Diploma in Clinical Research

Launch Your Career in Clinical Research

Start Date

20th July 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 in two installments.
First Installment :Rs 70,092
Second Installment: Rs 46728

Enroll Now

Course Fee:

1,499 USD

For International Students

Single Installment

Enroll Now

Frequently Asked Questions

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.

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.

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

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

  • MCQ's
  • Short-answer questions

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

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

As per the University guidelines, you are entitled to a maximum of two examination attempts without any additional examination fee. This includes your initial examination attempt and one additional attempt, which must be utilized in the immediately following batch.

If you are unable to successfully complete the examination within these two attempts, you will be discontinued from the course. To obtain certification thereafter, you will be required to enroll as a fresh candidate, pay the applicable course fee, and complete the course requirements again.

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.

Yes, through case studies and discussions.

A Diploma in Clinical Research upon successful completion.

The National Medical Commission does not officially recognize courses offered through online or blended learning platforms. Nevertheless, at MedTrain Academy of Medical Education, we collaborate with leading industry experts to deliver cutting-edge learning content. Our courses are designed to equip you with essential knowledge and skills for effective patient care, ensuring you remain proficient and up-to-date in your medical practice.

Doctors, Nurses, Pharmacists, Life Science Graduates, Biotechnologists, and Physiotherapists.

Dispute settlement - The venue of the arbitration will be Bangalore and the Indian laws will be applicable. The Bangalore court alone will have the exclusive jurisdiction to adjudication in case of any dispute.

For any Technical Issues or Assistance,

Contact MedTrain Tech Support: WhatsApp number: +91 79757 64489 Or write to contact@med-train.com.

Certified By

Our Instructors

Dr. Durga Gadgil

Clinical Research Consultant

Dr. Jeroze Engineer,

Clinical Research Consultant

Why Choose MedTrain?

  • Expert National & International faculities.
  • Self-paced flexible learning
  • Live sessions to engage with the faculty.
  • Interactive learning through engaging multimedia content for the lectures, case studies, group discussions, assignments, and presentations.
  • Individual performance evaluation.
  • Dedicated 1:1 mentoring during and after the course.
  • Certification from esteemed National and International organizations.