SCRI - The Program

About the course

The course is aimed at graduates who aim to be part of the clinical Industry. The course is designed by the industry experts keeping in mind latest development and multi-fold requirements of clinical Research Industry. The course intends to provide a holistic view of the Clinical Research industry and provide insights into each element which contribute the clinical research requirements. In addition to the specifics of clinical research, the course would also prepare candidates for a career in corporate setting with focus on communication and other skills.

The course will cover all the elements of clinical research and will be blend of classroom courses ( 4 hours a day , 5 days a week for 4months) and 1 month of the job training with exposure.

Course Details:

Course highlights


Module Details

  • Introduction to drug discovery and development
  • Clinical trial terminologies
  • History of clinical research
  • Pre-clinical trials
  • Definition of clinical trial
  • Phases of clinical trials
  • Introduction to pharmacology
  • Routes of drug administration
  • Pharmacodynamics and pharmacokinetics
  • Bio-availability and bio-equivalence
  • History of clinical research guidelines
  • International Conference on Harmonization (ICH)
  • Guidelines for Good Clinical Practice
  • ICMR Guidelines for human subjects research
  • Drug and cosmetic act
  • NDCT Rules 2019
  • Ethics committee role and responsibilities
  • Informed consent documents
  • Clinical trial protocol designing and writing
  • Informed consent preparation
  • Investigator’s Brochure (IB)
  • Writing clinical trial report
  • Project management – basics
  • Project financing
  • Conducting clinical trial feasibility
  • Selection of an investigator and site
  • Clinical trial stakeholders
  • Ethics committee and regulatory submissions
  • Investigator responsibilities
  • Sponsor and monitor’s responsibilities
  • Recruitment techniques
  • Retention of clinical trial subjects
  • Essential documents
  • Investigational product – labelling and packaging
  • Documentation in clinical trial conduct
  • Safety and adverse event reporting
  • Project auditing and preparation
  • Introduction to CDM and statistics
  • CRF designing
  • Clinical data entry
  • Electronic data capture
  • Data validation
  • Clinical data coding
  • SAE reconciliation
  • External data validation and reconciliation
  • Data and tests for data analysis
  • Maintaining quality in clinical research
  • Handling audits and inspections
  • Clinical trial management system
  • Electronic Trial Master File (eTMF)
  • Communication and soft skills
  • Presentation skills
  • Developing curriculum vitae
  • Attending interviews
  • Corporate compliance

Selection criteria

Important Dates

Placement Assistance


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