Clinical Research

The objective of Post Graduate Diploma In Clinical Research program is to develop students...

About Course

The objective of Post Graduate Diploma In Clinical Research program is to develop students, over the period of 6 months, by in depth industry oriented knowledge to reach top end positions in the clinical research Industry.

This program is developed and structured in a manner to match high academic standards and international industry requirements. The comprehensive mix syllabus of Clinical Research, Clinical Data Management and Pharmacovigilance curriculum along with workshop on Interview techniques program, CV development ensure a fast successful corporate career.


  • Best Equipped Training Center
  • Overall Development Through Academic Lectures + Presentation Skills + Interview Skills + CV Development
  • Free Prorelix Study Material
  • Free Wi-Fi
  • Industry Oriented Training
  • Visiting Lectures by Expert Industry People
  • Internship Opportunity
  • Placement Program

2018 Batches : January, April, July, October

Course Syllabus

Preclinical Studies and Clinical Phases of Drug Development

  • Drug discovery
  • CPCSEA guideline
  • Introduction to Toxicity Studies
  • In –vivo & in vitro methods
  • Definition of clinical trial
  • Clinical research past & present
  • Phase 1,2 – subtypes, phase 3 ,4
  • Bioavailability and Bioequivalence Studies
  • E –clinical trial

Ethics in Clinical Research, Drug Regulations and Schedule Y

    Background of ethics
  • Nuremberg code
  • Declaration of Helsinki
  • Belmont Report
  • CIOMS Guidelines (WHO)

  • IRB & IEC composition, roles & responsibility Informed consent process
  • Audio-Visual Recording of Informed Consent Process
  • Importance
  • Elements
  • Personnel involved
  • Precautions
  • Special consideration
  • The patient information sheet & informed Consent form

  • Privacy & confidentiality in clinical research,insurance In clinical research Drug regulations
  • History of Indian regulations
  • Drug & cosmetic Act -1940
  • Related Drug & cosmetic Rules -1945
  • Schedule – Y- Appendices
  • ICMR Guidelines
  • Indian GCP
  • Patent & TRIPS
  • Drugs & magic remedies Act 1954
  • Drug prices control order
  • Regulations for AYUSH
  • CTRI-Clinical trial registry of India.
  • Regulatory Authorities: USFDA, EMA,DCGI

Clinical Trial Documents, clinical Trial Designs & Quality A

    Clinical trial documents
  • Protocol
  • CRF-Paper CRF & E CRF
  • IB
  • Clinical study report
  • Trial master file
  • Clinical Trial logs
  • E-Trial Master file
  • Investigator responsibility Sponsor responsibility

    Audit & inspections
  • Types of audits
  • Preparation for audits
  • Agenda of audits
  • Audit report
  • Audit trail
  • Sponsor audit
  • IRB audit
  • Regulatory Audit (for investigator / clinical site) SOP’S introduction

  • Clinical Trial Designs Different types of trial design
  • Cross section
  • Parallel design
  • Cross over design
  • Observational studies
  • Multicentre trial
  • Randomization
  • Blinding

Role of Clinical Research Organization, Site Management and Monitoring in CR

  • Outline in clinical research
  • Benefits of CRO
  • Objectives of CRO
  • Role of CRO
  • Role of personnel involved
  • Patient requirement, patient safety, maintaining
  • Ethics in clinical trials
  • Roles and responsibility of sponsor.
  • Roles and responsibility of CRA
  • Roles and responsibility of CRC
  • Clinical trial monitoring & Types of monitoring

Clinical Data Management an Introduction Data Management Standards:

    CDISC 21CFR Part 11 CDMS Systems Setup
  • CDMS (e.g.: Oracle Clinical etc.)
  • What is EDC (ECRF, IVRS, IWRS)
  • Data management plan
  • eCRF Designing
  • eCRF Completion Guidelines.
  • Data Entry Guidelines
  • Edit check Specification
  • Data Privacy: Implications for Clinical Operations
  • User Acceptance Testing.

  • Conduct
  • Date Entry- Double Entry & Single Entry
  • Data Review & Validation
  • Discrepancy management
  • Query Writing
  • Data clarification form
  • Data review by using standard reports and J-review
  • Provided in ORACLE CLINICAL.
  • Creation of manual checks in J Review.

  • Medical coding
  • What is Medical Coding
  • Types of coding
  • Dictionaries (E.g.: MEDRA, WHODD, WHOART etc.)

  • Close out
  • Last query out
  • Last Patient out (LPO)/ Last patient last visit (LPLV)
  • Data base lock (Soft lock, hard lock)
  • Data storage and archive


  • Definition , overview and scope
  • UPPSALA Monitoring centre
  • Signal detection in Pharmacovigilance
  • Signal generation post marketing surveillance (PMS)
  • WHO program for international drug monitoring
  • Pharmacovigilance in India
  • National Pharmacovigilance policy and plan
  • Pharmacovigilance centres in India
  • Drug safety monitoring board
  • PSUR

Free Prorelix Study Material

Free Wi-Fi

Internship Opportunity

Best Equipped Training Center

Industry Oriented Training

Overall Development

Exam Evaluation

Final Written Exam Will Be Conducted and Certificate will Be Awarded to Successful Candidates Only.

Teaching Methodology

  • Classroom Lectures
  • Presentations
  • Assignments/ Project


B.Sc/M.Sc in Life Sciences / Microbiology / Biotechnology / Zoology / Biochemistry / Chemistry / Nursing
B.Pharm/ M.Pharm
BAMS/ BHMS/ BDS/ MBBS/ Physiotherapy.


6 Months- Monday to Thursday.


January, July and October Each Year

Placement Support Program

ProRelix provides complete placement support to its students. Students will get continuous job placement support including job emails on their email IDs provided to Prorelix Lifesciences Education Placement Support Program is for jobs in Pharma Companies, Clinical Research Organizations, Site Management Organizations and IT companies to start their career in clinical research industry with following positions.

  • Clinical Trial Associate
  • Clinical Research Coordinator
  • Clinical Research Associate
  • Data Safety Associate
  • Regulatory Associate
  • Investigator
  • Medical Coder
  • Medical Writer
  • Business Development Executive
  • Quality Assurance Associate
  • Trainer
  • Clinical Data Associate
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