Data & Safety Monitoring Committees in Clinical Trials

Course Content
This one day course will get you acquainted with the set-up and procedures of a Data Safety Monitoring Board (DSMB) from a pharmaceutical point of view and globally oriented. The interface between the DSMB and sponsor, the adaptation of the trial towards the use of DSMB and what is the input of data to DSMB.

Learning objectives, training objectives
To understand the work of Data Safety Monitoring Boards
To comprehend the set-up and interactions with Data Safety Monitoring Boards
To learn what data is required for Data Safety Monitoring Boards

Target Audience
Pharmaceutical physicians, pharmaceutical statisticians, regulatory affairs personnel.

Certifications
ISO9001:2008 / Q-for

Notes
All participants receive a copy of the book “Data and Safety Monitoring Committees in Clinical Research” - writer Mr. Jay Herson - publisher Chapman & Hall / CRC Biostatistics Series

Ms. Sunita Kelecom