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• Reference:USA 21 CFR Part 50 09-Apr-2025 Subpart D  + (Subpart D—Additional Safeguards for Children in Clinical Investigations […] § 50.50 IRB duties. […] § 50.51 Clinical investigations not involving grea…)
• Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart D  + (Subpart D—IRB Review and Approval § 812.60 IRB composition, duties, and functions. An IRB reviewing and approving investigations under this part shall…)
• Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart E  + (Subpart E—Registration of Institutional Review Boards […] § 46.501 What IRBs must be registered? Each IRB that is designated by an institution under a…)
• Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart E  + (Subpart E—Responsibilities of Investigators § 812.100 General responsibilities of investigators. An investigator is responsible for ensuring that an i…)
• Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart G  + (Subpart G—Records and Reports § 812.140 Records. (a) Investigator records. A participating investigator shall maintain the following accurate, complet…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 14  + (Subsequent addition of a Member State concerned 1. Where the sponsor wishes to extend an authorised clinical trial to another Member State (‘additi…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 21  + (Substantial modification of aspects covered by Parts I and II of the assessment report 1. Where a substantial modification relates to aspects cover…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 75  + (Substantial modifications to clinical investigations 1. If a sponsor intends to introduce modifications to a clinical investigation that are likely…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 71  + (Substantial modifications to performance studies 1. If a sponsor intends to introduce modifications to a performance study that are likely to have …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 50  + (Suitability of clinical trial sites The facilities where the clinical trial is to be conducted shall be suitable for the conduct of the clinical tria…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 49  + (Suitability of individuals involved in conducting the clinical trial The investigator shall be a medical doctor as defined in national law, or a pers…)
• Reference:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019 -  + (Summarized in "Electronic Execution of Documents - Industry Working Group Interim Report" (01-Feb-2022) https://assets.publishing.service.gov.uk/media…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR)  + (Suspected Unexpected Serious Adverse Reaction (SUSAR): an adverse reaction that meets three criteria: suspected, unexpected and serious. • Suspected…)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Suspected adverse reaction  + (Suspected adverse reaction means any adverse event for which there is a reasonable possibility that the drug caused the adverse event. For the purpose…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 31  + (Suspension or termination of clinical trial 31.—(1) If, in relation to a clinical trial— (a)the licensing authority have objective grounds for cons…)
• Reference:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 System Security  + (System Security [...] There should be the implementation of robust security procedures by the sponsor and investigator site/institution, such as; pass…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 38  + (Temporary halt or early termination by the sponsor for reasons of subject safety 1. For the purposes of this Regulation, the temporary halt or early…)
• Reference:EUR European Bioethics Convention 1997 -  + (The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, otherwise kno…)
• Reference:ICH ICH E2F Guideline 2010 1  + (The Development Safety Update Report (DSUR) proposed in this guideline is intended to be a common standard for periodic reporting on drugs under devel…)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13  + (The level of security should be proportionate to the sensitivity and confidentiality of the data (e.g. nominative data in electronic medical records a…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.1.4  + (The sponsor should ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures and data collec…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix C C.2.3  + (These essential records should be maintained in or referred to from repositories held by the sponsor and by the investigator/institution for their res…)
• Reference:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 -  + (This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for …)
• Reference:USA 21 CFR Part 56 09-Apr-2025 -  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 56 Institutional R…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 51  + (Traceability, storage, return and destruction of investigational medicinal products 1. Investigational medicinal products shall be traceable. They …)

• Reference:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 -  + (Transcelerate GCP mutual recognition programm FAQ…)

• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 66  + (Unauthorised investigational and unauthorised auxiliary medicinal products 1. The following information shall appear on the outer packaging and on …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section 2.5 No. 17-22  + (Unblinding treatment allocation 17. The investigator shall only unblind the treatment allocation of a subject in the course of a clinical trial if un…)
• Reference:AUT MPG – Medizinproduktegesetz 26-May-2022 § 22  + (Unerwünschte Ereignisse § 22. Die Meldungen gemäß Art. 80 Abs. 2 der Verordnung (EU) Nr. 745/2017 oder Art. 76 Abs. 2 der Verordnung (EU) Nr. 746/2017…)
• Reference:ICH ICH E2A Guideline 1994 II A. 3.  + (Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.,…)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Unexpected adverse event  + (Unexpected adverse event or unexpected suspected adverse reaction. An adverse event or suspected adverse reaction is considered “unexpected” if it is …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 54  + (Urgent safety measures 1. Where an unexpected event is likely to seriously affect the benefit-risk balance, the sponsor and the investigator shall …)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-001  + (Urgent safety measures 30.—(1) The sponsor and investigator may take appropriate urgent safety measures in order to protect the subjects of a clinical…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-002  + (Urgent safety measures 30.—(1) The sponsor and investigator may take appropriate urgent safety measures in order to protect the subjects of a clinical…)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 V.  + (V. FREQUENTLY ASKED QUESTIONS […] 1. What are some considerations for enrolling a child into a clinical investigation? [...] 2. Are there any addition…)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI C.  + (VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY [...] C. Delegation of Monitoring Responsibilities to a CRO If a sponsor of an IND study delegates …)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI D.  + (VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY […] D. Clinical Investigator and Site Selection and Initiation In addition to regulatory requiremen…)
• Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3.1  + (VIII.B.4.3. Study reports VIII.B.4.3.1. Progress report and interim report of study results The progress report is meant to include relevant informati…)
• Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3  + (VIII.B.4.3. Study reports [...] VIII.B.4.3.2. Final study report [...]…)
• Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.5  + (VIII.B.5. Publication of study results For studies that are fully or partially conducted by investigators who are not employees of the marketing auth…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 17 Paragraph 1-3  + (Validation of an application for the authorisation of a substantial modification of an aspect covered by Part I of the assessment report 1. The rep…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 20 Paragraph 1-3  + (Validation, assessment and decision regarding a substantial modification of an aspect covered by Part II of the assessment report 1. Within six day…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Vulnerable Participants  + (Vulnerable Participants Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justifie…)
• Reference:USA WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591 46114 -  + (WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591 […] Inappropriate Use of Artificial Intelligence in Pharmaceutical Manufacturing. During the …)
• Reference:WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 -  + (WHO Good Practices for Clinical Trial Design and Implementation This course supports understanding and application of key ethical, scientific princip…)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 WHO Principles of GCP  + (WHO Principles of GCP Principle 1: Research involving humans should be scientifi cally sound and conducted in accordance with basic ethical principl…)
• Reference:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 18  + (WOMEN AS RESEARCH PARTICIPANTS [...] Vulnerability of women. Despite the current general presumption that favours the inclusion of women in research, …)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 44  + (What about financial reimbursements to research subjects? Financial reimbursements to subjects are distinct from any benefi ts contributing to the ris…)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 28-29  + (What information should be included in a study protocol?…)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 78  + (What is an Independent Data and Safety Monitoring Board (DSMB, also known as an independent Data Monitoring Committee [DMC])? An independent data and …)
• Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D What needs to be reported  + (What needs to be reported? • Any serious breach of: (a) The conditions and principles of good clinical practice in connection with that trial (as def…)