4 - 6 Months (Self Paced)
Maximum Allowed Duration: 18 Months
Expected Effort: 10-15 hours/week
This program will give you a thorough understanding of all core concepts of clinical data management such as CRF design, data management plan, data management standards and an understanding of the Oracle Clinical software.
TOTAL CREDITS: 18
Next Start Date
Why study this program?
Clinical data management or CDM is one of the corner stones in medical drug and device development. Most organizations involved in conducting clinical trials have dedicated data management departments to help with the collection, verification, and validation of clinical trial data. The aim is to make sure that the data that is collected by conducting clinical trials is accurate and free of errors so that a correct analysis of the data can be performed to draw the right conclusions. Data management professionals help to develop the case report forms, put in place a data management plan, create various databases to enter the collected data, create queries in the system in case of inconsistent or incorrect data, and provide the statistical analysis team with a data management report.
Different organizations use different tools to manage clinical trial data however the most common tool is the Oracle Clinical software. Other less common tools are Medidata Rave, Open Clinica, Inform etc.
What will be taught?
MODULE 01: GENERAL INTRODUCTION
MODULE 02: PHARMACEUTICAL MEDICINE
MODULE 03: THERAPEUTIC AREAS
MODULE 04: INTRODUCTION TO DATA MANAGEMENT AND BIOSTATISTICS
MODULE 05: BASICS OF CLINICAL DATA MANAGEMENT
MODULE 06: CLINICAL DATA MANAGEMENT PROCESSES & STANDARDS
MODULE 07: CLINICAL DATA MANAGEMENT SYSTEMS
MODULE 08: ORACLE CLINICAL
TOTAL CREDITS: 18
MODE OF STUDY: ONLINE
The curriculum for the program - Professional Diploma in Clinical Data Management (PDCDM) is extensive, has been developed and evaluated by experienced data management professionals and is fully endorsed by the clinical research industry.
How will I be assessed?
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 Professional Diploma in Clinical Data Management (PDCDM) 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 Professional Diploma in Clinical 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:
People with training in clinical data management can explore career opportunities with many organizations such as pharma and biotech companies, contract research companies, pharma IT companies, IT consulting agencies etc. Positions that can be explored include Clinical Data Associate, Clinical Data Coordinator, Data Reviewer, Data Manager etc.
Clinical data management has seen rapid growth in developing economies that are actively conducting clinical trials. Countries such as India are at the forefront of clinical data management now due to availability of trained professionals, low cost advantage among many others. This field is all set to grow further in years to come.