CITI Program offers acceptable NIH training as well as specific training on topics of interest to NIH funded researchers. NIH policy.
Acceptable GCP Training for NIH Policy on Good Clinical Practice Training
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
- GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
- GCP - Social and Behavioral Research Best Practices for Clinical Research
- GCP FDA Refresher
- GCP ICH Refresher
- sIRB Use and Administration: When Relying on a sIRB - Explores key considerations when implementing sIRB relationships and what a participating site needs to do in preparation for relying on an external sIRB.
- sIRB Use and Administration: When Serving as a sIRB - Discusses key elements and considerations for setting up an IRB to serve as a sIRB.
- sIRB Use and Administration: Authorization Agreements - Introduces best practices for drafting, reviewing, and implementing authorization agreements between the sIRB and participating sites in multi-site research.
CITI Program content is also current with the new NIH Certificate of Confidentiality (CoC) Policy.
For help with creating a clinical trial protocol, ProtocolBuilder can help. Protocol Builder is an online protocol writing application that includes the updated NIH IND/IDE Template with the most recent changes made by the NIH and U.S. Food and Drug Administration (FDA). When both the relying and reviewing institution are CITI Program subscribers, learner coursework may be mutually recognized (depending on administrative and gradebook set-up). CITI Program Support can assist in creating new gradebooks and/or helping with mutual recognition and set-up for subscribing organizations. CITI Program training offers easy-to-use administrator options for tracking completions and developing customized gradebooks for learners.
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ReferencesHudson, Kathy L., Michael S. Lauer, and Francis S. Collins. 2016. “Toward a New Era of Trust and Transparency in Clinical Trials.” JAMA 316(13):1353-4.
National Institutes of Health (NIH). 2016a. “Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.” Accessed December 21, 2017.
National Institutes of Health (NIH). 2016b. “Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials.” Accessed December 21, 2017.