Office of Responsible Research Practices
The Ohio State University

CITI News

New CITI GCP Course Available for SBS Researchers

Wed, 28th June, 2017

A new Collaborative Institutional Training Initiative (CITI) course is now available for social and behavioral sciences researchers engaged in clinical trials of drugs, devices, biologics, and/or behavioral interventions.  The CITI Good Clinical Practices for Social and Behavioral Researchers course supports the NIH policy issued September 16, 2016 stating that NIH-funded investigators and staff “who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2)”. GCP principles constitute an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials.

To access CITI, log on at http://go.osu.edu/citi with your Ohio State Internet Username (last name.#) and Password. To enroll in the course, click on “Add a Course” and then check the box for “Good Clinical Practices for Social and Behavioral Researchers”.

For questions, please contact Ellen Patricia at patricia.1@osu.edu.

Category : CITI / IRB / ORRP

Human Subjects Research Newsletter (Summer 2017) now available

Thu, 1st June, 2017

The most recent edition of the “Human Subjects Research Newsletter” is now available on the Office of Responsible Research Practices (ORRP) IRB Newsletters webpage.  The new issue features information on SMART IRB, Common Rule changes, CITI training additions, event reporting guidance, and more.

Human Subjects Research Newsletter – Summer 2017

For additional information on the newsletter or any topics contained therein, please contact Ellen Patricia.

Category : Buck-IRB / CITI / IRB / ORRP

GCP and ICH CITI Training Update

Thu, 3rd November, 2016

Ohio State has added a Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) refresher course to its CITI course offering list.  Users first complete the basic course and then alternate between the refresher and basic courses every three years. The GCP and ICH CITI courses align with the new NIH policy issued on September 16, 2016 (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) stating that NIH-funded investigators and staff should be trained in GCP. This policy takes effect January 1, 2017.  The policy applies to all NIH-funded investigators and staff “who are involved in the conduct, oversight, or management of clinical trials” and states that the personnel “should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).” The basic and refresher GCP and ICH CITI courses can be accessed via the Office of Responsible Research Practices (ORRP) website.

Please contact Ellen Patricia at patricia.1@osu.edu with questions.

Category : CITI / IRB / ORRP