Observational Studies - Conduct & Operations

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  1. Informed Consent
  2. Data Management
  3. Data & Safety Monitoring (CSOC, Medical Monitor, Independent Safety Monitor)
  4. Clinical Site Monitoring
  5. Safety and Problem Event Reporting (AEs, Deviations, Unanticipated Problems, & Pregnancies)
  6. Quality Management
  7. Screening & Enrollment


Overview

If you are an NIDCR awardee and are conducting an observational clinical study, the following tools and templates may be helpful. 

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

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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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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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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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Safety and Problem Event Reporting (AEs, Deviations, Unanticipated Problems, & Pregnancies)

Resources Description
Safety Definitions for Clinical Research Provides definitions of important safety terminology for educational purposes. Terminology may also be used for protocol development.
Reportable Events Table Template Provides a template for organization of study-specific safety reporting requirements and a sample table for reference.
Adverse Events
Resources Description
Serious Adverse Event Form Completion Instructions Provides item-by-item instructions for completing the SAE Form.
Serious Adverse Event (SAE) Form For reporting Serious Adverse Events (SAEs) to NIDCR's Clinical Research Operations and Management Support (CROMS) contractor.
Adverse Event Log Provides a sample log for tracking Adverse Events that can be used as a template and modified for a specific study.
Protocol Deviations
Resources Description

Protocol Deviation Form

May be used to document and report protocol deviations to the study sponsor (NIDCR) and the IRB.

Protocol Deviation Form Completion Instructions

Provides item-by-item instructions for completing the Protocol Deviation Form.

Protocol Deviation Tracking Log

Used to record all protocol deviations that occur at a study site.
Unanticipated Problems
Resources Description
Unanticipated Problem Form Completion Instructions Provides item-by-item instructions for completing the UP Form.
Unanticipated Problems (UP) Form For reporting Unanticipated Problems (UPs) to NIDCR's Clinical Research Operations and Management Support (CROMS) contractor.

Pregnancy
Resources Description
Pregnancy Notification Form For reporting pregnancies to NIDCR's Clinical Research Operations and Management Support (CROMS) contractor.
Pregnancy Outcome Form For reporting pregnancy outcomes to NIDCR's Clinical Research Operations and Management Support (CROMS) contractor.

 

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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.
Quality Management Quarterly Review Tool Provides a structure for QM review of study-wide materials and processes to be completed on a quarterly basis.
Quality Management Annual Review Tool Provides a structure for QM review of study-wide materials and processes to be completed on an annual basis.
Quality Management Essential Documents Review Tool Provides a structure for the development of study and site-specific QM review of Essential Documents.
Quality Management Subject/Participant Data Review Tool Provides structure for QM review of subject data and associated materials. Both single subject and multiple subject formats are provided. Sample text is included that should be customized for study-specific needs.
Quality Management Summary Report Template Summarizes the results of site-level QM efforts and provides a framework for reporting results of QM activities.

 

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Screening & Enrollment

Resources Description
Site Screening and Enrollment Log Used to list subjects screened; includes those who fail screening and those who are enrolled.
Enrollment Report Template May be used to report study subject accrual and completion numbers to NIDCR. Includes definitions of study status and recruitment status terms.

 

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Last Reviewed
November 2021