Examples of ICH GCP in a sentence
The Sponsor is also required to document that each IRB/IEC meets regulatory and ICH GCP requirements by requesting and maintaining records of the names and qualifications of the IRB/IEC members and to make these records available for regulatory agency review upon request by those agencies.
Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.
In accordance with the principles of ICH GCP, the following areas listed in this section are also the responsibility of the Investigator.
The process of obtaining informed consent should be documented in the patient source documents.Novartis will provide to investigators in a separate document a proposed informed consent form that complies with the ICH GCP guideline and regulatory requirements and is considered appropriate for this study.
In all cases, MSD clinical trials will be conducted in compliance with local and/or national regulations (eg, International Council for Harmonisation Good Clinical Practice [ICH- GCP]) and in accordance with the ethical principles that have their origin in the Declaration of Helsinki.