6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week
This program is designed to provide you with a full overview of clinical trials, clinical research management, clinical trial monitoring and data management.
TOTAL CREDITS: 32
Next Start Date
Why study this program?
The combination of clinical research and data management is a comprehensive training course intended to deliver training in the fundamentals of clinical research, clinical trial processes and clinical data management.
What will be taught?
MODULE 01: GENERAL INTRODUCTION
MODULE 02: EPIDEMIOLOGY & EVIDENCE BASED MEDICINE
MODULE 03: PHARMACEUTICAL MEDICINE
MODULE 04: THERAPEUTIC AREAS
MODULE 05: ETHICS IN CLINICAL RESEARCH
MODULE 06: ROLES AND RESPONSIBILITIES
MODULE 07: CLINICAL TRIAL PREPARATION
MODULE 08: ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 09: STUDY START-UP
MODULE 10: CLINICAL TRIALS MONITORING
MODULE 11: COMPLIANCE AND AUDITS
MODULE 12: DATA MANAGEMENT AND BIOSTATISTICS
MODULE 13: REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 14: MEDICAL DEVICE TRIALS
MODULE 15: PROJECT AND VENDOR MANAGEMENT
MODULE 16: FINANCIAL MANAGEMENT OF CLINICAL TRIALS
MODULE 17: PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS
MODULE 18: BASICS OF CLINICAL DATA MANAGEMENT
MODULE 19: CLINICAL DATA MANAGEMENT PROCESSES & STANDARDS
MODULE 20: CLINICAL DATA MANAGEMENT SYSTEMS
MODULE 21: ORACLE CLINICAL
You will be assessed on an ongoing basis by the faculty based on the following criteria:
One is the completion of the online multiple choice question tests that follow each lesson; and second is the timely submission of assignments for each study module within the JLI e-Campus.
Your academic performance in the program will be assessed on a 4 point GPA scale. More details about our evaluation system is available in the following link: Evaluation System
Am I eligible?
The minimum eligibility criteria for Advanced Post-Graduate Diploma in Clinical Research & Data Management (APGDCR-DM) would include either of the following:
- Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
- Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
- Any degree in Pharmacy / Pharmaceutical Sciences
- Any degree in Chemistry / Biostatistics / Bioinformatics
- Any degree in Nursing / Allied Health
- Any degree in Computer Science / IT
- Students in their final year of graduation for the above courses are also eligible to apply.
If you lack the above mentioned educational prerequisite you may still be eligible to apply upon recommendation of your supervisor if you have some prior work experience in clinical research / data management / allied areas. Please contact our admission representatives / counsellor to discuss your case.
What support will I receive?
As a student you can interact online with the faculty members and fellow students to network and to discuss important topics via your e-Campus. The faculty promptly answers all questions related to the study in the Online Campus Tutoring Center (OCTC).
Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.
In addition, each participant registered in the Advanced Post-Graduate Diploma in Clinical Research & Data Management Course is provided with a mentor who is an experienced professional from the clinical research industry. The mentor can be contacted at any time via email or phone.
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James Lind Institute offers various masters degree programs in the areas of public health, business administration etc.
- MPH (with specializations)
- M.Sc in Health Mgmt
- MBA (various specializations)
For information on available masters programs via our School of Health Sciences; & our Business School click below:
This combination program of Clinical Research & Data Management opens up a number of career opportunities in the area of core clinical research as well as clinical data management. It thoroughly prepares freshers to get a breakthrough in the industry and also helps to propel working professionals to higher positions in clinical research / CDM departments. Positions that can be explored include Clinical Data Reviewer, Clinical Data Associate, Clinical Data Coordinator, Clinical Data Manager etc.
"Development of new information management and content management platforms are all set to reduce costs of clinical data management and of the drug development process at large. There is an immediate demand for highly trained Data Management Professionals who can contribute to this whole process"