Sixteen taught modules spanning clinical science, regulation, operations, safety, data, and communication. Internal assessments sit inside the modules, as set out in the 2026 syllabus.
I
Introduction to Clinical Research and General Pharmacology
2 wks
Needs and opportunities · Terminology · Dosage forms · PK/PD · Drug action and interactions · Dose–response · ADRs and OTC drugs
II
Pharmaceutical Medicine
2 wks
Drugs acting on ANS, CNS, respiratory, cardiovascular, renal, GI and endocrine systems · Antineoplastic and anti-infective drugs
III
FDA, ICH and GLP roadmap · Study types and contribution to trials · Alternative toxicity testing · 3Rs · GM animals and in vitro models
IV
Phases of Clinical Research and Drug Discovery
2 wks
Trial objectives and endpoints · Phases I–IV · Drug discovery and development · High-throughput screening · WHO GMP
V
Bioavailability types · Single and multiple dose studies · IVIVC · BCS · Analytical methods · Extended-release and combination products
VI
Guidelines and Regulations
2 wks
Indian regulatory history · Declaration of Helsinki · ICH GCP, Indian GCP, ICMR · Schedule Y and 21 CFR · IND/NDA · USA, UK and EU
VII
Belmont Report, Nuremberg Code · Randomisation and placebo · Ethics committee review · Informed consent · CTA, insurance, HIPAA
VIII
Scope and aims · ADR evaluation and prevention · Causality · DSMBs · ICH E2A/E2E · CIOMS · Signal detection and case processing
IX
Management of Clinical Trials and Outsourcing
1 wk
Project management · Clinical trial budgeting · Role of CROs · Advantages and limits of outsourcing
X
Clinical Trial Operations
1 wk
Recruitment and retention · AE / SAE / SUSAR · Site lifecycle · ISF and TMF · IP management · CTRI, EC, CDSCO, ClinicalTrials.gov
XI
Monitoring, Audits and Inspection
2 wks
Monitor, investigator, sponsor, CRA, CRC · Monitoring visits · QA/QC and SOPs · Site selection · Regulatory inspections and case studies
XII
Protocol purpose, format, writing and amendments · CRF design and data collection · Clinical study reports
XIII
Clinical Data Management
2 wks
CDMS, Excel and MIS · CRF design · EDC build and edit checks · Coding, SDV, discrepancy management · Data lock, freeze and export
XIV
Study design essentials · Types of data · Sample size · Estimation and hypothesis testing · Analysis and presentation of results
XV
PV Software, Database Training and Certification
1 wk
Safety databases · Duplicate search and case registration · Medical coding · E2B, CIOMS, MedWatch · Transmission to FDA, EMA and India
XVI
Presentation and interpersonal skills · Interview techniques and group discussion · Time and stress management