Advanced Diploma in Clinical Research & Data Management

Weekly Breakdown

Module 1: Trial Design & Ethics (Weeks 1–6)

Module 2: Monitoring & GCP Compliance (Weeks 7–12)

Module 3: Clinical Data Management & Biostats (Weeks 13–18)

Module 4: DCT & AI in Research (Weeks 19–24)

Learning Outcomes

Assessment Weightage

Program Details

🕰️ Duration:
6 Months (24 Weeks)
🧩 Structure:

4 Intensive Modules +1 Capstone Project
🧠 Delivery:

Hybrid (Interactive Lectures, Case Studies, Software Simulation, EDC Simulation)
🎯 Focus On:

Advanced Program Structure & Delivery

🎓 Applicable Audience

B.Pharm M.Pharm D.Pharm BPT BHMS BAMS BDS MBBS Nursing B.Sc BA BCOM MCOM BTECH MTECH MA

Detailed Syllabus & Weekly Breakdown

Module 1: Trial Design & Ethics (Weeks 1–6)

Week 1-2: Drug discovery phases; Clinical development plans
Week 3-4: Ethics in Research; IRB/IEC; Informed Consent (ICF)
Week 5-6: Protocol architecture; Endpoint selection; Investigator selection

Module 2: Monitoring & GCP Compliance (Weeks 7–12)

Week 7-8: ICH-GCP E6(R3) deep dive; Site Selection & Initiation (SIV)
Week 9-10: Monitoring visits (RMV/COV); Source Data Verification (SDV)
Week 11-12: eTMF management; Deviations, CAPA, and Audit Readiness

Module 3: Clinical Data Management & Biostats (Weeks 13–18)

Week 13-14: EDC systems; CRF/eCRF Designing; Data Management Plans
Week 15-16: Query management; Data cleaning; Database lock
Week 17-18: CDISC standards (SDTM/ADaM); Descriptive vs Inferential Biostats

Module 4: DCT & AI in Research (Weeks 19–24)

Week 19-20: Decentralized Clinical Trials (DCT); Wearables & ePRO
Week 21-22: Agentic AI for patient recruitment & site performance analytics
Week 23-24: Capstone: Development of a Trial Management Plan for a Phase III Study

Learning Outcomes & Assessment

Draft professional trial protocols and ICFs compliant with global standards
Execute clinical monitoring tasks and manage eTMF documentation
Perform data cleaning and query resolution using industry-standard EDC tools
Apply AI tools to optimize trial operations and patient recruitment

Term and Credit Structure

Term	Module	Weeks	Credits
Term 1	Module 1: Trial Design & Ethics	1–6	4
Term 1	Module 2: Monitoring & GCP Compliance	7–12	4
Term 2	Module 3: Clinical Data Management & Biostats	13–18	4
Term 2	Module 4: DCT & AI in Research	19–24	4
Total		24 Weeks	16 Credits

Assessment Weightage

Software Simulations (EDC/eTMF): 30%
Written Assignments (Safety Reports): 25%
Mid-Term Regulatory Quiz: 15%
Final Capstone & Oral Defense: 30%