Guidance

AHRQ: Mandatory Use of Data Safety and Monitoring Plans

IRBMED
Jun 17, 2011 1:30 pm

The Agency for Healthcare Research and Quality (AHRQ) has issued notice requiring Data Safety and Monitoring Plans (DSMPs) for certain AHRQ-conducted or -supported projects. As of May 6, 2011, the inclusion of DSMPs will be considered pa of conditions for new grant or contract awards.  

Note: This requirement for a DSMP is not applicable to projects that are either exempt under DHHS regulations or not-regulated under FDA regulations.

Effective: May 6, 2011

  • DATA SAFETY AND MONITORING PLAN

    A DSMP is a general plan that outlines how participant safety and data integrity will be monitored.  The goal of a DSMP is to ensure the safety of subjects and the validity of any collected data.  A DSMP submitted as part of an AHRQ application should address the following:

    • The potential for harm (as either a direct result of the proposed intervention or as an indirect result of withholding the intervention);
    • That the risks associated with participating in the research have been minimized;
    • That the method and degree of monitoring is commensurate with the degree of risk;
    • That the method and degree of monitoring is commensurate with the risk of harm to subjects;
    • How often the project will be assessed for performance, safety, and/or effectiveness;
    • Who will perform the monitoring activities, including details about appointment and membership;
    • The composition and independence of the monitoring entity;
    • Procedures for monitoring study progress, including how monitoring will occur and for responding to recommendations;
    • How protocol compliance will be assured;
    • The frequency, content and distribution of meeting reports;
    • Unanticipated problems, adverse events, and reporting forms;
    • The type of data or events to be captured under the DSMP.
  • MONITORING OPTIONS

    Monitoring entities must include expertise in relevant scientific disciplines in order to interpret the data and ensure the safety of participants.  Examples of monitoring options include:

    • A Data Safety and Monitoring Board (DSMB);
    • The principal investigator and institution;
    • An independent individual or safety office;
    • A designated medical monitor;
    • An internal data monitoring committee.
  • SUBMISSION

    Under AHRQ policy, proposed DSMPs must be submitted as part of the grant or contract application.  For grant applications, the DSMP needs to be included under “Research Strategy”; for contract applications, the DSMP needs to be included under “Technical Approach.”

    Additionally, the DSMP must be reviewed and approved by IRBMED before the accrual of subjects.

    Note: If modifications are made to a DSMP before a study begins, a final monitoring plan must be submitted to IRBMED, the IRB of record (if applicable), and to AHRQ

  • ADDITIONAL INFORMATION

    For the official AHRQ Notice, see: http://grants.nih.gov/grants/guide/notice-files/NOT-HS-11-015.html 

     

    Approved by the IRBMED Chairs and Director on 6-13-2011

    Updated on Website on 6-17-2011

     

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: mhayward@umich.edu
Last Updated: May 23, 2018 8:00 AM