Data & Safety Monitoring Boards (DSMB) in Clinical Trials

 

Data & Safety Monitoring Boards (DSMB) in Clinical Trials

Clinical Research Related Courses

Want to know more about setting up a DSMB, their procedures and their interface with the sponsor? Follow this one-day training and get acquainted with the statistical materials needed by a DSMB, the organisation of DSMB meetings and their output

dates
location
language
  • Full description & trainer
  • Programme highlights
  • Learning objectives
  • Workshops & extras
Full description

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.

Who should attend?

Pharmaceutical physicians, pharmaceutical statisticians, regulatory affairs personnel.

Trainers
  • What is a Data Safety Monitoring Board
  • Organization of a Data Safety Monitoring Board
  • Data Safety Monitoring Board meetings and their outcomes
  • Statistical issues, bias and pitfalls
  • 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
Extra's

All participants receive a copy of the book “Data and Safety Monitoring Committees in Clinical Research” - by Mr. Jay Herson (Publisher Chapman & Hall / CRC Biostatistics Series, 2009)