6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week
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
Why study this program?
Clinical research industry has achieved significant growth in the last 10 years. This growth is closely linked to an increased focus on quality in executing clinical trials. Quality systems need to be incorporated into the clinical research processes right from the planning stages and strict regulatory standards need to be maintained by all responsible parties throughout the conduct of the clinical trials. Although Quality Assurance was initially a concept limited to manufacturing, over the years Clinical Research Quality Assurance has turned out to be an important tool, in guaranteeing that developments are carried out within a rigorous quality framework.
“Quality is never an accident; it is always the result of intelligent effort” ... J. Ruskin
Maintaining Quality throughout a clinical trial is an ongoing process. The Quality Assurance (QA) function within an organization includes all Quality Control (QC) activities and serves as a link between the tasks conducted during clinical trial monitoring and the regulatory inspections (e.g. FDA inspections). Clinical Quality Assurance facilitates achieving standardization and maintaining consistency at each step of the clinical trial process. Clinical Quality Assurance (QA) tasks include developing and maintaining compliant standard procedures within the organization; planning, scheduling, and conducting site and system audits; assessment of quality level; & compliance with local & international guidelines and regulations as may be applicable.
This Advanced Clinical Research and Quality Assurance Training Program has been conceptualized and designed to meet the growing demand of the industry for professionals with clinical quality assurance training.
This program provides students the knowledge of all important quality assurance methods, processes and practices. It allows students to build a strong groundwork in the regulatory standards and aids to develop advanced skills and proficiency to create, manage and maintain quality systems and quality results. This Advanced Clinical Research and Quality Assurance Training Program provides students with a wide range of career options for future, ranging from progressing in their career to pursue further research and development, to becoming a competent Clinical Quality Assurance Auditor & Professional.
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: 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.
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 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.
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 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 & Business Development 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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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.
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.