Research Responsibilities and Compliance

ClinicalTrials.gov Training

The Clinical and Translational Science Institute (CTSI) offers a training resource to all researchers.

The ClinicalTrials.gov (CT.gov) training is now available to all study team members and principal investigators for Investigator-Initiated trials, conducting clinical trials to help identify and understand their responsibilities for:

  • CT.gov clinical trial registration
  • results reporting
  • required CT.gov updates

For more information contact ctsi-regulation@osumc.edu. 

On This Page

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
CITI training modules
Modules (and summary)Recommended for:

Overview: Protocol Registration and Summary Results Information Submission in ClinicalTrials.gov

  • Brief overview of CT.gov and the training course structure.
  • Record Owner
  • Responsible Party

Transparency in Clinical Research: ClinicalTrials.gov in Context

  • Reviews why CT.gov was created, what data must be captured, and who monitors CT.gov compliance.
  • Record Owner
  • Responsible Party

Applicable Clinical Trials (ACTs) and Responsible Party Identification and Responsibilities

  • Reviews which trials must be registered, determination of responsible party, required updates, study results reporting, timelines, estimated workload efforts, and deadlines.
  • Record Owner
  • Responsible Party

The Protocol Registration and Results System (PRS): Structure, Access, and Roles

  • Reviews the two different interfaces of CT.gov, how to access the CT.gov PRS system, its workflows, and the data entry roles.
  • Record Owner
  • Responsible Party

Protocol Registration

  • Provides very detailed information for registering a protocol in CT.gov-PRS.
  • Record Owner

Summary Results Information Submission

  • Provides very detailed information for entering study results in CT.gov-PRS.
  • Record Owner

ClinicalTrials.gov and Informed Consent

  • Reviews the requirement for uploading a consent form and the required language the consent must contain.
  • Record Owner
  • Responsible Party

 

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