Clinical Research Study Investigator's Toolbox
Data and Safety Monitoring
As depicted in Implementation of Policies for Human Intervention Studies, NIA is responsible for overseeing the data and safety monitoring the clinical research it supports. Data and safety monitoring of a clinical trial is commensurate with the risks posed to the study participants and with the size and complexity of the study.
- Data and Safety Monitoring Plan (DSMP) Template and Guidelines (MS Word, 85K) and DSMP Checklist (MS Word, 43K) were developed to assist investigators in preparation of a sound data and safety monitoring plan. All clinical trials require study-specific monitoring procedures to ensure participant safety and data integrity. The DSMP outlines procedures that investigators and study staff will follow when implementing a clinical trial. Investigators submitting grant applications for clinical trials are required to include a general description of the DSMP as part of the research grant application.
- Sample Data and Safety Monitoring Board (DSMB) Charter (MS Word, 49K) describes the responsibilities of the DSMB to ensure ongoing, independent study review and assure the study is conducted according to the highest scientific and ethical standards.
- Guideline for Budgeting for Data and Safety Monitoring Activities (MS Word, 25K) aids investigators in budgeting for an independent DSMB or a Safety Officer when preparing the budget section of a grant application.
- DSMB Conflict of Interest and Confidentiality Statement (MS Word, 25K) - All members of the DSMB are required to be independent of the studies being reviewed and need to certify this by signing a DSMB Conflict of Interest and Confidentiality statement.
- DSMB Reports Templates are provided as a guide to facilitate the development of comprehensive reports for submission to the DSMB. The DSMB usually approves the final content and format of the reports.