The PSCI DSMC is the Data and Safety Monitoring Board (DSMB) of record for all interventional clinical trials that are investigator initiated and do not have an approved external DSMC. Interventional non-therapeutic trials may also be assigned to the PSCI DSMC if the study design and intervention involves additional risk to subjects. This risk assessment is initially conducted by the PSCI Protocol Review Committee (PRC) at the time the study is first presented and reviewed by the PRC.

The PSCI DSMC achieves its mandate of providing oversight for the monitoring of clinical trial participant safety in addition to the validity and integrity of study data by reviewing:

• Study progress reports
• Internal audits and monitoring reports, including corrective actions plans if applicable, quality assurance and response reviews
• Protocol deviations
• Serious adverse events (SAEs) reports
• Statistical analysis plan and sample size justifications, for the integrity and credibility of the trial and the validity of the study results

How Trials are Referred to DSMC

Upon submitting a cancer-related protocol to PSCI PRC for approval, all interventional research must have a data and safety monitoring plan commensurate with the risk of the study. The PRC will complete a review and upon approval, will assign a risk level and ensure that the DSMP is appropriate for the risk of the trial. If the trial is initiated by an investigator at Penn State Health and does not have an external DSMB, then PRC will refer the study to DSMC for data and safety monitoring.

DSMC Meetings

DSMC will monitor assigned research protocols for adverse event reporting, data and safety monitoring and internal audit findings. Frequency of reviews will be based on the risk assignment designated by PRC and the DSMC relies on the investigator to provide progress reports including study status, accrual information, adverse events and deviations, and any auditing or monitoring reports.

DSMC meets regularly on the third Tuesday of the month. For trials undergoing review, the DSMC coordinator will contact the PI and study team to request relevant documents and reports approximately 4 weeks in advance of the meeting date. The PI or designated study team member will also be invited to attend the open discussion of the study review. The committee will review the following:

• DSMC Submission Form (Make sure all Deviations, SAEs & AEs are listed)
• Current Protocol – IRB Stamped
• Current Consent – IRB Stamped
• IRB Approvals with the IRB Submission Packet-Please include Detailed Summary of Protocol Changes
• RNI Approvals with the IRB Submission packet
• IRB Modification approvals with the Modification packet
• FDA Approvals
• IND Annual Report (If available)
• Meeting Minutes (If you have routine meetings with study team)
• Monitoring Reports (From PHS, QA or other Monitors)

How does DSMC achieve its mandate to monitor data and safety?

• Routine review of cancer-related IITs in monthly meetings
• Auditing and monitoring through PSCI QA Compliance program
• Review of Serious Adverse Events and Unanticipated Problems

Example schedule for DSMC monitoring: High-risk trial

• DSMC Review: Every 3 months
• Routine Auditing: Annually
• Monitoring: As per the study-specific data safety and monitoring plan
• SAE Reporting: Continuous, as event occurs

Example schedule for DSMC monitoring: Medium-risk trial

• DSMC Review: Every 6 months
• Routine Auditing: Annually
• Monitoring: As per the study-specific data safety and monitoring plan
• SAE Reporting: Continuous, as event occurs

Example schedule for DSMC monitoring: Low-risk trial

• DSMC Review: Every 12 months
• Monitoring: As per the study-specific data safety and monitoring plan
• SAE Reporting: Continuous, as event occurs