REGULATORY AFFAIRS AND CLINICAL TRIALS Question Papers (2008, Supple)

SET :1

1. Explain the Impartance of EU clinical Directive.
2. Write about Nuremberg code.
3. Write how the standard operating procedures monitors a particular clinical study.
4. Short notes on: (a) IEC (b) Essential documentation (c) Investigator (d) IRB.
5. During sponsors audit what are the documents inspected.
6. What are the Current and Future European requirements in clinical trials?
7. What are the requirements for gaining approval by FDA?
8. Write about UK ethics approval system

SET :2

1. Define clinical trials. What are the ethical principles for medical research involving human subjects with special emphasis on declaration of Helsinki 2000 amendment?
2. How to asses the mental competence of a person to recruit for the studies.
3. Write a short answers: (a) Clinical Audit (b) Monitering of clinical trial (c) Inspection of clinical trail (d) Audit conduct (e) Audit certificate
4. What are the commercial sanctions the sponsor will face in case of non-compliance of USA directives on GCP for clinical trials in India?
5. Write about the current regulatory guidelines for Investigational Product.
6. Mention the regulatory affairs for studies on human subjects.
7. Brief the content and format of an application required to submit for New Drug Approval.
8. Write short notes on the following: (a) Electronic records (b) electronic signatures.

SET :3

1. Write about the codes of practice for regulation of drug preparation and marketing.
2. What are the risks involved with the investigator during a clinical trial study.
3. Write about the difference in the auditing of in-house and On-site audits.
4. Write about the salient features of ICH GCP.
   
5. (a) What is clinical audit and explain various types of audits. (b) Explain how an investigator should prepare for audits. (c) Explain the purpose of Audits.
6. Explain the method of QSE documentation.
7. Brief the Post marketing reporting of adverse drug experience.
8. Write about UK ethics approval system.

SET :4

1. Write in detail about Clinical trial directives made by European Union.
2. Write short notes on: (a) Negleigence in clinical trails (b) Informed consent (c) Mental competence.
3. Write the roles of GCP auditor in Quality assurance unit.
4. What are the essential documents needed during the clinical conduct of the study.
5. (a) What is clinical audit and explain various types of audits. (b) Explain how an invertigator should prepare for audits. (c) Explain the purpose of Audits.
6. Explain. Medicine Health care Research Agency-QSE.
7. What are the requirements for gaining approval by FDA?
8. Write short notes on: (a) ICH principles (b) Inspection policy