1. Provide an overview of clinical research, regulatory issues and other major aspects of pharmacovigilance & clinical data management.
2. Gain in-depth knowledge on reporting, adverse events, safety data and conduct of research, data management & pharmacovigilance.
Duration (in months) :- 12 (Open and Distance Learning)
Intake :- 100
Reservation :- Not Applicable
Eligibility :- Candidate should be a graduate in life sciences or medical sciences from any recognized university/ institute.
Selection Procedure :- Based on fulfillment of eligibility norms and submission of documents.
Medium of Instruction :- English
Programme Pattern :- Annual
Course and Specialization :- As per Annexure A
Fees :- INR 46,000
Assessment :- Each course will have continuous assessment of 70 % and term end assessment of 30% of total marks except campus contact session.
Standard of Passing :- Candidate should secure at least 50% passing in continuous assessment and term end assessment separately.
Award of grade towards campus contact session be based on student's attendance to the same as below:
The student who fails to attend the campus contact session shall not be eligible for award of Diploma since this mandatory academic criterion is not fulfilled.
The Class is awarded based on the performance of the student in continuous & term end assessment.
Percentage Range | Class |
---|---|
50.00 to 54.99% | Second Class |
55.00 to 59.99% | Higher Second Class |
60.00 to 69.99% | First Class |
70% and above | First Class with Distinction |
Award of Degree/ Diploma/ Certificate :- Diploma in Pharmacovigilance & Clinical Data Management will be awarded at the end of program by taking into consideration the performance in all academic criteria.
Sample Diploma Certificate - Click Here
Annexure A :-
Course Title | Credit | Continuous Assessment | Term End Assessment | Total Marks |
---|---|---|---|---|
Generic Core Courses | ||||
Data Management Activities & Software | 6 | 105 | 45 | 150 |
Global Pharmacovigilance | 6 | 105 | 45 | 150 |
Project | 6 | 105 | 45 | 150 |
Introduction to Clinical Research | 4 | 70 | 30 | 100 |
Risk Management | 4 | 70 | 30 | 100 |
Standard Guidelines in Data Management | 4 | 70 | 30 | 100 |
Campus Contact Session | 0 | 0 | 0 | Non - Letter Grade (Mandatory) |
Total | 30 | 525 | 225 | 750 |