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• Document:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025  + (Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials (SCORE) Manual Appendix: Source Documentation Requirements)
• Document:ICH ICH E21 Concept paper 2023  + (E21: Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials Dated 26 May 2023)
• Document:EU MDCG Guidelines -  + (EMA – Medical Device Coordination Group (M … EMA – Medical Device Coordination Group (MDCG)</br>Guidance - MDCG endorsed documents and other guidance:</br></br>- Annex XVI products (Regulation EU 2017/745)</br>- Borderline and Classification</br>- Class I Devices</br>- Clinical investigation and evaluation</br>- COVID-19</br>- Custom-Made Devices</br>- European database on medical devices (EUDAMED)</br>- European Medical Device Nomenclature (EMDN)</br>- Implant cards</br>- In-house devices</br>- Authorised Representatives, Importers, Distributors</br>- In Vitro Diagnostic medical devices (IVD)</br>- New technologies</br>- Notified bodies</br>- Person responsible for regulatory compliance (PRRC)</br>- Post-Market Surveillance and Vigilance (PMSV)</br>- Standards</br>- Unique Device Identifier (UDI)</br>- Other topics</br>- Other guidance documents - Other topics - Other guidance documents)
• Document:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838  + (EMA/216030/2025 EMA staff members who have a Copilot 365 license can utilise Copilot's AI features in different context to support their day-to-day activities based on a risk-based methodology.)
• Document: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)
• Document: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)
• Document: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)
• Document: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)
• Document: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)
• Document: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)
• Document: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))
• Document: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)
• Document:FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025  + (ESSAIS CLINIQUES DE MEDICAMENTS RELEVANT D … ESSAIS CLINIQUES DE MEDICAMENTS RELEVANT DU REGLEMENT EUROPEEN N° 536/2014</br></br>PARTIE V</br></br>VIGILANCE DES ESSAIS CLINIQUES DE MEDICAMENT :</br>NOTIFICATION DES EVENEMENTS INDESIRABLES (GRAVES), DES EFFETS INDESIRABLES GRAVES ET INATTENDUS, DU RAPPORT ANNUEL DE SECURITE INATTENDUS, DU RAPPORT ANNUEL DE SECURITE)
• Document:DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021  + (Ergänzende Empfehlungen des BfArM und des PEI zur Europäischen Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic, Version 4)
• Document:EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011  + (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)
• Document:EU EMA Guidelines -  + (European Medicines Agency (EMA) Examples: … European Medicines Agency (EMA)</br></br>Examples:</br></br>- EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials</br></br>- EMA/INS/GCP/126568/2023 – Annual Report of the Good Clinical Practice [GCP) Inspectors' Working Group [IWG) 2022</br></br>- EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation [EU) No 536/2014 or the clinical trial protocolNo 536/2014 or the clinical trial protocol)
• Document: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))
• Document:AUT BASG - FAQ 11-Feb-2025  + (FAQ - BASG Website)
• Document:USA FDA Information - Observations and citations 20-Mar-2024  + (FDA - Inspectional Observations and Citations)
• Document:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023  + (Federal Food, Drug, and Cosmetic Act (FD&C Act) FD&C Act Reference Information United States Code, Title 21)
• Document:GBR MHRA GCP Inspection Dossier template V7.0  + (GCP Inspection Dossier template The follow … GCP Inspection Dossier template</br>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.</br>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. be related to the selected trial(s) only.)
• 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  + (GUIDANCE DOCUMENT Acceptance of Clinical … GUIDANCE DOCUMENT</br></br>Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions</br>Guidance for Industry and Food and Drug Administration Staff</br>February 2018</br>Final</br></br>Docket Number:</br>FDA-2013-N-0080</br>Issued by:</br>Center for Biologics Evaluation and Research</br>Center for Devices and Radiological HealthCenter for Devices and Radiological Health)
• 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)