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.
I
Describes the role of the ISM in monitoring the safety of a study.
Guidance document that details practices to consider when conducting and documenting the informed consent process with study participants.
Provides a framework for documenting the consent discussion and process with a potential study subject. May be modified to suit the needs of the clinical research study.
Provides a checklist for quality control review of informed consent documents. Lists essential and additional elements based on guidance from the Office for Human Research Protections.
M
Provides instructions for consistent study procedure implementation and data collection across participants and clinical sites. Details the study’s organization, operations, study procedures, data management, and quality control.
Provides a recommended structure for reporting data to the Medical Monitor. Includes example text, instructions, and sample data tables.
Completed by the clinical site monitor to document dates and purposes of clinical site monitoring visits.
P
For reporting pregnancies and pregnancy outcomes to NIDCR's Clinical Research Operations and Management Support (CROMS) contractor.
May be used to document and report protocol deviations to NIDCR.
Provides item-by-item instructions for completing the Protocol Deviation Form.