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
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
- Institutional Review Boards (IRBs)
- Clinical Investigators
- Sponsors/Monitors
Informed Consent... Answer- - more than just a signature on a form.
- process designed to give subjects all the information necessary to voluntarily decide to participate in a clinical trial.
- 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
be relevant to the subject's participation.
- must provide information in an understandable manner to the study subject.
Eight Basic Elements of Informed Consent Answer- 1. statement that the study involves research; purpose, duration, procedures, and experimental-only procedures
2. risks and discomforts
3. expected benefits
4. disclosure of alternative procedures
5. confidentiality of subject records/ who can inspect records
6. compensation/medical tx availability if injury occurs
7. Name and # for ppl or offices to contact
8. statement that participation is voluntary and can withdraw at any time w/o penalty
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
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
- Institutional Review Boards (IRBs)
- Clinical Investigators
- Sponsors/Monitors
Informed Consent... Answer- - more than just a signature on a form.
- process designed to give subjects all the information necessary to voluntarily decide to participate in a clinical trial.
- 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
be relevant to the subject's participation.
- must provide information in an understandable manner to the study subject.
Eight Basic Elements of Informed Consent Answer- 1. statement that the study involves research; purpose, duration, procedures, and experimental-only procedures
2. risks and discomforts
3. expected benefits
4. disclosure of alternative procedures
5. confidentiality of subject records/ who can inspect records
6. compensation/medical tx availability if injury occurs
7. Name and # for ppl or offices to contact
8. statement that participation is voluntary and can withdraw at any time w/o penalty
