MedTrain

Start Date

30th June 2026

Course Duration

12 Months

Batch Limit

Limited to 25 Students only

Eligibility

Doctors/ Nurses/ Pharmacists

Course Overview

This comprehensive diploma program is designed to provide in-depth knowledge of clinical research, regulatory frameworks, ethics, and operational practices. The course equips learners with the skills required to work as clinical investigators, clinical research coordinators, study monitors, project managers, pharmacovigilance professionals, and medical writers

The program spans 52 weeks, combining theoretical learning with case discussions, assignments, and practical insights. Sessions are conducted once a week (1.5–2 hours).

Program Highlights

Comprehensive understanding of Drug Development: Bench to Bedside
Clinical Trial Phases and Study Protocol Basics
Ethics in Clinical Research (Nuremberg Code, Declaration of Helsinki, Belmont Report)
ICH-GCP Guidelines (E6 R3)
NDCT Rules 2019 and ICMR Guidelines
Informed Consent Process (including AV Consent and eConsent)
Roles of Investigator, Sponsor, Monitor, and Ethics Committee
Audits and Inspections
Safety Reporting and Serious Adverse Events (SAE)
Rare Disease Research
Artificial Intelligence in Clinical Research
Real-World Data/Real-World Evidence Studies
Career Pathways in Clinical Research

Why Join This Program?

Structured and practical curriculum
Faculty-guided mentorship
Case-based learning approach
Ideal for working professionals
Strong foundation for careers in Clinical Research

Selection Process

Application submission
Short statement of interest
Document verification
1:1 Course Directors Selection

Key Highlights

Industry-aligned curriculum
Focus on Indian regulatory frameworks
Case studies and interactive learning
Diploma awarded upon successful completion

MODULE 01 : FOUNDATIONS OF CLINICAL RESEARCH & ETHICS

Introduction to clinical research

Evolution of research ethics

Good Clinical Practice (GCP)

Declaration of Helsinki & Belmont Report

Clinical trial phases

MODULE 02 : REGULATORY FRAMEWORKS

ICMR ethical guidelines

NDCTR 2019 Rules, (India)

Indian GCP guidelines

ICH-GCP E6(R3)

MODULE 03 : INFORMED CONSENT

Consent documentation

Consent process

Assent (pediatric research)

Special situations & AV consent

MODULE 04 : STAKEHOLDER RESPONSIBILITIES

Investigator, sponsor, and coordinator roles

Ethics committees

Monitoring (on-site, remote and risk-based)

Audits and inspections

MODULE 05 : REGULATORY SUBMISSIONS

SUGAM portal submissions

Ethics approvals

CTRIt registration & HMSC approvals

Protection of vulnerable populations

MODULE 06 : TRIAL PLANNING & PROJECT MANAGEMENT

Protocol development

CRFs/eCRFs

Budgeting & agreements

Site selection & initiation

Safety reporting (AE/SAE)

MODULE 07 : OPERATIONAL & ADVANCED TOPICS

Source data verification

Investigational product management

Protocol deviations

Data privacy & confidentiality

Research misconduct

Clinical data management

Emerging technologies & decentralized trials

Doctors
Nurses
Pharmacists
Life Sciences Graduates
Biotechnologist
Physiotherapists

Weeks 1–4: Foundations of Clinical Research & Ethics
Weeks 5–8: Regulatory Frameworks
Week 9: Case Discussions & Review
Weeks 10–14: Informed Consent
Week 15: Break
Week 16: Evaluation Exam (Modules 1–3)
Week 17: Re-exam window
Weeks 18–24: Stakeholder Responsibilities
Weeks 25–28: Regulatory Approvals
Weeks 29–34: Trial Planning & Management
Week 35: Review & assignments
Weeks 36–46: Operational & Advanced Topics
Week 47: Program-wide discussion
Week 48: Break
Week 49: Final Exam
Week 50: Re-exam
Week 51: Results Declaration

To successfully complete the course, participants must:

Achieve a minimum score of 80% in:

Mid-Term Evaluation (Modules 1–3)
Final Examination (All Modules)

Participate actively in:

Case studies
Assignments
Discussions

Re-examination opportunities are available if a participant does not clear the examination on the first attempt.

Upon successful completion, participants will receive a Diploma Certificate in Clinical Research.

Course Fee:

Rs.99,000/- + 18% GST

Course Fee will be accepted module wise of INR. 83898, INR. 15102.

Enroll Now

Course Fee:

1,499 USD

For International Students

Single Installment

Enroll Now

Frequently Asked Questions

What is the process for document verification?

During the enrollment process, it is essential to upload all required documents as self-attested soft copies to our portal for verification. Please note that original documents or hard copies are not needed. Verification of the submitted documents will be completed before the selection process.

1:1 Selection process by the Course Directors, following which the selection letter along with the payment details will be shared to your registered email ID and WhatsApp number.

Do I need to follow all or part of the course curriculum guidelines?

It will be mandatory for all the enrolled candidates to follow the course curriculum guidelines completely, failing which either their candidature may be cancelled or they will be not allowed to appear in the exit exam. The decision by DCR governing body will be final and binding to all in this regard.

What is the duration of the course?

The course runs for approximately 12 months (52 weeks).

What is the class schedule?

Classes are held once a week (Fridays, 7 PM onwards) for 1.5–2 hours via Zoom

What is the exam pattern?

MCQ's
Short-answer questions

What is are the passing criteria?

A minimum of 80% marks is required in both evaluations.

Are re-exams allowed?

Yes, re-exams are available for both mid-term and final exams.

Will I be able to get a refund?

There will be NO refund of any part of the fee after submission, even if the candidate chooses not to join the course or discontinue in between due to any reason. The fee will NOT be transferred to another candidates account if any candidate wishes to do so. In case of any unusual circumstance, the decision of the DCR governing body will be final and binding to everyone.

Certified By

Our Instructors

Dr. Durga Gadgil

Clinical Research Consultant

Dr. Jeroze Engineer,