IRB

Good Clinical Practices and ICH (GCP)

Training Requirements

CITI
To access the CITI Courses in the Protection of Human Research Subjects, visit the site at: www.citiprogram.org

Investigators and key personnel who participate in the design, conduct, or reporting of research involving human subjects at OSU must complete training in human subjects protection. The CITI Basic and Refresher Courses in The Protection of Human Research Subjects are used to meet this requirement. Sponsors or funding agencies may also require researchers who conduct clinical research to demonstrate knowledge of good clinical practices. The CITI Good Clinical Practice and ICH (GCP) Course can be used to meet this requirement. The CITI Basic Course is a prerequisite for taking the GCP Course. Formal GCP training for clinical investigators is not currently required by the University.

CITI GCP Course

The following topics are presented:

GCP Introduction
Overview of New Drug Development
International Conference on Harmonization
FDA Regulated Research and Conference on Harmonization
Conducting Investigator-Initiated Studies According to FDA Regulations and Good Clinical Practices
Investigator Obligations in FDA-Regulated Clinical Research
Managing Investigational Agents According to GCP Requirements
Conducting Clinical Trials of Medical Devices
Informed Consent
Detection and Evaluation of Adverse Events
Reporting Serious Adverse Events
Monitoring of Clinical Trials by Industry Sponsors
Audits and Inspections in Clinical Trial
Completing the CITI GCP Course

Each module includes an introduction, topic-specific content, references and resources, and quiz questions. Review of the required materials and completion of the quizzes will take about 15-20 minutes per topic. You do not have to complete the course all in one session. A minimum aggregate score of 80% is required to pass the GCP Course.

Note: The GCP Course may not be used to satisfy OSU requirements for training in human research subjects protection.

Registration and Course Completion

To access the CITI Courses, registration of a username and password on the CITI website is required. The username and password you choose will not be shared with anyone at OSU. See www.citiprogram.org for instructions. To retrieve a lost username and/or password, select the Forgot Username or Password link on the CITI homepage to have it sent to you by email.

You will be asked to choose the course and enroll in a Learner Group that is compatible with your interests and training requirements. The program will automatically select the modules you are required to complete. Follow the instructions and links on the Learner’s Menu to begin the course you selected. Use the “Add a course or update your Learner Group” link on the Learner’s Menu to select or change groups. For step-by-step instructions on how to choose a course and enroll in a Learner Group for the GCP Course, click here.

To view your course completion history and obtain a completion certificate, follow the link to the CITI Course Completion Report.

Print and retain a copy for your records.

Continuing Medical Education (CME or CEU)

Continuing education credits for physicians, physician's assistants, nurses, psychologists and other health care providers are available through the University of Miami Miller School of Medicine Division of Continuing Medical Education. Four AMA PRA Category 1 credits can be obtained by completing the Good Clinical Practice and ICH Course. See www.citiprogram.org for more information.

Questions or Assistance

Tani Prestage, Education Administrator
Office of Responsible Research Practices
Third Floor, Research Foundation Building
Phone: 614-292-0214
Fax: 614-688-0366
Email: prestage.2@osu.edu

Technical support is available at the CITI Help Desk at citisupport@med.miami.edu or 305-243-7970 (8am-5pm Eastern).

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