ICF Harmonised Guideline for GCP Flashcards
what is the ICH?
International Council for Harmonisation
ICH harmonised guideline for GCP
finalized in November 2016 – the Good Clinical Practices document describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs.
What does GCP cover?
aspects of monitoring, reporting and archiving of trials; incorporates Essential Documents and IB addenda agreed on earlier via ICH process
What is GCP?
international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.
what is the objective of the ICH GCP?
To provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
Australia, Canada, Nordic countries (Iceland, Norway, Sweden, Denmark and Finland) and WHO’s GCP were also taken into consideration
Adverse Drug Reaction
All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.
Adverse Event
untoward medical occurrence in a subject who received study drug that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.
Audit
systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s SOPs, GCP, and the applicable regulatory requirements
comparator
an investigational or marketed product, or placebo, used as a reference in a clinical trial
compliance
adherence to all the trial-related requirements, good clinical practice requirements, and the applicable requirements
confidentiality
prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity
coordinating commitee
a committee that a sponsor may organized to coordinate the conduct of a multicenter trial
coordinating investigator
an investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter trial
contract (clinical?) research organization (CRO)
a person or an organization contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions
direct access
Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.
inspection
The act by a regulatory authority of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authorities to be realted to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s facilities, or at other establishments deemed appropriate by the regulatory authorities.
13 principles of ICH GCP
1) ethics
2) trial risk vs trial benefit
3) trial participants
4) info on medicinal product
5) good quality trials
6) compliance with study protocol
7) medical decisions
8) trial staff
9) informed consent
10) clinical trial data
11) confidentiality
12) good manufacturing practice
13) quality assurance
when were ICH GCP guidelines developed?
1996
