Annexure-14B of AC-46/2023
 Annexure 1B: Clinical Research (Block 1)
Name of Block
Name of Elective
Location of hospital lab or
research facility
Name of Internal preceptor
Name of external preceptor
(if any)
Learning Objectives
Number of students that can
be accommodated in this
elective
Prerequisites for the elective
Learning resource for
students
List of activities in which the
student will participate
Block 1
Clinical Research
MGM Medical College and Hospital, Navi Mumbai
Dr Ipseeta Ray, Professor, Pharmacology
Dr Pradeep Jadhav, Associate Professor, Pharmacology
Nil
At the end of the Elective the learner shall be able to
 Understand the key phases of drug development
 Gain Knowledge on the basics of Clinical Research
Methodology
 Understand the Ethical Regulations and Guidelines governing
Clinical Research
 Get hands on experience on drafting Informed Consent
Documents
 Get hands on training on how to design a Clinical Research
Protocol
 Critical Appraisal of Published Research Article
10
None
 SK Gupta. Basic Principles of Clinical Research and
Methodology. Jaypee Brothers, Medical Publishers Pvt. Limited
 ICMR National Ethical Guidelines for Biomedical Research,
2017
 Morris B, Sharma P, Bennett P. Clinical Pharmacology.
Publisher: Elsevier – Saunders, Mosby, Churchill
o Participate in following teaching learning activities
Clinical Pharmacology
Lectures
o Drug development process
o Preclinical Studies
 o Phases of Clinical Trials
o Ethical Regulations and Guidelines governing Clinical Research
o Basics of Clinical Research Methodology
o Elements of Clinical Research Protocol
o Informed Consent Document
o Institutional Ethics Committee
o Critical Appraisal of Published Literature

Practical’s/Group Activity
o Drafting of Informed Consent Documents and Assent Form
o Designing of Clinical Research Protocols
o Critical Appraisal of Published Research Articles

Portfolio entry required  Documentation of lectures and practical sessions attended

 Documentation and presentation of worked up Informed
Consent Documents
 Documentation and presentation of worked up Assent form
Document
 Documentation and presentation of worked up Clinical Research
Protocol
 Documentation and presentation of worked up critical appraisal
of published article
 Preparation of Summary Report of Elective Module
 Documentation of Reflective Writing
Log book entry required  Completion of activities signed by
preceptor with a “meets expectation ‘(M)’grade”

Assessment  Documentation of attendance

 Successful completion of required portfolio and log book entries
 Presentation of worked up cases, seminars
 Participation in group discussions and team activities
 Reflection Writing

Other Comments Nil