Clinical Research Study Start-up Documents |
Clinical Terms of Award |
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| NIDCR Clinical Terms of Award |
The NIDCR policy that applies to grants involving human subject research. |
Protocol Templates |
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NIDCR Clinical Trial (Interventional) Protocol Template
(Word Template - 150 KB) |
Required for developing an NIDCR-funded clinical trial protocol that utilizes an intervention (a drug, device, behavioral therapy or procedure under study). Sample and suggested text are offered in this template. |
NIDCR Clinical Trial (Interventional) Protocol Working Shell
(Word Template - 54 KB) |
Contains headers and formatting for use in writing your protocol. Refer to the Clinical Trial Protocol Template for instructions and suggested text. As appropriate, modify the suggested text for your specific protocol. |
NIDCR Clinical Study(Observational) Protocol Template
(Word Template - 112 KB) |
Recommended to be used for some Clinical Research (Observational) studies that collect biospecimens, images, and other data. May be required if the study requires additional oversight. Sample and suggested text are offered in this template. |
NIDCR Clinical Research (Observational) Protocol Working Shell
(Word Template - 48 KB) |
Contains headers and formatting for use in writing your protocol. Refer to the Clinical Research (Observational) Protocol Template for instructions and suggested text. As appropriate, modify the suggested text for your specific protocol. |
Summary of Changes for Protocol Amendments Template
(Word - 47 KB) |
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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Study Associated Documents |
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Informed Consent Checklist
(Word - 28 KB) |
Lists essential and additional elements required by the Office of Human Subject Protections; should be used to review the content of the informed consent form. |
| Version Control Guidelines |
Provides instruction on how to number draft and final documents. Version control should be used for clinical research documents, including the protocol, consent document, case report forms, and Manual of Procedures. |
Manual of Procedures (MOP) Template
(Word - 109 KB) |
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. |
Running Agenda and Meeting Minutes (RAMM) Template
(Excel - 122 KB) |
Provides a structure for managing meeting minutes and agendas within one document. |
Safety Definitions for Clinical Research
(Word - 61 KB) |
Provides definitions of important safety terminology for educational purposes. Terminology may also be used for protocol development. |
Standard Operating Procedure (SOP)
(Word - 35 KB) |
Used to develop a Standard Operating Procedure (SOP). Provides standard formatting and sample section headings that can be customized. |
Study Reports Table Template
(Word - 90 KB) |
Provides a template for organization of study-specific reports / timelines and a sample table for reference. |
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Data and Safety Monitoring |
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| 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. |
| Data and Safety Monitoring Board (DSMB) Guidelines |
Describes the roles and responsibilities of the DSMB, including its organization, meeting format, and reports. |
DSMB Charter Template
(Word - 108 KB) |
Used for clinical trials that include medical and non-medical interventions. Describes the composition, responsibilities, and communication of the committee. |
NIDCR DSMB Conflict of Interest Template
(Word - 42 KB) |
To be completed by invited, prospective DSMB members; used to identify any conflicts of interest in studies that will be reviewed by the DSMB. |
DSMB Report Template
(Word - 263 KB) |
Provides a recommended structure for reporting data to the DSMB. Includes example text, instructions, and sample data tables. |
DSMB Final Study Report Template
(Word - 52 KB) |
MS Word template to be used as a starting point for preparing the final DSMB report associated with a completed or terminated study. Includes a proposed structure, draft language, and guidance. |
| 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 Charter Template
(Word - 103 KB) |
Used for clinical studies not involving an intervention. Such studies may be complex, involve risk or vulnerable populations, and may be observational, specimen collection, epidemiology, or surveillance studies. Describes the composition, responsibilities and communication of the committee. |
CSOC Conflict of Interest Template
(Word - 43 KB) |
To be completed by invited, prospective CSOC members; used to identify any conflicts of interest in studies that will be reviewed by the CSOC. |
CSOC Report Template
(Word - 271 KB) |
Provides a recommended structure for reporting data to the CSOC. Includes example text, instructions, and sample data tables. |
CSOC Final Study Report Template
(Word - 58 KB) |
MS Word template to be used as a starting point for preparing the final CSOC report associated with a completed or terminated study. Includes a proposed structure, draft language, and guidance. |
| Independent Safety Monitor (ISM) Guidelines |
Describes the role of the ISM in monitoring the safety of a study. |
NIDCR Medical Monitor Oversight Report Template for Clinical Studies
(Word - 276 KB) |
Provides a recommended structure for reporting data to the Medical Monitor. Includes example text, instructions, and sample data tables. |
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Essential Documents/Regulatory Binder |
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Essential Documents Checklist - Clinical Research (Non-interventional)
(Word - 35 KB) |
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 Checklist - Clinical Trial (Interventional)
(Word - 37 KB) |
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
(Word - 95 KB) |
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. |
Extramural Essential Documents Binder/File Tabs (with Instructions)
(PDF - 6.137 MB) |
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
(Word - 44 KB) |
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. |
Form FDA 1572
(PDF - 897 KB) |
Link to FDA Form required for clinical studies that are regulated by FDA under an IND. |
Financial Disclosure Form
(Word - 41 KB) |
Required for any clinical study submitted to FDA under an IND or IDE. Allows clinical research staff to disclose financial interests in a product under investigation. |
Steps for Completing the Financial Disclosure Form
(Word - 29 KB) |
Instructions for completing the Financial Disclosure Form for investigators participating in an FDA regulated study. |
Regulatory Document History Log
(Word - 53 KB) |
Used to organize date and topic of correspondence between the investigator and FDA. |
Delegation of Responsibilities
(Word - 34 KB) |
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
(Word - 52 KB) |
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. |
Site Screening and Enrollment Log
(Word - 50 KB) |
Used to list subjects screened; includes those who fail screening and those who are enrolled. |
Investigational Product Accountability Log: Stock Record
(Word - 82 KB) |
Used to document all study product disposition and accountability on the site level. |
Investigational Product Accountability Log: Subject Record
(Word - 86 KB) |
To be completed by NIDCR investigators for studies using investigational product; provides a comprehensive list of product disposition on a subject/participant level. Assists in compliance with the protocol and Good Clinical Practice. |
Specimen Tracking Log
(Word - 56 KB) |
Used to track the type of clinical specimen, purpose of storage, and location of storage. Also helpful to identify if the subject consented for the sample to be retained for future research. |
Monitoring Visit Log
(Word - 49 KB) |
Completed by the clinical site monitor to document dates and purpose of clinical site monitoring visits. |
Subject Code List
(Word - 49 KB) |
Used to document the subject/participant study identification number, name, and other identifying information. Must be stored securely and separate from research records since it is the link between a study ID and subject’s name. |
Telephone Contact Form
(Word - 46 KB) |
Used to document pertinent study-related telephone conversations with regulating bodies (FDA, IRB) NIDCR, and others. Not intended to document conversations with study subjects/participants. |
Telephone Log
(Word - 54 KB) |
Used to document study-specific conversations with a study subject/participant. |
IND Applicability Checklist
(Word - 59 KB) |
Used by an investigator to help determine if the study must be submitted to FDA for an Investigational New Drug Application (IND). |
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Data Management |
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Data Management Considerations
(Word - 68 KB) |
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
(Word - 201 KB) |
Provides a customizable template for studies using an Electronic Data Capture (EDC) system. Sections may be edited or deleted as needed. |
Enrollment Report Template
(Excel - 42 KB) |
May be used to report study subject accrual and completion numbers to OCTOM. Includes definitions of study status and recruitment status terms. |
Memo of Odd Data and Errata (MODE)
(Word - 27 KB) |
Used to document data oddities and how they will be handled during statistical analysis. |
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Pharmacy/Investigational Product |
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Study Product Guidelines and Considerations
(Word - 97 KB) |
Provides considerations and best practices for receipt, storage, use, and disposition of study products used in a clinical trial. Should be reviewed for clinical trials using marketed or investigational bio-medical products. |
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Clinical Site and Study Start-up |
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Guideline: Study Start-up through Site Initiation and Activation for Extramural Studies Requiring Additional Oversight
(Word - 387 KB) |
Clarifies the Extramural study start-up process from protocol development through site initiation and activation, explicitly including studies requiring additional NIDCR oversight. |
Extramural Site Activation Checklist
(Word - 43 KB) |
Provides a list of items required prior to site activation and tracks completion of tasks. |
Site Assessment Questionnaire
(Word - 204 KB) |
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 Template
(Word - 58 KB) |
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. |
Task Distribution List
(Word - 333 KB) |
Identifies who on the clinical research team is responsible for completing or managing specific tasks. |
Clinical Monitoring Plan Template
(Word - 72 KB) |
MS Word template to be used as a starting point for preparing a Clinical Monitoring Plan. Includes proposed structure, draft language, and guidance. |
NIDCR Clinical Monitoring Guidelines
(Word - 77 KB) |
Guidance document that provides detailed descriptions of the NIDCR Clinical Monitoring processes. |
NIDCR Guidelines for Level of Clinical Site Monitoring
(Word - 38 KB) |
Overview document that describes levels of clinical site monitoring and standards for implementation. |
Start-Up Timeline Calculator
(Excel - 25 KB) |
Excel file tool that provides a framework for start-up timelines based on average durations for common components of site activation. |
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Educational Materials |
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Clinical Care vs. Research Slides
(PPT - 1.5 MB) |
Clarifies similarities and differences between clinical care and clinical research. |
Clinical Monitoring Overview
(PPT - 50 KB) |
Reviews the site clinical monitoring process, types of visits, and monitoring activities that are completed during and following these visits. |
Investigator Responsibilities and Good Clinical Practice (GCP) Slides
(PPT - 253 KB) |
Provides an overview of Investigator Responsibilities and GCP. Includes information pulled directly from ICH E6 GCP Guidance (Sections 1.24 and 6) and 45 CFR 46: Protection of Human Subjects. |
Good Documentation Practice (GDP) Overview Slides
(PPT - 48 KB) |
Provides an overview of Good Documentation Practice standards and practices. |
Clinical Research Responsibilities for NIDCR-Funded Investigators Slides
(PPT - 195 KB) |
Provides an overview of the key roles and responsibilities of investigators and staff engaged in NIDCR-funded research. Includes Human Subjects Protection, regulatory responsibilities, research planning, and documentation. |
Sponsor Responsibilities (ICH5) Slides
(PPT - 250 KB) |
Provides an overview of Sponsor Responsibilities and includes information pulled directly from ICH E6 GCP Guidance (Section 5). |
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Quality Management |
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An Introduction to Site-Level Quality Management within the Clinical Research Process
(PPT - 1.5 MB) |
Clarifies Quality Management as it relates to site-level documentation, processes, and activities. Reviews tools available to support site-level QM. |
Clinical Quality Management Plan (CQMP) Template
(Word - 62 KB) |
Used as a starting point for preparing a CQMP. Provides a proposed structure, sample language, and other guidance. |
Quality Management of Clinical Research – Brief Overview
(Word - 27 KB) |
Reviews QM term definitions and activity examples, and provides an overview of available tools and templates. |
Quality Management Annual Review Tool
(Word - 70 KB) |
Provides a structure for QM review of study-wide materials and processes to be completed on an annual basis. |
Quality Management Quarterly Review Tool
(Word - 71 KB) |
Provides a structure for QM review of study-wide materials and processes to be completed on a quarterly basis. |
Quality Management Essential Documents Review Tool
(Word - 84 KB) |
Provides a structure for the development of study and site-specific QM review of Essential Documents. |
Quality Management Subject/Participant Data Review Tool
(Word - 80 KB) |
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
(Word - 84 KB) |
Summarizes the results of site-level QM efforts and provides a framework for reporting results of QM activities. |
Consent Form (CF) Tracker Template
(Excel - 20 KB) |
Provides a mechanism to track the review and signature of approved versions of multiple consents required throughout the course of a study. |
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Documents to be Used During the Conduct of Clinical Research |
Unanticipated Problems (UP) Form
(Word - 78 KB) |
May be used to document and report unanticipated problems to the study sponsor (NIDCR) and the IRB. |
Unanticipated Problem Form Completion Instructions
(Word - 24 KB) |
Provides item-by-item instructions for completing the UP Form. |
Serious Adverse Event (SAE) Form
(PDF - 222 KB) |
For reporting NIDCR Serious Adverse Events (SAEs) to NIDCR's Clinical Research Operations and Management Support (CROMS) contract. |
Serious Adverse Event Form Completion Instructions
(Word - 50 KB) |
Provides item-by-item instructions for completing the SAE Form. |
Protocol Deviation (PD) Form
(Word - 30 KB)
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May be used to document and report protocol deviations to the study sponsor (NIDCR) and the IRB. |
Protocol Deviation Form Completion Instructions
(Word - 20 KB) |
Provides item-by-item instructions for completing the Protocol Deviation Form. |
Protocol Deviation Tracking Log
(Word - 36 KB) |
Used to record all protocol deviations that occur at a study site. |
Adverse Event Log
(Word - 111 KB) |
Provides a sample log for tracking Adverse Events that can be used as a template and modified for a specific study. |
Reportable Events Table
(Word - 82 KB) |
Provides a template for organization of study-specific safety reporting requirements and a sample table for reference. |
Notes to File template
(Word - 53 KB) |
Used by clinical site staff to document a discrepancy or problem with the conduct of the clinical research study, and plans to resolve and prevent the problem from recurring. May be used to document a Corrective and Preventive Action Plan (CAPA). |
Documenting the Consent Process
(Word - 43 KB) |
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. |
Suggestions for Consenting / Assenting
(Word - 45 KB) |
Guidance document that details practices to consider when conducting and documenting the informed consent process with study participants. |
Visit Window Calculator
(Excel - 32 KB) |
Excel file tool that provides a framework for protocol-specific visit windows on a subject level to facilitate visit compliance. |
Visit Window Calculator – Multi-subject
(Excel - 122 KB) |
Excel file tool that provides a framework for protocol-specific visit windows on a subject-level to facilitate visit compliance; tracks/projects dates for multiple subjects. |
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Clinical Research Study Completion & Close-out Documents |
Site Close-out Visit Readiness Checklist
(Word - 44 KB) |
Checklist to clarify the items required prior to scheduling a site close-out visit for an NIDCR-supported study. |
Study Close-out Checklist
(Word - 34 KB) |
Helps the investigator plan orderly closure of study documents, data, and publication. |
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Resources |
NIDCR Glossary of Clinical Research Terms
(Word - 61 KB) |
Provides definitions of important clinical research terminology for educational purposes. Terminology may also be used for protocol development. |
Good Clinical Practice (ICH E6)
(PDF - 261 KB) |
Link to the International Conference on Harmonisation (ICH) Guidance for Industry: E6 Good Clinical Practice. |