Available Training Modules
This training consists of seven training modules designed for certain roles on the team, including:
- Responsible Party: the person responsible for meeting the FDAAA requirements for registering a protocol, reporting the results into ClinicalTrials.gov, verifying the accuracy of a study record, and releasing the protocol to ClinicalTrials.gov. (e.g., Principal Investigator (PI) of an Investigator-Initiated Trial)
- Record Owner: the person who creates a record in ClinialTrials.gov
Modules (and summary) | Recommended for: |
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Overview: Protocol Registration and Summary Results Information Submission in ClinicalTrials.gov
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Transparency in Clinical Research: ClinicalTrials.gov in Context
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Applicable Clinical Trials (ACTs) and Responsible Party Identification and Responsibilities
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The Protocol Registration and Results System (PRS): Structure, Access, and Roles
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Protocol Registration
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Summary Results Information Submission
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ClinicalTrials.gov and Informed Consent
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How to Access CITI Training
- Log in to CITI http://go.osu.edu/citi
- Scroll down to the “Learner Tools for Ohio State University” box
- Click “Add a Course”
- Check “Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov”
- Click “Submit”
- Find the course under “Courses Ready to Begin” and select “Start Now”
- Complete the training modules