PG Diploma in Clinical Research provides the learner an understanding on drug development process, ethical guidelines governing clinical trials in different countries and various procedures involved in conducting clinical trials through well-designed modules. This program also imparts knowledge and skills in conducting clinical trials by maintaining appropriate quality assurance and quality control.

This program is designed to provide foundation knowledge in conducting various clinical trials. At completion of this program, it is expected that the learner will be able to (know, do and appreciate):

• Drug development process
• Phases, types and designs of different clinical trials
• Ethical guidelines in conducting clinical trials and challenges in implementing ethical guidelines
• Regulatory requirements for conducting clinical trials in different countries
• Quality control and quality assurance in the conduct of clinical trial
• Clinical trial startup activities and various process involved in conducting clinical trials
• Responsibilities of various stakeholders in clinical trial
• Preparation of Essential documents required to conduct clinical trial

Structure of Program:

There are 2 theory courses and a practical/ Clinical research Experiential Training

• Course I: Clinical development and regulation (50 Hours)
• Course II: Clinical Research (50 hours)
• Practical: Experiential Training in Clinical Research (100 Hours)

Examinations:

Two internal exams in every course is scheduled periodically and forms the basis for formative assessment (Max. Marks – 50).

One annual examination for every course at the end of the academic year that will be the summative assessment (Max. Marks – 50).

The examinations will have a written as well as a practical (including viva voce) component.

Combined scores of formative and summative assessments will be stated in the marks card.