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EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 +
EMA/698382/2021
Quality and Safety of Medicines Department
Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol +
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 +
EMA/786433/2022
Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units +
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 +
EMA/INS/GCP/112288/2023
Good Clinical Practice Inspectors Working Group (GCP IWG)
Guideline on computerised systems and electronic data in clinical trials +
EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 +
EMA/INS/GCP/143492/2022
Good Clinical Practice Inspectors Working Group (GCP IWG)
ANNEX I
TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE +
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 +
EMA/INS/GCP/164938/2024
Inspections Office
Quality and Safety of Medicines Department
Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2023
Adopted by the GCP IWG on 26 November 2024 +
EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 +
EMA/INS/GCP/856758/2018
Good Clinical Practice Inspectors Working Group (GCP IWG)
Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) +
EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 +
EMEA/CHMP/313666/2005
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA +
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ESSAIS CLINIQUES DE MEDICAMENTS RELEVANT DU REGLEMENT EUROPEEN N° 536/2014
PARTIE V
VIGILANCE DES ESSAIS CLINIQUES DE MEDICAMENT :
NOTIFICATION DES EVENEMENTS INDESIRABLES (GRAVES), DES EFFETS INDESIRABLES GRAVES ET INATTENDUS, DU RAPPORT ANNUEL DE SECURITE +
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Ergänzende Empfehlungen des BfArM und des PEI zur Europäischen Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic, Version 4 +
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EudraLex The Rules Governing Medicinal Products in the European Union Volume 4
Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use
Chapter 4: Documentation +
European Medicines Agency (EMA)
Examples:
- EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials
- EMA/INS/GCP/126568/2023 – Annual Report of the Good Clinical Practice [GCP) Inspectors' Working Group [IWG) 2022
- EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation [EU) No 536/2014 or the clinical trial protocol +
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USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 +
Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure (1998) +
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FAQ - BASG Website +
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FDA - Inspectional Observations and Citations +
Federal Food, Drug, and Cosmetic Act (FD&C Act)
FD&C Act Reference Information
United States Code, Title 21 +
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GCP Inspection Dossier template
The following information is requested specifically in relation to clinical trials undertaken (for Investigational Medicinal Products) within the UK and should be provided within 30 days of the advance notice email date.
Note: the scope of the dossier request will be determined in the notification email you have received. If your organisation has been selected for a systems inspection, this dossier should be completed with all trial activities in scope. If you have been informed of our intention to conduct a trial specific inspection the dossier (and associated attachments) should be related to the selected trial(s) only. +
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USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 +
GUIDANCE DOCUMENT
Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions
Guidance for Industry and Food and Drug Administration Staff
February 2018
Final
Docket Number:
FDA-2013-N-0080
Issued by:
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health +
USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 +
GUIDANCE DOCUMENT
E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) +
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GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL +
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EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 +
GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC +
