ACRP Practice Exam-Questions and Answers all
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WMA - ✔✔World Medical Association
Declaration of Helsinki - ✔✔-Created by WMA in 1964
- Defines the ethical principles for medical research involving human subjects i.e.:
1. Importance of ICF Requirement of ethical review and approval of research before it is
undertaken
2. Acknowledgement and guidance of special protections for vulnerable subjects
3. Recommends trials are registered on public database
LAR - ✔✔Legally Acceptable Representative. (regarding consenting procedures)
International Conference on Harmonization (ICH) - ✔✔Mission is to provide a unified
standard for Europe, US, and Japan to facilitate the acceptance of clinical trials
Expected AEs - ✔✔Those that are consistent with the product information and were
present on previous and preclinical trials
Contents of the site TMF - ✔✔- IP accountability records
- Subject screening log
- Signed ICFs
Per ICH, how long must an IRB/IEC keep correspondence for after the completion of a
clinical trial - ✔✔at least 3 years
, The signature page is an optional section of the IB (T/F) - ✔✔True
Incapacitated subjects can provide consent as soon as capacity is regained (T/F) -
✔✔True
Who should send Annual Progress Reports to the IRB/IEC - ✔✔The Investigator
The investigator is required to share names of subjects with the IRB/IEC (T/F) -
✔✔False
CRAs(monitors) cannot review source documents of subjects who have withdrawn
consent. Even if the source document predates their consent withdrawal(T/F) -
✔✔True
When should research studies involving human subjects be registered in a publicly
accessible database - ✔✔before recruiting the first subject
Any changes to safety language in an IB should be submitted to the IRB/IEC (T/F) -
✔✔True
All SAE's must be life-threatening to be considered an SAE opposed to AE (T/F) -
✔✔True
After completion of a study, where should the final trial close-out monitoring report
prepared by the CRAbe filed - ✔✔in the Sponsor's files
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