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.
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.)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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® 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.
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