Technical support, resources, tips, and answers to frequently asked questions regarding the CITI Program.

Training on the NIH's Changes to Clinical Trial Policies

To address challenges in the “design, efficiency, and reporting of clinical trials,” the National Institutes of Health (NIH) issued several new policies to “ensure rigor and efficiency” in the U.S. clinical trial enterprise (Hudson, Lauer, and Collins 2016). CITI Program can help you meet the requirements of these new clinical trial policies.
 
CITI Program offers acceptable NIH training as well as specific training on topics of interest to NIH funded researchers.


Good Clinical Practice (GCP) training

Effective 1 January 2017, NIH (2016b) clinical trials policies require that all involved in the conduct, oversight, or management of clinical trials obtain GCP training every three years. CITI Program offers GCP courses that are acceptable GCP training for the NIH policy. 

Acceptable GCP Training for NIH Policy on Good Clinical Practice Training
   

Single IRB (sIRB) Policy

Effective 25 January 2018, the NIH (2016a) final policy on the Use of a Single IRB (sIRB) for Multi-Site Research requires the use of a sIRB of record for research that is NIH-funded, multi-site (more than one site), and non-exempt human subjects research conducted in the U.S. CITI Program offers three specific modules about sIRB review and administration. The modules cover when an IRB is relying on a sIRB, when an IRB is serving as a sIRB, and the reliance agreement. They are supplemental modules offered as part of our basic Human Subjects Research (HSR) and IRB Administration courses.
 
  • 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. 
Is your institution planning on serving as an sIRB? Contact us for more information.

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. 

View HSR Catalog | View IRB Administration Catalog | Add Modules

 

References

Hudson, 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.

 

Return to January 2018 Newsletter

Last Updated: 30-Jan-2018 2:36 p.m. EST

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