- Duration: 10 weeks
The Learning units are
1: Introduction to Clinical Research
Definition and purpose of clinical research
History and evolution of clinical trials
Overview of the drug development process
Phases of clinical trials (Phase I–IV)
Types of clinical research (interventional, observational, epidemiological)
2: Ethical Guidelines & Good Clinical Practice (GCP)
ICH-GCP principles and structure
Declaration of Helsinki
Belmont Report
Informed consent process and patient rights
Ethics committees/IRBs: role and responsibilities
3: Regulatory Affairs
Key global regulatory authorities: FDA (US), EMA (EU), CDSCO (India), MHRA (UK), PMDA (Japan)
IND, NDA, ANDA, CTA, and BLA submissions
Overview of regulatory pathways and approvals
Regulatory documentation and timelines
4: Clinical Trial Protocol and Design
Elements of a clinical trial protocol
Study objectives, endpoints, and inclusion/exclusion criteria
Randomization and blinding
Study design types (parallel, crossover, open-label, etc.)
5: Roles and Responsibilities
Investigator and site staff
Clinical Research Associate (CRA)
Clinical Trial Coordinator (CTC)
Sponsor and Contract Research Organization (CRO)
Data Safety Monitoring Board (DSMB)
6: Site Management and Monitoring
Site selection and feasibility
Investigator site file (ISF) setup
Initiation, monitoring, and close-out visits
Source data verification (SDV) and site audits
Common site challenges and resolutions
7: Clinical Trial Operations
Subject recruitment and retention
Enrolment logs and screening failures
Drug accountability and IP management
AE/SAE reporting and documentation
Trial master file (TMF) management
8: Data Management and Biostatistics
Overview of clinical data management (CDM)
Case report forms (CRFs) and electronic data capture (EDC)
Data cleaning and query management
Basic statistical concepts: p-value, confidence interval, mean, median
Role of biostatistics in clinical trial analysis
9: Safety Reporting and Pharmacovigilance
Adverse events (AEs) and serious adverse events (SAEs)
Causality assessment and reporting timelines
Safety databases and MedDRA coding
Signal detection and periodic safety reports (PSUR, DSUR)
10: Quality Assurance and Audits
Importance of quality control and assurance in trials
Internal audits vs. regulatory inspections
Common findings and CAPA implementation
Audit trails and documentation best practices
11: Clinical Trial Documentation
Essential documents (ICH E6 guidelines)
Informed consent forms, CRFs, ISF, TMF
Investigator Brochure (IB), Clinical Study Report (CSR)
Documentation for regulatory inspection
12: Career Development & Certification Exam
CV preparation and interview training
Overview of essential positions in clinical research: CRA, CRC, CTA, CDM and PV
Mock assessments and project work
Overview of certifications: ACRP, SOCRA, DIA, ICH GCP training
Final course assessment and certification
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