AHRQ: Mandatory Use of Data Safety and Monitoring Plans

 

Effective: May 6, 2011

NOTICE

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.  

A Data Safety and Monitoring Plan (DSMP) is required for any project:

  • That is either AHRQ-conducted or -supported;
  • Involves interventions with human subjects; and
  • Presents greater than minimal risk to the subjects. 

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

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

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