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

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

SET :1

1. Explain the Impartance of EU clinical Directive.
2. How to asses the mental competence of a person to recruit for the studies.
3. Write the roles and responsibilities of internal and external auditors.
4. Write briefly about GCP guidelines followed in India and discuss how the directives
5. will affect clinical research.
6. How “in company” audits are done.
7. Explain Case Report Form used in clinical research.
8. Steps used in subject treatment and submissions for use of investigational new drug.
9. Write about UK ethics approval system.

SET :2

1. What is case report form and what are the essential principles of CRF. [16]
2. Write about the role of ethics committee in the conduct of clinical trials.
3. Write about retrospective of clinical Audit.
4. What is GCP by ICH. Write about the guidelines mentioned in the ICH GCP?
5. Auditing of quality management system. Explain.
6. Explain. Medicine Health care Research Agency-QSE.
7. Write short notes on the following: (a) Waivers (b) Adverse drug experiences (c) Post marketing 15-day “Alert Reports”.
8. Brief the recent developments in Ethical guidelines.

SET :3

1. Write the significance of clinical trials in biomedical research.
2. Write about the obligations of investigators to obtain informed consent.
3. Write about different types or Audit findings and explain follow-up GCP audit reports.
4. What are the legal sanctions the sponsor will face in case of non-compliance of EU directives on GCP for clinical trials?
5. Explain Auditing of Investigation Drug.
6. Principles based on International Conference on Harmonization GCP guidelines.
7. Procedures for submission of supplement to an approved application.
8. Write short notes on : (a) WHO (b) FDA.

SET :4

1. Write about the features of information security followed by the organizations.
2. What are the basic criteria followed to recruit the patients for clinical trials.
3. Write how the standard operating procedures monitors a particular clinical study.
4. Write about the responsibilities of the investigator as stipulated by FDA directives.
5. Explain briefly about sponsor’s audit.
6. Requirements for Labeling of Investigational Medicinal Product.
7. Explain the steps involved in Investigational New Drug application.
8. What type of preparation you should do for inspection.