Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice
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1.20 Contract Research Organization (CRO)
A person or an organization (commercial, academic, or other) contracted by the sponsor to
perform one or more of a sponsor's trial-related duties and functions.
1.21 Direct Access
Permission to examine, analyze, verify, and reproduce any records and reports that are important
to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities,
sponsor's monitors and auditors) with direct access should take all reasonable precautions within
the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of
subjects' identities and sponsor’s proprietary information.
1.22 Documentation
All records, in any form (including, but not limited to, written, electronic, magnetic, and optical
records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct,
and/or results of a trial, the factors affecting a trial, and the actions taken.
1.23 Essential Documents
Documents which individually and collectively permit evaluation of the conduct of a study and
the quality of the data produced (see 8. Essential Documents for the Conduct of a Clinical Trial).
1.24 Good Clinical Practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and
reporting of clinical trials that provides assurance that the data and reported results are credible
and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
1.25 Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring
Board, Monitoring Committee, Data Monitoring Committee)
An independent data-monitoring committee that may be established by the sponsor to assess at
intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to
recommend to the sponsor whether to continue, modify, or stop a trial.
1.26 Impartial Witness
A person, who is independent of the trial, who cannot be unfairly influenced by people involved
with the trial, who attends the informed consent process if the subject or the subject’s legally
acceptable representative cannot read, and who reads the informed consent form and any other
written information supplied to the subject.
1.27 Independent Ethics Committee (IEC)
An independent body (a review board or a committee, institutional, regional, national, or
supranational), constituted of medical professionals and non-medical members, whose
responsibility it is to ensure the protection of the rights, safety and well-being of human subjects
involved in a trial and to provide public assurance of that protection, by, among other things,
reviewing and approving/providing favourable opinion on, the trial protocol, the suitability of the
investigator(s), facilities, and the methods and material to be used in obtaining and documenting
informed consent of the trial subjects.
The legal status, composition, function, operations and regulatory requirements pertaining to
Independent Ethics Committees may differ among countries, but should allow the Independent
Ethics Committee to act in agreement with GCP as described in this guideline.