.000020: 2. Research Institute for Tropical Medicine
p.000020: 3. Philippine Heart Center
p.000020: 4. St. Luke’s Medical Center
p.000020: 5. University of Santo Tomas
p.000020: 6. University of the Philippines
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p.000021: 21
p.000021: FDA AUGUST 31, 2012
p.000021:
p.000021: DE LA SALLE HEALTH SCIENCES INSTITUTE
p.000021:
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p.000021:
p.000021:
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p.000021:
p.000021: De La Salle Health Sciences Institute
p.000021: Dasmarinas City, Cavite, 4114 Philippines
p.000021:
p.000021:
p.000021: Guidelines for Regulatory Review of Clinical Trials
p.000021:
p.000021: 1. The company or study sponsor must first file an application for assessment at the Food and Drugs Administration
p.000021: (FDA). The applicant company shall likewise obtain necessary papers for the conduct of an ethical and technical review
p.000021: and submit to the FDA the required documents to ascertain safety, efficacy and quality of the products that will be
p.000021: subject to clinical study.
p.000021:
p.000021: 2. The FDA shall inform the applicant company to which Institutional Review Board/Ethics Review Board
p.000021: (IRB/ERB) they shall be assigned to. Study sponsors assigned to the De La Salle Health Sciences Institute (DLSHSI)
p.000021: IRB/ERB shall submit the protocols and other requirements to Mr. Andrew Casipi, the Project Coordinator for Clinical
p.000021: Trials, at the following address:
p.000021:
p.000021: Office of the Vice Chancellor for Research
p.000021: 3/F Room 6301, Angelo King Medical Research Center, De La Salle Health Sciences Institute,
p.000021: Gov. D. Mangubat Ave., Burol Main,
p.000021: Dasmariñas City, Cavite 4114
p.000021:
p.000021: 3. Documents to be submitted will include those in Parts A, B and C and such other documents or data as required by
p.000021: FDA to ascertain safety, efficacy and quality of the products that will be subject to clinical study.
p.000021:
p.000021: 3.1 PART A: Clinical Trial Protocol and other Pertinent Documents
p.000021:
p.000021: 3.1.1 Name and dosage form of product
p.000021: 3.1.2 Title and aim of the trial
p.000021: 3.1.3 Description of the trial design
p.000021: 3.1.4 Description of the subjects
p.000021: 3.1.5 Treatment profile
p.000021: 3.1.6 Operational aspects
p.000021: 3.1.7 Adverse events
p.000021: 3.1.8 Evaluation of results
p.000021: 3.1.9 Informed Consent Form, Case Report Form and Patient Information Sheet
p.000021: 3.1.10 Resumes of Principal and other Investigators
p.000021: 3.1.11 For multi-center studies, a list of Principal Investigators (and CVs) including Trial Sites
p.000021:
p.000021:
p.000021: GUIDELINES ON THE REGULATION OF CLINICAL TRIALS V. 1.0
p.000022: 22
p.000022:
p.000022: 3.2 PART B: Pharmaceutical Data to ascertain the quality and safety of the Investigational Product and to protect
p.000022: clinical trial subjects, FDA needs to ensure that the IP’s CMC and manufacturing process is in compliance with
p.000022: acceptable standards (GMP).
p.000022:
p.000022: 3.2.1 GMP statement from manufacturing/Certificate from Regulatory Body
p.000022: 3.2.2 Certificate of Analysis
p.000022: 3.2.3 Stability Data (storage conditions)
p.000022: 3.2.4 Manufacturing Data & Formulation
p.000022: 3.2.5 Product labeling (coded & labeled: blinding)
p.000022:
p.000022: 1.3 PART C: Investigator’s Brochure (Efficacy and Safety Data)
p.000022:
p.000022: 1.3.1 Safety Data
p.000022: 3.3.1a Non-Clinical Studies
p.000022: 3.3.1b Pharmacology; PK/PD studies 3.3.1c Toxicology Studies
p.000022: 3.3.1d Marketing Experience, Periodic Safety Update Reports (PSUR), product status if marketed abroad
p.000022: 3.3.1e Risks and ADR anticipated
p.000022:
p.000022: 1.3.2 Efficacy Data
p.000022: 3.3.2a PK/PD Data in human subjects 3.3.2b In-house preliminary data
p.000022: 3.3.2c Summaries of clinical trial studies conducted (Phase I, II, III)
p.000022: 3.3.2d Published clinical data
p.000022:
p.000022: 3 The following are required to be submitted for the regulatory review at DLSHSI:
p.000022: 3.3 One (1) electronic copy (compact disc) of Parts A and C.
p.000022: 3.4 Four (4) hard copies of Parts A and C
p.000022: 3.5 One (1) hard copy of Part B
p.000022: 3.6 Clinical Trial Reference Number from FDA
p.000022: 3.7 Permit for Regulatory Review from FDA
p.000022: 3.8 Check payment for Regulatory Review
p.000022:
p.000022: 4 The check payment must be payable to De La Salle Health Sciences Institute in the amount of Thirty Thousand Pesos
p.000022: (PhP 30,000.00 – not subject to tax). The review process will commence only upon receipt of the full
...
p.000023: (60) days from the start of the review process.
p.000023:
p.000023:
p.000023: For further inquiries, please contact:
p.000023:
p.000023: Mr. Andrew C. Casipi
p.000023: Project Coordinator for Clinical Trials Mobile No: 09207316391 or 09166194617
p.000023: Telefax: (046) 481-8000 local 4000 e-mail: casipi_andrew@yahoo.com
p.000023:
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p.000023: GUIDELINES ON THE REGULATION OF CLINICAL TRIALS V. 1.0
p.000024: 24
p.000024:
p.000024: RESEARCH INSTITUTE FOR TROPICAL MEDICINE
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p.000024: Co-chair, RITM IRB
p.000025: 25
p.000025: FDA AUGUST 31, 2012
p.000025:
p.000025: PHILIPPINE HEART CENTER
p.000025:
p.000025:
p.000025:
p.000025: Department / Division
p.000025: INSTITUTIONAL ETHICS REVIEW BOARD
p.000025:
p.000025: Page Number P/P Number
p.000025:
p.000025: Date Reviewed
p.000025: Page 1 of 8
p.000025:
p.000025: PHC-IERB-01-31-00
p.000025:
p.000025: PHILIPPINE HEART CENTER
p.000025:
p.000025: QUALITY MANUAL
p.000025: Title
p.000025: 3.6
p.000025: MANAGEMENT OF PROTOCOL SUBMITTED BY FDA-PPAD
p.000025:
p.000025:
p.000025: Registration Date Effective Date
p.000025:
p.000025:
p.000025: 9 July 2012
p.000025: 16 July 2012
p.000025: 1. Purpose
p.000025: To describe how the Institutional Ethics Review Board (IERB) manages protocol submitted by sponsor/s for
p.000025: regulatory review by FDA-PPAD.
p.000025:
p.000025: 2. Scope
p.000025:
p.000025: It covers the actions done from the time of submission of documents for IERB review by the sponsor to the IERB
p.000025: Secretariat to the return of same regulatory review documents to the FDA-PPAD.
p.000025:
p.000025: 3. Responsibility
p.000025:
p.000025: Secretariat – receives the initial protocol package and payment for the protocol review PPAD – sends the notification
p.000025: letter to the PHC IERB
p.000025: Sponsor – submits protocol package and payment for protocol review to PHC IERB IERB – evaluates the protocol and sends
p.000025: report and recommendations to FDA-PPAD
p.000025:
p.000025: 4. Policy
p.000025:
p.000025: 4.1 The PHC IERB shall receive permit letter regarding a protocol for regulatory review from
p.000025: FDA-PPAD.
p.000025:
p.000025: 4.2 The sponsor shall submit a protocol package to the PHC IERB.
p.000025:
p.000025: 4.3 Requirements for protocol submission can be accessed from the IERB Secretariat or through email
p.000025: (irbphc@gmail.com). The protocol package will be send by FDA to IERB.
p.000025:
p.000025: 4.4 The sponsor shall pay PHC-IERB an amount of P30,000.00 for every protocol review.
p.000025: 4.4.1 The sponsor shall give payment to PHC cashier for PHC IERB protocol review.
p.000025: 4.4.2 A copy of official receipt shall be forwarded to the IERB secretariat.
p.000025:
p.000025: 4.5 The Chairman shall invite an independent consultant for non-cardiology and non- pulmonary
p.000025: protocol.
p.000025:
p.000025: 4.6 The Board Secretary shall document all meetings regarding review of all protocols including decisions and
p.000025: recommendations to the FDA-PPAD.
...
p.000026: 5.1.1 receives the notification from FDA-PPAD
p.000026: 5.1.2 receives ten (10) copies of the initial protocol package with Initial IERB Application Form -
p.000026: PHC-IERB-03-21-01
p.000026: 5.1.3 stamps “RECEIVED” on the protocol package and signs the document receipt form
p.000026: 5.1.4 encodes the accession number of the protocol package to the assigned FDA-PPAD database.
p.000026:
p.000026: 5.2 Management of the protocol package The Secretariat:
p.000026: 5.2.1 Prepares copies of the protocol package for distribution to the reviewers.
p.000026:
p.000026: 5.3 Conduct of Full Board Review
p.000026: 5.3.1 The IERB Chairman schedules the protocol review
p.000026: 5.3.2 The IERB evaluates the protocol as a full board review in an en banc meeting.
p.000026: 5.3.3 The IERB makes a decision and gives recommendations to the FDA- PPAD.
p.000026: 5.3.4 The IERB members sign the IERB’s decision form.
p.000026:
p.000026: 5.4 Communication of recommendation to FDA -PPAD
p.000026: 5.4.1 The recommendations to FDA-PPAD are categorized into:
p.000026: 5.4.1.1 Approval
p.000026: 5.4.1.2 Deferment of action pending recommendation of condition under section 8
p.000026: 5.4.1.3 Disapproval
p.000026: 5.4.2 The IERB copy furnishes the FDA-PPAD of all communications with the sponsor.
p.000026: 5.4.3 The IERB gives final recommendation/s to the FDA-PPAD within 60 days.
p.000026: 5.4.4 The Secretariat returns all regulatory review documents to FDA-PPAD for archiving.
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p.000027: 27
p.000027: FDA AUGUST 31, 2012
p.000027:
p.000027: Department / Division
p.000027: INSTITUTIONAL ETHICS REVIEW BOARD
p.000027: Page Number P/P Number
p.000027:
p.000027: Date Reviewed
p.000027: Page 4 of 8
p.000027:
p.000027: PHC-IERB-01-31-00
p.000027:
p.000027: PHILIPPINE HEART CENTER
p.000027:
p.000027: QUALITY MANUAL
p.000027: Title
p.000027: 3.6
p.000027: MANAGEMENT OF PROTOCOL SUBMITTED BY FDA-PPAD
p.000027:
p.000027:
p.000027: Registration Date Effective Date
p.000027:
p.000027:
p.000027: 9 July 2012
p.000027: 16 July 2012
p.000027:
p.000027: 7 Annex
p.000027: Annex 1 - Document Receipt Form - PHC-IERB-03-14-01 Annex 2 - Initial IERB Application Form -
p.000027: PHC-IERB-03-21-01
p.000027:
p.000027: 8 References
p.000027: 8.1 World Health Organization, Operational Guidelines for Ethics Committees that Review Biomedical Research, 2000.
p.000027: 8.2 FERCAP SOP 2006
p.000027: 8.3 International Conference on Harmonization, Guidance on Good Clinical Practice (ICH GCP) 1996.
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p.000027:
p.000027: Annex 1
p.000027:
p.000027: GUIDELINES ON THE REGULATION OF CLINICAL TRIALS V. 1.0
p.000028: 28
p.000028:
p.000028: Department / Division
p.000028: INSTITUTIONAL ETHICS REVIEW BOARD
p.000028: Page Number P/P Number
p.000028: Date Reviewed
p.000028: Page 5 of 8
p.000028: PHC-IERB-01-31-00
p.000028:
p.000028: PHILIPPINE HEART CENTER
p.000028: QUALITY MANUAL
p.000028: Title
p.000028: 3.6
p.000028: MANAGEMENT OF PROTOCOL SUBMITTED BY FDA-PPAD
p.000028:
p.000028:
p.000028: Registration Date Effective Date
p.000028:
p.000028:
p.000028: 9 July 2012
p.000028: 16 July 2012
p.000028:
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p.000028: Annex 2
p.000028:
p.000028:
p.000029: 29
p.000029: FDA AUGUST 31, 2012
p.000029:
p.000029: Department / Division
p.000029: INSTITUTIONAL ETHICS REVIEW BOARD
p.000029: Page Number P/P Number
p.000029:
p.000029: Date Reviewed
p.000029: Page 6 of 8
p.000029:
p.000029: PHC-IERB-01-31-00
p.000029:
p.000029: PHILIPPINE HEART CENTER
p.000029:
p.000029: QUALITY MANUAL
p.000029: Title
p.000029: 3.6
p.000029: MANAGEMENT OF PROTOCOL SUBMITTED BY FDA-PPAD
p.000029:
p.000029:
p.000029: Registration Date Effective Date
p.000029:
p.000029:
p.000029: 9 July 2012
p.000029: 16 July 2012
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p.000029: GUIDELINES ON THE REGULATION OF CLINICAL TRIALS V. 1.0
p.000030: 30
p.000030:
p.000030: Department / Division
p.000030: INSTITUTIONAL ETHICS REVIEW BOARD
p.000030: Page Number P/P Number
p.000030: Date Reviewed
p.000030: Page 7 of 8
p.000030: PHC-IERB-01-31-00
p.000030:
p.000030: PHILIPPINE HEART CENTER
p.000030: QUALITY MANUAL
p.000030: Title
p.000030: 3.6
p.000030: MANAGEMENT OF PROTOCOL SUBMITTED BY FDA-PPAD
p.000030:
p.000030:
p.000030: Registration Date Effective Date
p.000030:
p.000030:
p.000030: 9 July 2012
p.000030: 16 July 2012
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p.000031: 31
p.000031: FDA AUGUST 31, 2012
p.000031:
p.000031: ST LUKE’S MEDICAL CENTER
p.000031:
p.000031:
p.000031: INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE
p.000031: Submission of Protocols for
p.000031: Regulatory Review
p.000031: SL-IERC SOP # 3.7
p.000031: Effective Date:
p.000031: July 2012
p.000031:
p.000031:
p.000031: 1. PURPOSE
p.000031: To ensure a standard process of submission of protocols for regulatory review.
p.000031:
p.000031: 2. SCOPE
p.000031: From the submission of protocol package, payment of regulatory review fee, conduct of review and forwarding of final
p.000031: recommendation to FDA
p.000031:
p.000031: 3. FLOWCHART
p.000031:
p.000031: PROCESS PERSON/S RESPONSIBLE
p.000031:
p.000031:
p.000031: Submission of Protocol Package with FDA-PPAD Notification/Permit
p.000031:
p.000031:
p.000031: Receipt of documents for regulatory review
p.000031:
p.000031:
p.000031: Evaluation of completeness of Protocol Package using Regulatory Review Submission Checklist
p.000031: Sponsor
p.000031:
p.000031:
p.000031: Secretariat
p.000031:
p.000031:
p.000031: Secretariat
p.000031:
p.000031:
p.000031:
p.000031: If incomplete, information sent to concerned Sponsor/FDA
p.000031: If complete, assignment of a Regulatory Review Tracking #
p.000031:
p.000031:
p.000031: Payment of Regulatory Review Fee
p.000031:
p.000031:
p.000031: Scheduling of joint IERC/ISRC meeting for the regulatory review
p.000031:
p.000031: Secretariat
p.000031:
p.000031:
p.000031: Sponsor Secretariat
p.000031:
p.000031: 4. PROCEDURE
p.000031: 4.1. Submission of Protocol: The sponsor shall submit the complete protocol package to:
p.000031:
p.000031: St. Luke’s-Institutional Ethics Review Committee
p.000031: Research and Biotechnology Division, Center for Clinical Trials Annex III, 5th Floor
p.000031: St. Luke’s Medical Center-Quezon City 279 E. Rodriguez Sr., Blvd, Quezon City Philippines 1102
p.000031: Contact Person: Anita B. Ahorro
p.000031: Clinical Trials Administrator
p.000031: Tel. No.: (632) 727-5562/7230101 local 7391
p.000031:
p.000031: GUIDELINES ON THE REGULATION OF CLINICAL TRIALS V. 1.0
p.000032: 32
p.000032:
p.000032: INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE
p.000032: Submission of Protocols for
p.000032: Regulatory Review
p.000032: SL-IERC SOP # 3.7
p.000032: Effective Date:
p.000032: July 2012
p.000032:
p.000032:
p.000032: 4.2. Receipt of documents for regulatory review.
p.000032: 4.2.1. The Secretariat shall receive the complete protocol package with the following:
p.000032: • FDA Clinical Trial Reference No.
p.000032: • Permit to Review from FDA
p.000032:
p.000032: 4.2.2. The Secretariat shall log receipt of the protocol package using the Regulatory Review Tracking Form and a
p.000032: designated logbook. (Refer to SL-IERC Form #20A)
p.000032: 4.3. Evaluation of completeness of the protocol package based on the Regulatory Review
p.000032: Submission Checklist. (Refer to SL-IERC Form#20B)
p.000032: • If the protocol package is incomplete, Secretariat informs the concerned sponsor/FDA. This is logged in the
p.000032: appropriate Tracking Form.
p.000032: • If the protocol package is complete, the Secretariat assigns a Regulatory Review Tracking # (RRT#) to the
p.000032: protocol.
p.000032: 4.4. Payment of Regulatory Review Fee
p.000032: 4.4.1. Regulatory Review Fee shall be paid in cash or cheque upon confirmation of completeness of protocol package
p.000032: submitted.
p.000032: 4.4.2. All cheque payments shall be made payable to St. Luke’s Medical Center.
p.000032:
p.000032: 4.5. Schedule for review: Secretariat shall
p.000032: • schedule the meeting for the regulatory review after payment of the regulatory review fee.
p.000032: • inform the sponsor of the schedule of the meeting
p.000032: • notify the concerned sponsor that a representative shall be present in case the committee en banc raises issues or
p.000032: questions.
p.000032:
p.000032:
p.000032: ---Nothing Follows---
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p.000032:
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| drug | Drug Usage |
| illness | Physically Disabled |
| minor | Youth/Minors |
| officer | Police Officer |
| poor | Economic/Poverty |
| single | Marital Status |
| substance | Drug Usage |
| union | Trade Union Membership |
| volunteers | Healthy People |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['substance'] |
| substance | ['drug'] |
Trigger Words
capacity
consent
ethics
protect
protection
risk
volunteer
Applicable Type / Vulnerability / Indicator Overlay for this Input