Observational Studies - Planning & Startup


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

Questions? Contact NIDCR-OCTOM@nidcr.nih.gov or your NIH Program Official.


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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.



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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.


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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 Template

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

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.

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.
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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) Template

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, Independent Safety Monitor)

Resources Description

Types of Additional Oversight for Observational 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 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 Template

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.

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.


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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) Template

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



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Last Reviewed
October 2021