Advanced Post-Graduate Diploma in Clinical Research
& Quality Assurance

Online Training in Clinical Research & Quality Assurance | Clinical Quality Assurance Training

Online Training in Clinical Research & Quality Assurance | Clinical Quality Assurance Training Course


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.


Course Structure

  • MODULE 1 GENERAL INTRODUCTION
  • MODULE 2 EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
  • MODULE 3 PHARMACEUTICAL MEDICINE
  • MODULE 4 THERAPEUTIC AREAS
  • MODULE 5 ETHICS IN CLINICAL RESEARCH
  • MODULE 6 ROLES AND RESPONSIBILITIES
  • MODULE 7 CLINICAL TRIAL PREPARATION
  • MODULE 8 ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
  • MODULE 9 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

The later part of the course would involve mock exercises concerned with a real-time role review of a Clinical Research Professional in different capacities.



Course duration

Self Paced 6 - 8 months (Maximum duration 24 months)

A student enrolled in the Advanced Post-Graduate Diploma in Clinical Research & Quality Assurance Course (APGDCR-QA) is expected to study online for a minimum of fifteen hours per week.


Course Assessment

Course assessment involves online MCQs for each lecture, followed by assignments and assessments by tutors throughout the course in the “Online Campus Tutoring Centre” by the method of interactive discussion.


Eligibility Criteria

The minimum eligibility criteria for Post-Graduate Diploma in Clinical Research Course (PGDCR) would include either of the following:

  • MBBS/BHMS/BAMS/BPT/MPT/BDS/BMLT/Bachelor in Naturopathy & Veterinary Science /MD/MS.

  • Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.

  • Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).

  • Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.

  • Graduate or equivalent degree in Nursing/Allied Health.

  • Students in their final year of graduation for the above courses may also apply.


Fee Structure

Course fee for all JLI courses is very reasonable. Please use our Course Fee Calculator below to know the course fee applicable to you.



If you are not sure about the fee applicable to you for Advanced Post-Graduate Diploma in Clinical Research & Quality Assurance for the academic year 2012-13 please send an email to admissions@jli.edu.in or chat with our online counsellor.

For more details about the admission procedure please click here.


Academic Support

Each student enrolled in the Advanced Post-Graduate Diploma in Clinical Research & Quality Assurance Course (APGDCR-QA) is assigned a mentor throughout the course who will be a senior professional from the industry. Students are in close contact with the “Student Success Team” during this clinical research course and thereafter as alumni. To know more about the “Student Success Team”, click here.


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