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

ICH E6(R3) Guideline

Legally Acceptable Representative

An individual or juridical or other body authorised under applicable law to consent, on behalf of a prospective participant, to the participant’s participation in the clinical trial. When a legally acceptable representative provides consent on behalf of a prospective participant, activities related to the consenting process (and re-consent, if applicable) and, where relevant, activities associated with the withdrawal of consent described in this guideline are applicable to the participant’s legally acceptable representative.

Metadata

The contextual information required to understand a given data element. Metadata is structured information that describes, explains or otherwise makes it easier to retrieve, use or manage data. For the purpose of this guideline, relevant metadata are those needed to allow the appropriate evaluation of the trial conduct.

Monitoring

The act of overseeing the progress of a clinical trial and of ensuring that the clinical trial is conducted, recorded and reported in accordance with the protocol, SOPs, GCP and the applicable regulatory requirement(s).

Monitoring Plan

A document that describes the strategy, methods, responsibilities and requirements for monitoring the trial.

Monitoring Report

A documented report following site and/or centralised monitoring activities.

Multicentre Trial

A clinical trial conducted according to a single protocol but at more than one investigator site.

Nonclinical Study

Biomedical studies not performed on human participants.

Protocol

A document that describes the objective(s), design, methodology, statistical considerations and organisation of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline, the term “protocol” refers to protocol and protocol amendments.

Protocol Amendment

A documented description of a change(s) to a protocol.

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