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
1.1Getting started in Research
1.2Effective Literature Search
1.3Drug development process and phases of CT
1.3Introduction to different clinical guidelines (Schedule Y, ICMR, ICH-GCP)
1.4Funding schemes
1.5Ethics in clinical research
1.6EC-constitution, roles & responsibilities, Communication with EC
1.7Informed Consent Documentaion
Sr.No.Module 2: Methodology
2.1Planning a protocol: an overview
2.2Elimination of bias and study designs
2.3Parameter selection, measurement and recording (End Point)
2.4Clinical trials on procedures and concepts (SOPs)
2.5B.A./B.E. Studies
2.6CRA- Roles and responsibilities.
2.7Monitoring- When,What, How?
Sr.No.Module 3: Pharmacovilgilance
3.1Basics of Pharmacovigilance
3.2Methods of Pharmacovigilance(ADR reporting,Forms,Submission,Processing)
3.3Pharmacovigilance – Industry Pespective
3.4Pharmacovigilance of ASU Drugs.
Sr.No.Module 4: Biostatistics
4.1Data types, Sources and Presentation of Data
4.2Sampling and sample size estimation
4.3Epidemiology, Demography, vital statistics
4.4Mesaures of location and variability
4.5Hypothesis generation and statistical errors
4.6Tests of significance I
4.7Tests of significance II
Sr.No.Module 5: Clinical Data Management
5.1CRF, CRF Tracking, Data Entry Processing
5.2Data Validation and Discrepancy Management.
5.3Documents in CDM
5.4QA ; QC in CDM
Sr.No.Module 6: Herbal Drug Development
6.1Standardization – QA; QC
6.2Basics of Toxicology and Pharmacological Studies
6.3Special Issues of ASU
6.4Clinical Trials of ASU Drugs
Sr.No.Module 7: Miscellaneous
7.1Principles of medical writing- IMRAD structure
7.2Making a good power point presentation, figures and graphs
7.3Drug approvals: Indian scenario, US FDA, EU
7.4Filing patents
7.5GCLP
7.6Qualitative Research
7.8Preparation for Audits and Inspections
7.9Preparation for Interviews
Total Fees

Rs. 70,000/-

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