OHSU Data And Safety Monitoring Plan Guide
This document is to assist investigators with NIH requirements for Data and Safety Monitoring Plans (DSMPs) for clinical research. The document contains:
- links to agency specific guidance
- OHSU IRB approval process
- considerations for trials conducted with the OCTRI, OHSU CI or both
- links to sample study design-dependent templates
Names and contact information for the OCTRI, OHSU CI and OHSU Clinical Research Program are also provided.
Applications for grants, cooperative agreements or contracts submitted to NIH since October 2000 should include a description of a data and safety monitoring plan (DSMP) for any clinical trials to be conducted under the award. These policies can be found at the following websites:
The policy states that each NIH institute will have its own system for data and safety monitoring. These institute specific policies are being developed and issued. Please see Appendix 1for a list of institute data and safety monitoring guidance links.
HOW TO PROCESS DSMPs AT OHSUWhen an NIH agency requests a copy of the final DSMP for agency approval prior to an actual award, it must be forwarded to the IRB for review. Append the plan to the Data and Safety Monitoring Plan IRB Questionnaire. If the letter from the agency states the DSMP requires signature by a business official, forward the final IRB approved version of the plan to the OHSU Research Integrity Office (ORIO)with the IRB approval letter. The IRB will sign the plan and forward it to the agency. If the letter from the agency does not require signature of the DSMP by a business official, forward the plan directly to your NIH program officer after obtaining IRB approval of the DSMP. Questions about the NIH DSMP policy or about the IRB review of DSMPs at OHSU may be directed to the IRB.
IF YOU ARE CONDUCTING A STUDY IN THE KNIGHT CANCER INSTITUTE
For all investigator-initiated studies conducted through the Knight Cancer Institute, there are additional requirements for safety reporting to the Knight Data and Safety Monitoring Committee (DSMC) that must be included in the study's DSMP. The Knight DSMP can be downloaded from OHSU workstations at Knight DSMP for more information regarding procedures for Knight review of safety data to include in your study specific plan. For questions regarding Knight DSMP requirements, please contact:
Elizabeth A. Anderson, MPH, BSN, Director, OHSU Knight Clinical Trials Office 503-494-1028 firstname.lastname@example.org
DSMP TEMPLATESIn order to assist investigators in complying with the NIH data safety monitoring policy, the Oregon Clinical & Translational Research Institute (OCTRI) has developed guidance and sample DSMP templates for use when you have received a formal notification from NIH to submit a final DSMP. These templates are meant to guide you through the issues to think about when writing a DSMP. They incorporate standard language whenever possible, however these plans must be individualized to the specific study design and therefore cannot be completely generic. Also, be sure to refer to your funding institute via the links in Appendix1 to be sure that institute-specific requirements are incorporated into your DSMP.
GENERAL TEMPLATE INSTRUCTIONS
- There are various templates below. Select the one that most closely resembles the design of your study. The wording and organization of these templates do not represent requirements. They are merely meant to guide you through possible issues when creating a plan for your study. They must be tailored to your study and your NIH institute's requirements.
- These documents are WORD templates. They will open as an unnamed WORD document. After opening the template, save the document to your computer.
- Instructions for completing the template are indicated in gray. If the gray instructions do not appear, go to tools/options/view and click "hidden text". These instructions are set to not appear when you print the document. Should you wish to print the document with the instructions, when you print click the "options" button in the print screen and click "hidden text". Don't forget to set the "hidden text" box back to the unchecked position for final printing.
- Items bracketed by "<>" are prompts to indicate issues to be addressed and items recommended to be incorporated into the plan. The information should be added and the text and brackets deleted.
- Delete the Table of Contents and reinsert a new Table of Contents when you have completed the plan.
- Single Center Clinical Trial
- This template is tailored to clinical trials being conducted only at OHSU and that are not overseen by the FDA (i.e., are not being conducted under an IND). The regulation outlining which clinical trials must be conducted under an IND are contained in 21CFR312.2.
- Multi-Center Clinical Trial
- This template is tailored to clinical trials being conducted at OHSU and at other institutions besides OHSU and that are not overseen by the FDA (i.e., are not being conducted under an IND). The regulation outlining which clinical trials must be conducted under an IND are contained in 21CFR312.2.
- Single Center FDA Clinical Trial
- This template is tailored to clinical trials being conducted only at OHSU and that are overseen by the FDA (i.e., are being conducted under an IND). The regulation outlining which clinical trials must be conducted under an IND are contained in 21CFR312.2.This template should not be used for gene therapy studies.
- Multi-Center FDA Clinical Trial
- This template is tailored to clinical trials being conducted at OHSU and at other institutions besides OHSU and that are overseen by the FDA (i.e., are being conducted under an IND). The regulation outlining which clinical trials must be conducted under an IND are contained in 21CFR312.2.This template should not be used for gene therapy studies.
- Single Center Gene Therapy Clinical Trial
- This template is tailored to gene therapy clinical trials being conducted only at OHSU.
- Multi-Center Gene Therapy Clinical Trial
- This template is tailored to gene therapy clinical trials being conducted at OHSU and at other institutions besides OHSU.
- NCCAM: http://nccam.nih.gov/research/policies/datasafety/
- NCI: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm, http://www.nci.nih.gov/clinicaltrials/conducting/page3
- NEI: http://www.nei.nih.gov/funding/policy/
- NHLBI: http://www.nhlbi.nih.gov/funding/policies/dsmb_est.htm,
- NIA: http://www.nia.nih.gov/funding/policy/humint.htm
- NIAAA: http://www.niaaa.nih.gov/Resources/ResearchResources/
- NIAID: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf, http://www.niaid.nih.gov/ncn/clinical/decisiontrees/datasafety.htm
- NIAMS: http://www.niams.nih.gov/Funding/Clinical_Research/NIAMS_guidelines.asp
- NICHD: http://www.nichd.nih.gov/funding/policies/datasafety.cfm
- NIDA: http://www.nida.nih.gov/Funding/DSMBSOP.html
- NIDCD: http://www.nidcd.nih.gov/research/clinicaltrials/datasafety.asp
- NIDCR: http://www.nidcr.nih.gov/ClinicalTrials/ClincalTrialsProgram/GuidelinesDataSMCT.htm
- NIDDK: http://www2.niddk.nih.gov/Research/ClinicalResearch/ClinicalTrials/ClinicalResearchPoliciesHuman
- NIEHS: http://www.niehs.nih.gov/dert/clinsafe.htm
- NIMH: http://www.nimh.nih.gov/ResearchFunding/safetymonitoring.cfm
- NINDS: http://www.ninds.nih.gov/funding/ninds_patient_safety_guidelines.htm
- NINR: http://www.niaid.nih.gov/ncn/clinical/decisiontrees/datasafety.htm