Post Graduate Diploma in Clinical Research
Overview Of The Program
- 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.
- 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
- 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
Part Time ( Saturday /Sunday 4 hrs in afternoon)
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.
|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)|
|1.5||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)|
|2.6||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|
|7.8||Preparation for Audits and Inspections|
|7.9||Preparation for Interviews|
(DD/ Cheque in favour of Dr. DY Patil College Of Ayurved ,Herbal Clinical Research)