Good Clinical Practice Exam Questions With Correct Answers.What are Good Clinical Practices (GCPs) Answer- A standard by which clinical trials are designed, conducted, recorded, and reported so that there is public assurance that the data are credible, and that the rights, welfare, safety and well-being of subjects are protected International Conference on Harmonization (ICH) Answer- - Brings together the regulatory authorities of Europe, Japan, and the United States
- Includes Experts from the pharmaceutical industry
- Discuss scientific and technical aspects of product development
- Institutional Review Boards (IRBs)
- Clinical Investigators
- Sponsors/Monitors
- process designed to give subjects all the information necessary to voluntarily
- must be IRB approved prior to beginning the trial.
- must be obtained before a subject participates in any research-only procedure.
- should be revised whenever important new information becomes available that may
- must provide information in an understandable manner to the study subject.
- risks and discomforts
- expected benefits
- disclosure of alternative procedures
- confidentiality of subject records/ who can inspect records
- compensation/medical tx availability if injury occurs
- Name and # for ppl or offices to contact
- statement that participation is voluntary and can withdraw at any time w/o penalty
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Objective of ICH Answer- Objective: economical use of human, animal, and material resources, and the elimination of unnecessary delay in global development and availability of new products while maintaining safeguards on quality, safety, efficacy, and regulatory requirements How are GCPs Upheld? Answer- - Informed Consent
Informed Consent... Answer- - more than just a signature on a form.
decide to participate in a clinical trial.
be relevant to the subject's participation.
Eight Basic Elements of Informed Consent Answer- 1. statement that the study involves research; purpose, duration, procedures, and experimental-only procedures