Clinical Development Sciences

PROGRAM DURATION

6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week

Advanced PG Diploma in Clinical Research & Data Management

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 Commencement Date

01 JUN

2019

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INTRODUCTION

Why study this program?


Introduction

The training course Advanced Post Graduate Diploma in Clinical Research & Data Management (APGDCR-DM) is designed to provide students with a complete overview of clinical research, clinical trial processes, clinical trial monitoring and clinical data management.

The course has been developed with extensive consultation with the clinical data management industry and is structured in a way so as to open up opportunities for students in the area of core clinical research as well as clinical data management (CDM).


The program is highly recommended for all individuals already working or planning to work with clinical data and other related health databases.

The program APGDCR-DM has been designed to provide students a stimulating and enjoyable experience so as to develop them into skilled, efficient professionals who are highly employable and capable to work from day one in clinical research and clinical data management.

The Advanced Post Graduate Diploma in Clinical Research & Data Management (APGDCR-DM) course curriculum is fully reviewed and endorsed by the clinical research and clinical data management industry thus imparting students the edge that they require to make an entrance in the this industry and empowers the professionals to move to higher cadres in the clinical research and data management hierarchy.

PROGRAM STRUCTURE

What will be taught?


Program Structure

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

TOTAL CREDITS: 32

MODE OF STUDY: ONLINE

The curriculum for the program - The Advanced Post Graduate Diploma in Clinical Research & Data Management (APGDCR-DM) is extensive, has been developed and evaluated by experienced data management professionals and is fully endorsed by the clinical research industry. Not only is this program suitable for new graduates but also for working professionals who either wish to grow further in their clinical research and/or data management career, or those who wish to make a move to the clinical research or data management sector from any other related industry.

ASSESSMENT

How will I be assessed?


Assessment

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

ELIGIBILITY

Am I eligible?


Eligibility

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.

ACADEMIC SUPPORT

What support will I receive?


Academic Support

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 Advanced Post-Graduate Diploma in Clinical Research & Data Management Course (APGDCR-DM) 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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Program Fee

How much will it cost?
Please use our online fee calculator to calculate the fee applicable to you.



CAREER OPPORTUNITIES

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.


MORE INSIGHT

"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"


james lind institute
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