Quiz 6: Sponsor and Investigator Oversight- Compliance and Managing Clinical Trial Challenges

1)According to ICH guidelines, a sponsor’s audit is conducted to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and applicable regulatory requirements. The audit should also:

1. 1. conducted by the monitors familiar with the investigative sites and clinical protocol
   2. conducted by the IRB/ethics committee which approved the clinical trial
   3. be managed and evaluated by the principal investigators participating in the trial
   4. be independent of and separate from routine monitoring

2. Which of the following terms describes a formal process for reacting to and fixing an existing problem and implementing processes to prevent future non-conformity?
   1. Corrective and Preventive Action (CAPA)
   2. Standard Operating Procedure
   3. (SOP)Quality Assurance (QA)
   4. None of the above

3. Which of the following is an example of protocol non-compliance (protocol deviation)?
   1. The protocol requires all SAEs reported to the sponsor within 24 hours of discovery.
   2. The protocol requires a physical assessment performed Day 1 + 3. The PI performs a physical assessment on Day 3.
   3. The protocol requires a Day 5 blood draw. The PI orders a blood draw on Day 5
   4. The protocol requires a Day 15 CT scan. The PI order an MRI scan on Day 15.
   5. The coordinator reports an SAE for subject 004 to the sponsor 18 hours after     discovery.

4. TRUE or FALSE: The following are possible consequences for non- compliance in clinical trials involving human research subjects:

1. Integrity of research data may be compromised
2. Safety profile of investigational product may be inaccurate
3. Disbarments and/or criminal prosecution
   1. True
   2. False

5. Choose the best answer: In clinical trials involving human subjects, who works to ensure compliance is maintained at the investigative site?
   1. Clinical Research Coordinator
   2. Sponsor/Monitor
   3. IRB
   4. Sponsor/Monitor, IRB, PI, and all site personnel assigned to the study
   5. Principal Investigator

6. Which of the following terms describes detailed written instructions to achieve uniformity of a specified function?
   1. Quality Control (QC)
   2. Standard Operating Procedure (SOP)
   3. Quality Assurance (QA)

1. 4. Corrective and Preventive Action (CAPA)

Questions 7-10: You are an auditor for a medical device company conducting an audit on five investigative sites currently active in a pivotal trial. The five sites are the highest enrolling sites in this trial and are known for their experience in conducting clinical research trials.

7. The main objective of your audit will be to determine each site’s level of compliance with the requirements of the clinical study and if each site has a system for managing any issues discovered. Which of the following elements will you need to evaluate?
   1. The Sponsor’s Standard Operating Procedures
   2. The IRB’s Standard Operating Procedures
   3. Protocol compliance and the handling of deviations
   4. Sponsor compliance with regulations

8. Which of the following audit observations found at one of the sites may be indicative of fraud?
   1. The site has an average number of protocol deviations
   2. There are an expected number of subject dropouts
   3. The site does not have Standard Operating Procedures
   4. The Investigator’s signature on case report forms in black ink yet the signature is dated in blue ink.

9. At one of the sites, you note a trend in the data and source documents that may potentially be a threat to the integrity of the clinical trial data. Which of the following would pose a threat to the integrity of the clinical trial data?
   1. The site does not have Standard Operating Procedures
   2. The site did not report the occurrence of numerous serious adverse events to the sponsor
   3. The site did not properly inform the IRB of numerous protocol deviations
   4. The site did not implement a CAPA to correct and prevent future issues