Study Conduct

Describes the roles and responsibilities of the DSMB, including its organization, meeting format, and reports.

Provides a recommended structure for reporting data to the DSMB. Includes example text, instructions, and sample data tables.

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 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 Medical Monitor. Includes example text, instructions, and sample data tables.

Describes the role of the ISM in monitoring the safety of a study.

Provides definitions of important safety terminology for educational purposes. Terminology may also be used for protocol development.

Provides a template for organization of study-specific safety reporting requirements and a sample table for reference.

Provides item-by-item instructions for completing the Serious Adverse Event (SAE) Form.

For reporting Serious Adverse Events (SAEs) to NIDCR's Clinical Research Operations and Management Support (CROMS) contractor.

Provides a sample log for tracking Adverse Events that can be used as a template and modified for a specific study.

May be used to document and report protocol deviations to NIDCR.

Provides item-by-item instructions for completing the Protocol Deviation Form.

Used to record all protocol deviations that occur at a study site. 

Provides item-by-item instructions for completing the UP Form.

For reporting Unanticipated Problems (UPs) to NIDCR's Clinical Research Operations and Management Support (CROMS) contractor.

For reporting pregnancies and pregnancy outcomes to NIDCR's Clinical Research Operations and Management Support (CROMS) contractor.

Used to list subjects screened; includes those who fail screening and those who are enrolled.

May be used to report study subject accrual and completion numbers to NIDCR. Includes definitions of study status and recruitment status terms.

Reviews QM term definitions and activity examples, and provides an overview of available tools and templates.

Provides a proposed structure, sample language, and other guidance to be used as a starting point for preparing a study specific Quality Management Plan (QMP).

Provides a structure for QM review of study-wide materials and processes to be completed on a quarterly basis.

Structure for QM review of study-wide materials and processes to be completed on an annual basis.

Structure for the development of study and site-specific QM review of Essential Documents.

Structure for QM review of subject data and associated materials. Both single subject and multiple subject formats are provided. Includes sample text.

Summarizes results of site-level QM efforts and provides a framework for reporting results of QM activities.

To clarify Quality Management as it relates to site-level documentation, processes, and activities. Secondary purpose: To clarify tools that are available to support site-level QM.