The Collaborative Institutional Training Initiative (CITI) is a collaboration between the University of Miami and the Fred Hutchinson Cancer Research Center to develop a web based training program in human research subjects protections.
SOCRA has joined The Collaborative Institutional Training Program (CITI) to offer SOCRA members free entry-level basic courses in Human Subjects Research, Good Clinical Practice (GCP), Health Information Privacy and Security (HIPS), Animal Care and Use (ACU), and Responsible Conduct of Research (RCR).
First Time User: If you have not registered for a citi program before, you will need to create a new account with CITI.
Returning User: If you are a returning user, visit www.citiprogram.org and enter your CITI program username and password.
SOCRA will recognize CE for the basic course Human Subjects Research and the Good Clinical Practice (GCP) courses. Appropriate curriculum reports are required to be retained for audit purposes by SOCRA members who are recertifying for the CCRP designation. Download a quick reference chart of CITI courses for SOCRA CE here.
CITI Program's Human Subjects Research (HSR) content includes two tracks, one with a biomedical focus, and another designed for the social, behavioral, and educational disciplines, each of which covers the historical development of human subjects protections as well as current information on regulatory and ethical issues.
Offers up to 9 CE.
For more information: https://www.citiprogram.org/index.cfm?pageID=88
GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA focus) is suitable for individuals proposing to conduct clinical trials of drugs and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum.
Offers up to 6 CE.
GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) is suitable for individuals involved in clinical trials on drugs and biologics when the research may be international or where the individuals would prefer a more ICH-focused curriculum. This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
Offers up to 4 CE.
GCP for Clinical Trials with Investigational Medical Devices is most appropriate for organizations or individuals who desire a more international-focused GCP curriculum or a more device-focused program.
Offers up to 3 CE.
For more information: https://www.citiprogram.org/index.cfm?pageID=90
CITI Program's Information Privacy and Security (IPS) materials cover the principles of data protection, focusing on the healthcare-related privacy and information security requirements of the Health Insurance Portability and Accountability Act (HIPAA).
Augmented penalties, audits, and required breach notifications under the Health Information Technology for Economic and Clinical Health (HITECH) Act's amendments to HIPAA have raised the stakes for an organization's compliance. Providing appropriate training is a critical component of HIPAA compliance. It is also a critical part of quality assurance and risk reduction.
Offers up to 3 CE.
For more information: https://www.citiprogram.org/index.cfm?pageID=264
CITI Program's Responsible Conduct of Research (RCR) series includes disciplinary courses for the biomedical sciences, engineering, the humanities, the physical sciences, and the social, behavioral and education sciences. A course that is specifically tailored to research administrators is also available.
Each of the RCR course offerings covers the core norms, principles, and rules governing the practice of responsible research. RCR training is now part of funding requirements of both the National Institutes of Health (NIH) and the National Science Foundation (NSF). RCR is increasingly viewed as an essential component of research training, regardless of a researcher’s source of funding.
Offers up to 4 CE.
For more information: https://www.citiprogram.org/index.cfm?pageID=265