0A4F4F9BD490A749D5437F821CF06DF1
Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on the Detailed Arrangements for the Good Clinical Practice Inspection Procedures Pursuant to Regulation (EU) No 536/2014 of the European Parliament and Council
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0556&from=EN
http://leaux.net/URLS/ConvertAPI Text Files/5D84620F0BA191CB18E2880EC49BEBE0.en.txt
Examining the file media/Synopses/5D84620F0BA191CB18E2880EC49BEBE0.html:
This file was generated: 2020-07-15 06:38:53
| 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 / political affiliation
Searching for indicator party:
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p.(None):
p.(None): 5. Inspectors shall be familiar with the procedures and technical methods for the recording and
p.(None): management of clinical data, and with the organisation and regulation of the healthcare systems in the
p.(None): relevant Member States and, where appropriate, in third countries.
p.(None):
p.(None): L 80/10 EN
p.(None): Official Journal of the European Union
p.(None): 25.3.2017
p.(None):
p.(None): 6. Inspectors shall be able to assess the degree of risk as regards the safety of the subjects enrolled in the
p.(None): clinical trial as well as the data integrity.
p.(None):
p.(None): 7. Inspectors shall be aware of the applicable rules as regards confidentiality and protection of personal data.
p.(None):
p.(None): 8. Member States shall keep records of the qualifications, training and experience of each inspector
p.(None): and maintain those records up-to-date for as long as inspector is in active duty.
p.(None):
p.(None):
p.(None): Article 5
p.(None):
p.(None): Conflict of interest and impartiality
p.(None):
p.(None): 1. Inspectors shall be free from any influence which could affect their impartiality or their judgement.
p.(None):
p.(None): 2. Inspectors shall not have conflicts of interest. In particular, they shall be independent of all
p.(None): of the following parties:
p.(None): (a) the sponsor;
p.(None): (b) the investigators involved in the clinical trial;
p.(None): (c) persons financing the clinical trial;
p.(None): (d) any other party involved in the conduct of the clinical trial.
p.(None): 3. Each inspector shall make an annual declaration of their financial interests and other links to
p.(None): the parties to be potentially inspected. That declaration shall be taken into consideration for the
p.(None): purposes of assigning an inspector to a specific inspection.
p.(None):
p.(None): CHAPTER III
p.(None): INSPECTION PROCEDURES
p.(None):
p.(None): Article 6
p.(None):
p.(None): Subject matter of inspections
p.(None):
p.(None): Inspectors shall verify the compliance with the requirements of Regulation (EU) No 536/2014, including protection of
p.(None): the rights and well-being of the clinical trial subjects, the quality and integrity of data generated
p.(None): in clinical trial, the compliance with principles of good clinical practice, including the ethical aspects and the
p.(None): relevant national legislation.
p.(None):
p.(None):
p.(None): Article 7
p.(None):
p.(None): Procedures to be established by Member States
p.(None):
p.(None): 1. Member States shall establish the relevant procedures for at least the following:
p.(None): (a) appointing experts to accompany inspectors, if additional expertise is required for an inspection;
p.(None): (b) arranging inspections outside the Union;
p.(None): (c) verification of good clinical practice compliance, including the modalities for examining the study
p.(None): management procedures and the conditions under which the clinical trial is planned, performed, monitored and recorded,
p.(None): as well as follow-up measures, such as a review of an analysis of the root cause of a significant
...
p.(None): most efficient use of inspection resources when planning their inspections.
p.(None):
p.(None): 4. Member States may request assistance from the national competent authority of another Member State
p.(None): in the matter of inspection.
p.(None):
p.(None):
p.(None): Article 10
p.(None):
p.(None): Powers of inspectors
p.(None):
p.(None): 1. Inspections shall be carried out by inspectors appointed by Member States.
p.(None):
p.(None): In order to ensure the availability of necessary skills for each inspection, Member States may appoint teams of
p.(None): inspectors and appoint experts with appropriate qualifications to accompany inspectors.
p.(None):
p.(None): 2. Inspectors shall be entitled to inspect the clinical trial sites, documents, facilities, records,
p.(None): including individual patients' records, quality arrangements, data and any other resources and entities
p.(None): that are deemed by the competent authority to be related to the clinical trial.
p.(None):
p.(None): 3. When performing an inspection, the inspectors shall be empowered to enter into sites, other related premises,
p.(None): and to access to data, including individual patients' records.
p.(None):
p.(None): 4. Inspectors shall be entitled to make copies of records and hard copies, print-outs of electronic
p.(None): records and take photos of premises and equipment.
p.(None):
p.(None): 5. Inspectors shall be entitled to ask any representative or member of staff of the inspected
p.(None): entity and any party involved in the clinical trial for explanations relating to the subject matter and purpose of
p.(None): the inspection and to record the answer.
p.(None):
p.(None): 6. Inspectors shall be empowered to contact the trial subjects directly, in particular in case of
p.(None): reasonable suspicion that they were not informed adequately of their participation in the clinical trial.
p.(None):
p.(None): 7. Member States shall provide inspectors with suitable means of their identification.
p.(None):
p.(None): 8. Member States shall establish a legal and administrative framework to ensure that inspectors from other Member
p.(None): States, on request and where appropriate, have access to sites, any premise of any entity related to the clinical trial
p.(None): as well as to related data.
p.(None):
p.(None): L 80/12 EN
p.(None): Official Journal of the European Union
p.(None): 25.3.2017
p.(None):
p.(None): Article 11
p.(None):
p.(None): Recognition of inspection conclusions
p.(None):
p.(None): Inspectors shall carry out inspections on behalf of the Union. The results of those inspections shall be recognised by
p.(None): all Member States.
p.(None):
p.(None): In case of divergences between Member States in relation to the verification of compliance with the
p.(None): applicable legislation, the Member States, or the European Medicines Agency within the framework of its powers as
p.(None): provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), shall
p.(None): inform the Commission. The Commission, after consulting those Member States and the European Medicines Agency, may
p.(None): request a new inspection.
p.(None):
p.(None):
...
Health / Drug Usage
Searching for indicator influence:
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p.(None): clinical trials and the granting of marketing authorisations.
p.(None):
p.(None): 4. Inspectors shall have the ability to make professional judgments in relation to the compliance
p.(None): with applicable Union and national legislation and guidelines. They shall be able to assess data
p.(None): integrity as well as aspects related to ethical conduct of clinical trials.
p.(None):
p.(None): 5. Inspectors shall be familiar with the procedures and technical methods for the recording and
p.(None): management of clinical data, and with the organisation and regulation of the healthcare systems in the
p.(None): relevant Member States and, where appropriate, in third countries.
p.(None):
p.(None): L 80/10 EN
p.(None): Official Journal of the European Union
p.(None): 25.3.2017
p.(None):
p.(None): 6. Inspectors shall be able to assess the degree of risk as regards the safety of the subjects enrolled in the
p.(None): clinical trial as well as the data integrity.
p.(None):
p.(None): 7. Inspectors shall be aware of the applicable rules as regards confidentiality and protection of personal data.
p.(None):
p.(None): 8. Member States shall keep records of the qualifications, training and experience of each inspector
p.(None): and maintain those records up-to-date for as long as inspector is in active duty.
p.(None):
p.(None):
p.(None): Article 5
p.(None):
p.(None): Conflict of interest and impartiality
p.(None):
p.(None): 1. Inspectors shall be free from any influence which could affect their impartiality or their judgement.
p.(None):
p.(None): 2. Inspectors shall not have conflicts of interest. In particular, they shall be independent of all
p.(None): of the following parties:
p.(None): (a) the sponsor;
p.(None): (b) the investigators involved in the clinical trial;
p.(None): (c) persons financing the clinical trial;
p.(None): (d) any other party involved in the conduct of the clinical trial.
p.(None): 3. Each inspector shall make an annual declaration of their financial interests and other links to
p.(None): the parties to be potentially inspected. That declaration shall be taken into consideration for the
p.(None): purposes of assigning an inspector to a specific inspection.
p.(None):
p.(None): CHAPTER III
p.(None): INSPECTION PROCEDURES
p.(None):
p.(None): Article 6
p.(None):
p.(None): Subject matter of inspections
p.(None):
p.(None): Inspectors shall verify the compliance with the requirements of Regulation (EU) No 536/2014, including protection of
p.(None): the rights and well-being of the clinical trial subjects, the quality and integrity of data generated
p.(None): in clinical trial, the compliance with principles of good clinical practice, including the ethical aspects and the
p.(None): relevant national legislation.
p.(None):
p.(None):
p.(None): Article 7
p.(None):
p.(None): Procedures to be established by Member States
p.(None):
p.(None): 1. Member States shall establish the relevant procedures for at least the following:
p.(None): (a) appointing experts to accompany inspectors, if additional expertise is required for an inspection;
p.(None): (b) arranging inspections outside the Union;
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): protocol and conducting the clinical trial. To the extent that those guidelines are compatible with the relevant Union
p.(None): law and EU guidelines, inspectors should refer to the ICH guidelines, taking into account the characteristics of each
p.(None): trial.
p.(None):
p.(None): (5) Member States should be required to set up quality systems to ensure that the inspection procedures are
p.(None): observed and consistently monitored. A well-functioning quality system should comprise an organisational structure,
p.(None): clear processes and procedures, including the standard operating procedures to be followed by inspectors
p.(None): when performing their tasks, clearly defined details of the inspectors' duties and responsibilities and ongoing
p.(None): training requirements, as well as adequate resources and mechanisms which aim at eliminating non-compliance.
p.(None):
p.(None): (1) OJ L 158, 27.5.2014, p. 1.
p.(None):
p.(None): L 80/8 EN
p.(None): Official Journal of the European Union
p.(None): 25.3.2017
p.(None):
p.(None): (6) It is necessary to enable inspectors to ensure the practical effectiveness of provisions on good
p.(None): clinical practice. That objective should be reflected in the minimum requirements for the qualification of
p.(None): inspectors, in particular as regards their education and training. For the same reasons, detailed rules on inspection
p.(None): procedures should be laid down.
p.(None):
p.(None): (7) In order to safeguard the effectiveness of inspection, the inspectors should be granted the
p.(None): necessary powers of access to the premises and data. This includes in particular any laboratory used for analysis in
p.(None): the clinical trial, any contract research organisation's facilities or the sponsor's premises. They should
p.(None): also be empowered to contact the trial subjects in justified cases.
p.(None):
p.(None): (8) In order to ensure the compliance with arrangements for good clinical practice inspections and
p.(None): in accordance with Article 77 of Regulation (EU) No 536/2014 Member States should take corrective
p.(None): measures if necessary. When during an inspection a major non-compliance or breach is identified, or the
p.(None): inspectors' investigatory powers are not recognised by the sponsors, Member States should have recourse to penalties.
p.(None):
p.(None): (9) In order to ensure the protection of confidential information, in particular personal data of clinical trial
p.(None): subjects related to their health as well as commercially confidential information, the inspectors and
p.(None): experts involved in inspections should be bound by the highest standards of confidentiality and the applicable
p.(None): requirements of the Union law, national laws and international agreements. The inspectors and experts involved in
p.(None): inspections should comply with the requirements of Directive 95/46/EC of the European Parliament and of
p.(None): the Council (1) when processing personal data.
p.(None):
p.(None): (10) Commission Directive 2005/28/EC (2) should be repealed in order to ensure that only one set of rules applies
p.(None): to the conduct of good clinical practice inspections of clinical trials, including clinical trials governed by
...
p.(None): importations of such products (OJ L 91, 9.4.2005, p. 13).
p.(None): (3) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the
p.(None): laws, regulations and
p.(None): administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct
p.(None): of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
p.(None):
p.(None): 25.3.2017 EN
p.(None): Official Journal of the European Union
p.(None): L 80/9
p.(None):
p.(None): (b) clinical trials referred to in the applications for clinical trial authorisations pursuant to Article 25(5) of
p.(None): Regulation (EU) No 536/2014;
p.(None): (c) clinical trials conducted in third countries and referred to in marketing authorisation applications in the Union.
p.(None):
p.(None):
p.(None): Article 2
p.(None):
p.(None): Time frame for inspections
p.(None):
p.(None): Inspections may take place in any of the following circumstances:
p.(None): (a) before, during or after the conduct of a clinical trial;
p.(None): (b) as part of the verification of applications for marketing authorisation;
p.(None): (c) as a follow-up to the granting of a marketing authorisation.
p.(None):
p.(None):
p.(None): Article 3
p.(None):
p.(None): Quality system
p.(None):
p.(None): 1. Each Member State shall set up a properly designed quality system ensuring that the inspection
p.(None): procedures are observed and consistently monitored.
p.(None):
p.(None): Member States shall maintain those quality systems up to date.
p.(None):
p.(None): 2. Each inspector shall have access to and comply with standard operating procedures, details of their duties,
p.(None): respon sibilities and training requirements.
p.(None):
p.(None):
p.(None): CHAPTER II
p.(None):
p.(None): INSPECTORS
p.(None):
p.(None): Article 4
p.(None):
p.(None): Qualifications, training and experience
p.(None):
p.(None): 1. Inspectors shall have completed education at university level, or have equivalent experience, in
p.(None): medicine, pharmacy, pharmacology, toxicology or other fields relevant to the principles of good clinical practice.
p.(None):
p.(None): 2. Inspectors shall receive appropriate training, including participation in inspections. Their training needs,
p.(None): necessary to maintain or improve their skills, shall be assessed regularly by a person appointed for that task.
p.(None):
p.(None): 3. Inspectors shall have knowledge of principles and processes that apply to the development of medicinal products
p.(None): and clinical research and have knowledge of applicable Union and national legislation and guidelines on the conduct of
p.(None): clinical trials and the granting of marketing authorisations.
p.(None):
p.(None): 4. Inspectors shall have the ability to make professional judgments in relation to the compliance
p.(None): with applicable Union and national legislation and guidelines. They shall be able to assess data
p.(None): integrity as well as aspects related to ethical conduct of clinical trials.
p.(None):
p.(None): 5. Inspectors shall be familiar with the procedures and technical methods for the recording and
...
p.(None):
p.(None): 2. The Commission shall make publicly available any guidance documents on the commonly recognised standards for
p.(None): the conduct of inspections, developed in collaboration with Member States and the European Medicines Agency.
p.(None):
p.(None): 3. The European Medicines Agency shall process and make available to Member States information on
p.(None): inspections that are envisaged, scheduled, or conducted, in order to assist Member States to ensure the
p.(None): most efficient use of inspection resources when planning their inspections.
p.(None):
p.(None): 4. Member States may request assistance from the national competent authority of another Member State
p.(None): in the matter of inspection.
p.(None):
p.(None):
p.(None): Article 10
p.(None):
p.(None): Powers of inspectors
p.(None):
p.(None): 1. Inspections shall be carried out by inspectors appointed by Member States.
p.(None):
p.(None): In order to ensure the availability of necessary skills for each inspection, Member States may appoint teams of
p.(None): inspectors and appoint experts with appropriate qualifications to accompany inspectors.
p.(None):
p.(None): 2. Inspectors shall be entitled to inspect the clinical trial sites, documents, facilities, records,
p.(None): including individual patients' records, quality arrangements, data and any other resources and entities
p.(None): that are deemed by the competent authority to be related to the clinical trial.
p.(None):
p.(None): 3. When performing an inspection, the inspectors shall be empowered to enter into sites, other related premises,
p.(None): and to access to data, including individual patients' records.
p.(None):
p.(None): 4. Inspectors shall be entitled to make copies of records and hard copies, print-outs of electronic
p.(None): records and take photos of premises and equipment.
p.(None):
p.(None): 5. Inspectors shall be entitled to ask any representative or member of staff of the inspected
p.(None): entity and any party involved in the clinical trial for explanations relating to the subject matter and purpose of
p.(None): the inspection and to record the answer.
p.(None):
p.(None): 6. Inspectors shall be empowered to contact the trial subjects directly, in particular in case of
p.(None): reasonable suspicion that they were not informed adequately of their participation in the clinical trial.
p.(None):
p.(None): 7. Member States shall provide inspectors with suitable means of their identification.
p.(None):
p.(None): 8. Member States shall establish a legal and administrative framework to ensure that inspectors from other Member
p.(None): States, on request and where appropriate, have access to sites, any premise of any entity related to the clinical trial
p.(None): as well as to related data.
p.(None):
p.(None): L 80/12 EN
p.(None): Official Journal of the European Union
p.(None): 25.3.2017
p.(None):
p.(None): Article 11
p.(None):
p.(None): Recognition of inspection conclusions
p.(None):
p.(None): Inspectors shall carry out inspections on behalf of the Union. The results of those inspections shall be recognised by
p.(None): all Member States.
p.(None):
p.(None): In case of divergences between Member States in relation to the verification of compliance with the
p.(None): applicable legislation, the Member States, or the European Medicines Agency within the framework of its powers as
p.(None): provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), shall
p.(None): inform the Commission. The Commission, after consulting those Member States and the European Medicines Agency, may
p.(None): request a new inspection.
p.(None):
p.(None):
p.(None): Article 12
p.(None):
p.(None): Resources
p.(None):
p.(None): Member Sates shall appoint an adequate number of inspectors to ensure effective verification of compliance of clinical
p.(None): trials with applicable requirements, as well as the timely reporting of inspection findings.
p.(None):
p.(None):
p.(None): Article 13
p.(None):
p.(None): Inspection reports and records
p.(None):
p.(None): Without prejudice to the obligation to submit the inspection reports via the EU Portal in accordance with Article 78(6)
p.(None): of Regulation (EU) No 536/2014, Member States shall keep for at least 25 years relevant records of national inspections
p.(None): as well as of the inspections performed outside their territory, including information on the outcome of the inspection
p.(None): as regards good clinical practice compliance status as well as any action taken by the sponsor or Member State in the
p.(None): follow-up of the inspection. The inspection reports submitted through the EU portal shall not contain personal data of
p.(None): clinical trials' subjects.
p.(None):
p.(None):
p.(None): Article 14
p.(None):
p.(None): Confidentiality
p.(None):
p.(None): The inspectors and experts appointed to the inspection team shall maintain the confidentiality of information to which
p.(None): they gain access as a result of good clinical practice inspections.
p.(None):
p.(None): CHAPTER IV
p.(None): FINAL PROVISIONS
p.(None):
p.(None): Article 15
p.(None):
p.(None): Repeal
p.(None):
p.(None): Directive 2005/28/EC is repealed from the date referred to in the second paragraph of Article 17.
p.(None):
p.(None): Article 16
p.(None):
p.(None): Transitional provisions
p.(None):
p.(None): Directive 2005/28/EC, except for its Chapters 5 and 6, shall continue to apply to the clinical trials governed by
p.(None): Directive 2001/20/EC pursuant to Article 98 of Regulation (EU) No 536/2014.
p.(None):
p.(None): (1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community
p.(None): procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a
p.(None): European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
p.(None):
p.(None): 25.3.2017 EN
p.(None): Official Journal of the European Union
p.(None): L 80/13
p.(None):
p.(None): Article 17
p.(None):
p.(None): Entry into force
p.(None):
p.(None): This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal
p.(None): of the European Union.
p.(None):
p.(None): It shall apply from 6 months after the date of publication in the Official Journal of the European
p.(None): Union of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014.
p.(None):
p.(None): This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24
p.(None): March 2017.
p.(None):
p.(None): For the Commission The President
...
Social / Trade Union Membership
Searching for indicator union:
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p.(None): 25.3.2017 EN
p.(None): Official Journal of the European Union
p.(None): L 80/7
p.(None):
p.(None): COMMISSION IMPLEMENTING REGULATION (EU) 2017/556
p.(None): of 24 March 2017
p.(None): on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation
p.(None): (EU) No 536/2014 of the European Parliament and of the Council
p.(None):
p.(None): (Text with EEA relevance)
p.(None):
p.(None): THE EUROPEAN COMMISSION,
p.(None):
p.(None): Having regard to the Treaty on the Functioning of the European Union,
p.(None):
p.(None): Having regard to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April
p.(None): 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (1), and
p.(None): in particular Article 78(7) thereof,
p.(None):
p.(None): Whereas:
p.(None):
p.(None): (1) Regulation (EU) No 536/2014 lays down the legal framework for the conduct of clinical trials
p.(None): on medicinal products for human use in the Union to ensure that the rights, safety and well-being of
p.(None): the subjects are protected, and the data generated in clinical trials are robust and reliable. In particular, the
p.(None): sponsor of a clinical trial and the investigator are to ensure that the clinical trial is conducted in accordance with
p.(None): the relevant protocol and the principles of good clinical practice. Compliance with the applicable legal requirements,
p.(None): the protocol and the principles of good clinical practice, including with standards relating to data integrity and
p.(None): ethical conduct of the clinical trial, is to be verified by means of inspections conducted under the responsibility of
p.(None): the Member State where the inspection takes place.
p.(None):
p.(None): (2) The inspection in the context of clinical trials may concern good manufacturing practices as regards the
p.(None): manufac turing of the investigational medicinal products or good clinical practice as regards the conduct of clinical
p.(None): trials. Article 63 of Regulation (EU) No 536/2014 empowers the Commission to adopt delegated acts
p.(None): specifying the detailed arrangements for good manufacturing practice inspections as regards investigational medicinal
p.(None): products. Therefore, this Regulation should only lay down detailed arrangements for good clinical practice
p.(None): inspections procedures and requirements regarding training and qualifications of good clinical practice inspectors.
p.(None):
p.(None): (3) Member States may conduct inspections of clinical trials performed in third countries, either
p.(None): because a clinical trial is related to a clinical trial authorised in the Union or because the data of the clinical
p.(None): trial is being referred to in a clinical trial authorisation application in the Union. Those inspections
p.(None): should allow verifying whether such clinical trials were conducted in accordance with standards equivalent
p.(None): to Union standards. Inspections of clinical trials in third countries may also be conducted in order to verify
p.(None): whether the clinical trials, whose results are referred to in marketing authorisation applications in the
p.(None): Union, meet the ethical requirements set out in Regulation (EU) No 536/2014. Therefore, provisions on
p.(None): detailed arrangements for the inspection procedures should apply also to inspections conducted outside the Union
p.(None): in accordance with Regulation (EU) No 536/2014.
p.(None):
p.(None): (4) The International Conference on Harmonisation (‘ICH’) reached a consensus in 1995 to provide a
p.(None): harmonised approach for good clinical practice. Pursuant to Article 47 of Regulation (EU) No 536/2014, the ICH
p.(None): guidelines should be appropriately taken into account by the sponsor when drafting the clinical trial
p.(None): protocol and conducting the clinical trial. To the extent that those guidelines are compatible with the relevant Union
p.(None): law and EU guidelines, inspectors should refer to the ICH guidelines, taking into account the characteristics of each
p.(None): trial.
p.(None):
p.(None): (5) Member States should be required to set up quality systems to ensure that the inspection procedures are
p.(None): observed and consistently monitored. A well-functioning quality system should comprise an organisational structure,
p.(None): clear processes and procedures, including the standard operating procedures to be followed by inspectors
p.(None): when performing their tasks, clearly defined details of the inspectors' duties and responsibilities and ongoing
p.(None): training requirements, as well as adequate resources and mechanisms which aim at eliminating non-compliance.
p.(None):
p.(None): (1) OJ L 158, 27.5.2014, p. 1.
p.(None):
p.(None): L 80/8 EN
p.(None): Official Journal of the European Union
p.(None): 25.3.2017
p.(None):
p.(None): (6) It is necessary to enable inspectors to ensure the practical effectiveness of provisions on good
p.(None): clinical practice. That objective should be reflected in the minimum requirements for the qualification of
p.(None): inspectors, in particular as regards their education and training. For the same reasons, detailed rules on inspection
p.(None): procedures should be laid down.
p.(None):
p.(None): (7) In order to safeguard the effectiveness of inspection, the inspectors should be granted the
p.(None): necessary powers of access to the premises and data. This includes in particular any laboratory used for analysis in
p.(None): the clinical trial, any contract research organisation's facilities or the sponsor's premises. They should
p.(None): also be empowered to contact the trial subjects in justified cases.
p.(None):
p.(None): (8) In order to ensure the compliance with arrangements for good clinical practice inspections and
p.(None): in accordance with Article 77 of Regulation (EU) No 536/2014 Member States should take corrective
p.(None): measures if necessary. When during an inspection a major non-compliance or breach is identified, or the
p.(None): inspectors' investigatory powers are not recognised by the sponsors, Member States should have recourse to penalties.
p.(None):
p.(None): (9) In order to ensure the protection of confidential information, in particular personal data of clinical trial
p.(None): subjects related to their health as well as commercially confidential information, the inspectors and
p.(None): experts involved in inspections should be bound by the highest standards of confidentiality and the applicable
p.(None): requirements of the Union law, national laws and international agreements. The inspectors and experts involved in
p.(None): inspections should comply with the requirements of Directive 95/46/EC of the European Parliament and of
p.(None): the Council (1) when processing personal data.
p.(None):
p.(None): (10) Commission Directive 2005/28/EC (2) should be repealed in order to ensure that only one set of rules applies
p.(None): to the conduct of good clinical practice inspections of clinical trials, including clinical trials governed by
p.(None): Directive 2001/20/EC of the European Parliament and of the Council (3). However, in order to ensure
p.(None): consistency with Article 98 of Regulation (EU) No 536/2014 setting up a transitional period maintaining,
p.(None): as regards certain requests for authorisation of a clinical trial, the applicability of Directive
p.(None): 2001/20/EC, Directive 2005/28/EC should, with the exception of its Chapters 5 and 6 referring to good clinical
p.(None): practice inspection procedures and inspectors, remain applicable during that transitional period to all
p.(None): clinical trials authorised on the basis of Directive 2001/20/EC.
p.(None):
p.(None): (11) This Regulation should become applicable at the same time as Regulation (EU) No 536/2014.
p.(None):
p.(None): (12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
p.(None): Medicinal Products for Human Use,
p.(None):
p.(None):
p.(None): HAS ADOPTED THIS REGULATION:
p.(None):
p.(None): CHAPTER I
p.(None):
p.(None): GENERAL PROVISIONS
p.(None):
p.(None): Article 1
p.(None):
p.(None): Scope
p.(None):
p.(None): This Regulation applies to inspections of:
p.(None):
p.(None): (a) clinical trials conducted in the Union, including clinical trial sites related to those trials but
p.(None): located outside the Union;
p.(None):
p.(None): (1) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of
p.(None): individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995,
p.(None): p. 31).
p.(None): (2) Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical
p.(None): practice as regards
p.(None): investigational medicinal products for human use, as well as the requirement for authorisation of the manufacturing or
p.(None): importations of such products (OJ L 91, 9.4.2005, p. 13).
p.(None): (3) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the
p.(None): laws, regulations and
p.(None): administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct
p.(None): of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
p.(None):
p.(None): 25.3.2017 EN
p.(None): Official Journal of the European Union
p.(None): L 80/9
p.(None):
p.(None): (b) clinical trials referred to in the applications for clinical trial authorisations pursuant to Article 25(5) of
p.(None): Regulation (EU) No 536/2014;
p.(None): (c) clinical trials conducted in third countries and referred to in marketing authorisation applications in the Union.
p.(None):
p.(None):
p.(None): Article 2
p.(None):
p.(None): Time frame for inspections
p.(None):
p.(None): Inspections may take place in any of the following circumstances:
p.(None): (a) before, during or after the conduct of a clinical trial;
p.(None): (b) as part of the verification of applications for marketing authorisation;
p.(None): (c) as a follow-up to the granting of a marketing authorisation.
p.(None):
p.(None):
p.(None): Article 3
p.(None):
p.(None): Quality system
p.(None):
p.(None): 1. Each Member State shall set up a properly designed quality system ensuring that the inspection
p.(None): procedures are observed and consistently monitored.
p.(None):
p.(None): Member States shall maintain those quality systems up to date.
p.(None):
p.(None): 2. Each inspector shall have access to and comply with standard operating procedures, details of their duties,
p.(None): respon sibilities and training requirements.
p.(None):
p.(None):
p.(None): CHAPTER II
p.(None):
p.(None): INSPECTORS
p.(None):
p.(None): Article 4
p.(None):
p.(None): Qualifications, training and experience
p.(None):
p.(None): 1. Inspectors shall have completed education at university level, or have equivalent experience, in
p.(None): medicine, pharmacy, pharmacology, toxicology or other fields relevant to the principles of good clinical practice.
p.(None):
p.(None): 2. Inspectors shall receive appropriate training, including participation in inspections. Their training needs,
p.(None): necessary to maintain or improve their skills, shall be assessed regularly by a person appointed for that task.
p.(None):
p.(None): 3. Inspectors shall have knowledge of principles and processes that apply to the development of medicinal products
p.(None): and clinical research and have knowledge of applicable Union and national legislation and guidelines on the conduct of
p.(None): clinical trials and the granting of marketing authorisations.
p.(None):
p.(None): 4. Inspectors shall have the ability to make professional judgments in relation to the compliance
p.(None): with applicable Union and national legislation and guidelines. They shall be able to assess data
p.(None): integrity as well as aspects related to ethical conduct of clinical trials.
p.(None):
p.(None): 5. Inspectors shall be familiar with the procedures and technical methods for the recording and
p.(None): management of clinical data, and with the organisation and regulation of the healthcare systems in the
p.(None): relevant Member States and, where appropriate, in third countries.
p.(None):
p.(None): L 80/10 EN
p.(None): Official Journal of the European Union
p.(None): 25.3.2017
p.(None):
p.(None): 6. Inspectors shall be able to assess the degree of risk as regards the safety of the subjects enrolled in the
p.(None): clinical trial as well as the data integrity.
p.(None):
p.(None): 7. Inspectors shall be aware of the applicable rules as regards confidentiality and protection of personal data.
p.(None):
p.(None): 8. Member States shall keep records of the qualifications, training and experience of each inspector
p.(None): and maintain those records up-to-date for as long as inspector is in active duty.
p.(None):
p.(None):
p.(None): Article 5
p.(None):
p.(None): Conflict of interest and impartiality
p.(None):
p.(None): 1. Inspectors shall be free from any influence which could affect their impartiality or their judgement.
p.(None):
p.(None): 2. Inspectors shall not have conflicts of interest. In particular, they shall be independent of all
p.(None): of the following parties:
p.(None): (a) the sponsor;
p.(None): (b) the investigators involved in the clinical trial;
p.(None): (c) persons financing the clinical trial;
p.(None): (d) any other party involved in the conduct of the clinical trial.
p.(None): 3. Each inspector shall make an annual declaration of their financial interests and other links to
p.(None): the parties to be potentially inspected. That declaration shall be taken into consideration for the
p.(None): purposes of assigning an inspector to a specific inspection.
p.(None):
p.(None): CHAPTER III
p.(None): INSPECTION PROCEDURES
p.(None):
p.(None): Article 6
p.(None):
p.(None): Subject matter of inspections
p.(None):
p.(None): Inspectors shall verify the compliance with the requirements of Regulation (EU) No 536/2014, including protection of
p.(None): the rights and well-being of the clinical trial subjects, the quality and integrity of data generated
p.(None): in clinical trial, the compliance with principles of good clinical practice, including the ethical aspects and the
p.(None): relevant national legislation.
p.(None):
p.(None):
p.(None): Article 7
p.(None):
p.(None): Procedures to be established by Member States
p.(None):
p.(None): 1. Member States shall establish the relevant procedures for at least the following:
p.(None): (a) appointing experts to accompany inspectors, if additional expertise is required for an inspection;
p.(None): (b) arranging inspections outside the Union;
p.(None): (c) verification of good clinical practice compliance, including the modalities for examining the study
p.(None): management procedures and the conditions under which the clinical trial is planned, performed, monitored and recorded,
p.(None): as well as follow-up measures, such as a review of an analysis of the root cause of a significant
p.(None): non-compliance and verification of corrective and preventive actions implemented by the sponsor.
p.(None): Member States shall make those procedures and rules publicly available.
p.(None):
p.(None): 2. Member States shall also define the powers of experts appointed to accompany inspectors.
p.(None):
p.(None): 25.3.2017 EN
p.(None): Official Journal of the European Union
p.(None): L 80/11
p.(None):
p.(None): Article 8
p.(None):
p.(None): Unannounced inspections
p.(None):
p.(None): The inspections may, where necessary, be carried out unannounced.
p.(None):
p.(None):
p.(None): Article 9
p.(None):
p.(None): Collaboration between Member States
p.(None):
p.(None): 1. Member States shall collaborate with each other, with the Commission and with the European Medicines Agency to
p.(None): develop and improve commonly recognised standards of good clinical practice inspections. This collaboration
p.(None): may take the form of joint inspections, agreed processes and procedures and sharing of experience and training.
p.(None):
p.(None): 2. The Commission shall make publicly available any guidance documents on the commonly recognised standards for
p.(None): the conduct of inspections, developed in collaboration with Member States and the European Medicines Agency.
p.(None):
p.(None): 3. The European Medicines Agency shall process and make available to Member States information on
p.(None): inspections that are envisaged, scheduled, or conducted, in order to assist Member States to ensure the
p.(None): most efficient use of inspection resources when planning their inspections.
p.(None):
p.(None): 4. Member States may request assistance from the national competent authority of another Member State
p.(None): in the matter of inspection.
p.(None):
p.(None):
p.(None): Article 10
p.(None):
p.(None): Powers of inspectors
p.(None):
p.(None): 1. Inspections shall be carried out by inspectors appointed by Member States.
p.(None):
p.(None): In order to ensure the availability of necessary skills for each inspection, Member States may appoint teams of
...
p.(None): that are deemed by the competent authority to be related to the clinical trial.
p.(None):
p.(None): 3. When performing an inspection, the inspectors shall be empowered to enter into sites, other related premises,
p.(None): and to access to data, including individual patients' records.
p.(None):
p.(None): 4. Inspectors shall be entitled to make copies of records and hard copies, print-outs of electronic
p.(None): records and take photos of premises and equipment.
p.(None):
p.(None): 5. Inspectors shall be entitled to ask any representative or member of staff of the inspected
p.(None): entity and any party involved in the clinical trial for explanations relating to the subject matter and purpose of
p.(None): the inspection and to record the answer.
p.(None):
p.(None): 6. Inspectors shall be empowered to contact the trial subjects directly, in particular in case of
p.(None): reasonable suspicion that they were not informed adequately of their participation in the clinical trial.
p.(None):
p.(None): 7. Member States shall provide inspectors with suitable means of their identification.
p.(None):
p.(None): 8. Member States shall establish a legal and administrative framework to ensure that inspectors from other Member
p.(None): States, on request and where appropriate, have access to sites, any premise of any entity related to the clinical trial
p.(None): as well as to related data.
p.(None):
p.(None): L 80/12 EN
p.(None): Official Journal of the European Union
p.(None): 25.3.2017
p.(None):
p.(None): Article 11
p.(None):
p.(None): Recognition of inspection conclusions
p.(None):
p.(None): Inspectors shall carry out inspections on behalf of the Union. The results of those inspections shall be recognised by
p.(None): all Member States.
p.(None):
p.(None): In case of divergences between Member States in relation to the verification of compliance with the
p.(None): applicable legislation, the Member States, or the European Medicines Agency within the framework of its powers as
p.(None): provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), shall
p.(None): inform the Commission. The Commission, after consulting those Member States and the European Medicines Agency, may
p.(None): request a new inspection.
p.(None):
p.(None):
p.(None): Article 12
p.(None):
p.(None): Resources
p.(None):
p.(None): Member Sates shall appoint an adequate number of inspectors to ensure effective verification of compliance of clinical
p.(None): trials with applicable requirements, as well as the timely reporting of inspection findings.
p.(None):
p.(None):
p.(None): Article 13
p.(None):
p.(None): Inspection reports and records
p.(None):
p.(None): Without prejudice to the obligation to submit the inspection reports via the EU Portal in accordance with Article 78(6)
p.(None): of Regulation (EU) No 536/2014, Member States shall keep for at least 25 years relevant records of national inspections
p.(None): as well as of the inspections performed outside their territory, including information on the outcome of the inspection
p.(None): as regards good clinical practice compliance status as well as any action taken by the sponsor or Member State in the
p.(None): follow-up of the inspection. The inspection reports submitted through the EU portal shall not contain personal data of
p.(None): clinical trials' subjects.
p.(None):
p.(None):
p.(None): Article 14
p.(None):
p.(None): Confidentiality
p.(None):
p.(None): The inspectors and experts appointed to the inspection team shall maintain the confidentiality of information to which
p.(None): they gain access as a result of good clinical practice inspections.
p.(None):
p.(None): CHAPTER IV
p.(None): FINAL PROVISIONS
p.(None):
p.(None): Article 15
p.(None):
p.(None): Repeal
p.(None):
p.(None): Directive 2005/28/EC is repealed from the date referred to in the second paragraph of Article 17.
p.(None):
p.(None): Article 16
p.(None):
p.(None): Transitional provisions
p.(None):
p.(None): Directive 2005/28/EC, except for its Chapters 5 and 6, shall continue to apply to the clinical trials governed by
p.(None): Directive 2001/20/EC pursuant to Article 98 of Regulation (EU) No 536/2014.
p.(None):
p.(None): (1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community
p.(None): procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a
p.(None): European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
p.(None):
p.(None): 25.3.2017 EN
p.(None): Official Journal of the European Union
p.(None): L 80/13
p.(None):
p.(None): Article 17
p.(None):
p.(None): Entry into force
p.(None):
p.(None): This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal
p.(None): of the European Union.
p.(None):
p.(None): It shall apply from 6 months after the date of publication in the Official Journal of the European
p.(None): Union of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014.
p.(None):
p.(None): This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24
p.(None): March 2017.
p.(None):
p.(None): For the Commission The President
...
Social / education
Searching for indicator education:
(return to top)
p.(None): (4) The International Conference on Harmonisation (‘ICH’) reached a consensus in 1995 to provide a
p.(None): harmonised approach for good clinical practice. Pursuant to Article 47 of Regulation (EU) No 536/2014, the ICH
p.(None): guidelines should be appropriately taken into account by the sponsor when drafting the clinical trial
p.(None): protocol and conducting the clinical trial. To the extent that those guidelines are compatible with the relevant Union
p.(None): law and EU guidelines, inspectors should refer to the ICH guidelines, taking into account the characteristics of each
p.(None): trial.
p.(None):
p.(None): (5) Member States should be required to set up quality systems to ensure that the inspection procedures are
p.(None): observed and consistently monitored. A well-functioning quality system should comprise an organisational structure,
p.(None): clear processes and procedures, including the standard operating procedures to be followed by inspectors
p.(None): when performing their tasks, clearly defined details of the inspectors' duties and responsibilities and ongoing
p.(None): training requirements, as well as adequate resources and mechanisms which aim at eliminating non-compliance.
p.(None):
p.(None): (1) OJ L 158, 27.5.2014, p. 1.
p.(None):
p.(None): L 80/8 EN
p.(None): Official Journal of the European Union
p.(None): 25.3.2017
p.(None):
p.(None): (6) It is necessary to enable inspectors to ensure the practical effectiveness of provisions on good
p.(None): clinical practice. That objective should be reflected in the minimum requirements for the qualification of
p.(None): inspectors, in particular as regards their education and training. For the same reasons, detailed rules on inspection
p.(None): procedures should be laid down.
p.(None):
p.(None): (7) In order to safeguard the effectiveness of inspection, the inspectors should be granted the
p.(None): necessary powers of access to the premises and data. This includes in particular any laboratory used for analysis in
p.(None): the clinical trial, any contract research organisation's facilities or the sponsor's premises. They should
p.(None): also be empowered to contact the trial subjects in justified cases.
p.(None):
p.(None): (8) In order to ensure the compliance with arrangements for good clinical practice inspections and
p.(None): in accordance with Article 77 of Regulation (EU) No 536/2014 Member States should take corrective
p.(None): measures if necessary. When during an inspection a major non-compliance or breach is identified, or the
p.(None): inspectors' investigatory powers are not recognised by the sponsors, Member States should have recourse to penalties.
p.(None):
p.(None): (9) In order to ensure the protection of confidential information, in particular personal data of clinical trial
p.(None): subjects related to their health as well as commercially confidential information, the inspectors and
p.(None): experts involved in inspections should be bound by the highest standards of confidentiality and the applicable
p.(None): requirements of the Union law, national laws and international agreements. The inspectors and experts involved in
p.(None): inspections should comply with the requirements of Directive 95/46/EC of the European Parliament and of
...
p.(None):
p.(None): 25.3.2017 EN
p.(None): Official Journal of the European Union
p.(None): L 80/9
p.(None):
p.(None): (b) clinical trials referred to in the applications for clinical trial authorisations pursuant to Article 25(5) of
p.(None): Regulation (EU) No 536/2014;
p.(None): (c) clinical trials conducted in third countries and referred to in marketing authorisation applications in the Union.
p.(None):
p.(None):
p.(None): Article 2
p.(None):
p.(None): Time frame for inspections
p.(None):
p.(None): Inspections may take place in any of the following circumstances:
p.(None): (a) before, during or after the conduct of a clinical trial;
p.(None): (b) as part of the verification of applications for marketing authorisation;
p.(None): (c) as a follow-up to the granting of a marketing authorisation.
p.(None):
p.(None):
p.(None): Article 3
p.(None):
p.(None): Quality system
p.(None):
p.(None): 1. Each Member State shall set up a properly designed quality system ensuring that the inspection
p.(None): procedures are observed and consistently monitored.
p.(None):
p.(None): Member States shall maintain those quality systems up to date.
p.(None):
p.(None): 2. Each inspector shall have access to and comply with standard operating procedures, details of their duties,
p.(None): respon sibilities and training requirements.
p.(None):
p.(None):
p.(None): CHAPTER II
p.(None):
p.(None): INSPECTORS
p.(None):
p.(None): Article 4
p.(None):
p.(None): Qualifications, training and experience
p.(None):
p.(None): 1. Inspectors shall have completed education at university level, or have equivalent experience, in
p.(None): medicine, pharmacy, pharmacology, toxicology or other fields relevant to the principles of good clinical practice.
p.(None):
p.(None): 2. Inspectors shall receive appropriate training, including participation in inspections. Their training needs,
p.(None): necessary to maintain or improve their skills, shall be assessed regularly by a person appointed for that task.
p.(None):
p.(None): 3. Inspectors shall have knowledge of principles and processes that apply to the development of medicinal products
p.(None): and clinical research and have knowledge of applicable Union and national legislation and guidelines on the conduct of
p.(None): clinical trials and the granting of marketing authorisations.
p.(None):
p.(None): 4. Inspectors shall have the ability to make professional judgments in relation to the compliance
p.(None): with applicable Union and national legislation and guidelines. They shall be able to assess data
p.(None): integrity as well as aspects related to ethical conduct of clinical trials.
p.(None):
p.(None): 5. Inspectors shall be familiar with the procedures and technical methods for the recording and
p.(None): management of clinical data, and with the organisation and regulation of the healthcare systems in the
p.(None): relevant Member States and, where appropriate, in third countries.
p.(None):
p.(None): L 80/10 EN
p.(None): Official Journal of the European Union
p.(None): 25.3.2017
p.(None):
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): subjects related to their health as well as commercially confidential information, the inspectors and
p.(None): experts involved in inspections should be bound by the highest standards of confidentiality and the applicable
p.(None): requirements of the Union law, national laws and international agreements. The inspectors and experts involved in
p.(None): inspections should comply with the requirements of Directive 95/46/EC of the European Parliament and of
p.(None): the Council (1) when processing personal data.
p.(None):
p.(None): (10) Commission Directive 2005/28/EC (2) should be repealed in order to ensure that only one set of rules applies
p.(None): to the conduct of good clinical practice inspections of clinical trials, including clinical trials governed by
p.(None): Directive 2001/20/EC of the European Parliament and of the Council (3). However, in order to ensure
p.(None): consistency with Article 98 of Regulation (EU) No 536/2014 setting up a transitional period maintaining,
p.(None): as regards certain requests for authorisation of a clinical trial, the applicability of Directive
p.(None): 2001/20/EC, Directive 2005/28/EC should, with the exception of its Chapters 5 and 6 referring to good clinical
p.(None): practice inspection procedures and inspectors, remain applicable during that transitional period to all
p.(None): clinical trials authorised on the basis of Directive 2001/20/EC.
p.(None):
p.(None): (11) This Regulation should become applicable at the same time as Regulation (EU) No 536/2014.
p.(None):
p.(None): (12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
p.(None): Medicinal Products for Human Use,
p.(None):
p.(None):
p.(None): HAS ADOPTED THIS REGULATION:
p.(None):
p.(None): CHAPTER I
p.(None):
p.(None): GENERAL PROVISIONS
p.(None):
p.(None): Article 1
p.(None):
p.(None): Scope
p.(None):
p.(None): This Regulation applies to inspections of:
p.(None):
p.(None): (a) clinical trials conducted in the Union, including clinical trial sites related to those trials but
p.(None): located outside the Union;
p.(None):
p.(None): (1) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of
p.(None): individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995,
p.(None): p. 31).
p.(None): (2) Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical
p.(None): practice as regards
p.(None): investigational medicinal products for human use, as well as the requirement for authorisation of the manufacturing or
p.(None): importations of such products (OJ L 91, 9.4.2005, p. 13).
p.(None): (3) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the
p.(None): laws, regulations and
p.(None): administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct
p.(None): of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
p.(None):
p.(None): 25.3.2017 EN
p.(None): Official Journal of the European Union
p.(None): L 80/9
p.(None):
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): non-compliance and verification of corrective and preventive actions implemented by the sponsor.
p.(None): Member States shall make those procedures and rules publicly available.
p.(None):
p.(None): 2. Member States shall also define the powers of experts appointed to accompany inspectors.
p.(None):
p.(None): 25.3.2017 EN
p.(None): Official Journal of the European Union
p.(None): L 80/11
p.(None):
p.(None): Article 8
p.(None):
p.(None): Unannounced inspections
p.(None):
p.(None): The inspections may, where necessary, be carried out unannounced.
p.(None):
p.(None):
p.(None): Article 9
p.(None):
p.(None): Collaboration between Member States
p.(None):
p.(None): 1. Member States shall collaborate with each other, with the Commission and with the European Medicines Agency to
p.(None): develop and improve commonly recognised standards of good clinical practice inspections. This collaboration
p.(None): may take the form of joint inspections, agreed processes and procedures and sharing of experience and training.
p.(None):
p.(None): 2. The Commission shall make publicly available any guidance documents on the commonly recognised standards for
p.(None): the conduct of inspections, developed in collaboration with Member States and the European Medicines Agency.
p.(None):
p.(None): 3. The European Medicines Agency shall process and make available to Member States information on
p.(None): inspections that are envisaged, scheduled, or conducted, in order to assist Member States to ensure the
p.(None): most efficient use of inspection resources when planning their inspections.
p.(None):
p.(None): 4. Member States may request assistance from the national competent authority of another Member State
p.(None): in the matter of inspection.
p.(None):
p.(None):
p.(None): Article 10
p.(None):
p.(None): Powers of inspectors
p.(None):
p.(None): 1. Inspections shall be carried out by inspectors appointed by Member States.
p.(None):
p.(None): In order to ensure the availability of necessary skills for each inspection, Member States may appoint teams of
p.(None): inspectors and appoint experts with appropriate qualifications to accompany inspectors.
p.(None):
p.(None): 2. Inspectors shall be entitled to inspect the clinical trial sites, documents, facilities, records,
p.(None): including individual patients' records, quality arrangements, data and any other resources and entities
p.(None): that are deemed by the competent authority to be related to the clinical trial.
p.(None):
p.(None): 3. When performing an inspection, the inspectors shall be empowered to enter into sites, other related premises,
p.(None): and to access to data, including individual patients' records.
p.(None):
p.(None): 4. Inspectors shall be entitled to make copies of records and hard copies, print-outs of electronic
p.(None): records and take photos of premises and equipment.
p.(None):
p.(None): 5. Inspectors shall be entitled to ask any representative or member of staff of the inspected
p.(None): entity and any party involved in the clinical trial for explanations relating to the subject matter and purpose of
p.(None): the inspection and to record the answer.
p.(None):
p.(None): 6. Inspectors shall be empowered to contact the trial subjects directly, in particular in case of
p.(None): reasonable suspicion that they were not informed adequately of their participation in the clinical trial.
p.(None):
p.(None): 7. Member States shall provide inspectors with suitable means of their identification.
p.(None):
p.(None): 8. Member States shall establish a legal and administrative framework to ensure that inspectors from other Member
p.(None): States, on request and where appropriate, have access to sites, any premise of any entity related to the clinical trial
p.(None): as well as to related data.
p.(None):
p.(None): L 80/12 EN
p.(None): Official Journal of the European Union
p.(None): 25.3.2017
p.(None):
p.(None): Article 11
p.(None):
p.(None): Recognition of inspection conclusions
p.(None):
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| education | education |
| influence | Drug Usage |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| union | Trade Union Membership |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input