ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

ICH E6(R3) Guideline

Blinding/Masking

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).

Case Report Form (CRF)

A data acquisition tool designed to record protocol-required information to be reported by the investigator to the sponsor on each trial participant (see Data Acquisition Tool ).

Certified Copy

A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information as the original, including relevant metadata, where applicable.

Clinical Trial

Any interventional investigation in human participants intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s); and/or to identify any adverse reactions to an investigational product(s); and/or to study absorption, distribution, metabolism and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.

Clinical Trial/Study Report (CSR)

A documented description of a trial of any investigational product conducted in human participants, in which the clinical and statistical description, presentations and analyses are fully integrated into a single report (see ICH E3 Structure and Content of Clinical Study Reports).

Comparator

An investigational or authorised medicinal product (i.e., active control), placebo or standard of care used as a reference in a clinical trial.

Compliance (in relation to trials)

Adherence to the trial-related requirements, GCP requirements and the applicable regulatory requirements.

Confidentiality

Prevention of disclosure to other than authorised individuals of a sponsor’s proprietary information or of a participant’s identity or their confidential information.

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