Post Graduate Diploma in Clinical Research (P.G.D.C.R.) Admission 2016-2017

The course is conducted by D. Y. Patil School of Ayurved, Nerul, Navi Mumbai under the ambit of D.Y. Patil Universisty, Nerul, Navi Mumbai since July 2011. The course proposal has been unanimously passed in
  • B.O.S. meeting of a) Preclinical b) Paraclinical and c) Clinical Board dated on 30/09/2009;
  • Academic Council;
  • 17th Board of Management meeting held on 27/03/2010.
And the course was commenced with the special permission from the then chancellor Shri. Vijay D. Patil  on 2nd July 2011.
We have completed the fifth batch of P.G.D.C.R. successfully in the year 2015-2016. Admission process is going on for the sixth batch since June 2016.
I am taking this opportunity to highlight the salient features of the course as follows :
Aims:  
  • To provide formal training in clinical research to the graduates and P.G.students of all the medical disciplines and basic science.
  • To conduct C.M.E.s and workshops in clinical research for university faculty.
Objective:
  • To inculcate research culture in the university.
  • To encourage research papers from the university faculty.
  • To give opportunity to Ayurvedic and Medical graduates to work in clinical research Industry.
  • To enhance clinical trials by building capacity to research.
  • To boost the academia –industry relationship.
  • To raise the funds for research
Appedix I
Course Description
Name of the course: POST GRADUATE DIPLOMA IN CLINICAL RESEARCH (PGDCR)
Duration:  12 months
Schedule:  Part Time ( Saturday /Sunday 4 hrs. in afternoon)
Eligibility:
  • Graduate & Post Graduate of Ayurevd
  • Graduate & Post Graduate of Allopathy
  • Graduate & Post Graduate of Homeopathy
  • Graduate & Post Graduate of Unani and Siddha.
  • Graduate & Post Graduate in Biological sciences/ Life sciences.
  • Graduate in Nursing.
Course Fees: Rs. 70,000/-
(DD/ Cheque in favour of Dr. DY Patil College Of Ayurved ,Herbal Clinical Research)
Application Procedure:
  • Forms available Online / College Office
  • 2 Copies of Passport size photographs.
  • Photocopy of Certificate of Graduation
  • Address proof and photo identity
  • Birth Date Certificate.
  • Mark sheet of final year.
Career Avenues:
  • Pharmaceutical Companies(Indian & MNCs)
  • Contract Research Organization (CRO)
  • IT & Data Management Companies
  • Clinical Research Academic Organization
  • Biotech Companies
 Entry Level Opportunities:
  • Clinical Research Coordinator ( CRC)
  • Clinical Research Associate (CRA)
  • Clinical Research Physician( CRP)
  • Data Management Coordinator ( DMC)
  • Medical Writer
  • Statistical Analyst
  • Manager Pharmaco-vigilance
Course Venue:
       Clinical Research Unit, 2nd Floor,
       D.Y. Patil School of Ayurved,
       Nerul, Navi Mumbai
Contact : Dr. Rahul D. Palshetkar  
                 Phone Number:- 9820233397          
Appedix II
Advisory Board: -
Shri. Vijay D. Patil ( President- DYPU, Nerul, Navi Mumbai)
Dr. Sanjay Oak ( V.C. – DYPU, Nerul, Navi Mumbai )
Dr.(Mrs.) Priya R. Cholera (Medical Director- DYPU, Nerul, Navi Mumbai)
Dr.(Mrs.) Nandita P. Palshetkar ( Trustee- DYPU, Nerul, Navi Mumbai)
Dr. Maheshkumar Harit (Dean- DYPU-School of Ayutrved, Nerul, Navi Mumbai)
Scientific Advisory Committee:
Dr. Supriya Bhalerao. [Scientist – IRSHA- Bharti Vidyapeeth, Pune.]
Dr. Saket Ghaisas [ Regional Clinical Development Director- Pfizer Products India Pvt. Ltd.]
Treasurer :
Dr. Ajit Nandanikar [ Professor- DYPU, Nerul Navi Mumbai]
Dr. Rahul Palshetkar.[A.P.- D.Y.Patil School of Ayurevd, Nerul, Navi Mumbai]
Course Coordinator:
Dr. Rahul Palshetkar.[ A.P.- D.Y.Patil School of Ayurevd, Nerul, Navi Mumbai]
Appedix III
Teaching Faculty
Inhouse faculty.
Dr.Vinay Pawar………………….DYP SAYU
Dr.Rahul Palshetkar……………..DYP SAYU
Dr.Sangita Sukumaran………….DYPMC
Invited faculty from other universities
Dr.Dipak Langade……………. Terna Dental College.
Dr.Girish Tillu………………..Pune Vidyapeeth
Dr.Supriya Bhalerao……………Bharti Vidyapeeth, Pune.
Dr.Rakhi Tripathi……………..GSMC-MUHS
Dr Padmaja Marathe………….GSMC-MUHS
Dr. Kannan Shridharan……….GSMC-MUHS
Dr.Sudhir Pawar………………LTMC-MUHS
Dr.Pankaj Sarkate……………..TNMC-MUHS
Dr.Renuka Munshi……………TNMC-MUHS
Invited faculty from industry:
Dr. Anant Patil…………………….Independent Clinical Research Consultant.
Mrs.Vasumati Shriganeshan………Independent Literature Search Expert.
NiNad Satam………………………Pfizer
Dr. Viraj Rajadhyaksha……………Sanoffi Aventis
Dr. Saket Ghaisas…………………..Pfizer
Dr. Abhijit Pednekar………………B.M.S.
Dr. Chitra Bargaje…………………B.M.S.
Dr.Saifuddin Kharawala…………..Independent CRA
Dr. Madhucchanda Pattanaik………Quintiles
Mr.Uday Nehte…………………….TCS
Dr.Pratima Pawse…………………. Lundbeck
Mrs. Purva Gaikar………………….Cognizant Solutions.
Sr.No. Module 1: Introduction & Ethics
1.1 Getting started in Research
1.2 Effective Literature Search
1.3 Drug development process and phases of CT
1.3 Introduction to different clinical guidelines (Schedule Y, ICMR, ICH-GCP)
1.4 Funding schemes
1.5 Ethics in clinical research
1.6 EC-constitution, roles & responsibilities, Communication with EC
1.7 Informed Consent Documentaion
Sr.No. Module 2: Methodology
2.1 Planning a protocol: an overview
2.2 Elimination of bias and study designs
2.3 Parameter selection, measurement and recording (End Point)
2.4 Clinical trials on procedures and concepts (SOPs)
2.5 B.A./B.E. Studies
2.6 CRA- Roles and responsibilities.
2.7 Monitoring- When,What, How?
Sr.No. Module 3: Pharmacovilgilance
3.1 Basics of Pharmacovigilance
3.2 Methods of Pharmacovigilance(ADR reporting,Forms,Submission,Processing)
3.3 Pharmacovigilance – Industry Pespective
3.4 Pharmacovigilance of ASU Drugs.
Sr.No. Module 4: Biostatistics
4.1 Data types, Sources and Presentation of Data
4.2 Sampling and sample size estimation
4.3 Epidemiology, Demography, vital statistics
4.4 Mesaures of location and variability
4.5 Hypothesis generation and statistical errors
4.6 Tests of significance I
4.7 Tests of significance II
Sr.No. Module 5: Clinical Data Management
5.1 CRF, CRF Tracking, Data Entry Processing
5.2 Data Validation and Discrepancy Management.
5.3 Documents in CDM
5.4 QA ; QC in CDM
Sr.No. Module 6: Herbal Drug Development
6.1 Standardization – QA; QC
6.2 Basics of Toxicology and Pharmacological Studies
6.3 Special Issues of ASU
6.4 Clinical Trials of ASU Drugs
Sr.No. Module 7: Miscellaneous
7.1 Principles of medical writing- IMRAD structure
7.2 Making a good power point presentation, figures and graphs
7.3 Drug approvals: Indian scenario, US FDA, EU
7.4 Filing patents
7.5 GCLP
7.6 Qualitative Research
7.8 Preparation for Audits and Inspections
7.9 Preparation for Interviews
Appendix V:
Examination Pattern :
The written examination is conducted after each module by the course co-ordinator. The Papers are of 50 marks including MCQs. , matching the pair, short questions and are set and checked by the lecturers invited for the topic.
Passed out candidates:
Year2011-2012     –    9
Year 2012-2013    –  19
Year 2013-2014  – 20.
Year 2014-2015 – 19
Year 2015-16  – 18