Name of the University : The Tamilnadu Dr. M.G.R. Medical University
Degree : D.Pharm
Subject Code/Name : 3824/Clinical Research
Year : V
Paper : I
Document Type : Question Bank
Website : tnmgrmu.ac.in
Download Model/Sample Question Paper :
2011-2014 : https://www.pdfquestion.in/uploads/web.tnmgrmu.ac.in/PHARMACY/3819-383825KX.pdf
Clinical Research Question Bank :
September 2010 :
[KX 825]
Sub. Code: 3825
Related : TNMGRMU Clinical Toxicology D.Pharm Question Bank : www.pdfquestion.in/3817.html
DOCTOR OF PHARMACY (PHARM. D / POST BACCALAUREATE) DEGREE EXAMINATION :
(Regulations 2008 – 2009)
(Candidates admitted from 2008-2009 onwards)
Paper I : CLINICAL RESEARCH
Q.P. Code : 383825
Time : Three hours
Maximum : 70 marks
Answer All questions :
I. Essay Questions : (2 x 20 = 40)
1. Define Clinical Trials? Discuss in detail five various phases involved in drug development process.
2. Discuss the composition, responsibilities and procedures of IRB/IEC.
II. Write Short Notes : (6 x 5 = 30)
1. Significance of post marketing surveillance.
2. Roles and responsibilities of Investigations.
3. Study designs in a clinical trail.
4. Informed consent process.
5. ICH guidelines in clinical trials.
6. Purposes of an audit in a clinical trial.
October 2011 :
I. Elaborate on :
1. (a) Define investigational new drug application and describes the component and categories of investigational new drug application
(b) What are the essential documents for the conducting of clinical trials and its purpose?
2. (a) Roles and responsibilities of auditors in clinical research (b) Define serious adverse event in clinical trial and responsibilities of investigators in reporting
II. Write notes on :
1. Various phases of clinical trial
2. Informed consent process
3. Central drug standard control organisation and food and drug administration
4. Investigators brochure
5. Randomization
6. Source documents in clinical trial
7. Vulnerable subjects
8. Roles and responsibilities of regulatory authority in relation to clinical trial
9. What are the responsibilities of clinical data manager?
10. Define the followings:
(i). Blinding (ii). Comparator (iii). Good clinical practice.
OCTOBER 2013 :
I. Elaborate on: (2 x 20 = 40)
1. What is ANDA?
What are the drugs come under ANDA?
What is meant by generic drugs?
Write a note on post marketing surveillance.
2. What is Institutional human ethical committee? Give the composition, qualification required for the members. Explain the functions of the committee.
II. Write notes on: (10 x 3 = 30)
1. Explain the importance of Pharmacological information in drug discovery.
2. Name various chemical characteristics of the drug.
3. Write a not on GCP.
4. What are the challenges faced by the investigator in clinical trials.
5. Write a not on schedule Y.
6. Explain the responsibility of the auditors in clinical trials.
7. Explain the protocol involved in data management in clinical research.
8. Differentiate Phase II & Phase III clinical trials.
9. Why randomization is important in clinical research?
10. Write the significance of preclinical testing in clinical research.
APRIL 2014 :
I. Elaborate on : (2×20=40)
1. a) What is clinical research and why do we need to conduct research?
b) What are the different stages of drug development process?
2. a) Roles and responsibilities of contract research organizations in clinical research.
b) Define Investigator’s brochure and describes about its components.
II. Write notes on : (10×3=30)
1. Good clinical practice and its principles
2. Informed consent process
3. Central drug standard control organisation and food and drug administration
4. Various ethical guidelines in clinical research
5. Safety monitoring in clinical trials
6. Source documents in clinical trial
7. Vulnerable subjects
8. Roles and responsibilities of Investigator in clinical trial
9. What are the responsibilities of regulatory authority in clinical research?
10.Define the followings:
a) Case report form (CRF)
b) Impartial witness
c) Schedule- Y
Syllabus :
Clinical Research [Theory]
1. Drug development process :
Introduction :
Various Approaches to drug discovery
1. Pharmacological
2. Toxicological
3. IND Application
4. Drug characterization
5. Dosage form
2. Clinical development of drug :
1. Introduction to Clinical trials
2. Various phases of clinical trial.
3. Methods of post marketing surveillance
4. Abbreviated New Drug Application submission.
5. Good Clinical Practice – ICH, GCP, Central drug standard control organisation (CDSCO) guidelines
6. Challenges in the implementation of guidelines
7. Ethical guidelines in Clinical Research
8. Composition, responsibilities, procedures of IRB/IEC
9. Overview of regulatory environment in USA, Europe and India.
10. Role and responsibilites of clinical trial personnel as per ICH GCP
a. Sponsor
b. Investigators
c. Clinical research associate
d. Auditors
e. Contract research coordinators
f. Regulatory authority
11. Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment)
12. Informed consent Process
13. Data management and its components
14. Safety monitoring in clinical trials