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• Document: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))
• Document: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)
• Document: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)
• Document:ICH ICH E6 Guideline R3 (2025)  + (GUIDELINE FOR GOOD CLINICAL PRACTICE)
• Document:ICH ICH E6 Guideline - Annex 2 R3 Annex 2  + (GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3) Annex 2)
• Document:GBR MEDDEV 2.7/3 revision 3 May-2015  + (GUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC.)
• Document:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022  + (Gemeinsame Empfehlungen des Bundesinstitut … Gemeinsame Empfehlungen des Bundesinstituts für Arzneimittel und Medizinprodukte und des Paul-Ehrlich-Instituts zur Anzeige von Anwendungsbeobachtungen nach § 67 Absatz 6 Arzneimittelgesetz und zur Anzeige von nichtinterventionellen Unbedenklichkeitsstudien nach § 63f Arzneimittelgesetzkeitsstudien nach § 63f Arzneimittelgesetz)
• Document:DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022  + (Gesetz zum Schutz vor der schädlichen Wirkung ionisierender Strahlung (Strahlenschutzgesetz – StrlSchG))
• Document:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022  + (Gesetz zur Durchführung unionsrechtlicher Vorschriften betreffend Medizinprodukte (Medizinprodukterecht-Durchführungsgesetz – MPDG))
• Document:DEU AMG - Arzneimittelgesetz 19-Jul-2023  + (Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz – AMG))
• Document:DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024  + (Gesetz über den Verkehr mit Tierarzneimitteln und zur Durchführung unionsrechtlicher Vorschriften betreffend Tierarzneimittel1 (Tierarzneimittelgesetz - TAMG))
• Document:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447  + (Guidance Access to Electronic Health Recor … Guidance</br>Access to Electronic Health Records by Sponsor representatives in clinical trials</br>The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.sioners Office (ICO), on behalf of the UK.)
• Document:GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015  + (Guidance Good clinical practice for clinical trials How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.)
• Document:GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021  + (Guidance Managing clinical trials during Coronavirus (COVID-19) How investigators and sponsors should manage clinical trials during COVID-19)
• Document:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009  + (Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection)
• Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015  + (Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS)
• Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007  + (Guidance for Industry Computerized Systems Used in Clinical Investigations)
• Document:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013  + (Guidance for Industry Electronic Source Data in Clinical Investigations)
• Document:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009  + (Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects)
• Document:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021  + (Guidance on legislation Clinical investigations of medical devices – compiling a submission to MHRA)
• Document:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023)  + (Guide on Methodological Standards in Pharmacoepidemiology European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP))
• Document:EU GVP: Module XVI EMA/204715/2012 Rev. 3 (2024)  + (Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures (Rev 3) (Including NIS))
• Document:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)  + (Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 3))
• Document:INT ISPE - GPP Revision 3 (2015)  + (Guidelines for Good Pharmacoepidemiology Practices (GPP) International Society for Pharmacoepidemiology (ISPE))
• Document:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005  + (HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) GUIDANCE FOR IMPLEMENTATION)

• Document:GBR HRA - Ending your project 28-Jan-2025  + (HRA - Ending your project)

• Document:ICH ICH E8 Guideline R1 (2021)  + (ICH guideline E8 (R1) on general considerations for clinical studies)
• Document:IMDRF IMDRF – Guidelines -  + (IMDRF: International Medical Device Regula … IMDRF: International Medical Device Regulators Forum </br></br>IMDRF documents - https://www.imdrf.org/documents/library </br>- Technical documents</br></br>Global Harmonization Task Force (GHTF) - https://www.imdrf.org/documents/ghtf-final-documents </br>GHTF Study Group 1 - Pre-market Evaluation</br>GHTF Study Group 2 - Post-market Surveillance/Vigilance</br>GHTF Study Group 3 - Quality Systems</br>GHTF Study Group 4 - Auditing</br>GHTF Study Group 5 - Clinical Safety/Performancetudy Group 5 - Clinical Safety/Performance)
• Document:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998  + (INFORMATION SHEET Recruiting Study Subjects Guidance for Institutional Review Boards and Clinical Investigators)
• Document: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 Compliance and Inspections Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP (Inspection reports to EMA 2000-2012))
• Document:GBR IRAS - Integrated Research Application System 28-Jan-2025  + (IRAS: Integrated Research Application System ; provides a single gateway for researchers to apply to the new NIHR Coordinated System for gaining NHS Permissions (NIHR CSP).)
• Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020  + (ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice)
• Document:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023  + (Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors)
• Document:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007  + (Instruction interministérielle DHOS/E1/DAF/DPACI no 2007-322 et (no DAF/DPACI/RES/no 2007-014) du 14 août 2007 relative à la conservation du dossier médical NOR : SJSH0730928J)
• Document:USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3  + (Internal notes: HUMAN DRUG CGMP NOTES (Vo … Internal notes:</br>HUMAN DRUG CGMP NOTES</br></br>(Volume 8, Number 3)</br></br>September, 2000</br></br>(A Memo for FDA Personnel on Current Good Manufacturing Practice For Human Use Pharmaceuticals)</br></br>Issued By: The Division of Manufacturing and Product Quality, HFD-320</br></br>Office of Compliance</br>Center for Drug Evaluation and Research</br>Project Manager: C. Russ Rutledge, HFD-325Project Manager: C. Russ Rutledge, HFD-325)
• Document:ICH ICH Guidelines -  + (International Council for Harmonisation of … International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)</br></br>- Q: Quality guidelines (conduct of </br>stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management, …)</br></br>- S: Safety Guidelines (uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity, non-clinical testing strategy for assessing the QT interval prolongation liability, …)</br></br>- E: Efficacy Guidelines (design, conduct, safety and reporting of clinical trials)</br></br>- M: Multidisciplinary Guidelines (cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology [MedDRA], the Common Technical Document [CTD] and the development of Electronic Standards for the Transfer of Regulatory Information [ESTRI])ransfer of Regulatory Information [ESTRI]))
• Document:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016  + (International Ethical Guidelines for Health-related Research Involving Humans Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO))
• Document:WHO WHO - ICD 11  + (International Statistical Classification of Diseases and Related Health Problems (ICD))
• Document:FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025  + (Investigations cliniques de dispositids médicaux relevant du r`glement européen n°2017/745 Partie II Demande de mise en oeuvre Modalités pratiques)
• Document:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018  + (Leitlinien und Empfehlungen zur Sicherung von Guter Epidemiologischer Praxis (GEP) - Deutsche Gesellschaft für Epidemiologie (DGEpi))
• Document:FRA Constitution du 4 octobre 1958 10-Mar-2024  + (Loi constitutionnelle du 3 juin 1958)
• Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020  + (MDCG 2020-10/1 Rev 1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745)
• Document: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)
• Document:GBR Medicines and Medical Devices Act 2021 21-Feb-2021  + (Medicines and Medical Devices Act 2021)
• Document: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, by Transcelerate Inc.)
• Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024  + (National Cancer Institute GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs)
• Document:GBR National Health Service Act 2006 02-Dec-2019  + (National Health Service Act 2006)
• Document:AUT FAQ - COVID-19 Studien 15-Mar-2021  + (Nationale Regelung zum Quelldatenvergleich aus der Ferne (remote SDV))
• Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013  + (Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Guidance for Industry)
• Document:USA Recognized Consensus Standards - ISO 14155 21-Dec-2020  + (Part B: Supplementary Information Sheet (S … Part B: Supplementary Information Sheet (SIS)</br>FR Recognition List Number 055 </br></br>Date of Entry 12/21/2020 </br></br>FR Recognition Number 2-282</br>Standard </br>ISO 14155 Third edition 2020-07</br>Clinical investigation of medical devices for human subjects - Good clinical practiceor human subjects - Good clinical practice)
• Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble  + (Preamble Regulation (EU) 2017/745 (for information))