RR COLLEGE OF PHARMACY

Chikkabanavara, Bangalore-560090
Accredited by NAAC with ‘A’ Grade
INTERNAL QUALITY ASSURANCE CELL (IQAC)

College Name: R R College of Pharmacy Academic year : 2023-24

Programme : Pharm D Semester or Year : V
Subject Name :Clinical Research Subject Code :5.1
Total contact hours : 75 IA Marks: 30

Faculty Name: Dr. Narendra Varma J Reviewed by:

Signature : Signature :

Lesson Plan
Significance of the Subject:This course is designed to make the students to understand the principles and gain
adequate knowledge regarding the various approaches to drug discovery including clinical phase of development. Also
enables the students to understand and implement all regulatory and ethical requirements that are required during the
process of drug development.
Course Objective:At completion of this subject it is expected that students will be able to understand –
 Discuss process of preclinical and clinical development of a new drug
 Describe the different regulatory requirements to conduct a clinical trial
 List out various clinical trial documents and describe their respective components
 Explain the roles and responsibilities of various clinical trial personnel as per ICHGCP
 Explain the process of reporting safety information to various stakeholders
Course Outcomes:
CO1: Discuss the Pharmacological and Toxicological considerations in process of development of new drugs.
CO2: Know the new drug development process.
CO3: Discuss the principles and phases in clinical trial of drug. Design the documents of clinical trial.
CO4: Explain the guidelines for ethics and safe monitoring in clinical trial of a drug.
CO5: Distinguish the guidelines of national and international regulatory bodies for clinical trial.
CO6: Recognize differing roles and obligations of the Investigator, Sponsor and Institutional Review Board.

Page 1 of 8
 RR COLLEGE OF PHARMACY
Chikkabanavara, Bangalore-560090
Accredited by NAAC with ‘A’ Grade
INTERNAL QUALITY ASSURANCE CELL (IQAC)

Teachi

Development
Module No &
Hours as per

Date

Blooms level
University

ng aids

Remarks
Class No

CO’s
Skill
Topic to be covered (CT/
Online/ Planned Completed
PPT)
CT/ CO
Drug development process: L1,
1 Online/ PS 2-1-24 1
Introduction L2
PPT
CT/ CO
L1,
2 Drug development process: Process Online/ PS 5-1-24 1
L2
PPT
CT/ CO
Various Approaches to drug L1,
3 Online/ PS 8-1-24 1
discovery: Introduction L2
PPT
CT/ CO
Various Approaches to drug L1,
4 Online/ PS 9-1-24 1
discovery: Pharmacological L2
PPT
CT/ CO
Drug Various Approaches to drug L1,
5 Online/ PS 11-1-24 1
develop discovery: Toxicological L2
PPT
ment CT/
Various Approaches to drug L1, CO
process:
6 Online/ PS 12-1-24 1
10 hrs discovery: IND Application L2
PPT
CT/ CO
Various Approaches to drug L1,
7 Online/ PS 16-1-24 1
discovery: IND Application L2
PPT
CT/ CO
L1,
8 Drug characterization Online/ PS 17-1-24 1
L2
PPT
CT/ CO
L1,
9 Dosage form Online/ PS 23-1-24 1
L2
PPT
CT/ CO
Testing procedures for quality if L1,
10 Online/ PS 29-1-24 1
drugs L2
PPT
Clinical CO
develop CT/
Clinical development of drug: L1, 3
11 ment of Online/ PS 30-1-24
Introduction L2 CO
drug: PPT
4
65 hrs
CO
CT/ 3
L1,
12 Introduction to Clinical trials Online/ PS 30-1-24 CO
L2
PPT 4
13 Various phases of clinical trial: CT/ PS 2-2-24 L1, CO
Pre-clincical trials Online/ L2 3
PPT CO
4

Page 2 of 8
 RR COLLEGE OF PHARMACY
Chikkabanavara, Bangalore-560090
Accredited by NAAC with ‘A’ Grade
INTERNAL QUALITY ASSURANCE CELL (IQAC)

CO
CT/ 3
Various phases of clinical trial: L1,
14 Online/ PS 5-2-24 CO
Phase I & Phase II L2
PPT 4
CO
CT/ 3
Various phases of clinical L1,
15 Online/ PS 6-2-24 CO
trial:Phase III & Phase IV L2
PPT 4
CO
CT/ 3
Methods of post marketing L1,
16 Online/ PS 9-2-24 CO
surveillance: Descriptive methods L2
PPT 4
CO
CT/ 3
Methods of post marketing L1,
17 Online/ PS 9-2-24 CO
surveillance: Analytical methods L2
PPT 4
CO
CT/ 3
Methods of post marketing L1,
18 Online/ PS 12-2-24 CO
surveillance: Cross sectional L2
PPT 4
CO
CT/ 3
Abbreviated New Drug L1,
19 Online/ PS 13-2-24 CO
Application submission. L2
PPT 4
CO
CT/ 3
Abbreviated New Drug L1,
20 Online/ PS 13-2-24 CO
Application submission. L2
PPT 4
CO
CT/ 3
L1,
21 ANDA chart Online/ PS 16-2-24 CO
L2
PPT 4
CO
CT/ 3
L1,
22 NDA documentation Online/ PS 19-2-24 CO
L2
PPT 4
23 Good Clinical Practice: ICH, GCP CT/ PS 20-2-24 L1, CO
Online/ L2 2
PPT

Page 3 of 8
 RR COLLEGE OF PHARMACY
Chikkabanavara, Bangalore-560090
Accredited by NAAC with ‘A’ Grade
INTERNAL QUALITY ASSURANCE CELL (IQAC)

CT/ CO
Central drug standard control L1,
24 Online/ PS 23-2-24 2
organisation (CDSCO) guidelines L2
PPT
CT/ CO
Central drug standard control L1,
25 Online/ PS 23-2-24 2
organisation (CDSCO) guidelines L2
PPT
CT/ CO
L1,
26 Study of CDSCO functions Online/ PS 26-2-24
L3 2
PPT
CT/ CO
L1,
27 ICH-GCP working module Online/ PS 1-3-24 2
L2
PPT
CT/
Challenges in the implementation L1,
28 Online/ PS 5-3-24
of guidelines L2
PPT
CT/
Challenges in the implementation L1,
29 Online/ PS 11-3-24
of guidelines L2
PPT
Ethical guidelines in Clinical CT/ CO
L1,
30 Research: Introduction, Aims & Online/ PS 12-3-24 2
L2
Objectives PPT
CT/ CO
Ethical guidelines in Clinical L1,
31 Online/ PS 15-3-24 2
Research: Guideline 1-5 L2
PPT
CT/ CO
Ethical guidelines in Clinical L1,
32 Online/ PS 18-3-24 2
Research: Guideline 6-10 L2
PPT
CT/ CO
Ethical guidelines in Clinical L1,
33 Online/ PS 19-3-24 2
Research: Guideline 11-15 L2
PPT
CT/ CO
Ethical guidelines in Clinical L1,
34 Online/ PS 1-4-24 2
Research: Guideline 16-21 L2
PPT
CT/ CO
Ethical guidelines in Clinical L1,
35 Online/ PS 2-4-24 2
Research: A brief L2
PPT
CT/
L1, CO
36 SPSS Software Online/ PS 8-4-24
L2 1
PPT
CT/
IR B / IEC: L1, CO
37 Online/ PS 12-4-24
Introduction ,Responsibilities L2 1
PPT
CT/
L1, CO
38 IR B / IEC: Procedures Online/ PS 15-4-24
L2 1
PPT
CT/
IR B / IEC: documents and its L1, CO
39 Online/ PS 16-4-24
process L2, 1
PPT
40 Overview of regulatory CT/ PS 24-4-24 L1, CO
environment: Introduction Online/ L2

Page 4 of 8
 RR COLLEGE OF PHARMACY
Chikkabanavara, Bangalore-560090
Accredited by NAAC with ‘A’ Grade
INTERNAL QUALITY ASSURANCE CELL (IQAC)

PPT 2
CT/ CO
L1,
41 Regulatory environment in USA Online/ PS 15-4-24 2
L2
PPT
CT/ CO
L1,
42 Regulatory environment in: Europe Online/ PS 16-4-24 2
L2
PPT
CT/ CO
L1,
43 Regulatory environment in: India. Online/ PS 24-6-24 2
L2
PPT
CT/ CO
L1,
44 Regulatory environment in: Canada Online/ PS 25-6-24 2
L2
PPT
CT/ CO
Role and responsibilities of: L1,
45 Online/ PS 28-6-24 5
Sponsor L2
PPT
CT/ CO
Role and responsibilities of: L1,
46 Online/ PS 1-7-24 5
Investigators L2
PPT
CT/ CO
Role and responsibilities of: L1,
47 Online/ PS 2-7-24 5
Clinical research associate L2
PPT
CT/ CO
Role and responsibilities of: L1,
48 Online/ PS 2-7-24 5
Auditors L2,
PPT
CT/ CO
Role and responsibilities of: L1,
49 Online/ PS 5-7-24 5
Contract research coordinators L2,
PPT
CT/ CO
Role and responsibilities of: L1,
50 Online/ PS 8-7-24 5
Contract research coordinators L2,
PPT
CT/ CO
Role and responsibilities of: L1,
51 Online/ PS 9-7-24 5
Regulatory authority L2
PPT
CT/ CO
L1,
52 Role of research principal Online/ PS 9-7-24 5
L2
PPT
CT/ CO
Designing of clinical study L1,
53 Online/ PS 11-7-24 5
documents: protocol L2
PPT
CT/ CO
Designing of clinical study L1,
54 Online/ PS 15-7-24 5
documents: CRF L2
PPT
CT/ CO
Designing of clinical study L1,
55 Online/ PS 16-7-24 5
documents: CF L2,
PPT
56 Designing of clinical study CT/ PS 16-7-24 L1, CO
documents: PIC-I Online/ L2, 5
PPT

Page 5 of 8
 RR COLLEGE OF PHARMACY
Chikkabanavara, Bangalore-560090
Accredited by NAAC with ‘A’ Grade
INTERNAL QUALITY ASSURANCE CELL (IQAC)

CT/ CO
L1,
57 Process of documentation: PIC Online/ PS 19-7-24 5
L2,
PPT
CT/ CO
L1,
58 Informed consent: Introduction Online/ PS 23-7-24 5
L2
PPT
CT/ CO
L1,
59 Informed consent: Process Online/ PS 23-7-24 5
L3
PPT
CT/ CO
L1,
60 Data management: Introduction Online/ PS 26-7-24 5
L4
PPT
CT/ CO
L1,
61 Data management: components Online/ PS 29-7-24 5
L5
PPT
CT/ CO
L1,
62 Data management process Online/ PS 30-7-24 5
L2
PPT
CT/ CO
L1,
63 Safety monitoring in clinical trials. Online/ PS 5-8-24 5
L2,
PPT
CT/ CO
L1,
64 Safety monitoring in clinical trials. Online/ PS 6-8-24 5
L2
PPT
CT/ CO
L1,
65 Challanges in trials-I Online/ PS 6-8-24 5
L2
PPT
CT/ CO
L1,
66 Challanges in trials-II Online/ PS 9-8-24 5
L2,
PPT
CT/ CO
L1,
67 SAS Software & ANDA chart Online/ PS 12-8-24 5
L2,
PPT
CT/ CO
ANDA documentation & SPSS L1,
68 Online/ PS 13-8-24 5
Software L2,
PPT
CT/ CO
EpiInfo software & Designing of L1,
69 Online/ PS 16-8-24 5
clinical study documents: CF L2
PPT
CT/ CO
L1,
70 ANOVA & Challanges in trials-II Online/ PS 19-8-24 5
L2
PPT
CT/ CO
L1,
71 ADR- Uppsala monitoring Online/ PS 20-8-24 5
L2
PPT
CT/ CO
L1,
72 Research protocol preparation-I Online/ PS 23-8-24 5
L2,
PPT
73 Research protocol preparation-II CT/ PS 26-8-24 L1, CO
Online/ L2,

Page 6 of 8
 RR COLLEGE OF PHARMACY
Chikkabanavara, Bangalore-560090
Accredited by NAAC with ‘A’ Grade
INTERNAL QUALITY ASSURANCE CELL (IQAC)

PPT 5
CT/ CO
L1,
74 LD50, ED50 calculation Online/ PS 6-9-24 5
L2,
PPT
CT/ CO
L1,
75 Functions of DMF. Online/ PS 10-9-24
L2, 5
PPT

Text Books:
1 Principles and practice of pharmaceutical medicine, Second edition. Authors:Lionel. D.
Edward,[Link] Anthony W Fos , Peter D Sloaier Publisher:Wiley
2 Handbook of clinical research. Julia Lloyd and Ann Raven Ed. Churchill Livingstone
3 Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes
Reference Books:
1 Central Drugs Standard Control Organization. Good Clinical Practices-Guidelines for
Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health; 2001
2 International Conference on Harmonisation of Technical requirements for registration of
Pharmaceuticals for human use. ICH Harmonised Tripartite Guideline. Guideline for Good
Clinical Practice.E6; May 1996.
3 Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council of
Medical Research, New Delhi.
4 Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green, March
2005, John Wiley and Sons.
5 Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes
6 Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second Edition,
Jan 2000, Wiley Publications.
7 Goodman & Gilman: JG Hardman, LE Limbard, 10th Edn. McGraw Hill Publications, 2001

Self-Study topics (not included in syllabus)

[Link]. Self-Study topics Suggested reference Cos

Course Articulation Matrix

PO1 PO PO PO PO PO PO PO PO9 PO10 PO11 PO12
CO1  
CO2  

Page 7 of 8
 RR COLLEGE OF PHARMACY
Chikkabanavara, Bangalore-560090
Accredited by NAAC with ‘A’ Grade
INTERNAL QUALITY ASSURANCE CELL (IQAC)

CO3  

CO4  

CO5  

Curricula Gap Analysis

[Link]. Curricula Gap Action taken Date- Resource % of Relevance
Month- Person with students to POs, PSOs
Year designation present
1

Signature of Faculty Signature of HOD

Page 8 of 8