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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (k)-(l) +
Ethics committee opinion
15.— [...]
(5) In preparing its opinion, the committee shall consider, in particular, the following matters—
(k)the amounts,… +
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EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Organisation +
Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" a… +
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Randomisation +
Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" a… +
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - SD +
Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" a… +
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Monitoring +
Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" a… +
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - ComCompliance +
Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" a… +
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USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 - +
FDA requires that an Institutional Review Board (IRB) review and have authority to approve, requiremodifications in, or disapprove all research activi… +
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Free and Informed Consent
25. Free and informed consent is an essential component of respect for individual autonomy. Participation by individuals ca… +
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GCP Inspection Dossier template
[…]
13. Artificial Intelligence and Machine Learning
Please explain where artificial intelligence and/or machine learn… +
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GENERAL PRINCIPLES
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7. The primary purpose of medical research involving human participants is to generate knowledge to understand the causes, de… +
GENERAL PRINCIPLES
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9. It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, autonom… +
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General principles
A substantial modification, including the addition of a clinical trial site or the change of a principal investigator in the clini… +
General requirements regarding clinical investigations conducted to demonstrate conformity of devices
1. Clinical investigations shall be designed,… +
General requirements regarding clinical investigations conducted to demonstrate conformity of devices
(j) the medical care provided to the subjects i… +
General requirements regarding performance studies
1. The manufacturer shall ensure that a device for performance study complies with the general s… +
General rules
(f) the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate,… +
General rules
1. A clinical trial may be conducted only where all of the following conditions are met:
(a) the anticipated benefits to the subject… +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - Good Clinical Practice (GCP) +
Good Clinical Practice (GCP)
A standard for clinical studies which encompasses the design, conduct, monitoring, termination, audit, analyses, reportin… +
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Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the conduct of trials that involve human participants. … +
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CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 20 +
Guideline 2: Ethical review committees
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Commentary on Guideline 2
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Failure to submit a protocol to the committee should be considered a clea… +
