All Tools & Templates
The following is a comprehensive list of tools and templates that may be helpful for planning and conducting clinical research. For tools and templates that are tailored according to the type of study and stage of research, visit the Stages of Conducting Clinical Research.
Provides a recommended structure for reporting data to the DSMB. Includes example text, instructions, and sample data tables.
Describes the roles and responsibilities of the DSMB, including its organization, meeting format, and reports.
Provides a recommended structure for reporting data to the DSMC overseeing research conducted by NIDCR’s Division of Intramural Research. Includes example text, instructions, and sample data tables.
Provides a recommended structure for reporting data to the Data and Safety Monitoring Committee (DSMC) to be used as a starting point for preparing the final DSMC report associated with a completed or terminated study. Includes a proposed structure, draft language, and guidance.
Provides a customizable template for studies using an Electronic Data Capture (EDC) system.
Used to list all study personnel and their specific responsibilities, signatures, and dates of obligation during the conduct of a clinical research study.
May be used to report study subject accrual and completion numbers to NIDCR. Includes definitions of study status and recruitment status terms.
This checklist can be used to guide the collection of documents to be reviewed by clinical research site planning to engage in a human research project.
Provides a table to organize storage locations for study-specific essential documents. Locations are listed to indicate if they are stored in the Essential Documents Binder, filed in an alternate location, and/or stored electronically.
Describes the role of the ISM in monitoring the safety of a study.