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 Retention | Recommendations from the Recruitment Innovation Center (Cook et al, June 2022 in Journal of Clinical and Translational Sciences). |
| FDA Clinical Investigator Training Course | Link to slides and presentations from the FDA about how to conduct IND/IDE studies. |
| 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. |
| REDCap | Research Electronic Data Capture (REDCap) is an easy-to-use, freely available software tool for clinical study management and data capture. |
| ResearchMatch | Available only to CTSA-affiliated sites, ResearchMatch provides a secure place for volunteers and researchers to get connected. |