This comprehensive programme in Clinical Research is designed to equip B.Pharmacy and MBBS graduates with the foundational and advanced knowledge required to work in the clinical trials and pharmaceutical research sector. It covers clinical trial design, regulatory requirements, ethical considerations, safety monitoring, data management, and Good Clinical Practice (GCP), as recognized globally (ICH-GCP, CDSCO, USFDA, EMA, WHO).

The course bridges the gap between academic learning and industry expectations, preparing students for careers as Clinical Research Associates (CRAs), Coordinators, Pharmacovigilance Officers, Data Managers, and Regulatory Professionals.

Module 1: Introduction to Clinical Research

  • History and Evolution of Clinical Trials

  • Phases of Clinical Trials (Phase I–IV)

  • Key Stakeholders in Clinical Research (Sponsor, CRO, Ethics Committee, Investigator)

  • Roles of MBBS and B.Pharm professionals in trials

Module 2: Regulatory Affairs in Clinical Research

  • ICH-GCP Guidelines

  • Indian Regulations: CDSCO, NDCT Rules 2019

  • USFDA, EMA, MHRA regulations

  • Informed Consent Process

  • Institutional Ethics Committees (IEC)

Module 3: Clinical Trial Protocol and Design

  • Clinical Trial Protocol Structure

  • Randomization, Blinding, Placebo Control

  • Study Design Types (Parallel, Crossover, Observational, Interventional)

  • Endpoints and Outcome Measures

Module 4: Roles and Responsibilities

  • Role of Clinical Research Associate (CRA)

  • Role of Principal Investigator and Study Team

  • Clinical Trial Coordinator and Site Staff Duties

  • Monitoring, Audits, and Inspections

Module 5: Pharmacovigilance and Safety Reporting

  • Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs)

  • Safety Monitoring Boards

  • Signal Detection and Risk Minimization

  • Global PV Reporting Systems (EudraVigilance, MedDRA, WHO-UMC)

Module 6: Data Management and Biostatistics

  • Case Report Forms (CRFs) and Electronic Data Capture (EDC)

  • Source Data Verification

  • Basic Biostatistics for Clinical Trials

  • Data Cleaning and Locking

Module 7: Documentation and Quality Systems

  • Trial Master File (TMF) and Essential Documents

  • SOPs in Clinical Research

  • Audit Trails and Quality Control Measures

  • CAPA in Clinical Trials

Module 8: Career Skills and Industry Tools

  • Job Roles and Growth Pathways in Clinical Research

  • Resume Preparation & Interview Readiness

  • Tools: eCRF, EDC (e.g., Medidata, Oracle), CTMS, Argus

  • Soft Skills for Clinical Professionals

Project / Internship

  • Protocol Designing Assignment

  • Mock Ethics Committee Submission

  • Internship (Optional / Assisted Placement with CROs or Hospitals)

Assessment

  • Module-wise MCQs / Assignments

  • Final Case Study or Viva

  • Certification on successful completion

Key Outcomes

After completing this program, learners will:

  • Understand clinical trial processes and regulations

  • Prepare and monitor real-world clinical trials

  • Ensure ethical conduct and patient safety

  • Work confidently in CROs, hospitals, or pharmaceutical R&D

Career Pathways

  • Clinical Research Associate (CRA)

  • Clinical Trial Coordinator (CTC)

  • Drug Safety Associate / Pharmacovigilance Executive

  • Regulatory Affairs Executive

  • Data Manager

  • Medical Writer

Related courses

Clinical Research Pharmacovigilance