NCCIH Clinical Research Toolbox

An NIH staff member gowes over a form with someone.

The NCCIH Clinical Research Toolbox provides a Web-based information repository for investigators and staff involved in NCCIH-funded clinical research. The Toolbox contains templates, sample forms, and information materials to assist clinical investigators in the development and conduct of high-quality clinical research studies.

Clinical Research Start Up

Protocol Template

NCCIH requires that study investigators submit a final protocol document for all funded clinical projects. The protocol must be submitted to the NCCIH Program Director prior to study implementation. (Note: If the clinical study is being conducted at an institution that has a Clinical and Translational Science Award (CTSA), study investigators may be required to generate a protocol specified by their CTSA.)

NCCIH Protocol Template [80KB Word file]: Recommended for developing an NCCIH-funded clinical study protocol.

Case Report Forms

Clinical studies use a series of case report forms to collect data in a consistent manner. The forms below are commonly used in clinical studies and can be customized to meet the needs of the specific clinical study. Investigators may need to create additional forms to capture all data elements required in the clinical study.

Adverse Event Forms[24KB Word file]: Sample form to record participant-specific adverse events. It should be modified to match the protocol and DSMP.
Demographics[33KB Word file]: Sample form to record participant’s demographic information. May be modified to meet individual study needs.
Documentation of Informed Consent[1MB Word file]: Provides a framework for documenting the consent discussion and process with a potential study participant. May be modified to suit the needs of the clinical research study.
Inclusion/Exclusion Criteria [34KB Word file]: Sample checklist that is used to ensure that participants meet eligibility criteria. Must be modified to meet individual study needs.
Medical History (a)[36KB Word file]: Checklist form that may to record participant’s medical history. May be modified to meet individual study needs.
Medical History (b)[37KB Word file]: Narrative form used to record participant’s medical history. May be modified to meet individual study needs.
Physical Exam[42KB Word file]: Sample form used to record participant’s physical exam findings. May be modified to meet individual study needs.
Prior and Concomitant Medications [24KB Word file]: Sample form to record participant’s medication usage. May be modified to meet individual study needs.
Randomization and Enrollment [36KB Word file]: Sample form to record that a participant was randomized. May be modified to meet individual study needs. Note: this form is not intended to capture randomization assignment.
Serious Adverse Events Form [1MB Word file]: Sample form to record a serious adverse event. May be modified to meet individual study needs or IRB requirements.
Study Completion[33KB Word file]: Sample form to record participant’s study status. May be modified to meet individual study needs.
Baseline Visit Checklist[32KB Word file]: Checklist which may be used to ensure that all assessments scheduled to be done at the baseline visit have been completed. Must be modified to meet individual study needs.
On Study Visit Checklist[35KB Word file]: Checklist which may be used to ensure that all assessments scheduled to be done at on-study visits have been completed. Must be modified to meet individual study needs.
Vital Signs [34KB Word file]: Sample form to record participant vital sign information. May be modified to meet individual study needs.

Protocol Associated Documents

Guidelines for Developing a Manual of Operations and Procedures (MOP)[170KB Word file]: 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.
Version Control Guidelines [543KB PDF]: 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.
Protocol Amendment Summary of Changes Template [1MB Word file]: Supports the documentation of changes from one institutional review board (IRB)-approved version of a protocol to the next.
Informed Consent Checklist [35KB Word file]: This document presents required and additional elements of the consent form as set forth in the Code of Federal Regulations.
Informed Consent Template [69KB Word file]: This document provides a general outline of a study-specific informed consent document. It is essential that investigators consult with their local institutional review board (IRB) for any institution-specific templates and/or requirements pertaining to the format and content of the consent document.

Data and Safety Monitoring

NCCIH is responsible for overseeing the data and safety monitoring (DSM) of the clinical research it supports and has developed guidelines to assist grant applicants in developing DSM plans, in accordance with NIH requirements. The purpose of the DSM plan is to ensure the safety of participants in clinical studies and the security/integrity of collected data.

Data and Safety Monitoring Plan (DSMP) Independent Monitoring[133KB Word file]: Provides a recommended structure for a data and safety monitoring plan. Includes example text, instruction, and sample data tables, as well as a report template.
Independent Monitoring Committee (IMC) Report Template [314KB Word template]: This template includes a proposed structure for a IMC report as well as draft language and other guidance.
Independent Monitoring Committee (IMC) Charter Template [121KB Word template]: This template includes a proposed structure for a IMC Charter as well as draft language and other guidance.
NCCIH Policy on Data and Safety Monitoring: Policy for establishing system of appropriate oversight and monitoring of the conduct of NCCIH-supported clinical research.
NIH Policy and Guidance: NIH policies and IC guidance for data and safety monitoring of clinical trials.

Essential Documents/Regulatory Binder

Several essential documents must be organized and retained for clinical studies. These organized documents are referred to as the Regulatory Binder (or Investigator Binder), which is retained at the Investigator’s clinical site.

Regulatory Binder Checklist [1.1MB Word file]: Provides an at-a-glance reference for including essential documents for clinical research in a Regulatory Binder.
Essential Regulatory Documents Guidance and Binder Tabs[4.5MB Word file]: Provides instructions for organizing essential documents for clinical research in a 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.
FDA Document History Log [1MB Word file]: Used to organize date and topic of correspondence between the investigator and FDA.
Delegation of Authority Log [1.1MB Word file]: 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 [1MB Word file]: 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[1MB Word file]: Used to list subjects screened; includes those who fail screening and those who are enrolled.
Specimen Tracking Log[1MB Word file]: 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.
Unanticipated Problem (UP) Form [1MB Word file]: Sample form to record any unanticipated problems that occur during the study. May be modified to meet individual study needs or IRB requirements.
Protocol Deviation Tracking Log [1MB Word file]: Used to record all protocol deviations that occur at a study site.
Monitoring Visit Log[1MB Word file]: Completed by the clinical site monitor to document dates and purpose of clinical site monitoring visits.
NCCIH Document History Log [1MB Word file]: Used to organize date and topic of correspondence between the investigator and NCCIH.

Pharmacy/Investigational Product

Investigational Product Accountability Log: Stock Record [1MB Word file]: Used to document all study product disposition and accountability on the site level.
Investigational Product Accountability Log: Subject Record[1MB Word file]: May be completed by NCCIH investigators for studies using an investigational product; provides a comprehensive list of product disposition on a subject/participant level. Assists in compliance with the protocol and Good Clinical Practice.
Study Product Guidelines and Considerations [37KBWord file]: This document is intended to guide research teams on important considerations and best practices regarding receipt, storage, use, and disposition of study product during a study to assure smooth study conduct, valid study product handling, and compliance with applicable regulations and guidelines. These best practices apply to all clinical research, whether or not the research falls under IND regulations or other regulatory regimes.

Quality Management

GCP Learning Center: Link to NIAID Self-Paced Good Clinical Practice training. A pre-test allows users to skip sections over which they have mastery.
Quality Management Study-wide Review Tool[1.1MB Word file]: Provides structure for quality management review of study-wide materials and processes. Sample text is included that should be customized for study-specific needs.
Quality Management Subject Review Tool[1.1MB Word file]: Provides structure for quality management review of subject data and associated materials. Both single subject and multiple subject formats are provided. Sample text is included that may be customized for study-specific needs.

Additional Tools/Resources

NCCIH Policy on Natural Product Integrity: Provides information and a link to NCCIH Policy on Natural Product Integrity.
Device Information: If the clinical study uses a medical device as part of the intervention that is not legally marketed in the United States, the investigators must contact the FDA for determination as to whether an Investigational Device Exemption (IDE) application will be needed for the study.
PROMIS: PROMIS® stands for Patient-Reported Outcomes Measurement Information System, which is a system of highly reliable, precise measures of patient–reported health status for physical, mental, and social well–being.
REDCap: Research Electronic Data Capture (REDCap) is an easy-to-use, freely available software tool for clinical study management and data capture.

Documents Used During the Conduct of Clinical Research

Unanticipated Problem (UP) Form [1MB Word file]: May be used to document and report unanticipated problems to the study sponsor (NCCIH) and the IRB.
Note to File Template[29KB Word file]: Used by clinical site staff to document a discrepancy or problem with the conduct of the clinical research study, and plans to resolve the problem and prevent it from recurring.
Site Screening and Enrollment Log[1MB Word file]: Used to list subjects screened; includes those who fail screening and those who are enrolled.
NCCIH Policy on Protocol Amendments: Provides clinical investigators with guidance on what protocol amendments require approval by NCCIH prior to their implementation.

NCCIH Clinical Terms of Award

NCCIH Clinical Terms of Award for Human Subjects Research: The NCCIH policy that applies to grants involving human subject research.
Guidance for Compliance With the NCCIH Clinical Terms of Award: Provides guidance on how to comply with the NCCIH Clinical Terms of Award.

On-Site Monitoring Program

Describes the NCCIH site monitoring process and different types of site monitoring visits.

Site Initiation Checklist[20KB Word file]: Provides an overview of what will be reviewed by monitors during an NCCIH Site Initiation Visit (SIV).
Frequently Asked Questions About NCCIH Initiation Visits
Interim Site Visit Checklist [19KB Word file]: Provides an overview of what will be reviewed by monitors during an NCCIH Interim Site Visit (IMV).
Frequently Asked Questions About NCCIH Interim Visits
Closeout Site Visit Checklist [20KB Word file]: Provides an overview of what will be reviewed by monitors during an NCCIH Closeout Site Visit (CSV).
Frequently Asked Questions About NCCIH Closeout Visits

Additional Training and Recruitment Resources

GCP Learning Center: Link to NIAID Self-Paced Good Clinical Practice training. A pre-test allows users to skip sections over which they have mastery.
AccrualNet: Advice and training on patient recruitment. It is sponsored by NCI but is applicable to all studies.
FDA Clinical Investigator Training Course: Link to slides and presentations from the FDA about how to conduct IND/IDE studies.
ResearchMatch: Available only to CTSA-affiliated sites, ResearchMatch provides a secure place for volunteers and researchers to get connected.
REDCap: Research Electronic Data Capture (REDCap) is an easy-to-use, freely available software tool for clinical study management and data capture.