Question Bank

1. Write the note on Historical Development of International Regulations in Clinical Research 2. Define protocol. Who constructs a protocol? What are different sections of a protocol? 3. What you understand by Clinical Research ? Why clinical research is needed ? 4. Explain about drug development process 5. Write process of data management in clinical research 6. Write about TMF and list which documents are there in investigators file 7. Write the phases of clinical trial 8. Briefly describe the following departments and their main functions FDA DGGI ICH GCP 9. List the essential documents which are present in site master file. 9. Write about AE,SAE 10. Enumerate the advantages of India to conduct clinical trials 11. Give basic principals of Belmont report 12. Write note on Nazi experiment 13. How the clinical trials can be classified 14. Explain AE and SAE 15. write a note on source documents 16. What are the elements of CRF design 17. List down which can act as source documents 18. Explain about IND review process 19. Explain NDA review process 20. Write a note on ADME 21. Why new drugs are needed? 22. MCQ

1) Clinical research means, 1) Study to discover new drugs 2) Study that involves human volunteers 3) Drug development process 4) Research at clinic

2) What is NCE 1) New clinical entity 2) New chemical entity 3) New cosmetic entity 4) None of above 3) Drug development involves, 1) Preclinical and clinical studies 2) Only preclinical studies 3) Only clinical studies 4) Preclinical, clinical and formulation development studies 4) Clinical trials are conducted 1) To find out new drugs 2) To measure safety of new drugs 3) To measure effectiveness of new drugs 4) To measure safety and efficacy of drugs 5) Number of patients involved in phase 1 trials 1) 0 10 2) 10 - 100 3) More than 100 4) Less than 100 6) Multi-centric clinical trial means 1) Clinical trials on lot of patients 2) Same trial at various sites 3) Global clinical trials 4) Different centers performing clinical trials 7) ICH means 1) International clinical harmonization 2) International chemical harmonization 3) International circular of harmonization 4) International conference of harmonization 8) No. Of patients involved in Phase III trials 1) 100 1000 2) 1000 - 3000 3) Lot of patients 4) 3000 - 5000 9) CRF means 1) Clinical research form 2) Case report form 3) Clinical record form 4) Clinical report form

10) For a clinical trial patient if a scheduled investigation (as specified in the protocol schedule of events) is missed at a particular visit, which of the following is a best approach: 1) Prepare a deviation file note describing the root cause of the deviation and its impact on the safety/efficacy data followed by an action plan & continue thereafter with the patient in the study. 2) Conduct the missed investigation on a later date and prepare a deviation file note to document the delay. 3) Exclude the patient from the study. 4) Stop the trial at the site. 5) b & c above 11. For a clinical trial patient if a scheduled investigation (as specified in the protocol schedule of events) is missed at a particular visit, which of the following is a best approach: a. Prepare a deviation file note describing the root cause of the deviation and its impact on the safety/efficacy data followed by an action plan & continue thereafter with the patient in the study. b. Conduct the missed investigation on a later date and prepare a deviation file note to document the delay. c. Exclude the patient from the study. d. Stop the trial at the site. e. b & c above 12. Can a Sponsor transfer any or all of the sponsors trial related duties & functions to a CRO (Contract Research Organization)? a. Yes b. No 13. Ethics Committee should approve the patient information sheet and informed consent form before use in a study 1. True 2. False 14. How frequently the trial progress report should be submitted to EC/IEC/IRB? a) Once a year b) Once in 6 months c) As per EC/IEC/IRB Standard Operating Procedures (SOP) however at least once per year d) At trial completion 15. "Can a Sponsor directly interact with the EC/IEC/IRB/ERB for a trial related discussion?

i) ii)

Yes No

16. Which of the following monitoring report is required to be

placed in the file(s) located at Investigators Site? f. g. h. i. j. k. l. Pre-trial monitoring report (site assessment report) Site/trial initiation monitoring report Routine monitoring visit report(s) Site close-out monitoring report All the above None of the above a, b & c

17. With regards to the Investigational Product (IP) which of the

following statement is correct? a) 100% accountability of IP is required at all levels [Sponsor, CRO, Investigator site, patient (if applicable) b) Certificate of analysis is required to be retained by Sponsor for all batches of IP c) All transactions (receipt, dispensing, return, destruction etc.) are required to be documented at the level of Sponsor, CRO, Investigator site, patient (if applicable) d) IP should be labeled as Clinical Trial Material, Not for Sale e) All the above
18. For a clinical trial patient if a scheduled investigation (as specified

in the protocol schedule of events) is missed at a particular visit, which of the following is a best approach: m. Prepare a deviation file note describing the root cause of the deviation and its impact on the safety/efficacy data followed by an action plan & continue thereafter with the patient in the study. n. Conduct the missed investigation on a later date and prepare a deviation file note to document the delay. o. Exclude the patient from the study.

p. Stop the trial at the site. q. b & c above

19. How many patients are involved in phase III trial

iii) iv) v)

1000-3000 20-80 < than 1000