Toolkit - Observational Studies


If you are an NIDCR grant applicant or awardee planning to conduct clinical research, you may need the following documents for your clinical studies.

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Clinical Terms of Award

Resources Description

Clinical Terms of Award

The NIDCR policy that applies to grants involving human subject research.


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Protocol Template

Resources Description

Clinical Study (Observational) Protocol

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.


Summary of Changes for Protocol Amendments

Used to list changes made from a previous version of a protocol or consent document; informs the IRB and other readers of the changes between final versions.


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Planning & Site Activation

Resources Description

Guideline: Study Start-up through Site Initiation and Activation for Extramural Studies Requiring Additional Oversight

Clarifies the Extramural study start-up process from protocol development through site initiation and activation, explicitly including studies requiring additional NIDCR oversight.

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 Checklist

Provides a list of items required prior to site activation and tracks completion of tasks.

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 Assessment Questionnaire

Completed in collaboration with the clinical site monitor, investigator, and clinical site staff. Used to assess the staff experience with clinical research studies, facilities, and other operational needs to perform a clinical research study.

Site Initiation Visit Agenda

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.


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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

Provides a customizable template for studies using an Electronic Data Capture (EDC) system. Sections may be edited or deleted as needed.


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Essential Documents Binder

Resources Description

Extramural Essential Documents Binder/File Tabs (with Instructions)

Provides instructions for organizing essential documents for clinical research in an Essential Documents Binder. Sometimes called an Investigator Binder or Regulatory Binder, this is retained at the investigator’s clinical site or office. Samples of documents to be filed in the Investigator Binder are included.

Extramural Essential Documents Binder/File Tabs

Used to print tabs for the Essential Documents Binder (sometimes called the Investigator Binder or Regulatory Binder), which is retained at the investigator's clinical site or office. Samples of documents to be filed in the Binder are below.

Essential Documents Checklist -Clinical Research (Non-interventional)

Guides collection of documents to be reviewed by NIDCR for activating a clinical research site planning to engage in a more-than-minimal-risk, non-interventional human research project.

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.


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Resources Description

Suggestions for Consenting / Assenting

Guidance document that details practices to consider when conducting and documenting the informed consent process with study participants.


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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)

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

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Data & Safety Monitoring (CSOC, Medical Monitor)

Resources Description

NIDCR Policy on Data and Safety Monitoring

Policy for establishing system of appropriate oversight and monitoring of the conduct of NIDCR-supported clinical research. Describes the format of oversight for different types of clinical research, including observational, specimen collection, biomedical, and behavioral intervention studies.


NIDCR Clinical Study Oversight Committee (CSOC)

Resources Description

Clinical Study Oversight Committee (CSOC) Guidelines

Describes the roles and responsibilities of the CSOC, its membership and reports, and types of studies requiring a CSOC.

CSOC Report

Provides a recommended structure for reporting data to the CSOC. 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.


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Clinical Site Monitoring

Resources Description

NIDCR Clinical Monitoring Guidelines

Guidance document that provides detailed descriptions of the NIDCR Clinical Monitoring processes.

NIDCR Guidelines for Level of Clinical Site Monitoring

Overview document that describes levels of clinical site monitoring and standards for implementation.

Clinical Monitoring Plan

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.


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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)

Used as a starting point for preparing a CQMP. Provides a proposed structure, sample language, and other guidance.



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Last Reviewed on
February 2018