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Diploma Program

Clinical Research and Data Management

Program overview

The Diploma in Clinical Research and Data Management is a job-focused training program that equips learners with foundational knowledge and hands-on skills in clinical research operations and data management. Designed for graduates in life sciences and healthcare, this program covers clinical trial phases, CRF design, data validation, clinical coding, regulatory compliance, and the use of standard CDM systems. Learners will gain practical exposure through real-world case studies and projects, making them industry-ready for entry-level roles in the global clinical research sector.

Duration: 6 Months
Mode: Online (Instructor-led) + Project

Level: Diploma – Industry-Ready

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Certification

  • Diploma in Clinical Research and Data Management – Issued by IDDCR Global Institute

  • Project Completion Certificate

  • Optional Add-on: Clinical Society Membership or EDC Hands-on Certificate

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Program Highlights

  • Job-focused training with real-world simulation

  • Short-term, high-impact program to enter the clinical research domain

  • Foundation for career growth into Clinical Data Manager, CRA, or SAS Programmer

  • Exposure to industry tools, coding standards, and documentation processes

  • Affordable and accessible pathway to enter the global clinical trial workforce

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Career Outcomes

Upon successful completion, learners will be ready for entry-level roles such as:

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  • Clinical Data Coordinator

  • Clinical Data Associate

  • Clinical Research Assistant

  • Clinical Data Analyst

  • Medical Coder

  • Data Validation Associate

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Assessment & Certification

  • Module-wise Assignments & Quizzes

  • Final Project Submission

  • Viva & Practical Evaluation

  • Minimum 70% attendance and 60% score required for certification

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Skills You Will Learn

  • Understanding of clinical research operations across phases

  • Designing and managing data collection tools (CRFs & eCRFs)

  • Performing discrepancy management and data validation

  • Comprehension of data cleaning, data freeze, and lock processes

  • Applying SOPs, ICH-GCP, and GCDMP standards

  • Using Medical Dictionaries (MedDRA/WHO Drug)

  • Navigating compliance: 21 CFR Part 11, ICH GCP etc., 

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Eligibility

  • Final year students & graduates in Life Sciences, Pharmacy, Biotechnology, Nursing, BPT, MBBS, BDS, or Allied Health Sciences

Data Drives Discovery

The global clinical trials market is projected for significant growth, driving a constant need for skilled professionals in data management and research coordination.

Course Contents

Module 1: Clinical Research Foundation

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  • Overview of Drug Development Process (Phases I–IV)

  • Roles of CROs, Sponsors, Investigators

  • Ethics Committees, Regulatory Bodies (DCGI, EMA, FDA)

  • Introduction to ICH-GCP Guidelines

  • Introduction to Protocols and Study Design

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Module 2: Clinical Data Management (CDM)

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  • Overview of Clinical Data Management Lifecycle

  • Data Management Plan (DMP)

  • Case Report Form (CRF) Design

  • Query Management & Data Review

  • Introduction to Standard Operating Procedures (SOPs) in CDM

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Module 3: Clinical Data Management Systems (CDMS)

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  • Introduction to Electronic Data Capture (EDC)

  • CDMS platforms (e.g., Medidata, Oracle RDC, Inform)

  • User Roles & Access Management

  • Data Entry, Data Lock, and Audit Trails

  • Title 21 CFR Part 11 & Computer System Validation

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Module 4: Clinical Coding

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  • Medical Coding Fundamentals

  • WHO Drug and MedDRA Dictionary

  • AE/SAE Coding Principles

  • Coding Standards and Best Practices

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Module 5: Project / Internship

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  • Work on a mini-project or simulation based on real-world datasets

  • CRF creation, Data Entry Simulation, Query Handling

  • Hands-on with Dummy EDC Tool / Excel-based CDM

  • Project Presentation + Internal Viva

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Launch Your Career in the Clinical Research and Data Management

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