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NCCIH Clinical Research Toolbox Resources and Frequently Asked Questions

Web resources and frequently asked questions about the NCCIH clinical study review process.

Clinical Research Toolbox FAQs 

Independent Monitoring Resources

NCCIH Data and Safety Monitoring Board Charter Sample Document [314KB Word]This template includes a proposed structure for a DSMB report as well as draft language and other guidance.
Independent Monitoring Committee Charter Sample Document [29KB Word] This template includes a proposed structure for an IMC Charter as well as draft language and other guidance.
Individual Randomized Trial Independent Monitoring Meeting Report Form [414KB Word] This report form can be used to document progress in an Individual Randomized Clinical Study or Trial 
Group Randomized Trial Independent Monitoring Meeting Report Form [419KB Word]This report form can be used to document progress in a Group Randomized Clinical Study or Trial 
Individual Randomized Trial Accrual and Safety Updates Independent Monitoring Meeting Report Form [24KB Word]This report form can be used as a periodic update for an Individual Randomized Clinical Study or Trial 
Group Randomized Trial Group Randomized Trial Accrual and Safety Updates Independent Monitoring Meeting Report Form [25KB Word]This report form can be used as a periodic update for a Group Randomized Clinical Study or Trial
Closed Session Independent Monitoring Meeting Report Form [171KB Word]This report form can be used for the Closed Session section of an Independent Monitoring Committee meeting, for either individual or group randomized clinical study or trial 

Investigator Resources

Article on Recruitment and RetentionRecommendations from the Recruitment Innovation Center (Cook et al, June 2022 in Journal of Clinical and Translational Sciences).
FDA Clinical Investigator Training CourseLink to slides and presentations from the FDA about how to conduct IND/IDE studies.
GCP Learning CenterLink to NIAID Self-Paced Good Clinical Practice training. A pre-test allows users to skip sections over which they have mastery.
REDCapResearch Electronic Data Capture (REDCap) is an easy-to-use, freely available software tool for clinical study management and data capture.
ResearchMatchAvailable only to CTSA-affiliated sites, ResearchMatch provides a secure place for volunteers and researchers to get connected.
Public reporting burden for this collection of information is estimated to average 1 minute per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0648). Do not return the completed form to this address.