Introduction to GCL Flashcards
(10 cards)
What is Good Clinical Practice?
It is an international ethical and scientific standard for conducting biomedical and behavioural research involving human participants.
What is the objective of GCP guidelines?
This guideline’s objective is to provide a unified standard across the European Union (EU), Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by Regulatory Authorities.
For whom is GCP training necessary?
This training is important for all staff involved in Clinical Research and ensures an understanding of the principles adopted in research.
GCP is specific to a protocol (True or False)
FALSE, GCP is not specific to a protocol but is general and applicable to all protocols.
Who should complete the GCP training?
Anyone directly involved in the design or conduct, oversight, or management of research involving human participants, including research site staff, back-up staff, contractors, subcontractors, and consultants who perform key study functions.
Non-study staff at the research site who provide standard care or other non-study related services should be encouraged to complete the GCP training, but they are not required to do so (True or False)
True
The Good Clinical Practice (GCP) guidelines were prepared in association with
the International Council for Harmonization (ICH)
What is the purpose of the ICH GCP guidelines?
The purpose of the ICH GCP guidelines is twofold:
1-To ensure that the rights, safety, and confidentiality of participants in clinical trials are protected.
2-To ensure that the data collected in clinical trials, as well as the reported results of clinical trials, are accurate and credible.
What are the ICH GCP Principles? 13 points
1-Clinical trials should be conducted by the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
2-Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial participant and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
3-The rights, safety, and well-being of trial participants are the most important considerations and should prevail over the interests of science and society.
4-The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
5-Clinical trials should be scientifically sound and described in a clear, detailed protocol.
6-A trial should be conducted in compliance with a protocol that has received prior institutional review board (IRB) approval.
7-The medical care given to, and medical decisions made on behalf of, participants should always be the responsibility of a qualified physician or, when appropriate, a qualified dentist.
8-Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
9-Freely given informed consent should be obtained from every participant before clinical trial participation.
10-All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification.
11-The confidentiality of records that could identify participants should be protected, respecting the privacy and confidentiality rules of the applicable regulatory requirement(s).
12-Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
13- Systems with procedures that assure the quality of every aspect of the trial should be implemented.
What is the Code of Federal Regulations?
The Code of Federal Regulations (CFR) is the codification (systematic arrangement) of rules published in the Federal Register by the executive departments and agencies of the U.S. Government.
