Question 1:
Describe the need for Harmonization in clinical trials? Brief on the Revised ICH terms of reference and explain the structure of ICH?
- Need for Harmonization in clinical trials
- Revised ICH terms of reference
- structure of ICH
Question 2:
Describe Adverse Event, Adverse Drug Reaction and Unexpected Adverse Event. Describe the reporting time frames in clinical safety data management?
- Definition of Adverse Event, Adverse Drug Reaction and Unexpected Adverse Event
- Reporting time frames in clinical safety data management.
Question 3:
Prepare a short note on MedDRA and MSSO?
- Note on MedDRA
- Note on MSSO