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Online PG Diploma in Clinical Research

Course Objective

To provide participants in the online course in clinical research with a broad understanding of the basic principles employed within it both domestically and internationally.

Course Content

Delivered through fourteen focused modules spanning over ten months.

Module I – Introduction to Clinical Research

Module II – Basic Pharmacology and Pharmacy in Clinical Research

Module III – New Drug Development

Module IV – Ethical Guidelines in Clinical Research

Module V – Ethics in Clinical Research

Module VI – Regulations in Clinical Research

Module VII – Biostatistics in Clinical Research

Module VIII – Specialist Clinical Trials and Clinical Trial Designs

Module IX – Clinical Trial Documentation

Module X – Quality in Clinical Trials

Module XI – Clinical Data Management

Module XII – Clinical Trial Management

Module XII – Drug Safety and Pharmacovigilance

Module XIV – Soft Skills for a Clinical Research Professional

Classroom teaching by eminent faculty involving Lectures and PowerPoint Presentations.

Assignments are given to students, which include preparation of CRF’s (Case Record Forms), IC (Informed Consent Forms), PIs (Patient Information Sheets), Protocol Designing, PMS (Post Marketing Surveillance Studies) plan designing.

Exercises are given to students wherein data on Toxicology, Bioavailability, Bio-equivalence is made available to the students and inferences, graphs and calculations are drawn from the same. Exercises are also in the form of MCQs (Multiple choice questions), Q&A (questions and answers) and Report writing.

Workshops are conducted for students emphasizing on problem-solving through interaction and exchange of information. Students have access to Institute’s Computer and Internet Facilities enabling them in Data Searches and Computer-aided decision-making. Students have access to the Well-equipped library on online clinical research courses with latest books, periodicals, newspapers, Journals, prints and records are available for reading & reference.

Course timings

4 hours on every Saturday of the month

Duration of course

6 months

Eligibility

Minimum eligibility criteria for application to the online clinical data management course would be either of the following:

MBBS

BAMS

BDS

BHMS

Physiotherapy and Occupational Therapy Graduates

B.Pharm/M.Pharm

Graduates/ Post Graduates in Sciences/Life sciences/ BioSciences with any of the following subjects-Chemistry, Botany, Zoology, Biochemistry, Microbiology, Genetics and Biotech.