Course Objective

To provide participants with a broad understanding of the basic principles employed within Clinical Research and pharmacovigilance 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 universities Computer and Internet Facilities enabling them in Data Searches and Computer-aided decision-making. Students have access to the Well-equipped library on Clinical Research with latest books, periodicals, newspapers, journals, prints and records are available for reading & reference.

Eligibility

Minimum eligibility criteria for application to the 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 with min 50%.

Duration

10 months