Multi-Site Protocol Template Language

Data and Safety Monitoring Procedures

Instructions to customize this template for your protocol:
Where items are in [brackets] and bold complete the following:
1.  Frequency of meetings
a.  Select quarterly or monthly
b.  Delete brackets and un bold
2.  Determine if the co-investigator can sign the Data Safety Monitoring Report and Protocol Deviations
a.  If yes, delete brackets and un-bold.
b.  If no, delete the [or co-investigator].

The Data and Safety Monitoring Committee (DSMC) of The University of Michigan Comprehensive Cancer Center (UMCCC) is the DSMC for this study. This committee is responsible for monitoring the safety and data integrity of the trial.

At each site the study team is required to meet [quarterly/monthly] to discuss matters related to:

Ø  Enrollment rate relative to expectations, characteristics of participants

Ø  Safety of study participants (Serious Adverse Event & Adverse Event reporting)

Ø  Adherence to protocol (protocol deviations)

Ø  Completeness, validity and integrity of study data

Ø  Retention of study participants

These meetings are to be documented by the site data manager or study coordinator using the Protocol Specific Data and Safety Monitoring Report (DSMR), signed by the site principal investigator [or co-investigator]. Each site is required to submit the completed DSMR to the Multi-Site Coordinator at the University of Michigan Coordinating Center on a [quarterly/monthly] basis together with other pertinent documents.

Similarly, protocol deviations are to be documented using the Notice of Protocol Deviation Form and requires the signatures of both the sites data manager or study coordinator and the site principal investigator [or co-investigator]. These reports are to be sent to the University of Michigan Coordinating Center within 7 calendar days of awareness of the event and on a [quarterly/monthly] basis with the Protocol Specific Data and Safety Monitoring Report.

The Coordinating Center is responsible for collating all the Data and Safety Monitoring Reports from all the participating sites, and providing the information to the Data and Safety Monitoring Committee.

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Version Date: 01/12/2017