Section X:

Monitoring Activities

WPP #: X-2

Title 2:

Data and Safety Monitoring Plan Requirements

Effective Date:

05-14-14

Revision History:

06-07-04, 6-21-06

Policy Statement

All research protocols proposing to involve human subjects that may involve greater than minimal risk must contain a plan for monitoring data in order to assure the safety of participants, as outlined in 45 CFR 46.111. The principal investigator must provide thorough information regarding a data and safety monitoring plan (DSMP) or data and safety monitoring board (DSMB), as applicable.

Description and Procedures

In the case of protocols sponsored by an agency or organization that requires data and safety monitoring, the PI is required to meet the data and safety standards set forth by the sponsor. In submitting such protocols to the IRB for review and approval, it is sufficient for the PI to state that the protocol will comply with all Data and Safety monitoring requirements set forth by the sponsor. A copy of the sponsor’s Data and Safety monitoring requirements should be attached to the protocol.

The PI is required to forward any protocol revisions recommended by the sponsor to the IRB of record within 5 working days if those revisions are necessary to ensure subject safety (and otherwise report within 20 working days).

Requirement for a DSM Plan:

All research protocols that may involve more than minimal risk and for which no provision is made for data and safety monitoring by any sponsor shall include a Data and Safety Monitoring Plan prepared by the PI that is suitable for the level of risk to be faced by subjects, and the nature of the research involved. A variety of Data and Safety Monitoring Plans may be approved by the IRB of record.

Some examples of Data and Safety Monitoring Plans (DSMP) are:

  • Engaging a knowledgeable expert (who is not otherwise associated with the study) to review data on all subjects at appropriate intervals to assure that risks to subjects are and remain reasonable. Such expert may be un-blinded if that is appropriate for the safety of subjects.
  • Arranging for a statistician to assess the probability of future serious adverse events in the light of experience gained at periodic intervals in the course of the study. Such statistician may be un-blinded if that is appropriate for the safety of subjects.
  • Establishing a Data and Safety Monitoring Board with appropriate expertise to review all data related to study subjects at regular intervals appropriate to the level of risk to subjects and the design of the study. Such Board will establish “stopping rules” for the study. Data and Safety Board Members may be un-blinded if that is appropriate for the safety of subjects.
  • Other methods for monitoring the safety of subjects in the study may be submitted to and approved by the IRB of record.

The IRB of record may waive the requirement for a Data and Safety Monitoring Plan if a rationale for the waiver is provided by the PI. However, the waiver of a Data and Safety Monitoring Plan will not eliminate the need for reporting UNANTICIPATED PROBLEMS (involving risk to research subjects or others) to the VCU IRB.

If there is no DSMB, results of the PI’s ongoing DSMP must be submitted to the IRB each time that continuing review of the protocol is conducted by the IRB.

References

NIH Guidance for Data and Safety Monitoring of Clinical Trials
45 CFR 46.111 Criteria for IRB Approval of Research