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 & Quality Assurance

This program has been conceptualized and designed to meet the growing demand of the industry for professionals with clinical quality assurance training. It introduces you to important quality assurance methods, processes and practices.

TOTAL CREDITS: 32

Next Commencement Date

01 SEP

2019

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INTRODUCTION

Why study this program?


Introduction

Advancement in clinical research has increased exponentially over the last decade. This is twinned with an increasing focus on quality while conducting clinical trials. Quality has to be built in to the clinical research process right from its inception and stringent regulatory standards needed to be maintained by all stake holders. Quality Assurance in clinical research has become an essential tool, in ensuring that developments are implemented within a rigorous quality framework...

“Quality is never an accident; it is always the result of intelligent effort”. ─J. Ruskin

Maintaining Quality throughout the clinical study is a continual dynamic process. Quality Assurance system encompasses all quality control activity and acts as a link between the monitoring activities and the regulatory inspection. Quality assurance helps achieving standardization and maintaining reliability at every stage of clinical trial process. Quality Assurance (QA) activities include planning, scheduling conducting audits and evaluation of quality level & compliance with GCP guidelines and applicable regulations.
Advanced Postgraduate Diploma in Clinical Research and Quality Assurance (APGDCR+QA) program is devised to meet increasing demand by industry for quality assurance professionals. APGDCR+QA program is carefully designed by the experienced faculty from the industry, especially to provide understanding of core quality assurance methods, process and practices. The program enables the professional to develop a solid foundation in the regulatory standards and helps to cultivate advance skills and competence to manage and deliver quality systems and quality results. The Advanced Postgraduate Diploma in Clinical Research and Quality Assurance program will give you a broad range of choice for your next steps, right from advancing your career to pursuing further research and professional development activities and to become a skilled Quality Assurance Auditor & Professional.

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: QUALITY & QUALITY MANAGEMENT
MODULE 19: THE QUALITY ASSURANCE FUNCTION
MODULE 20: AUDITS
MODULE 21: QUALITY GUIDELINES
MODULE 22: GCP/GMP/GLP

TOTAL CREDITS: 32

MODE OF STUDY: ONLINE

The curriculum for the program - Advanced Post Graduate Diploma in Clinical Research & Quality Assurance (APGDCR-QA) is comprehensive, has been developed and evaluated by experienced clinical quality assurance professionals and is fully endorsed by the clinical research industry. Not only is this online training course suitable for new graduates but also for working professionals who either wish to grow further in their clinical research and/or quality assurance career, or those who wish to make a move to the clinical research or clinical quality assurance domain 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 & Quality Assurance (APGDCR-QA) 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.
- Students in their final year of graduation for the above courses are also eligible to apply.

Candidates without any science background who have work experience in the pharmaceutical industry / quality assurance / allied areas may also be eligible for this program. Please discuss your case with our counsellors.

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 & Quality Assurance Course (APGDCR-QA) 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 & Quality Assurance is a unique program that opens up a number of career opportunities not only in the area of core clinical research but also in clinical quality assurance. Positions that can be explored include Clinical Research Associate, Clinical Research Coordinator, Site Monitor, Clinical Trial Manager, Quality Auditor, Quality Assurance Executive / Associate / Manager etc.


TRAINING APPROACH

The curriculum for the quality assurance training and its course material provided to students is as per the expectations of the industry. Although theoretical aspects of all topics are covered however emphasis is also laid on the practical aspects of various concepts where applicable. Mentors/tutors are always available for supporting students throughout the program duration.


james lind institute
James Lind Institute (India) - Golden Square, 2nd floor # 579 32nd D Cross Road, 10th Main Rd, 4th Block, Jayanagar, Bengaluru 560011 | Phone: +91-80-46473435, +91 40 42023318,
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