Advanced Course of Clinical Research, Data Management & PVG

Clinical Trials are indispensable to the drug development process to ensure safety and efficacy of any new drug. Innovation and execution of clinical trials go hand in hand and need skilled workforce to implement each piece of the research. Global clinical research industry is as big as $40 billion and has an immense career opportunities. This course brings you Clinical Research in conjunction with  Data Management and Pharmacovigilance , which are key essentials for the growing potential.

Course Curriculum is for 6 months (weekend classes):

Clinical Research Course: 2 months (8 classes)

1. Introduction to Clinical Research

2. Historical aspect of development of Good Clinical Practices

3. The International Conference on Harmonization and Its Impact

4. Overview of Drug Development Process

5. Regulatory Guidelines: ICH GCP, Schedule Y, Indian GCP, ICMR, FDA, IND, NDA, ANDA

6. Essential Documents in Clinical Trial

7. Ethics Committee: Formation, accreditation, functioning

8. Pharmacodynamics & Pharmacokinetics

9. Principles in Clinical Research design; Types of study designs

10. Phases of Clinical Trials

11. Site Management Activities: Subject Pre-screening, Recruitment, IP handling, Good Documentation practices, Source data Verification

12. Stages of Clinical Trial: Site Selection, Site Initiation, Monitoring, Close out

13. Trial differences for Nutraceuticals, new drugs, medical devices

14. Bioequivalence studies for generics

15. GCP – Roles and Definitions

16. Risk Based Monitoring

17. Roles & Responsibilities of a Sponsor & Regulator

18. Roles & Responsibilities of an Investigator

19. Roles & Responsibilities of a Monitor


Clinical Data Management: 1.5 months(6 classes) & access to CDM Software

  1. Data – Definition & Types
    1.  CRF Design for Clinical Trial
    2.  Query Resolution
    3.  Database update, drug safety and database locking
    4.  EDC System and 21CFR Part 11 compliance
    5.  Data Privacy: Implications for Clinical Operations


  1. Data management plan and Data Validation Plan (DM documentation)
    1.  Data management standards in clinical research
    2. Design and development of data collection
    3. Edit check design principles
    4. Electronic data capture-Concepts and study start up
    5. Electronic data capture-Study conduct
    6. Electronic data capture-Study close out
  2. Data management plan and Data Validation Plan (DM documentation)
    1. CRF Completion Guidelines
    2. Data validation, programming and standards
    3. Data Quality and Data Integrity
    4. Medical coding dictionary management and maintenance
  3. Handling Safety Information
    1. Safety data management and reporting
    2. Serious adverse event data reconciliation
  4. Study Close out
    1. Database closure
    2. Clinical data archiving
  5.  Live Demo and Access to DM software as trainee ( Live Demo need to be used where ever the trainer feels that it is needed for understanding , preferred in class 2, 4, 5,)


Medical Writing: 2 weeks (2 classes)

 1. Importance of Medical writing in clinical research

2. Medical terminology

3. Ingredients of good medical writing

4. ICH E3 structure & content of clinical study reports

5. Standardization of medical terms, MedRA and other coding dictionaries

6. Introduction to Clinical Data Interchange Standards Consortium


Quality: 2 weeks (2 classes)

1. Audit – Definition, types & procedures

2. Audit standards

3. Audit trail & its role in authenticity of data

4. Audit plan

5. Audit by regulatory authorities

6. GMP Guidelines

7. Preparing and delivering audit reports


Pharmacovigilance: 1 month (4 classes)

  1. Introduction to Pharmacovilance
  2. Pharmacovigilance Terminology
  3. Global Prospective of PV and ADR Reporting
  4. Guidelines and Standards governing ADR Reporting
  5. Periodic Safety Update Reports
  6. Expedited Reporting
  7. Causality assessment and Signals
  8. Medical Dictionary for Drug Regulatory Activities (MedDRA)

Project / Internship as CRC

Course Details   Duration (hours)
No Data
Total 0 hrs

Have A Question?