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QA/QC Quiz
|
Test your knowledge about QA/QC
issues by taking the quiz below. Quiz questions and answers will be
added to the page on a regular basis.
Send your ideas for questions to: QA/QCForumModerators@hptn.org
| 1. |
Must
questionnaires that are used to assess a participants' comprehension
of the consent process be submitted to an IRB? |
True |
False |
| 2. |
Maintaining copies of
laboratory normal ranges in the investigator's essential
documents file is a GCP requirement? |
True |
False |
| 3. |
Must all clinical laboratories that
support the conduct of an FDA regulated clinical trial be certified
under the Clinical Laboratory Improvement Act (CLIA)? |
True |
False |
| 4. |
According to the FDA's
Financial Disclosure Rule (21 CFR 54), a clinical investigator, with
significant equity interests in a Sponsor, cannot be a principal
investigator for a study by that sponsor. |
True |
False |
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