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?
- Chemical name
- Chemical synthesis procedures
- Instructions for destruction of the investigational product
- 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
