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.