Advance PG Diploma in Clinical Research

Module 1: Clinical Research Operations

• ICH-GCP Guidelines
• New Drug & Clinical Trials Rules
• TMF/eTMF

Module 2: Clinical Data Management (CDM)

• Introduction to CDM & Process flow of CDM
• Data entry & Database
• Data review & Essential documents in CDM

Module 3: Pharmacovigilance

• Introduction to Pharmacovigilance
• Eudravigilance & Signal Detection
• PSUR & CIOMS/MedWatch

Module 4: Medical Writing

• Introduction to Medical Writing & Protocol Writing
• IB & ICD Writing
• Manuscript & Publication Writing

Module 5: Regulatory Affairs

• Regulatory Agencies
• Common Technical Documents - CTD (API & Formulation)
• Introduction to eCTD

Module 6: Interpersonal Skills

• Soft Skill Development & Presentation Skills
• CV Preparation / Writing
• LinkedIn Profile Creation & Networking