Post Graduate Diploma in Clinical Research – Full Time

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

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.

Teaching Methodology

  • Classroom Lectures
  • Presentations
  • Assignments/ Project

Duration

6 Months- Monday to Thursday.

  • 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

Fundamental of Clinical Research

  • 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

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
  • SOP’S introduction
  • Clinical Trial Designs

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
  • ICH 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

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 (clinical research associate)
    • Roles and responsibility of CRC (clinical research coordinator)
  • Clinical trial monitoring & Types of monitoring

Clinical Data Management An Introduction Data Management Standards

  • CDISC
  • 21CFR Part 11
  • CDMS Systems

Setup

  • CDMS (eg: 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

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

Pharmacovigilance

  • 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

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

Eligibility

B.Sc/M.Sc in Life Sciences / Microbiology / Biotechnology / Zoology / Biochemistry / Chemistry / Nursing

B.Pharm/ M.Pharm

BAMS/ BHMS/ BDS/ MBBS/ Physiotherapy.

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

Companies enrolling clinical research candidates –
Cognizant Technology Solutions, Syntel, Jahangir Clinical Development Centre, JSS Medical Research, ACCESS Healthcare, Crest Healthcare, IT Cube Solutions, TCS, Sciformix, Lupin, Cipla, Tata Memorial Hospital, Quintiles, Covance, Accenture, Bioclinca, Freyer

January, April, July and October Each Year

Highlights

Free Study Material

Free Wifi

Internship Opportunity

Best Equipped Training Center

Industry Oriented Training

Overall Development

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