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• Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (8)  + ((8))

• Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (9)  + ((9))
• Reference:WMA Declaration of Helsinki 2024 -  + (-)
• Reference:EUR European Bioethics Convention 1997 -  + (-)
• Reference:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 -  + (-)
• Reference:ICH ICH E8 Guideline R1 (2021) -  + (-)
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 -  + (-)
• Reference:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019 -  + (-)
• Reference:INT ISPE - GPP Revision 3 (2015) -  + (-)
• Reference:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 -  + (-)
• Reference: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 -  + (-)
• Reference:USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 -  + (-)
• Reference:FRA Guide de légistique 07-Feb-2024 -  + (-)
• Reference:FRA Infographie - La hiérarchie des normes 22-Mar-2024 -  + (-)
• Reference:USA 21 CFR Part 56 09-Apr-2025 -  + (-)
• Reference:FRA SI RIPH 2G - Website 16-May-2025 -  + (-)
• Reference:FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025 -  + (-)
• Reference:FRA AEC DOC010 V.04 01-Jun-2018 -  + (-)
• Reference:GBR NIHR - National Institute for Health and Care Research 28-Jan-2025 -  + (-)
• Reference:N.A. SPIRIT 2013 - Chan et al. 2013 -  + (-)
• Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) -  + (-)
• Reference:N.A. Article from Mora et al. 2023 -  + (-)
• Reference:ICH ICH E11 Guideline R1 (2017) -  + (-)
• Reference:ICH ICH E7 Guideline 1993 -  + (-)
• Reference:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 -  + (-)
• Reference:GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 -  + (-)
• Reference:USA FDA Information - Observations and citations 20-Mar-2024 -  + (-)
• Reference:WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report -  + (-)
• Reference:USA 45 CFR Part 160 09-Apr-2025 -  + (-)
• Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 -  + (-)
• Reference:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019 -  + (-)
• Reference:DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021 -  + (-)
• Reference:AUT FAQ - COVID-19 Studien 15-Mar-2021 -  + (-)
• Reference:FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024 -  + (-)
• Reference:GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021 -  + (-)
• Reference:GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021 -  + (-)
• Reference:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 -  + (-)
• Reference:IMDRF IMDRF – Guidelines - -  + (-)
• Reference:USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) -  + (-)
• Reference:DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021 -  + (-)
• Reference:GBR NHS: Records Management Code of Practice 07-Aug-2023 -  + (-)
• Reference:AUT Question - BASG 11-Feb-2025 -  + (-)
• Reference:ICH ICH E3 Guideline 1995 -  + (-)
• Reference:N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008 -  + (-)
• Reference:GBR HRA - Ending your project 28-Jan-2025 -  + (-)
• Reference:DEU Deutsches Ärzteblatt 45849 -  + (-)
• Reference:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838 -  + (-)
• Reference:WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 -  + (-)
• Reference:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 -  + (-)
• Reference:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 -  + (-)