About Course
We provide full time clinical research program with internship certificate 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 (PGDCR) is to develop students, over the period of 04 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
- Group Discussion
Duration
04 months
Benefits
- 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 Certificate Opportunity
- Placement Program
- International Level Certificate
Program Syllabus
| 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 & informed -Consent form Privacy & Amp Confidentiality In Clinical Research, Compensation In Clinical Research Drug Regulations -History of Indian regulations -Drug & cosmetic Act -1940 -Drug & cosmetic Rules -1945 -New Drugs and Clinical Trials Rules, 2019 -ICMR Guidelines -Indian GCP -ICH GCP -ICH GCP principles -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 |
| 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 & 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) 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 |
Admission Procedure and Eligibility
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
Placement Support Program
ProRelix Education 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
Regulatory Associate
Business Development Executive
Clinical Research Associate
Medical Coder
Quality Assurance Associate
Clinical Research Coordinator
Investigator
Quality Assurance Associate
Data Safety Associate
Clinical Data Associate
Medical Writer
Trainer
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
Batches
Full Time :
March, June, November Each Year
Monday – Thursday – 2Hrs
FAQ
What is Post Graduate Diploma in Clinical Research?
A Postgraduate Diploma in Clinical Research (PGDCR Course) is a full-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.
What is the scope of Clinical Research in India?
Clinical research is one of the developing and most sought-after educational niches in India and is very soon going to be a multi-billion dollar industry after 2022. There was a tremendous increase in non-industry-sponsored clinical trials in 2020 i.e 64.9% which is way above the national average of clinical trials that happened over the last decade. Looking at the above facts, one thing is clear that there will be a huge demand in the job market for clinical research professionals.
Is Clinical Research a good career option?
Yes, it is because it includes all of the elements that a solid career should have including future opportunities, personal development, lucrative positions, upskilling chances, and a global career are all factors to consider. This niche will not only help you with communication, leadership, planning, organizing, and other interpersonal skills, but it will also help you to crack offshore and MNC jobs.
Job opportunities after completing Post Graduate Diploma In Clinical Research (PGDCR) course?
There are abundant job opportunities after completing a professional course in Post Graduate Diploma in Clinical Research (PGDCR). You will be adequately qualified for various jobs such as CRA (Clinical Research Associate), CTA (Clinical Trial Assistant), CRC (Clinical Research Coordinator), CRE (Clinical Research Executive), and more.
What is the average salary I will get after completing a course in Clinical Research (PGDCR)?
The salary constraint totally depends on your skillset, abilities and the organization that you are placed in!! One can expect an average starting salary anywhere between 1.5 lakh to 7 lakh per year.
