General Policy Information

Data and Safety Monitoring Information for Grantees and Potential Applicants

Updated July 31, 2001

NIH/NCI has specific requirements for Data and Safety Monitoring (DSM) of all clinical trials supported by grant funds.

The following Web sites provide up to date information on DSM policies, procedures and guidance.

Link to the DSM policy that was originally announced in the NIH Guide to Grants and Contracts
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html

Essential elements of an adequate DSM plan
http://cancertrials.nci.nih.gov/researchers/dsm/index.html

Sample DSM Plans

Generic Data and Safety Monitoring Plan (does not require a DSM Board)
http://www.niddk.nih.gov/patient/Clinical_Trials/MonitplanwoutDSMB.pdf

Generic Monitoring Plan for Trials Requiring a DSM Board
http://www.niddk.nih.gov/patient/Clinical_Trials/genmonitoring.pdf

Generic Monitoring Plan for Trials Requiring a Safety Officer
http://www.niddk.nih.gov/patient/Clinical_Trials/genmonitoring.pdf

Compliance with all DSM policies and procedures will enable Grants Management Specialists (working with Program Directors) to award grants more quickly.

If you have specific questions regarding DSM and your grant, please contact your NCI Program Director. Thank you.