🕒 Duration: 6 Months
💻 Mode: Online (Weekends Only – 3 Hours on Sat & Sun)
👉 Ideal For: Those seeking an in-depth, career-oriented training to build a strong foundation for roles like CRC, CRA, Safety Associate, Regulatory Associate and more.
📚 Core Learning Domains
- Good Clinical Practice (GCP) & Research Ethics
- Pharmacovigilance & Drug Safety
- Regulatory Affairs & Trial Governance
- Medical Writing & Data Management
- Clinical Trial Operations
🌟 Why Choose This Program
- ✅ GCP-compliant curriculum
- 👨⚕️ Delivered by professionals from top hospitals & CROs
- 📊 Real-time projects & case studies
- 🌍 Covers global regulations: ICH-GCP, CDSCO, FDA, EMA
- 🎤 Guest lectures by renowned industry experts
Welcome to the Advanced Diploma in Clinical Research, a comprehensive and career-focused program designed to equip aspiring professionals with the in-depth knowledge and practical skills required to excel in the dynamic and evolving field of clinical research.
Clinical research plays a pivotal role in the development of new therapies, diagnostics, and medical advancements that improve patient outcomes and public health. With increasing global demand for skilled clinical research professionals, this advanced diploma provides a solid foundation in the ethical, regulatory, and scientific aspects of clinical trials. Throughout this program, students will explore key topics including study design, regulatory guidelines, data management, pharmacovigilance, biostatistics, and Good Clinical Practice (GCP). Emphasis is placed on real-world application through case studies, project work, and hands-on training, ensuring that graduates are well-prepared to meet industry expectations.
Whether you are a life science graduate, healthcare professional, or someone seeking to transition into the clinical research industry, this diploma will enhance your competencies and open up diverse career opportunities across pharmaceutical companies, CROs, hospitals, and regulatory bodies.
We are excited to have you embark on this journey toward becoming a confident and capable clinical research professional.
| Module | Topics Covered |
|---|---|
| Module 1: Introduction to Clinical Research – Overview & Scope |
Clinical Research and Clinical Trial overview Clinical Research Industry Clinical Research Terminologies General Medical Terminologies |
| Module 2: Drug Development Process and Clinical Drug Development Phases |
Drug discovery Target Identification Lead Identification Lead Optimization Preclinical studies |
| Module 3: Historical Perspectives of Clinical Research |
Evolution of Ethical and Regulatory Framework Nuremberg Code, 1946 Declaration of Helsinki Thalidomide Tragedy Belmont Report Schedule Y, Drugs and Cosmetics Act 1945 |
| Module 4: Ethical Issues in Clinical Research |
History of ICH ICH Guidelines ICH GCP – E6 R2, R3 ICMR Ethical Guidelines Ethics on use of Placebo in Clinical Trials |
| Module 5: Clinical Research Stakeholders and Core Team |
Investigator Sponsor Contract Research Organization (CRO) Clinical Research Coordinator (CRC) Clinical Research Associate (CRA) |
| Module 6: Types and Designs used in Clinical Research |
Diagnostic and Treatment Trials Interventional and Observational studies Case control and Cohort studies Randomized controlled trials Quasi experiments |
| Module 7: Clinical Research Documentation |
Essential Documents (ICH GCP) Protocol Informed Consent Documents Investigator’s Brochure Case Report Form Clinical Study Report |
| Module 8: Pharmacovigilance and Safety Monitoring |
Adverse Drug Reaction Serious Adverse Events (SAE) SAE Reporting timelines Pharmacovigilance methods Signal Detection and Data Mining PvPI Risk Management Plan |
| Module 9: Virtual Clinical Trials (AI/ML) |
E-Consent (Audio Visual Consent) E-Patient Reported Outcomes (e-PRO) IWRS Telemedicine Patient e-Diaries Remote Patient Monitoring |
| Module 10: Clinical Trial – Latest Updates (2019–24) |
ICH-GCP E6 R3 NDCT Rules: 2019 & Amendment (2023) ICMR-HMSC Recent CDSCO Notices NABH Ethics Committee Standards |
| Module 11: Industry-Based Case Studies | Real-world projects and scenario-based case studies drawn from pharma and CRO environments. |
Programme Deliverables:
A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.
- Interactive online live sessions on all key areas of the programme giving all flexibility to the participants.
- Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
- Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
- Assignments for all the programme modules for continuous evaluation and guidance.