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A.7 Statistical design and analysis… +
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A2.2.5 Protecting research participants
Researchers should allocate adequate time and resources for measures and materials to obtain properly informed… +
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EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3 +
A5.3 Electronic informed consent
Ethics committees will review all material related to the informed consent process. Before the implementation of an e… +
EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 1. +
ANNEX III
Protocols, abstracts and final study reports for post-authorisation safety studies
1. Format of the study protocol
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EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 2. ; 3. +
ANNEX III
Protocols, abstracts and final study reports for post-authorisation safety studies
[...]
2. Format of the abstract of the final study rep… +
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. +
APPLICATION FOR ETHICS COMMITTEE OPINION
1. An application document including the following information or, in each case, an explanation of why that … +
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Additional national measures
Member States may maintain additional measures regarding persons performing mandatory military service, persons deprived… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5 (j) +
Additional requirements for certain performance studies
(j) the medical care provided to the subjects is the responsibility of an appropriately quali… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 1 – 3 +
Additional requirements for certain performance studies
1. Any performance study:
(a) in which surgically invasive sample-taking is done only for … +
Additional requirements for certain performance studies
1. Any performance study:
(a) in which surgically invasive sample-taking is done only for … +
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Adverse Drug Reaction (ADR):
• in the pre-approval clinical experience with a new investigational product or its new usages (particularly as the ther… +
Adverse Event (AE):
Any unfavourable medical occurrence in a trial participant administered the investigational product.
The adverse event does not … +
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Adverse Events and Causality
2. Medication errors, pregnancies and uses outside what is foreseen in the protocol, including misuse and abuse of the p… +
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Adverse event categorization… +
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Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.… +
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Agreement
A document or set of documents describing the details of any arrangements on delegation or transfer, distribution and/or sharing of activit… +
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Amendments by the sponsor
24.—(1) A sponsor may make an amendment to a clinical trial authorisation, other than a substantial amendment, at any time.
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Amendments to clinical trial authorisation
22. Subject to regulation 30, an amendment to a clinical trial authorisation may be made—
(a)by the lic… +
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Annex 11: Computerised Systems
14. Electronic Signature
Electronic records may be signed electronically. Electronic signatures are expected to:
a. ha… +
EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 Annex 1 +
Annex 1: Protection of trial participants’ rights during remote source data verification
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- A documented risk assessment should be performed […]
- … +
