Category-Archiv:

Adverse Device Effect

Adverse Drug Reaction

Adverse event

Medicinal products act

Act on the Reform of the Market for Medicinal Products

Audit

Audit trail

Baseline

Federal Institute for Drugs and Medical Devices

A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the participant(s) being unaware, and double-blinding usually refers to the participant(s) and investigator(s) and, if appropriate, other investigator site staff or sponsor staff being unaware of the treatment assignment(s). ICH E6(R3)