Post Graduate Diploma in Clinical Research

Programme Overview

The PG Diploma in Clinical Research provides a comprehensive understanding of the clinical research ecosystem, integrating scientific concepts with regulatory, ethical, and practical applications. This programme equips learners with the knowledge and skills required to excel in clinical trials, data management, safety monitoring, and regulatory compliance.

Programme Curriculum

1. Introduction to Clinical Research

Gain a strong foundation in clinical research by exploring the industry landscape, historical development, and core terminologies. Understand the difference between clinical research and clinical trials, and familiarize yourself with essential medical vocabulary.

2. Historical and Ethical Perspectives

Study the evolution of ethical and regulatory frameworks that shape modern clinical research. Examine landmark milestones such as the Declaration of Helsinki, the Thalidomide Tragedy, and regulatory acts like Schedule Y under the Drugs & Cosmetics Act (1945).

3. Ethical Issues and Regulatory Guidelines

Delve into key ethical principles and global regulations including ICH guidelines, GCP (E6 R2/R3), ICMR ethical standards, placebo ethics, and the role of ethics committees.

4. National & International Regulatory Bodies

• CDSCO – India
• ICMR – India
• USFDA – USA
• EMA – Europe
• MHRA – UK
• TGA – Australia

5. Roles & Responsibilities of Clinical Research Stakeholders

Understand the roles of Investigators, Sponsors, CROs, CRCs, and CRAs in trial execution, coordination, and oversight.

6. Research Methodology & Biostatistics

Learn research problem formulation, sampling strategies, hypothesis testing, parametric and non-parametric tests, and basics of scientific writing.

7. Types and Designs of Clinical Studies

• Diagnostic and treatment trials
• Interventional vs observational studies
• Case-control and cohort studies
• Randomized controlled trials
• Quasi-experimental designs

8. Clinical Research Documentation

Protocols, informed consent, investigator brochures, CRFs, study reports, and regulatory dossiers.

9. Clinical Trial Data Management

Electronic data capture, E-CRFs, IWRS, database locking, and documentation practices.

10. Pharmacovigilance & Safety Monitoring

ADR and SAE reporting, signal detection, PvPI, risk management planning.

11. Quality Assurance & Control

Quality systems, audits, inspections, and common regulatory observations.

12. Medical Device Clinical Trials (MDCTs)

Medical Device Rules (2017), device classification, materiovigilance, and device trial phases.

13. Medical Writing for Clinical & Regulatory Submissions

Protocols, CRFs, informed consent forms, CSRs, and publication writing.

14. Virtual Clinical Trials & Emerging Technologies

AI, ML, e-Consent, e-PRO, telemedicine, remote patient monitoring.

15. Clinical Trial Trends & Latest Updates (2019–2024)

• ICH-GCP E6 R3
• NDCT Rules (2019, 2023)
• ICMR-HMSC Guidelines
• Latest CDSCO notifications
• NABH Ethics Committee standards

16. Industry Case Studies

Real-world clinical research case studies for practical understanding.

Programme Details

Eligibility: Graduates in any discipline

Programme Duration: Minimum 3 months – Maximum 6 months

Programme Mode: Online