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G
Definitions
For the purposes of this Directive the following definitions shall apply:
(a)‘clinical trial’: any investigation in human subjects intend… +
E
Definitions
[...]
(30) ‘Good clinical practice’ means a set of detailed ethical and scientific quality requirements for designing, conducting, perform… +
D
Deutsches Ärzteblatt
Publication of the GCP related courses programms in Germany for trial site personnel, by the German federal chamber of physician… +
A
Die Aufzeichnungen sowie die sonstigen der Dokumentation im Sinne des Abs. 1 dienlichen Unterlagen sind mindestens zehn Jahre aufzubewahren.… +
E
Documentation Practices
4.7 Handwritten entries should be made in clear, legible, indelible way.
[…]
4.9 Any alteration made to the entry on a documen… +
I
Double-Dummy
A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. Su… +
Dropout
A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the study protocol… +
E21: Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials
Dated 26 May 2023
[...]
2. Background to the proposal and statement of th… +
E
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 a… +
G
ETHICS COMMITTEES
United Kingdom Ethics Committees Authority
5.—(1) The body responsible for establishing, recognising and monitoring ethics committee… +
E
EU Regulation 2017/745 – Preamble:
(64) The rules on clinical investigations should be in line with well-established international guidance in this fi… +
EU Regulation 2017/746 – Preamble:
(66) The rules on performance studies should be in line with well-established international guidance in this field,… +
Electronic system on clinical investigations
1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an elect… +
Electronic system on performance studies
1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an electroni… +
End of a clinical trial, temporary halt and early termination of a clinical trial and submission of the results
4. Irrespective of the outcome of a… +
End of a clinical trial, temporary halt and early termination of a clinical trial and submission of the results
1. The sponsor shall notify each Me… +
D
Ergänzende Empfehlungen des BfArM und des PEI zur Europäischen Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemi… +
I
Essential clinical investigation documents
[...]
Table E.1 - Essential clinical investigation documents prior to clinical investigation
[...]
Table E.… +
Essential clinical investigation documents
[...]
Table E.1 - Essential clinical investigation documents prior to clinical investigation
[...]
Table E.… +
G
Ethics committee opinion
15.— [...]
(5) In preparing its opinion, the committee shall consider, in particular, the following matters—
(d)the suitabi… +
