DATA SAFETY MONITORING PLANS

(Sent to C&G Representatives 5/11/01; updated 11/2/01, 2/26/02, 4/4/02 and 6/25/03)

As previously announced in a series of notices within the NIH Guide for Grants and Contracts, applications for grants, cooperative agreements or contracts submitted to NIH since October 2000 should include a description of a data safety monitoring plan (DSMP) for any clinical trials to be conducted under the award. These policies can be found at the following websites:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm

The policy states that each institute will have its own system for data and safety monitoring. These institute-specific policies are being developed and issued. Institute data and safety monitoring policies that are known at this time include:

• NCCAM: http://nccam.nih.gov/research/policies/datasafety/



• NCI: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm
  http://www.nci.nih.gov/clinical_trials/conducting/



• NEI: http://www.nei.nih.gov/funding/policy/policy6.asp



• NHLBI: http://www.nhlbi.nih.gov/funding/policies/dsmb_est.htm
  http://rover2.nhlbi.nih.gov/funding/policies/dsm-12.htm
  http://rover2.nhlbi.nih.gov/funding/policies/dataqual.htm
  http://www.nhlbi.nih.gov/funding/policies/dsmb_othr.htm



• NIA: http://www.nia.nih.gov/grantsandtraining/policies/implementationpolicies.htm



• NIAID: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf



• NIAMS: http://www.niams.nih.gov/rtac/clinical/dsmb3.html
  http://www.niams.nih.gov/rtac/funding/grants/datasafe.htm



• NICHD: http://www.nichd.nih.gov/funding/datasafety.htm



• NIDA: http://www.nida.nih.gov/Funding/DSMBSOP.html



• NIDCD: http://www.nidcd.nih.gov/research/clinicaltrials/datasafety.asp



• NIDDK: http://www.niddk.nih.gov/patient/datasafetymonitor.htm



• NIDCR: http://www.nidcr.nih.gov/ClinicalTrials/ClincalTrialsProgram/GuidelinesDataSMCT.htm



• NIDDK: http://www.niddk.nih.gov/patient/patient.htm#policy



• NIMH: http://www.nimh.nih.gov/researchfunding/safetymonitoring.cfm



• NINDS: http://www.ninds.nih.gov/funding/ninds_patient_safety_guidelines.htm
  

In order to assist investigators in complying with the NIH data safety monitoring policy, the campus has developed guidance and sample DSMP templates for campus use.

• Single Center Clinical Trial This template is tailored to clinical trials being conducted only at UCSF that are not overseen by the FDA.



• Multi-Center Clinical Trial This template is tailored to clinical trials being conducted at UCSF and at other institutions besides UCSF that are not overseen by the FDA.



• Single Center FDA Clinical Trial This template is tailed to clinical trials being conducted only at UCSF and that are overseen by the FDA.



• Multi-Center FDA Clinical Trial This template is tailored to clinical trials being conducted at UCSF and at other institutions beside UCSF that are overseen by the FDA.



• Single Center Gene Therapy Clinical Trial This template is tailed to gene therapy Clinical trials being conducted only at UCSF.



• Multi-Center Gene Therapy Clinical Trial This template is tailored to gene therapy clinical trials being conducted at UCSF and at other institutions beside UCSF.

When an NIH agency requests a copy of the final DSMP for agency approval prior to an actual award, these plans require University approval. Currently, the DSMP should be submitted to C&G for authorization before forwarding to NIH. C&G will pass the plan to the Committee on Human Research for review and approval before marking institutional approval and forwarding it on to NIH. Questions regarding preparation of the data safety monitoring plan may be directed to Lisa Voss at lisa.voss@ucsf.edu.

Additional guidance on DSMPs can be found on the GCRC website http://www.gcrc.ucsf.edu/dsmpinst.htm.