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Interventional Studies - Planning & Startup

On this page

Clinical Terms of Award

Protocol Template

Planning & Site Activation

Data Management

Essential Documents Binder

Informed Consent

Manual of Operations

Data & Safety Monitoring (DSMB, Medical Monitor, Independent Safety Monitor)

Clinical Site Monitoring

Quality Management

Overview

If you are an NIDCR grant applicant or awardee planning to conduct an interventional study, you may need the following documents. Questions? Contact NIDCR-OCTOM@nidcr.nih.gov or your NIH Program Official.

Clinical Terms of Award

Resources	Description
Clinical Terms of Award	The NIDCR policy that applies to grants involving human subject research.

Protocol Template

Resources	Description
Interventional Protocol 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.
NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template	Applicants conducting phase 2 or 3 clinical trials that require 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. This is a link to an NIH Clinical Trials webpage with access to this protocol template.

Planning & Site Activation

Resources	Description
Version Control Guidance	Provides guidance for consistent document versioning of clinical research documents (e.g., protocol, consent document, case report forms, Manual of Procedures).
Extramural Site Activation Reference List	Provides a list of items required prior to site activation.
Start-Up Timeline Calculator	Excel file tool that provides a framework for start-up timelines based on average durations for common components of site activation.
Site Initiation Visit Agenda Template	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.
Delegation of Responsibilities	Used to list all study personnel and their specific responsibilities, signatures, and dates of obligation during the conduct of a clinical research study.
Training Log	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.
Task Distribution List	Identifies who on the clinical research team is responsible for completing or managing specific tasks.

Data Management

Resources	Description
Data Management Considerations	Helps an investigator evaluate the data management system’s ability to capture and validate data that is collected on paper or electronically.
Clinical Data Management Plan Template	Provides a customizable template for studies using an Electronic Data Capture (EDC) system. Sections may be edited or deleted as needed.

Essential Documents Binder

Resources	Description
Essential Documents Checklist - Clinical Trial (Interventional)	Guides collection of documents to be reviewed by NIDCR for activating a clinical research site planning to engage in an interventional human research project (whether IND-regulated or not).
Essential Documents Storage Location Table Template	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.

Resources	Description
Suggestions for Consenting / Assenting	Guidance document that details practices to consider when conducting and documenting the informed consent process with study participants.
Documenting the Consent Process	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.
Informed Consent Document Review Checklist for NIDCR-Supported Research	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.

Manual of Operations

Resources	Description
Manual of Procedures (MOP) Template	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.
Standard Operating Procedure (SOP) Template	Used to develop a Standard Operating Procedure (SOP). Provides standard formatting and sample section headings that can be customized.

Data & Safety Monitoring (DSMB, Medical Monitor, Independent Safety Monitor)

Resources	Description
Types of Additional Oversight for Interventional Studies	NIDCR has established the following oversight mechanisms to ensure the safety of participants, the validity and integrity of the data, the appropriate conduct of the study, and the availability of data in a timely manner. As listed below, the level of oversight assigned to each study varies, depending on the risk to human subjects and the complexity of the study. This oversight is advisory to NIDCR and described in the NIDCR Clinical Terms of Award.

NIDCR Data and Safety Monitoring Board (DSMB)

Resources	Description
Data and Safety Monitoring Board (DSMB) Guidelines	Describes the roles and responsibilities of the DSMB, including its organization, meeting format, and reports.
DSMB Report Template	Provides a recommended structure for reporting data to the DSMB. Includes example text, instructions, and sample data tables.

NIDCR Medical Monitor

Resources	Description
NIDCR Medical Monitor Oversight Report Template for Clinical Studies	Provides a recommended structure for reporting data to the Medical Monitor. Includes example text, instructions, and sample data tables.

NIDCR Independent Safety Monitor

Resources	Description
Independent Safety Monitor (ISM) Guidelines	Describes the role of the ISM in monitoring the safety of a study.

Clinical Site Monitoring

Resources	Description
NIDCR Clinical Monitoring Guidelines	Guidance document that provides detailed descriptions of the NIDCR Clinical Monitoring processes.
Clinical Monitoring Plan Template	MS Word template to be used as a starting point for preparing a Clinical Monitoring Plan. Includes proposed structure, draft language, and guidance.
Monitoring Visit Log	Completed by the clinical site monitor to document dates and purpose of clinical site monitoring visits.

Quality Management

Resources	Description
Quality Management of Clinical Research – Brief Overview	Reviews QM term definitions and activity examples, and provides an overview of available tools and templates.
Clinical Quality Management Plan (CQMP) Template	Used as a starting point for preparing a CQMP. Provides a proposed structure, sample language, and other guidance.

Last Reviewed
August 2024