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.
This is a general checklist to guide Extramural investigators and study teams on action items that are typically completed prior to study/site activation and recruitment of research participants.
Provides a sample log for tracking Adverse Events that can be used as a template and modified for a specific study.
Guidance document that provides detailed descriptions of the NIDCR Clinical Monitoring processes.
Includes proposed structure, draft language, and guidance to be used as a starting point for preparing a Clinical Monitoring Plan.
Provides a recommended structure for reporting data to the Clinical Study Oversight Committee (CSOC) to be used as a starting point for preparing the final CSOC report associated with a completed or terminated study. Includes a proposed structure, draft language, and guidance.
Provides a recommended structure for reporting data to the CSOC. Includes example text, instructions, and sample data tables.
Describes the roles and responsibilities of the CSOC, its membership and reports, and types of studies requiring a CSOC.
Provides a recommended structure for reporting data to the Data and Safety Monitoring Board (DSMB), to be used as a starting point for preparing the final DSMB report associated with a completed or terminated study. Includes a proposed structure, draft language, and guidance.
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.