Clinical research methodology (question bank)

Q1 Answer the following.

Select the best Answer.
1. According to ICH GCP, what do the following have in common? Patients with Incurable
diseases and homeless persons?
A. Nothing
B. Neither should be included in a clinical trial
C. A witness should sign the consent form
D. Both are considered vulnerable subjects.
2. Declaration of Helsinki is entitled as:
A. Ethical principles for Medical research Involving Human subjects
B. Ethical Principles and guidelines for the protection of Human subjects of research
C. Guidelines for Biomedical Research involving human Subjects.
D. Guidance document for Ethical Trials.
3. The structure and content of Clinical Study Report are described in ____of schedule Y 2005.
A. Appendix II
B. Appendix Iv
C. Appendix v
D. Annexure II
4. Which of the following is NOT the responsibility of Clinical Data management team.
A. CRF design and development
B. Discrepancy management
C. Database transfer
D. Preparation of Trial master File
5. According to ICH GCP “A person or an organization contracted by the sponsor to perform one
or more of a sponsor’s trial-related duties and functions” is called as:
A. Contract research Organization
B. Trial management Centre
C. Clinical Study Centre
D. Site Management organization
Match the following.
Group A Group B
1. ANDA A. Serious Adverse Event
2. PSUR B. Independent Data Monitoring Committee
3. IDMC C. Abbreviated New Drug Application
4. SAE D. Periodic Safety Update Report
5. ICMR E. Institutional Drug Monitoring Council
F. Indian Council Of Medical Research

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Q.P. Code :10753

C] Explain the following terms (ANY FIVE)

1. New Drug as per Schedule Y

2. Micro dosing

3. Vulnerable subjects

4. Randomization

5. Pharmaco-economics

6. Periodic safety Update Report