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