Data and Safety Monitoring
A criterion for IRB approval is that “when appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.” Monitoring, an ongoing process of overseeing the progress of a study, is an element for determining whether study activities are being carried out as planned and whether there are any unexpected safety concerns. When appropriate, a Data and Safety Monitoring Plan (DSMP) should be developed, and monitoring results should be reported to the IRB on an ongoing basis, as detailed below.
Data and Safety Monitoring Plan (DSMP)
A Data and Safety Monitoring Plan (DSMP) should be risk based with a focus on safety and scientific integrity. Monitoring enables study teams to identify and correct any deficiencies in the conduct of the study, record keeping, or reporting. It also helps to ensure the safety of participants.
When is a DSMP required?
Greater than Minimal Risk Research
Research that is greater than minimal risk should have a DSMP designed based on complexity and risk of the protocol. Review the Data and Safety Monitoring Plan Guidance below for details on what a DSMP should entail.
Minimal Risk Research
Research that is minimal risk usually does not require a DSMP, with most exceptions falling under expedited category 1 or research requiring GCP compliance (minimal risk clinical trials). For all minimal risk research, there should be clear methods to protect confidentiality and privacy as well as subject safety that are commensurate with the risk.
Principal Investigator Compliance Assessment (PICA)
Penn Medicine study teams conducting greater than minimal risk biomedical research who do not have a sponsor appointed study monitor for quality control of site activities are expected to complete the Principal Investigator Compliance Assessment (PICA). The IRB may also require study teams from other schools to complete this form on a case-by-case basis.
The PICA for the prior year’s activity should be completed within 90 days prior to the IRB approval expiration date and filed in the study team’s regulatory binder.
The continuing review process prompts the study team to provide confirmation that the PICA is filed in the regulatory binder and has been sent to the Penn Medicine Office of Research Compliance for review.
The PICA form should be submitted directly to the Office of Clinical Research. Do not submit completed PICA forms to the IRB.
Data and Safety Monitoring Boards
A DSMB is an independent committee set up specifically to monitor data throughout the duration of a study to determine if continuation of the study is scientifically and ethically appropriate. A Data and Safety Monitoring Board / Committee (DSMB/C) is one component of a DSMP. A DSMB is not always required. For more information, please review the DSMP guidance above.
Submitting DSMB/ DSMC Reports to the IRB
DSMB Reports should be submitted promptly upon study team receipt, via a modification submission in HSERA. It is important that the study team submit the DSMB reports to the IRB in a timely manner so that the IRB may assess the appropriateness of study continuation. Any reports not submitted in real time should be provided with the annual request for continuing approval. However, failure to submit in real time will be raised to the Investigator’s attention in their annual continuing approval letter and may require additional follow-up.
Recommendations for Continuation without Changes
The IRB expects these reports to be submitted in a timely manner via a modification submission in HSERA as noted above.
Recommendations that Require Response or Action
Reports that contain recommendations from the DSMB that require response or action from the study team or sponsor should be submitted in real-time. These reports must be accompanied by a response to any issues noted in the report. These reports can sometimes constitute a reportable event.