Planning & Activation Process

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.

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. 

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 guidance for consistent document versioning of clinical research documents (e.g., protocol, consent document, case report forms, Manual of Procedures).

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.

Excel file tool that provides a framework for start-up timelines based on average durations for common components of site activation.

Describes topics, tasks, and operations that are discussed during a site initiation meeting to ensure all staff, facilities, and procedures are in place to conduct the clinical research study.

Used to list all study personnel and their specific responsibilities, signatures, and dates of obligation during the conduct of a clinical research study.

Documents study-specific training completed by staff, exhibiting their qualifications to perform tasks involved in the clinical research study. Other training may also be listed on this log.

Identifies who on the clinical research team is responsible for completing or managing specific tasks.

Helps an investigator evaluate the data management system’s ability to capture and validate data that is collected on paper or electronically.

Provides a customizable template for studies using an Electronic Data Capture (EDC) system. 

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.

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.

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.

Used to develop a Standard Operating Procedure (SOP). Provides standard formatting and sample section headings that can be customized.

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.

Completed by the clinical site monitor to document dates and purposes of clinical site monitoring visits.

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.

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 CSOC. Includes example text, instructions, and sample data tables.

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.

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.