Cert Prep Exam flashcards
Which entity is primarily charged with considering subject rights and well-being during clinical trials?
IRB / IEC
Thirty-two subjects are enrolled in a neurology study in which 50 subjects eventually will be enrolled. The CRC notes that 25 of these 32 subjects have developed a cough. The CRC should now do which of the following actions.
* Report the observation to the sponsor.
* Ask the IRB/IEC permission to continue the study.
* Inform the CRA at the next monitoring visit.
* Modify the screening questionnaire to ask about cough.
Report the observation to the sponsor
A CRA noticed that a subject showed clinically significant liver function test abnormalities on the subject’s last study visit. The test was conducted at a local laboratory not listed in the protocol. The CRA then discovered that the local laboratory was not accredited. What should the CRA do first?
* Recommend suspending study activities at the site.
* Recommend admitting the subject to the hospital.
* Request a repeat liver function test at an accredited laboratory.
* Request subjects’ randomization codes for the coordinator at the site.
Request a repeat liver function test at an accredited laboratory.
An Investigator’s Brochure should contain which of the following about an investigational product?
1. Chemical name
2. Chemical synthesis procedures
3. Instructions for destruction of the investigational product
4. Adverse drug reactions
- 1 and 2 only
- 2 and 3 only
- 3 and 4 only
- 1 and 4 only
1 and 4 only
The 3 cognitive levels used in the exam are:
* Recall, Understanding, Analysis
* Recall, Evaluation, Creating
* Recall, Remembering, Understanding
* Recall, Application, Analysis
Recall, Application, Analysis
The following are guidelines tested during the certification exam: (Select all that apply)
* The Nuremberg Code
* ICH GCP (E6)
* The Belmont Report
* The Declaration of Helsinki
* ICH E2A
- ICH GCP (E6)
- The Declaration of Helsinki
- ICH E2A
