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.
P
Used to record all protocol deviations that occur at a study site.
Behavioral and social sciences research involves the systematic study of behavioral and social phenomena relevant to health. This template is a suggested format for clinical trials testing a behavioral or social intervention or experimental manipulation. Use of this template is optional.
Provides a recommended structure for developing an NIDCR-funded protocol that utilizes an intervention (a drug, device, behavioral therapy, or procedure under study). Sample and suggested text are offered in this template.
Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications can use an NIH-FDA template with instructional and sample text to help write protocols. Use of this template is optional.
Provides a recommended structure for developing an NIDCR-funded protocol for an observational study that collects biospecimens, images, and other data. Sample and suggested text are offered in this template.
Q
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.
Reviews QM term definitions and activity examples, and provides an overview of available tools and templates.
Provides a structure for QM review of study-wide materials and processes to be completed on a quarterly basis.
Structure for QM review of subject data and associated materials. Both single subject and multiple subject formats are provided. Includes sample text.