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Post Graduate Diploma in Clinical Research (Part Time)

We provide full time and part time clinical research program with internship opportunity. We provide class room training with high quality presentations by our industrial expert trainers.

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.

This program is integrated with the certification in International Drug Regulatory Affairs with discounted fees in the optional basis.

Teaching Methodology

  • Classroom Lectures
  • Presentations
  • Assignments/ Project

Duration

6 months

Students
  • 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
  • Integrated Certification in International Drug Regulatory Affairs.
  • International Level Certificate

Sub Code

Title of The Paper

101

Fundamental Of Clinical Research

Introduction to clinical research

  • Terminologies
  • History of clinical research
  • Drug discovery
  • In Vivo &amp In Vitro studies

Introduction to Preclinical Trial

  • Types of toxicity studies
  • CPCSEA guideline

Clinical development

  • Phase 1
  • Phase 2 – subtypes
  • Phase 3 – subtypes
  • Phase 4

Bioavailability and Bioequivalence Studies

e-clinical trial

Clinical trial essential documents

  • Protocol
  • CRF
  • IB
  • SOP’s introduction
  • Clinical study report
  • Trial master file &amp e-Trial master file
  • Clinical Trial logs

Investigator responsibility

Sponsor responsibility

Audit &amp inspections

Clinical Trial Designs

102

Ethics In Clinical Research And New Drugs And Clinical Trials Rules

Background of ethics:

  • Nuremberg code
  • Declaration of Helsinki
  • Belmont report
  • CIOMS guidelines (WHO)

Introduction to ethics committee

  • Types of ethics committee
  • IRB &amp IEC composition
  • Roles &amp responsibilities

Informed consent process

  • Audio-Visual recording of informed consent process
  • Importance
  • Elements
  • Personnel involved
  • The patient information sheet &amp informed
  • Consent form

Privacy &amp confidentiality in clinical research,

Compensation in clinical research

Drug regulations

  • History of Indian regulations
  • Drug &amp cosmetic Act -1940
  • Drug &amp cosmetic Rules -1945
  • New Drugs and Clinical Trials Rules, 2019
  • ICMR Guidelines
  • Indian GCP
  • ICH GCP
  • ICH GCP principles
  • Patent &amp TRIPS
  • Drugs &amp magic remedies Act 1954
  • Drug prices control order
  • Regulations for AYUSH
  • CTRI-Clinical trial registry of India

Regulatory Authorities

  • USFDA
  • EMA
  • DCGI

103

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

CRO

  • Introduction to CRO
  • Objectives of CRO
  • Role of CRO
  • Role of personnel involved

Site management organization (SMO)

Subject requirement, subject safety.

Roles and responsibilities of clinical research associate (CRA)

Roles and responsibilities of (CRC)

Roles and responsibilities of sponsor

Clinical trial monitoring & Types of monitoring

104

Clinical Data Management an Introduction

Data Management Standards:

CDISC
21CFR Part 11
CDMS Systems

Setup

  • CDMS (eg: Oracle Clinical etc.)
  • What is EDC (e CRF, IVRS, IWRS)
  • Data management plan
  • e CRF Designing
  • e CRF Completion Guidelines
  • Data Entry Guidelines
  • Edit check Specification
  • Data Privacy: Implications for Clinical Operations
  • User Acceptance Testing

Conduct

  • Date Entry- Double Entry &amp Single Entry
  • Data Review &amp 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)

Closeout

  • Data base lock (Soft lock, Hard lock)
  • Data storage and archive

105

Pharmacovigilance

  • Definition , overview and scope
  • WHO program for international drug monitoring
  • UPPSALA Monitoring centre
  • Signal detection in Pharmacovigilance
  • Signal generation post marketing surveillance (PMS)
  • Pharmacovigilance in India
  • National Pharmacovigilance policy and plan
  • Pharmacovigilance centres in India
  • Serious adverse reactions
  • Applications of pharmacovigilance
  • Aims and objectives of pharmacovigilance
  • 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

1. Full Time :

January, April, July, October Each Year
Monday – Thursday

2. Part Time :

January, July each Year
Only on Sunday

FAQ

What is Post Graduate Diploma in Clinical Research?

A Postgraduate Diploma in Clinical Research (PGDCR Course) is a part-time professional program designed to train students to be professional clinical researchers. The comprehensive mixed syllabus of fundamentals of clinical trials, clinical development, protocol, site management, and pharmacovigilance along with interactive sessions on resume building are enough to ensure great corporate growth.

Is Post Graduate Diploma in Clinical Research (PGDCR) a good course?

A Postgraduate Diploma in Clinical Research can be an excellent choice for those life sciences students who want to enter into the medical research domain and are looking to learn the process behind approval of any medical or pharmaceutical product. In India, the demand for professionals in this field is increasing day by day as companies are expanding and investing more in this field. So it is indeed a good course and perhaps the most recommended one due to its rich scope and association with the healthcare industry.

Benefits of pursuing a Post Graduate Diploma in Clinical Research (PGDCR) course?

A Postgraduate Diploma in Clinical Research is a thorough program that involves exposure to different aspects of clinical research. This course is outlined in such a way that it will give students a complete 360 degree knowledge of the industry because it covers everything right from fundamentals of clinical research to all the way upto pharmacovigilance and its sub-modules!! Which opens up doors of endless opportunities for students to learn, pursue, and excel their career in clinical research!!

Will I get placement assistance after completing this course?

ProRelix Education provides excellent placement support to pass out “Clinical Research” students who have successfully completed all the course modules and syllabus. By becoming a part of our institute you will not only get high-quality education but also lifetime job placement support, CV development assistance, mock interview call preparation, guest lectures, internship opportunities, and much more. We provide placement assistance to our students in the following associations i.e pharma industries, hospitals, CRO’s, healthcare organizations, MNCs, IT companies, etc.

Highlights

Book

Free Study Material

Name plate

Best Equipped Training Center

Microscope

Industry Oriented Training

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