Post Graduate Diploma in Clinical Research

Overview Of The Program

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
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.
Duration Of Course

12 months

Part Time ( Saturday /Sunday 4 hrs in afternoon)

Calendar Year

July 2016-June 2017

List Of Documents
  • 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.
Subjects Covered
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
Total Fees

Rs. 70,000/-

(DD/ Cheque in favour of Dr. DY Patil College Of Ayurved ,Herbal Clinical Research)