Document Index
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This page lists all regulatory documents in this wiki. Use GxPlex Search for filter-based browsing, or Special:Ask for custom queries.
All documents
| Document name | Scope | Region | Status | Type | |
|---|---|---|---|---|---|
| N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008 | (STROBE)statement: guidelines for reporting observational studies | INS | N.A. | N.A. | International guideline |
| EU 2011/C 172/01 - CT-3 11-Jun-2011 | 2011/C 172/01 - CT-3 | G | EU | Current | Regulatory requirement |
| USA 21 CFR Part 11 09-Apr-2025 | 21 CFR Part 11 | G | USA | Current | Legal act |
| USA 21 CFR Part 312 09-Apr-2025 | 21 CFR Part 312 | HM | USA | Current | Legal act |
| USA 21 CFR Part 314 09-Apr-2025 | 21 CFR Part 314 | HM | USA | Current | Legal act |
| USA 21 CFR Part 320 09-Apr-2025 | 21 CFR Part 320 | HM | USA | Current | Legal act |
| USA 21 CFR Part 50 09-Apr-2025 | 21 CFR Part 50 | G | USA | Current | Legal act |
| USA 21 CFR Part 54 09-Apr-2025 | 21 CFR Part 54 | G | USA | Current | Legal act |
| USA 21 CFR Part 56 09-Apr-2025 | 21 CFR Part 56 | G | USA | Current | Legal act |
| USA 21 CFR Part 809 06-May-2024 | 21 CFR Part 809 | G | USA | Current | Legal act |
| USA 21 CFR Part 812 09-Apr-2025 | 21 CFR Part 812 | MD | USA | Current | Legal act |
| USA 42 CFR Part 11 09-Apr-2025 | 42 CFR Part 11 | G | USA | Current | Legal act |
| USA 45 CFR Part 160 09-Apr-2025 | 45 CFR Part 160 | G | USA | Current | Legal act |
| USA 45 CFR Part 46 09-Apr-2025 | 45 CFR Part 46 | G | USA | Current | Legal act |
| FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025 | AEC-DM-DMDIV_DOC006 v04 AAP_RDM_Partie II_Modalités pratiques | MD | FRA | Current | Official recommendation |
| FRA AEC DOC010 V.04 01-Jun-2018 | AEC_DOC010 V.04 | HM | FRA | Current | Official recommendation |
| FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 | AEC_DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II | MD | FRA | Current | Official recommendation |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 | AMG - Arzneimittelgesetz | HM ; NIS ; Other | DEU | Current | Legal act |
| AUT AMG – Arzneimittelgesetz 04-Mar-2023 | AMG – Arzneimittelgesetz | HM | AUT | Current | Legal act |
| DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019 | AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung | MD ; HM | DEU | Current | Regulatory requirement |
| AUT AVG – Allgemeines Verwaltungsverfahrens-gesetz 23-Nov-2021 | AVG – Allgemeines Verwaltungsverfahrens-gesetz | G | AUT | Current | Legal act |
| 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 | Acceptance of Clinical Data to Support
Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff | MD | USA | Current | Official recommendation |
| N.A. Article from Mora et al. 2023 | Article from Mora et al. | G | N.A. | N.A. | Litterature article |
| AUT BASG - FAQ 11-Feb-2025 | BASG - FAQ | G | AUT | Superseded / Invalid | Information from official body |
| DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023 | BGB - Bürgerliches Gesetzbuch | Other | DEU | Current | Legal act |
| FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024 | Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) | G | FRA | Current | Official recommendation |
| DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021 | Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form | Other | DEU | Current | Regulatory requirement |
| EU CHMP Guidelines - | CHMP Guidelines | HM | EU | N.A. | Corpus of texts |
| CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 | CIOMS - International Ethical
Guidelines for Health-related Research Involving Humans | G | CIOMS | Current | International guideline |
| CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 | CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects | G | CIOMS | Current | International guideline |
| CIOMS CIOMS Publications - | CIOMS Publications | G | CIOMS | N.A. | Corpus of texts |
| EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 | COMMISSION IMPLEMENTING DECISION (EU) 2022/729 | MD ; IVD | EU | Current | Regulatory requirement |
| USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) | CTCAE - Common Terminology Criteria for Adverse Events | G | USA | Current | Official recommendation |
| GBR Clinical Trial toolkit 28-Jan-2025 | Clinical Trial toolkit | G | GBR | Current | Information from official body |
| GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 | Clinical investigations of medical devices – compiling a submission to MHRA | MD | GBR | Current | Official recommendation |
| FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 | Code de la Santé Publique
- Partie Réglementaire - 1ere partie, Livre 1er, Titre II | G | FRA | Current | Legal act |
| FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025 | Code de la Santé Publique
- Partie législative - 1ere partie, Livre 1er, Titre II | G | FRA | Current | Legal act |
| FRA Constitution du 4 octobre 1958 10-Mar-2024 | Constitution du 4 octobre 1958 | G | FRA | Current | Legal act |
| DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 | DGEPi - GEP Guter Epidemiologischer Praxis | NIS | DEU | Current | Official recommendation |
| FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 | DHOS/E1/DAF/DPACI no 2007-322 | G | FRA | Current | Regulatory requirement |
| GBR Data Protection Act 2018 06-Jun-2022 | Data Protection Act 2018 | G | GBR | Current | Legal act |
| WMA Declaration of Helsinki 2024 | Declaration of Helsinki | G | WMA | Current | International guideline |
| DEU Deutsches Ärzteblatt 45849 | Deutsches Ärzteblatt | G | DEU | Current | Information from official body |
| GBR Directive 2001/20/EC 04-Apr-2001 | Directive 2001/20/EC | HM | GBR | Current | Legal act |
| EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 | Directive 2001/83/EC - Community code relating to medicinal products for human use | NIS | EU | Current | Regulatory requirement |
| GBR Directive 90/385/EEC 05-Sep-2007 | Directive 90/385/EEC | MD | GBR | Current | Legal act |
| GBR Directive 93/42/EEC 11-Oct-2007 | Directive 93/42/EEC | MD | GBR | Current | Legal act |
| GBR Directive 98/79/EC 20-Dec-2011 | Directive 98/79/EC | IVD | GBR | Current | Legal act |
| EU EMA Guidelines - | EMA Guidelines | HM | EU | N.A. | Corpus of texts |
| EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 | EMA/298712/2022 - Complex clinical trials – Questions and answers | HM | EU | Current | Information from official body |
| EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 | EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site | G | EU | Current | Official guideline |
| 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
- Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol | G | EU | Current | Official guideline |
| 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 | G | EU | Current | Official guideline |
| EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 | EMA/INS/GCP/112288/2023
- Guideline on computerised systems and electronic data in clinical trials | G | EU | Current | Official guideline |
| EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 | EMA/INS/GCP/126568/2023
- Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 | G | EU | Current | Official guideline |
| 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
- ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE | G | EU | Current | Official guideline |
| 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
Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) | G | EU | Current | Official guideline |
| 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
- GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA | HM | EU | Current | Official guideline |
| EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) | ENCePP - Guide on Methodological Standards in Pharmacoepidemiology | INS | EU | Current | Official recommendation |
| DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021 | Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 | G | DEU | Current | Official recommendation |
| EU EudraLex – Volume 10 - | EudraLex – Volume 10 | HM | EU | Current | Corpus of texts |
| EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 | Eudralex - volume 4
GMP Guidelines Annex 11 | G | EU | N.A. | Corpus of texts |
| EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011 | Eudralex - volume 4
GMP Guidelines Chapter 4 | G | EU | N.A. | Corpus of texts |
| EUR European Bioethics Convention 1997 | European Bioethics Convention | G | EUR | Current | International treaty |
| EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838 | European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 | G | EU | Current | Information from official body |
| 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 | G | USA | Current | Official recommendation |
| AUT FAQ - COVID-19 Studien 15-Mar-2021 | FAQ - COVID-19 Studien | G | AUT | Superseded / Invalid | Information from official body |
| USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 | FD&C Act - Federal Food, Drug, and Cosmetic Act | MD ; Other | USA | Current | Legal act |
| USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 | FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry | G | USA | Current | Official recommendation |
| USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3 | FDA - HUMAN DRUG CGMP NOTES | G | USA | Superseded / Invalid | Other |
| USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 | FDA Guidance for Clinical
Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection | G | USA | Superseded / Invalid | Official recommendation |
| USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 | FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects | G | USA | Current | Official recommendation |
| USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015 | FDA Guidance for Industry -
Computerized Systems Used in Clinical Trials | G | USA | Current | Official recommendation |
| USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 | FDA Guidance for Industry -
Computerized Systems Used in Clinical Investigations | G | USA | Current | Official recommendation |
| USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 | FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency | G | USA | Superseded / Invalid | Official recommendation |
| USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 | FDA Guidance for Industry - Electronic Source Data in Clinical Investigations | G | USA | Current | Official recommendation |
| USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 | FDA Guidance for Industry -
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring | G | USA | Current | Official recommendation |
| USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 | FDA INFORMATION SHEET -
Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators | HM | USA | Current | Official recommendation |
| USA FDA Information - Observations and citations 20-Mar-2024 | FDA Information - Observations and citations | G | USA | Current | Information from official body |
| GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 | GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL | HM | GBR | Current | Official guideline |
| 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 | G | EU | Current | Official recommendation |
| EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) | GVP: Module VIII EMA/813938/2011 | NIS | EU | Current | Official guideline |
| EU GVP: Module XVI EMA/204715/2012 Rev. 3 (2024) | GVP: Module XVI EMA/204715/2012 | G | EU | Current | Official guideline |
| DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 | Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien | NIS | DEU | Current | Official recommendation |
| GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 | Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials | G | GBR | Current | Official recommendation |
| GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021 | Guidance Managing clinical trials during Coronavirus (COVID-19) | G | GBR | Current | Official recommendation |
| GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 | Guidance - Good clinical practice for clinical trials | HM | GBR | Current | Official recommendation |
| FRA Guide de légistique 07-Feb-2024 | Guide de légistique | G | FRA | Current | Information from official body |
| GBR HRA - Ending your project 28-Jan-2025 | HRA - Ending your project | G | GBR | Current | Official recommendation |
| ICH ICH E11 Guideline R1 (2017) | ICH E11 Guideline | G | ICH | Current | International guideline |
| ICH ICH E19 Guideline 2022 | ICH E19 Guideline | G | ICH | Current | International guideline |
| ICH ICH E21 Concept paper 2023 | ICH E21 Concept paper | G | ICH | N.A. | International guideline |
| ICH ICH E2A Guideline 1994 | ICH E2A Guideline | G | ICH | Current | International guideline |
| ICH ICH E2F Guideline 2010 | ICH E2F Guideline | G | ICH | Current | International guideline |
| ICH ICH E3 Guideline 1995 | ICH E3 Guideline | G | ICH | Current | International guideline |
| ICH ICH E6 Guideline R3 (2025) | ICH E6 Guideline | HM | ICH | Current | International guideline |
| ICH ICH E6 Guideline - Annex 2 R3 Annex 2 | ICH E6 Guideline - Annex 2 | HM | ICH | Draft | International guideline |
| ICH ICH E7 Guideline 1993 | ICH E7 Guideline | G | ICH | Current | International guideline |
| ICH ICH E8 Guideline R1 (2021) | ICH E8 Guideline | HM | ICH | Current | International guideline |
| ICH ICH E9 Guideline 1998 | ICH E9 Guideline | HM | ICH | Current | International guideline |
| ICH ICH E9 Guideline - Addendum R1 20-Nov-2019 | ICH E9 Guideline - Addendum R1 | HM | ICH | Current | International guideline |
| ICH ICH Guidelines - | ICH Guidelines | HM | ICH | N.A. | Corpus of texts |
| IMDRF IMDRF – Guidelines - | IMDRF – Guidelines | MD | IMDRF | N.A. | Corpus of texts |
| EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 | INS/GCP/46309/2012
- Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP | G | EU | Current | Information from official body |
| GBR IRAS - Integrated Research Application System 28-Jan-2025 | IRAS - Integrated Research Application System | G | GBR | Current | Information from official body |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 | ISO 14155 - Clinical investigation of medical devices for human subjects | MD | ISO | Current | International guideline |
| INT ISPE - GPP Revision 3 (2015) | ISPE - GPP | INS | INT | Current | International guideline |
| FRA Infographie - La hiérarchie des normes 22-Mar-2024 | Infographie - La hiérarchie des normes | G | FRA | Current | Information from official body |
| USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 | Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors | G | USA | Current | Official recommendation |
| DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 | KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung | HM | DEU | Current | Regulatory requirement |
| AUT LekV – Leit-Ethikkommissions-Verordnung 29-Nov-2024 | LekV – Leit-Ethikkommissions-Verordnung | G | AUT | Current | Regulatory requirement |
| DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 | MBO - Berufsordnung der Ärzt:innen | G | DEU | Current | Regulatory requirement |
| EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 | MDCG 2020-10/1
- Safety reporting in clinical investigations of medical devices | MD | EU ; GBR | Current | Official recommendation |
| EU MDCG Guidelines - | MDCG Guidelines | MD | EU | N.A. | Corpus of texts |
| GBR MEDDEV 2.7/3 revision 3 May-2015 | MEDDEV 2.7/3 revision 3 | MD | GBR | Current | Official guideline |
| GBR MHRA GCP Inspection Dossier template V7.0 | MHRA GCP Inspection Dossier template | G | GBR | Current | Information from official body |
| DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 | MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung | MD | DEU | Current | Regulatory requirement |
| DEU MPBetreibV - Medizinprodukte-Betreiberverordnung 24-Apr-2021 | MPBetreibV - Medizinprodukte-Betreiberverordnung | MD | DEU | Current | Regulatory requirement |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 | MPDG - Medizinprodukterecht-Durchführungsgesetz | MD ; IVD | DEU | Current | Legal act |
| AUT MPG – Medizinproduktegesetz 26-May-2022 | MPG – Medizinproduktegesetz | MD | AUT | Current | Legal act |
| GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021 | Making changes to a research study to manage the impact of COVID-19 | G | GBR | Current | Official recommendation |
| GBR Medicines and Medical Devices Act 2021 21-Feb-2021 | Medicines and Medical Devices Act 2021 | G | GBR | Current | Legal act |
| N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 | Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training | HM | N.A. | Current | Other |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 | NCI GUIDELINES FOR INVESTIGATORS:
ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs | G | USA | Current | Other |
| GBR NHS: Records Management Code of Practice 07-Aug-2023 | NHS: Records Management Code of Practice | G | GBR | Current | Regulatory requirement |
| USA NIH - SCORE Manual N.A. | NIH - SCORE Manual | G | USA | Current | Corpus of texts |
| USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 | NIH - SCORE Manual: Appendix Source Documents Requirements | G | USA | Current | Official recommendation |
| USA NIH - Glossary 27-May-2025 | NIH - Glossary | NIS | USA | Current | Information from official body |
| GBR NIHR - National Institute for Health and Care Research 28-Jan-2025 | NIHR - National Institute for Health and Care Research | G | GBR | Current | Information from official body |
| GBR National Health Service Act 2006 02-Dec-2019 | National Health Service Act 2006 | G | GBR | Current | Legal act |
| INT Nuremberg Code 1947 | Nuremberg Code | G | INT | N.A. | Jurisprudence |
| AUT Question - BASG 11-Feb-2025 | Question - BASG | G | AUT | N.A. | Other |
| USA Recognized Consensus Standards N.A. | Recognized Consensus Standards | G | USA | Current | Corpus of texts |
| USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 | Recognized Consensus Standards - ISO 14155 | G | USA | Current | Official recommendation |
| EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 | Recommendations of the expert group - Risk proportionate approaches in clinical trials | HM | EU | Current | Official recommendation |
| EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023 | Regulation (EC) No 1223/2009 - Cosmetic Products | G | EU ; GBR | Current | Legal act |
| EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022 | Regulation (EC) No 178/2002 - Food Safety | G | EU ; GBR | Current | Legal act |
| EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22 | Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use | NIS | EU | Current | Legal act |
| EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 | Regulation (EU) 2016/679 (GDPR) | G | EU | Current | Legal act |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble | Regulation (EU) 2017/745 - Medical Device Regulation | MD | EU | N.A. | Preamble of legal act |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 | Regulation (EU) 2017/745 - Medical Device Regulation | MD | EU | Current | Legal act |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble | Regulation (EU) 2017/746 - in vitro diagnostic medical devices | IVD | EU | N.A. | Preamble of legal act |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 | Regulation (EU) 2017/746 - in vitro diagnostic medical devices | IVD | EU | Current | Legal act |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 | Regulation (EU) 536/2014 - clinical trials | HM | EU | Current | Legal act |
| EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble | Regulation (EU) 536/2014 - clinical trials | HM | EU | N.A. | Preamble of legal act |
| EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 | Regulation (EU) 910/2014 - electronic identification | G | EU | Current | Legal act |
| EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 | Regulation (EU) No 520/2012 - performance of pharmacovigilance activities | G | EU | Current | Regulatory requirement |
| DEU Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. und | Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. und Bundesärztekammer | G | DEU | Current | Information from official body |
| DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988 | SGB V
- Sozialgesetzbuch Fünftes Buch | NIS | DEU | Current | Legal act |
| FRA SI RIPH 2G - Website 16-May-2025 | SI RIPH 2G - Website | MD | FRA | Current | Information from official body |
| SMW Test | SMW Test Document | TEST | Current | ||
| N.A. SPIRIT 2013 - Chan et al. 2013 | SPIRIT 2013 - Chan et al. | G | N.A. | N.A. | Litterature article |
| FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025 | SURV_VIG_DOC118 V01 REC-Avis aux promoteurs -Partie V | HM | FRA | Current | Official recommendation |
| DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022 | StrlSchG - Strahlenschutzgesetz | Other | DEU | Current | Legal act |
| DEU StrlSchV - Strahlenschutzverordnung 08-Oct-2021 | StrlSchV - Strahlenschutzverordnung | Other | DEU | Current | Regulatory requirement |
| DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024 | TAMG - Tierarzneimittelgesetz | Other | DEU | Current | Legal act |
| GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019 | The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 | G | GBR | Current | Legal act |
| GBR The Human Medicines Regulations 2012 01-Jan-2025 | The Human Medicines Regulations 2012 | HM | GBR | Current | Legal act |
| GBR The Medical Devices Regulations 2002 11-Feb-2021 | The Medical Devices Regulations 2002 | MD | GBR | Current | Legal act |
| GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 | The Medicines for Human Use (Clinical Trials) Regulations 2004 | HM | GBR | Current | Legal act |
| N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 | Transcelerate GCP mutual recognition programm FAQ | HM | N.A. | Current | Other |
| USA U.S. Code Title 21 30-Sep-2023 | U.S. Code Title 21 | G | USA | Current | Legal act |
| GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020 | UK GDPR - United Kingdom General Data Protection Regulation | G | GBR | Current | Legal act |
| USA WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591 46114 | WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591 | G | USA | N.A. | Information from official body |
| WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report | WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS | G | WHO | N.A. | Other |
| WHO WHO - Guidance for best practices for clinical trials 2024 | WHO - Guidance for best practices for clinical trials | G | WHO | Current | International guideline |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 | WHO - Guidelines for GCP for trials on pharmaceutical products* | HM | WHO | Current | International guideline |
| WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 | WHO - HANDBOOK
FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) | HM | WHO | Current | International guideline |
| WHO WHO - ICD 11 | WHO - ICD | HM | WHO | Current | International guideline |
| WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 | WHO Good Practices for Clinical Trial Design and Implementation | HM | WHO | Current | Other |
| WHO World Health Organization - | World Health Organization | HM | WHO | N.A. | Corpus of texts |
| AUT Ärztegesetz 08-Mar-2023 | Ärztegesetz | G | AUT | Current | Legal act |
By status
Current
| Document name | Scope | Region | Type | |
|---|---|---|---|---|
| EU 2011/C 172/01 - CT-3 11-Jun-2011 | 2011/C 172/01 - CT-3 | G | EU | Regulatory requirement |
| USA 21 CFR Part 11 09-Apr-2025 | 21 CFR Part 11 | G | USA | Legal act |
| USA 21 CFR Part 312 09-Apr-2025 | 21 CFR Part 312 | HM | USA | Legal act |
| USA 21 CFR Part 314 09-Apr-2025 | 21 CFR Part 314 | HM | USA | Legal act |
| USA 21 CFR Part 320 09-Apr-2025 | 21 CFR Part 320 | HM | USA | Legal act |
| USA 21 CFR Part 50 09-Apr-2025 | 21 CFR Part 50 | G | USA | Legal act |
| USA 21 CFR Part 54 09-Apr-2025 | 21 CFR Part 54 | G | USA | Legal act |
| USA 21 CFR Part 56 09-Apr-2025 | 21 CFR Part 56 | G | USA | Legal act |
| USA 21 CFR Part 809 06-May-2024 | 21 CFR Part 809 | G | USA | Legal act |
| USA 21 CFR Part 812 09-Apr-2025 | 21 CFR Part 812 | MD | USA | Legal act |
| USA 42 CFR Part 11 09-Apr-2025 | 42 CFR Part 11 | G | USA | Legal act |
| USA 45 CFR Part 160 09-Apr-2025 | 45 CFR Part 160 | G | USA | Legal act |
| USA 45 CFR Part 46 09-Apr-2025 | 45 CFR Part 46 | G | USA | Legal act |
| FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025 | AEC-DM-DMDIV_DOC006 v04 AAP_RDM_Partie II_Modalités pratiques | MD | FRA | Official recommendation |
| FRA AEC DOC010 V.04 01-Jun-2018 | AEC_DOC010 V.04 | HM | FRA | Official recommendation |
| FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 | AEC_DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II | MD | FRA | Official recommendation |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 | AMG - Arzneimittelgesetz | HM ; NIS ; Other | DEU | Legal act |
| AUT AMG – Arzneimittelgesetz 04-Mar-2023 | AMG – Arzneimittelgesetz | HM | AUT | Legal act |
| DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019 | AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung | MD ; HM | DEU | Regulatory requirement |
| AUT AVG – Allgemeines Verwaltungsverfahrens-gesetz 23-Nov-2021 | AVG – Allgemeines Verwaltungsverfahrens-gesetz | G | AUT | Legal act |
| 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 | Acceptance of Clinical Data to Support
Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff | MD | USA | Official recommendation |
| DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023 | BGB - Bürgerliches Gesetzbuch | Other | DEU | Legal act |
| FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024 | Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) | G | FRA | Official recommendation |
| DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021 | Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form | Other | DEU | Regulatory requirement |
| CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 | CIOMS - International Ethical
Guidelines for Health-related Research Involving Humans | G | CIOMS | International guideline |
| CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 | CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects | G | CIOMS | International guideline |
| EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 | COMMISSION IMPLEMENTING DECISION (EU) 2022/729 | MD ; IVD | EU | Regulatory requirement |
| USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) | CTCAE - Common Terminology Criteria for Adverse Events | G | USA | Official recommendation |
| GBR Clinical Trial toolkit 28-Jan-2025 | Clinical Trial toolkit | G | GBR | Information from official body |
| GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 | Clinical investigations of medical devices – compiling a submission to MHRA | MD | GBR | Official recommendation |
| FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 | Code de la Santé Publique
- Partie Réglementaire - 1ere partie, Livre 1er, Titre II | G | FRA | Legal act |
| FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025 | Code de la Santé Publique
- Partie législative - 1ere partie, Livre 1er, Titre II | G | FRA | Legal act |
| FRA Constitution du 4 octobre 1958 10-Mar-2024 | Constitution du 4 octobre 1958 | G | FRA | Legal act |
| DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 | DGEPi - GEP Guter Epidemiologischer Praxis | NIS | DEU | Official recommendation |
| FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 | DHOS/E1/DAF/DPACI no 2007-322 | G | FRA | Regulatory requirement |
| GBR Data Protection Act 2018 06-Jun-2022 | Data Protection Act 2018 | G | GBR | Legal act |
| WMA Declaration of Helsinki 2024 | Declaration of Helsinki | G | WMA | International guideline |
| DEU Deutsches Ärzteblatt 45849 | Deutsches Ärzteblatt | G | DEU | Information from official body |
| GBR Directive 2001/20/EC 04-Apr-2001 | Directive 2001/20/EC | HM | GBR | Legal act |
| EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 | Directive 2001/83/EC - Community code relating to medicinal products for human use | NIS | EU | Regulatory requirement |
| GBR Directive 90/385/EEC 05-Sep-2007 | Directive 90/385/EEC | MD | GBR | Legal act |
| GBR Directive 93/42/EEC 11-Oct-2007 | Directive 93/42/EEC | MD | GBR | Legal act |
| GBR Directive 98/79/EC 20-Dec-2011 | Directive 98/79/EC | IVD | GBR | Legal act |
| EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 | EMA/298712/2022 - Complex clinical trials – Questions and answers | HM | EU | Information from official body |
| EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 | EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site | G | EU | Official guideline |
| 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
- Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol | G | EU | Official guideline |
| 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 | G | EU | Official guideline |
| EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 | EMA/INS/GCP/112288/2023
- Guideline on computerised systems and electronic data in clinical trials | G | EU | Official guideline |
| EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 | EMA/INS/GCP/126568/2023
- Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 | G | EU | Official guideline |
| 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
- ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE | G | EU | Official guideline |
| 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
Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) | G | EU | Official guideline |
| 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
- GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA | HM | EU | Official guideline |
| EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) | ENCePP - Guide on Methodological Standards in Pharmacoepidemiology | INS | EU | Official recommendation |
| DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021 | Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 | G | DEU | Official recommendation |
| EU EudraLex – Volume 10 - | EudraLex – Volume 10 | HM | EU | Corpus of texts |
| EUR European Bioethics Convention 1997 | European Bioethics Convention | G | EUR | International treaty |
| EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838 | European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 | G | EU | Information from official body |
| 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 | G | USA | Official recommendation |
| USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 | FD&C Act - Federal Food, Drug, and Cosmetic Act | MD ; Other | USA | Legal act |
| USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 | FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry | G | USA | Official recommendation |
| USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 | FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects | G | USA | Official recommendation |
| USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015 | FDA Guidance for Industry -
Computerized Systems Used in Clinical Trials | G | USA | Official recommendation |
| USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 | FDA Guidance for Industry -
Computerized Systems Used in Clinical Investigations | G | USA | Official recommendation |
| USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 | FDA Guidance for Industry - Electronic Source Data in Clinical Investigations | G | USA | Official recommendation |
| USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 | FDA Guidance for Industry -
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring | G | USA | Official recommendation |
| USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 | FDA INFORMATION SHEET -
Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators | HM | USA | Official recommendation |
| USA FDA Information - Observations and citations 20-Mar-2024 | FDA Information - Observations and citations | G | USA | Information from official body |
| GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 | GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL | HM | GBR | Official guideline |
| 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 | G | EU | Official recommendation |
| EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) | GVP: Module VIII EMA/813938/2011 | NIS | EU | Official guideline |
| EU GVP: Module XVI EMA/204715/2012 Rev. 3 (2024) | GVP: Module XVI EMA/204715/2012 | G | EU | Official guideline |
| DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 | Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien | NIS | DEU | Official recommendation |
| GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 | Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials | G | GBR | Official recommendation |
| GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021 | Guidance Managing clinical trials during Coronavirus (COVID-19) | G | GBR | Official recommendation |
| GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 | Guidance - Good clinical practice for clinical trials | HM | GBR | Official recommendation |
| FRA Guide de légistique 07-Feb-2024 | Guide de légistique | G | FRA | Information from official body |
| GBR HRA - Ending your project 28-Jan-2025 | HRA - Ending your project | G | GBR | Official recommendation |
| ICH ICH E11 Guideline R1 (2017) | ICH E11 Guideline | G | ICH | International guideline |
| ICH ICH E19 Guideline 2022 | ICH E19 Guideline | G | ICH | International guideline |
| ICH ICH E2A Guideline 1994 | ICH E2A Guideline | G | ICH | International guideline |
| ICH ICH E2F Guideline 2010 | ICH E2F Guideline | G | ICH | International guideline |
| ICH ICH E3 Guideline 1995 | ICH E3 Guideline | G | ICH | International guideline |
| ICH ICH E6 Guideline R3 (2025) | ICH E6 Guideline | HM | ICH | International guideline |
| ICH ICH E7 Guideline 1993 | ICH E7 Guideline | G | ICH | International guideline |
| ICH ICH E8 Guideline R1 (2021) | ICH E8 Guideline | HM | ICH | International guideline |
| ICH ICH E9 Guideline 1998 | ICH E9 Guideline | HM | ICH | International guideline |
| ICH ICH E9 Guideline - Addendum R1 20-Nov-2019 | ICH E9 Guideline - Addendum R1 | HM | ICH | International guideline |
| EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 | INS/GCP/46309/2012
- Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP | G | EU | Information from official body |
| GBR IRAS - Integrated Research Application System 28-Jan-2025 | IRAS - Integrated Research Application System | G | GBR | Information from official body |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 | ISO 14155 - Clinical investigation of medical devices for human subjects | MD | ISO | International guideline |
| INT ISPE - GPP Revision 3 (2015) | ISPE - GPP | INS | INT | International guideline |
| FRA Infographie - La hiérarchie des normes 22-Mar-2024 | Infographie - La hiérarchie des normes | G | FRA | Information from official body |
| USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 | Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors | G | USA | Official recommendation |
| DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 | KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung | HM | DEU | Regulatory requirement |
| AUT LekV – Leit-Ethikkommissions-Verordnung 29-Nov-2024 | LekV – Leit-Ethikkommissions-Verordnung | G | AUT | Regulatory requirement |
| DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 | MBO - Berufsordnung der Ärzt:innen | G | DEU | Regulatory requirement |
| EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 | MDCG 2020-10/1
- Safety reporting in clinical investigations of medical devices | MD | EU ; GBR | Official recommendation |
| GBR MEDDEV 2.7/3 revision 3 May-2015 | MEDDEV 2.7/3 revision 3 | MD | GBR | Official guideline |
| GBR MHRA GCP Inspection Dossier template V7.0 | MHRA GCP Inspection Dossier template | G | GBR | Information from official body |
| DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 | MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung | MD | DEU | Regulatory requirement |
| DEU MPBetreibV - Medizinprodukte-Betreiberverordnung 24-Apr-2021 | MPBetreibV - Medizinprodukte-Betreiberverordnung | MD | DEU | Regulatory requirement |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 | MPDG - Medizinprodukterecht-Durchführungsgesetz | MD ; IVD | DEU | Legal act |
| AUT MPG – Medizinproduktegesetz 26-May-2022 | MPG – Medizinproduktegesetz | MD | AUT | Legal act |
| GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021 | Making changes to a research study to manage the impact of COVID-19 | G | GBR | Official recommendation |
| GBR Medicines and Medical Devices Act 2021 21-Feb-2021 | Medicines and Medical Devices Act 2021 | G | GBR | Legal act |
| N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 | Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training | HM | N.A. | Other |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 | NCI GUIDELINES FOR INVESTIGATORS:
ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs | G | USA | Other |
| GBR NHS: Records Management Code of Practice 07-Aug-2023 | NHS: Records Management Code of Practice | G | GBR | Regulatory requirement |
| USA NIH - SCORE Manual N.A. | NIH - SCORE Manual | G | USA | Corpus of texts |
| USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 | NIH - SCORE Manual: Appendix Source Documents Requirements | G | USA | Official recommendation |
| USA NIH - Glossary 27-May-2025 | NIH - Glossary | NIS | USA | Information from official body |
| GBR NIHR - National Institute for Health and Care Research 28-Jan-2025 | NIHR - National Institute for Health and Care Research | G | GBR | Information from official body |
| GBR National Health Service Act 2006 02-Dec-2019 | National Health Service Act 2006 | G | GBR | Legal act |
| USA Recognized Consensus Standards N.A. | Recognized Consensus Standards | G | USA | Corpus of texts |
| USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 | Recognized Consensus Standards - ISO 14155 | G | USA | Official recommendation |
| EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 | Recommendations of the expert group - Risk proportionate approaches in clinical trials | HM | EU | Official recommendation |
| EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023 | Regulation (EC) No 1223/2009 - Cosmetic Products | G | EU ; GBR | Legal act |
| EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022 | Regulation (EC) No 178/2002 - Food Safety | G | EU ; GBR | Legal act |
| EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22 | Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use | NIS | EU | Legal act |
| EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 | Regulation (EU) 2016/679 (GDPR) | G | EU | Legal act |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 | Regulation (EU) 2017/745 - Medical Device Regulation | MD | EU | Legal act |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 | Regulation (EU) 2017/746 - in vitro diagnostic medical devices | IVD | EU | Legal act |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 | Regulation (EU) 536/2014 - clinical trials | HM | EU | Legal act |
| EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 | Regulation (EU) 910/2014 - electronic identification | G | EU | Legal act |
| EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 | Regulation (EU) No 520/2012 - performance of pharmacovigilance activities | G | EU | Regulatory requirement |
| DEU Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. und | Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. und Bundesärztekammer | G | DEU | Information from official body |
| DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988 | SGB V
- Sozialgesetzbuch Fünftes Buch | NIS | DEU | Legal act |
| FRA SI RIPH 2G - Website 16-May-2025 | SI RIPH 2G - Website | MD | FRA | Information from official body |
| SMW Test | SMW Test Document | TEST | ||
| FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025 | SURV_VIG_DOC118 V01 REC-Avis aux promoteurs -Partie V | HM | FRA | Official recommendation |
| DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022 | StrlSchG - Strahlenschutzgesetz | Other | DEU | Legal act |
| DEU StrlSchV - Strahlenschutzverordnung 08-Oct-2021 | StrlSchV - Strahlenschutzverordnung | Other | DEU | Regulatory requirement |
| DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024 | TAMG - Tierarzneimittelgesetz | Other | DEU | Legal act |
| GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019 | The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 | G | GBR | Legal act |
| GBR The Human Medicines Regulations 2012 01-Jan-2025 | The Human Medicines Regulations 2012 | HM | GBR | Legal act |
| GBR The Medical Devices Regulations 2002 11-Feb-2021 | The Medical Devices Regulations 2002 | MD | GBR | Legal act |
| GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 | The Medicines for Human Use (Clinical Trials) Regulations 2004 | HM | GBR | Legal act |
| N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 | Transcelerate GCP mutual recognition programm FAQ | HM | N.A. | Other |
| USA U.S. Code Title 21 30-Sep-2023 | U.S. Code Title 21 | G | USA | Legal act |
| GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020 | UK GDPR - United Kingdom General Data Protection Regulation | G | GBR | Legal act |
| WHO WHO - Guidance for best practices for clinical trials 2024 | WHO - Guidance for best practices for clinical trials | G | WHO | International guideline |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 | WHO - Guidelines for GCP for trials on pharmaceutical products* | HM | WHO | International guideline |
| WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 | WHO - HANDBOOK
FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) | HM | WHO | International guideline |
| WHO WHO - ICD 11 | WHO - ICD | HM | WHO | International guideline |
| WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 | WHO Good Practices for Clinical Trial Design and Implementation | HM | WHO | Other |
| AUT Ärztegesetz 08-Mar-2023 | Ärztegesetz | G | AUT | Legal act |
Draft
| Document name | Scope | Region | |
|---|---|---|---|
| ICH ICH E6 Guideline - Annex 2 R3 Annex 2 | ICH E6 Guideline - Annex 2 | HM | ICH |
Superseded
By scope
Human Medicines (HM)
Medical Devices (MD)
In Vitro Diagnostics (IVD)
| Document name | Status | Region | |
|---|---|---|---|
| EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 | COMMISSION IMPLEMENTING DECISION (EU) 2022/729 | Current | EU |
| GBR Directive 98/79/EC 20-Dec-2011 | Directive 98/79/EC | Current | GBR |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 | MPDG - Medizinprodukterecht-Durchführungsgesetz | Current | DEU |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble | Regulation (EU) 2017/746 - in vitro diagnostic medical devices | N.A. | EU |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 | Regulation (EU) 2017/746 - in vitro diagnostic medical devices | Current | EU |
GMP / PV / NIS
References
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