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List of results

• Document:AUT AVG – Allgemeines Verwaltungsverfahrens-gesetz 23-Nov-2021  + (Allgemeines Verwaltungsverfahrensgesetz 1991 – AVG)

• Document:FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024  + (Bonnes pratiques CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES)
• Document:AUT MPG – Medizinproduktegesetz 26-May-2022  + (Bundesgesetz betreffend Medizinprodukte 2021 (Medizinproduktegesetz 2021 – MPG 2021))
• Document:AUT AMG – Arzneimittelgesetz 04-Mar-2023  + (Bundesgesetz vom 2. März 1983 über die Herstellung und das Inverkehrbringen von Arzneimitteln (Arzneimittelgesetz – AMG))
• Document:AUT Ärztegesetz 08-Mar-2023  + (Bundesgesetz über die Ausübung des ärztlichen Berufes und die Standesvertretung der Ärzte (Ärztegesetz 1998 – ÄrzteG 1998))
• Document: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)
• Document:DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023  + (Bürgerliches Gesetzbuch (BGB))
• Document:ICH ICH E11 Guideline R1 (2017)  + (CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION)
• Document:ICH ICH E2A Guideline 1994  + (CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING E2A)
• Document:GBR Directive 90/385/EEC 05-Sep-2007  + (COUNCIL DIRECTIVE - of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices)
• Document:GBR Directive 93/42/EEC 11-Oct-2007  + (COUNCIL DIRECTIVE 93/42/EEC - of 14 June 1993 concerning medical devices)
• Document:GBR NIHR - National Institute for Health and Care Research 28-Jan-2025  + (Clinical Trials Toolkit Routemap R&D Submission)
• Document:USA NIH - Glossary 27-May-2025  + (ClinicalTrials.gov Glossary Terms)
• Document:FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025  + (Code de la santé publique Partie législati … Code de la santé publique</br>Partie législative (Articles L1110-1 à L6441-1)</br>Première partie : Protection générale de la santé (Articles L1110-1 à L1545-4)</br>Livre Ier : Protection des personnes en matière de santé (Articles L1110-1 à L1181-1)</br>Titre II : Recherches impliquant la personne humaine (Articles L1121-1 à L1128-12sonne humaine (Articles L1121-1 à L1128-12)
• Document:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025  + (Code de la santé publique Partie réglement … Code de la santé publique</br>Partie réglementaire (Articles R1110-1 à R6441-2)</br>Première partie : Protection générale de la santé (Articles R1110-1 à R1563-1)</br>Livre Ier : Protection des personnes en matière de santé (Articles R1110-1 à D1181-1)</br>Titre II : Recherches impliquant la personne humaine (Articles R1121-1 à R1127-26)onne humaine (Articles R1121-1 à R1127-26))
• Document:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022  + (Commission Implementing Decision (EU) 2022/729 of 11 May 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for quality management systems and for application of risk management to medical devices)
• Document:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12  + (Commission Implementing Regulation (EU) No … Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council Text with EEA relevance</br></br>(Including NIS)l Text with EEA relevance (Including NIS))
• Document:USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017)  + (Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Published: November 27, 2017 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES)
• Document:EU 2011/C 172/01 - CT-3 11-Jun-2011  + (Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use ( ‘CT-3’ ))
• Document:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022  + (Complex clinical trials – Questions and answers Version 2022-05-23)
• Document:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020  + (Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards)
• Document:EUR European Bioethics Convention 1997  + (Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine)
• Document:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016  + (Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects)
• Document:ICH ICH E2F Guideline 2010  + (DEVELOPMENT SAFETY UPDATE REPORT)
• Document:GBR Directive 2001/20/EC 04-Apr-2001  + (DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLI … DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - of 4 April 2001</br>on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use</br></br>The European Directive (2001/20/EC) no longer applies in the UK. The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 to enable the MHRA to operate as a regulator outside the EU. to operate as a regulator outside the EU.)
• Document:GBR Directive 98/79/EC 20-Dec-2011  + (DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - of 27 October 1998 on in vitro diagnostic medical devices)
• Document:GBR Data Protection Act 2018 06-Jun-2022  + (Data Protection Act 2018 2018 CHAPTER 12 A … Data Protection Act 2018</br>2018 CHAPTER 12</br>An Act to make provision for the regulation of the processing of information relating to individuals; to make provision in connection with the Information Commissioner's functions under certain regulations relating to information; to make provision for a direct marketing code of practice; and for connected purposes.e of practice; and for connected purposes.)
• Document:WMA Declaration of Helsinki 2024  + (Declaration of Helsinki Medical Research I … Declaration of Helsinki</br>Medical Research Involving Human Participants</br></br>The Declaration of Helsinki (DoH) is the World Medical Association’s (WMA) best-known policy statement. The first version was adopted in 1964 and has been amended seven times since, most recently at the General Assembly in October 2024. The current (2024) version is the only official one; all previous versions* have been replaced and should not be used or cited except for historical purposes. The WMA would like to thank all those who submitted comments and suggestions for the most recent revision of the DoH.s for the most recent revision of the DoH.)
• Document:DEU Deutsches Ärzteblatt 45849  + (Deutsches Ärzteblatt Publication of the GCP related courses programms in Germany for trial site personnel, by the German federal chamber of physicians.)
• Document:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12  + (Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use)
• Document:USA NIH - SCORE Manual N.A.  + (Division of AIDS (DAIDS) Site Clinical Ope … Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials (SCORE) Manual</br></br>The Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials (SCORE) Manual describes operational requirements for Clinical Research Sites (CRSs) implementing DAIDS-sponsored clinical research within the DAIDS Clinical Trials Networks. This manual serves as a resource for CRSs by consolidating operational requirements in a central location and providing tools to facilitate compliance with these requirements. CRS staff should direct any questions related to these requirements to their Office of Clinical Site Oversight (OCSO) Program Officers (POs) and/or the Pharmaceutical Affairs Branch (PAB) Pharmacists as appropriate.s Branch (PAB) Pharmacists as appropriate.)
• 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)