Journal Provides Practical Advice for Data Safety Monitoring in Research Involving Human Subjects

Pilot project to encourage managed care plans and their beneficiaries to contribute medical research funds
    • July 1, 2006

Staff at the American Federation for Medical Research, Washington, developed and published a supplement to the November 2004 Journal of Investigative Medicine (Vol. 52, No. 7) that provides practical advice about developing data and safety monitoring plans for research involving human subjects.

Key Results

The articles include:

  • "Considerations in Developing Data and Safety Monitoring Plans: A Framework." This introduction to the series of articles summarizes four principles of data and safety monitoring plans:

    • All clinical trials require monitoring.
    • The method and degree of monitoring should be commensurate with the level of risk involved in the research.
    • The method and degree of monitoring should be commensurate with the size and complexity of the trial.
    • The risk associated with trial participation should be minimized to the extent practical.
  • "Monitoring Participant Safety in Phase I and II Interventional Trials: Options and Controversies."

  • "Forming Your Phase III Trial's Data and Safety Monitoring Board: A Perspective on Safety."

  • "Evaluating and Implementing Data and Safety Monitoring Plans."

  • "Role of Research Subject Advocates in the Development of Data Safety and Monitoring Plans."