ICH E6 R2
Which of the following is NOT a reason for the revisions to ICH GCP E6?
(Select the best answer)
A. Clinical trials have increased in scale and complexity.
B. Clinical trials have become more global.
C. There is a decreased need for explicit guidance around clinical trials.
D. There is an increased use of technology in clinical trials.
C. There is a decreased need for explicit guidance around clinical trials.
When designing a Protocol, what considerations should the Sponsor take into account?(Select the best answer)
A. Only activities pertaining to the development of the protocol
B. Ensuring safety of subjects and maintaining integrity of data.
C. Collaboration across researchers and study team.
D. Ensuring safety of subjects and maintaining integrity of data and collaboration across researchers and study team.
D. Ensuring safety of subjects and maintaining integrity of data and collaboration across researchers and study team.
Who should keep a record of the location of essential documents? (Select the best answer)
A. Sponsors
B. Investigators
C. Both Sponsors and Investigators should keep a record of all essential documents.
D. Sponsors and Investigators should keep a record of their respective essential documents.
D. Sponsors and Investigators should keep a record of their respective essential documents.
What are the 4 topics of the ICH Guidelines
A. Phase I, Phase II, Phase III, and Phase IV
B. Data Integrity, Subject Safety, Trained Personnel, and Qualified Resources
C. Multidisciplinary, Quality, Efficacy, and Safety
D. None of the above
C. Multidisciplinary, Quality, Efficacy, and Safety
Which of the following is the responsibility of the Sponsor? (Select the best answer)
A. Developing a well-thought-out monitoring plan.
B. Selecting the appropriate type of monitoring.
C. Ensuring that monitoring reports have sufficient detail to verify compliance with the monitoring plan.
D. All of the above.
D. All of the above.
If there is a change to source data, which of the following should the Investigator ensure? (Select the best answers.)
A. Changes do not obscure the original entry.
B. Changes can be explained if necessary (e.g. using an audit trail)
C. Original entry is deleted permanently.
D. Changes are traceable.
A & B & D
A. Changes do not obscure the original entry.
B. Changes can be explained if necessary (e.g. using an audit trail)
D. Changes are traceable.
Which of the following is part of the suggested risk-based approach to monitoring? (Select the best answer)
A. Identify Critical Data and Processes, Evaluate Risks, Implement Control Measures, and Report Risks.
B. Implement a Quality Management System
C. Ensure oversight of vendors through the development of a monitoring plan.
D. All of the above
D. All of the above
How does Gilead address noncompliance with impact to subject safety or data integrity?
A. Report the noncompliance issue to other Sponsor companies to ensure that others are aware of potential issues.
B. Ensure proper documentation in our TMF and report individual(s) to regulatory authorities.
C. Perform a root cause analysis and implement appropriate corrective actions.
D. None of the above answers.
C. Perform a root cause analysis and implement appropriate corrective actions.
Which of the following statement(s) is most accurate pertaining to CRF data?
[Select the best answer(s)]
A. Sponsors should have exclusive control over CRF data reported to Sponsors.
B. Investigators should ensure that Sponsors have access to and control over CRF data reported to Sponsors.
C. Sponsors should ensure that Investigators have access to and control over CRF data reported to Sponsors.
D. Neither Sponsor nor Investigators should have control over CRF data reported to Sponsors.
C. Sponsors should ensure that Investigators have access to and control over CRF data reported to Sponsors.
What are the 3 categories in which the core principles of ICH GCP R(2) are divided?
A. Life, Liberty, and the Pursuit of Happiness
B. Data Integrity, Study Quality and Subject Safety
C. Subject Safety, Data Integrity, and Qualified Resources
D. Quality, Efficacy and Safety
C. Subject Safety, Data Integrity, and Qualified Resources
What is the requirement for Gilead to report an AE or SAE to the local or central ethics committee?
(Select all that apply)
A. Semi-annual report that lists study discontinuation due to AEs, SAEs and deaths
B. As soon as it is discovered or when we are informed
C. Within 15 days
D. Less than 24 hours
B & C
B. As soon as it is discovered or when we are informed.
C.Within 15 days
What investigator responsibilities are described in the investigator agreement and qualifications?
(Select ALL that apply)
A. Investigator is thoroughly familiar with the investigational product and its appropriate use.
B. Investigator must be properly qualified to assume responsibility for conduct of the study.
C. Sponsor must adhere to meeting standards and regulations set by regulatory authorities.
D. Investigator is willing to comply with GCP and applicable regulations and be prepared for audits and monitoring.
E. Sponsor should monitor any trial-related duties and functions carried out by the investigator.
A & B & D
A. Investigator is thoroughly familiar with the investigational product and its appropriate use.
B. Investigator must be properly qualified to assume responsibility for conduct of the study.
D. Investigator is willing to comply with GCP and applicable regulations and be prepared for audits and monitoring.