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E
Clinical trials on pregnant or breastfeeding women
A clinical trial on pregnant or breastfeeding women may be conducted only where, in addition to th… +
Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from … +
Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from … +
Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from … +
I
Comparator
An investigational or authorised medicinal product (i.e., active control), placebo or standard of care used as a reference in a clinical t… +
Compliance (in relation to trials)
Adherence to the trial-related requirements, GCP requirements and the applicable regulatory requirements.… +
E
Compliance with the protocol and good clinical practice
The sponsor of a clinical trial and the investigator shall ensure that the clinical trial is … +
Compliance with the protocol and good clinical practice
The sponsor of a clinical trial and the investigator shall ensure that the clinical trial is … +
Compliance with the protocol and good clinical practice
The sponsor of a clinical trial and the investigator shall ensure that the clinical trial is … +
I
Computerised Systems Validation
A process of establishing and documenting that the specified requirements of a computerised system can be consistentl… +
G
Conclusion of clinical trial
27.—(1) Subject to paragraph (2), within 90 days of the conclusion of a clinical trial the sponsor shall notify the licen… +
E
Conduct of a clinical investigation
1. The sponsor and the investigator shall ensure that the clinical investigation is conducted in accordance wit… +
Conduct of a clinical investigation
2. In order to verify that the rights, safety and well-being of subjects are protected, that the reported data … +
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-002 +
Conduct of a clinical investigation
3. All clinical investigation information shall be recorded, processed, handled, and stored by the sponsor or i… +
Conduct of a clinical investigation
5. Member States shall inspect, at an appropriate level, investigation site(s) to check that clinical investiga… +
Conduct of a clinical investigation
6. The sponsor shall establish a procedure for emergency situations which enables the immediate identification … +
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-001 +
Conduct of a clinical investigation
[...]
3. All clinical investigation information shall be recorded, processed, handled, and stored by the sponso… +
G
Conduct of a clinical trial
[…]
(b)without prejudice to point (a), in the light of the circumstances, notably the occurrence of any new event relating… +
Conduct of a clinical trial
[…]
(b)without prejudice to point (a), in the light of the circumstances, notably the occurrence of any new event relating… +
Conduct of a clinical trial
[…]
(c)within 90 days of the end of a clinical trial the sponsor shall notify the competent authorities of the Member Stat… +
