Module 1: Clinical Research

 Drug discovery process

1. Introduction to Clinical
 Position of Clinical research in the process
Research
 Def: clinical research

 Different phases, study designs in clinical

research, glossary

 Regulatory authorities
2. Different parties involved in
 IRB/IEC
Clinical Research
 Sponsor

 CRO

 SMO

 Investigator

 Patients

 Food drug & cosmetic act

3. Clinical Research History
 Nuremberg code

 Declaration of Helsinki

 ICH

 Kefauver-Harris Amendments

 Belmont report
  National Research Act

 Sulfanilamide disaster

 Thalidomide disaster

 FDA
4. Different Regulatory Bodies
 DCGI
– an overview
 MHRA

 MHLW

 TGA

 IRB/IEC

 Guidelines
5. ICH – GCP

 Appendices
6. Schedule Y

 Regulatory requirements & forms

7. IND & NDA Application

 Roles of different parties

8.
 Compliance to guidelines and regulatory
Clinical Trial process & its
standards.
monitoring

 Adverse event
9. Pharmacovigilance –
 Adverse drug reaction its type,
overview
 Safety reporting & reporting requirements

 Annual safety reports

 Audits & Inspections in  Types of audits/inspection
10.
Clinical Trial  Reporting of findings.

Module 2: PHARMACOVIGILANCE

1. Introduction to Pharmacovigilance

a) Drug development in pharmaceutical industry

b) History and objective of Pharmacovigilance

2. Introduction to Adverse events

a) Adverse events

b) Adverse drug reactions

c) Serious adverse events

d) Expected and unexpected adverse events

3. Regulatory guidelines and laws governing Pharmacovigilance

a) ICH guidelines

b) USFDA guidelines

c) European union Guidelines

4. Adverse event reporting method

a) Sources of reports

b) Reporting forms

c) Criteria of reporting

5. Pharmacovigilance in India

a) National Pharmacovigilance program

b) National Pharmacovigilance centers

6. Individual Case safety Report Processing

a) Case triage

b) Recording of ICSR information

c) Follow up of adverse events

7. Specific events scenarios

a) Drug over dose , abuse and misuse

b) Drug exposure during pregnancy

8) Narrative writing

9) Coding with MedDra

10) Expedited reporting

a) Expedited reporting for clinical trials drugs

b) Expedited reporting for post marketed drugs

11. Periodic safety updates reporting

12. Case Assessment

a) Assessment of case report as reportable or not

b) Assessment of seriousness of adverse event

c) Assessment based on expectedness of adverse event

d)Assessment of causality of adverse event

13. Pharmacovigilance Compliance

a) Purpose and scope of SOPS

b) Internal audit of PV activities within a company

c) Quality control and quality assurance

14. Qualified person for Pharmacovigilance

15. Safety data privacy and sharing

 Module 3 : CDM

A. Clinical Trail Process and Design

B. ICH-GCP and GCDMP

C. Clinical Data Management (Process Flow)

1. CRF Design

2. Data Entry

3. Data Collection

4. Data Load/Transfer

5. Data Storage

6. Data Validation

7. Data Export (SDTM)

8. Query Management

9. Data Archiving

10.Quality Systems,SOPs and Audits

11.Safety Management and Pharmacovigilance

12.Data Management Systems and Tools

13.Medical Codings and Medical Dictionaries

14.CDMS,AERS,EDC,OCTMS

15.Documentation and Document Management System

D. Statistical Analysis and Reporting

1. Analytical Tools
E. Project Management

F. Security Systems

PRACTICALS

1. CDMS

2. Study Set-Up

3. DB Creation

4. Data Entry

5. Data Validation

6. Query Management

7. DB lock.

Module 4: Medical Writing

What is Medical Writing

Scope of Medical Writing

Medical Writing in Clinical Trial

Medical Writing & Scientific Writing

Fundamentals of Medical Writing

Marketing Medical Writing

Regulatory Medical Writing

The Writing Process

Good Writing Skills

 Introduction to basic rules

 Elements of style

 Grammar and good writing

Good Clinical Practice Guidelines

The Clinical Study Report

Introduction to Publication Writing

Regulations and Industry Standards

Writing Effective Documents

 Writing Standard Operating Procedures Policies, Procedures, Instructions,

and Methods

 Writing Quality Manuals and Plans