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List of results

• Document: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  + (21-Feb-2018)
• Document:GBR Medicines and Medical Devices Act 2021 21-Feb-2021  + (21-Feb-2021)
• Document:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025  + (21-May-2025)
• Document:DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023  + (22-Dec-2023)
• Document:FRA Infographie - La hiérarchie des normes 22-Mar-2024  + (22-Mar-2024)
• Document:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019  + (23-Jan-2019)
• Document:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022  + (23-May-2022)
• Document:AUT AVG – Allgemeines Verwaltungsverfahrens-gesetz 23-Nov-2021  + (23-Nov-2021)
• Document:DEU MPBetreibV - Medizinprodukte-Betreiberverordnung 24-Apr-2021  + (24-Apr-2021)
• Document:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017  + (25-Apr-2017)
• Document:AUT MPG – Medizinproduktegesetz 26-May-2022  + (26-May-2022)
• Document:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble  + (27-May-2014 Preamble)
• Document:USA NIH - Glossary 27-May-2025  + (27-May-2025)
• Document:GBR Clinical Trial toolkit 28-Jan-2025  + (28-Jan-2025)
• Document:GBR HRA - Ending your project 28-Jan-2025  + (28-Jan-2025)
• Document:GBR IRAS - Integrated Research Application System 28-Jan-2025  + (28-Jan-2025)
• Document:GBR NIHR - National Institute for Health and Care Research 28-Jan-2025  + (28-Jan-2025)
• Document:EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22  + (28-Jan-22)
• Document:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022  + (28-Jun-2022)
• Document:AUT LekV – Leit-Ethikkommissions-Verordnung 29-Nov-2024  + (29-Nov-2024)
• Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024  + (30-Aug-2024)
• Document:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023  + (30-Sep-2023)
• Document:USA U.S. Code Title 21 30-Sep-2023  + (30-Sep-2023)
• Document:GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020  + (31-Dec-2020)
• Document:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022  + (31-Jan-2022)

• Document:N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008  + (Apr-2008)

• Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013  + (Aug-2013)
• Document:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023  + (Aug-2023)
• Document:WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report  + (Forty-fifth report)
• Document:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998  + (Jan-1998)
• Document:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009  + (Jan-2009)
• Document:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011  + (Jan-2011)
• Document:EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011  + (Jan-2011)
• Document:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020  + (Mar-2020)
• Document:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018  + (March 2018)
• Document:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021  + (May 2021)
• Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007  + (May-2007)
• Document:GBR MEDDEV 2.7/3 revision 3 May-2015  + (May-2015)
• Document:USA NIH - SCORE Manual N.A.  + (N.A.)
• Document:USA Recognized Consensus Standards N.A.  + (N.A.)
• Document:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009  + (Oct-2009)
• Document:ICH ICH E11 Guideline R1 (2017)  + (R1 (2017))
• Document:ICH ICH E8 Guideline R1 (2021)  + (R1 (2021))
• Document:ICH ICH E6 Guideline R3 (2025)  + (R3 (2025))
• Document:ICH ICH E6 Guideline - Annex 2 R3 Annex 2  + (R3 Annex 2)
• Document:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025  + (Rev 01 16-Aug-2025)
• Document:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)  + (Rev. 3 (2017))
• Document:EU GVP: Module XVI EMA/204715/2012 Rev. 3 (2024)  + (Rev. 3 (2024))
• Document:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023)  + (Revision 11 (2023))
• Document:INT ISPE - GPP Revision 3 (2015)  + (Revision 3 (2015))
• Document:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013  + (Sep-2013)