Submitting a Report to the Safety Monitoring Committee (SMC)

SOP #:  PM-15

Next Review Date:  01/2015

Version #:  1.0

Interval Period:  Biennial

Approved Version #: 1.0 Date:  01/2013

Policy Reference: 

Purpose: To identify the process for submitting reports to the Safety Monitoring Committee (SMC). 
Step 1:  Determine if a protocol meets the criteria for submitting to the SMC

Criteria for determining whether protocol has to be reviewed by SMC:

The SMC will meet quarterly to review any studies that meet the requirements for SMC review. Protocols that meet the criteria for SMC review will be reviewed initially as soon as possible after their annual NCI-IRB continuing review date.   Subsequently, each protocol will be reviewed as close to annually as the quarterly meeting schedule permits or more frequently as may be required by the SMC.

The criteria for review are listed below:

The PI will receive email notification from Susan McMullen of the due date for submission of the SMC report.  Usually, notification is sent out 2 months prior to the review date. 
Note: If there is no protocol related treatment and no protocol related toxicity within the review period, then, the PI or proxy should contact Susan McMullen to let her know.

Follow the template for the SMC report.

Data to be obtained:
The following information should be collected from the research team and then complied into the SMC report:
Note: See the template below. Some requested information may not apply.

The completed report should be reviewed by the PI and then emailed to Susan McMullen by the due date.

Receipt of Approval from SMC:

Uploading Outcome letter / Approval into iRIS:

Step 2: Preparation of Report for Safety Monitoring Committee

Guidelines for Preparing NCI CCR Safety Monitoring Committee (SMC) Reports

General:  The NCI SMC requests that all communications with the Committee come through the study Principal Investigator (PI).

Format of SMC Reports

Please note:  The Harris IT team will create a customized report for each protocol once it is placed on the agenda. Susan McMullen will enter a request for the report with the IT team. It will be the responsibility of the teams to insure that their AE data is current in C3D through the date of the notification of the impending SMC review (data entry to be completed no later than 3 weeks prior to the submission due date), to review the reports for accuracy, and to include the reports with their SMC submissions.