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Dr Heike Hennig

+49 (0) 441 798-4969

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Deputy Head

Dr Andreas Molitor

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Sponsor QM

Dr Andreas Molitor

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Glossary (KKS)

Good Clinical Practice (GCP)

Good clinical practice (GCP) is an international ethical and scientific standard for planning, conducting, documenting and reporting clinical trials on humans. It focuses on the protection of trial participants and their informed consent as well as the quality of the trial results. Compliance with this standard creates confidence that the rights, safety and well-being of trial participants are protected and that the data collected during the clinical trial is credible.

Guideline for good clinical practice E6(R3)

Investigator Initiated Trial (IIT)

Non-commercial clinical trials are also known as investigator-initiated trials
(IIT). They strengthen the research profile and thus the reputation of
universities and medical schools and are not only required as a supplement to commercial studies in terms of content, but also
as a corrective.

Sponsor (in clinical trials, according to ICH-GCP)

"A person, company, institution or organisation that assumes responsibility for the initiation, management and financing of a clinical trial. ..."
[ICH E6 (R3) Guideline for good clinical practice (GCP), Glossary, translation]

(Changed: 11 Feb 2026)  Kurz-URL:Shortlink: https://uol.de/p88953en
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