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 Commencement Date
Why study this program?
Clinical Data Management (CDM) involves apt procedures that are followed for entering, verifying, validating & further reviewing of the gathered data during a clinical trial. The kind of data managed during clinical trials is mostly related to the safety & efficacy of the drug, device or biologic that is under study. The data that arrives from clinical research centers such as hospitals or healthcare clinics are case report forms and those that arrive from clinical laboratories are non-case report forms. In Clinical Data Management, one needs to collect & validate both these types of clinical trial data & conduct its quality assurance in order to ensure that the data is error free. The clinical research industry works in the epicenter of web-based systems as many online tools are used to manage this data. This online course provides students & professionals an overview of Oracle Clinical (OC) which is considered to be the gold standard in data management.
There is need and high demand for trained man-power with knowledge of good clinical data management practices, clinical trial designs, adverse events, audits, data management tools etc. This course has been extensively developed & is industry focused which aids in providing career opportunities in clinical data management.
This program is suggested to students & professionals who would be interested to pursue a career or hold a specialization in this domain.
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?
Course assessment involves online multiple choice questions for each lecture, followed by assignments for each study module.
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?
Throughout the course, the students can interact with the faculty and other students via the e-Campus to discuss any coursework related issues.
Each student enrolled in the Professional Diploma in Clinical Data Management Course (PDCDM) is also assigned a mentor throughout the course who will be a senior professional from the industry. Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.
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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.