Details of Training:

Duration: The training is for one week (Monday through Saturday 9AM – 5 PM) at the center indicated below. 

Eligibility: Clinicians who are working in Medical Colleges/Hospitals with M.B.B.S or M.D qualification are eligible to apply.  Preference will be given to junior level faculty /clinical investigators with enthusiasm and high interest to initiate clinical research/trials.

Participants: The number of trainees will be limited to 20 / centre and TA/DA will be provided for the selected candidates by DBT. Accommodation will be arranged by the institution, which is conducting the course.

The training is likely to be initiated during August 2008. 

1. Literature Search and Review:
PubMed, Open Access; Search optimization techniques; Systematic Review and Meta-analysis. [6 hrs.]

2. ICMR Guidelines on Clinical Research [2 hrs.]

3. Overview of Medicinal Product Research and Development [2 hrs.]
Drug Discovery and Pre-Clinical Research;
The Clinical Research and New Drug Application Approval Process;
The Biologics Research, Development, and Licensing Process;
Medical Device Research, Development, and Marketing

4. Good Clinical Practice (GCP) [2 hrs.]
Investigational New Drug Application: Sponsor’s Obligations;
Investigational New Drug Application: Investigator’s Obligations;
Institutional Review Boards;
Protection of Human Subjects;
Financial Disclosure.

5. International Conference of Harmonization [2 hrs.]
The History of the International Conference of Harmonization;
The ICH Good Clinical Practice Consolidated Guideline (E6);
The ICH Clinical Safety Data Guideline (E2).

6. Clinical Trial Development [12 hrs.]
Basic clinical biostastistics;
Protocol Design and Development;
Estimation of sample size and methods.
Descriptive Data analysis methods
Inference Data analysis methods
Case Report Form Design and Development;
Principles of Data Management and the Query Resolution Process;
The Study Types Providing Expanded Access to Investigational Products.

7. Clinical Trial Management [2 hrs.]
Investigator Site Perspective: Coordinating a Clinical Trial at the Site
Essentials of Source Documentation;
Maintaining and Managing Essential Documents;
Recording and Reporting Non-Serious and Serious Adverse Events.
Sponsor’s Perspective: Managing a Clinical Trial [2 hrs.]
Selecting Investigators and Monitors;
Maintaining and Managing Essentials Documents;
Case Report Form Data Transmission and Generation of the Clinical Study Report;
Reviewing and Reporting of Serious Unexpected Adverse Drug Experiences;
Implementing a Monitoring Plan and Performing Quality.

8. Monitoring Obligations and Methods [10 hrs.]
Monitoring Role and Responsibilities According to the FDA/ICMR Guideline;
Monitoring Role and Responsibilities According to ICH Good Clinical Practice
Consolidated Guideline (E6);
Monitoring Responsibilities: Type of Monitoring Visits, Monitoring Activities Pre- Visit, On-Site, and Post Visit;
Monitoring Method: Implementing a Systematic Monitoring Approach to Effectively Monitor a Multi-Center Trial;
Problem Solving and Trouble Shooting GCP / ICH Issues;
Writing Strategic Monitoring Reports and Follow-Up.