Clinical Trial Research Course
Learn GCP guidelines, trial protocol management, site monitoring, SAE reporting, and data integrity — the complete skill set for a successful clinical research career.
FREE with Special Combo Offer
Get this course FREE when you enroll in Pharmacovigilance + Medical Device Vigilance together for just ₹12,000 — saving ₹3,000.
Included in Special Combo
FREE
with Combo at ₹12,000 total (save ₹3,000)
What You'll Learn
A comprehensive curriculum covering GCP, trial protocols, regulatory frameworks, data management, and site monitoring — everything to launch your clinical research career.
Introduction to Clinical Trials
- What are clinical trials? Phases I–IV explained
- Importance of clinical research in drug development
- Key stakeholders: Sponsor, CRO, Investigator, IRB/IEC
- Overview of the drug development lifecycle
Good Clinical Practice (GCP)
- ICH E6 (R2) GCP guidelines in depth
- Roles and responsibilities of all trial personnel
- Informed consent process and documentation
- Investigator Site File (ISF) and Trial Master File (TMF)
Trial Protocol & Study Design
- Reading and interpreting a clinical trial protocol
- Study design types: RCT, crossover, adaptive
- Inclusion/exclusion criteria and patient selection
- Protocol deviations and amendments
Regulatory & Ethics Framework
- CDSCO Schedule Y and New Drugs & Clinical Trials Rules 2019
- US FDA 21 CFR Parts 312 & 320 overview
- Ethics committee submissions and approvals
- Declaration of Helsinki principles
Data Management & Safety Reporting
- Case Report Form (CRF) completion and review
- Electronic Data Capture (EDC) systems introduction
- SAE reporting in clinical trials (expedited timelines)
- Data integrity, audit trails, and 21 CFR Part 11
Site Monitoring & Career Preparation
- Clinical Research Associate (CRA) role and site visits
- Site initiation, monitoring, and close-out visits
- Resume building for CRA, CRC, and data management roles
- Mock interviews and placement assistance
Course Outcomes
- Understand all phases of clinical drug development
- Apply ICH GCP E6(R2) principles in trial conduct
- Read and interpret clinical trial protocols confidently
- Handle SAE reporting and CRF data management
- Perform site monitoring activities as a CRA
- Qualify for CRA, CRC, and clinical data roles
Who Is This For?
- B.Pharm / M.Pharm graduates seeking CRO or pharma roles
- MBBS / BDS / Nursing professionals exploring clinical research
- Life sciences graduates (Biotechnology, Microbiology, Biochemistry)
- Pharmacovigilance professionals looking to expand their skill set
- Working professionals transitioning into clinical research
Want all 3 courses at the best price?
Check our Special Combo Offer →Frequently Asked Questions
Get All 3 Courses for ₹12,000
Pharmacovigilance + Medical Device Vigilance + Clinical Trial Research — the complete pharma safety skill set in one combo.
Save ₹3,000 vs enrolling separately
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