ClinicalTrials.gov: New guidelines and the support to follow them

If you conduct clinical trials, you should know that OHSU has new guidelines for reporting clinical trials to ClinicalTrials.gov — and new resources to help you comply. The new guidance is in response to recent federal changes expanding the requirements around reporting Clinical Trials results to the website. The new guidance is effective Dec. 1, 2018.

Clinicaltrials.gov Part 2: Maintenance and results reporting
Learn how to maintain your ClinicalTrials.gov record(s) and report your study results.
Thursday, Jan. 17, 2019, noon to 1 p.m.
Mackenzie Hall, room 2201

New support for clinical researchers

John Hicks, research compliance specialist, joined OHSU in this role in June 2018. He has been working to develop guidance documents and processes to help researchers with their ClinicalTrials.gov registration, maintenance, and results reporting. The guidance document describes which studies must be reported and the responsibilities of the researcher in the reporting process. The guidance also details the new compliance assurance process.

Learning about the guidelines

John Hicks, research compliance specialist with Clinical Research Services Office

We are providing support with the guidelines in a few different ways.

  • The guidance documents are online. Please review these documents — they are clear and useful.
  • John is available. Please email John with questions — he’s available to walk you through the resources and answer your questions about the guidelines.
  • Oregon Clinical and Translational Research Insititute is hosting events to provide hands-on help to faculty and staff with the guidelines.

John and Lara Fournier, project manager at OHSU Cancer Institute Informatics, will be leading the workshops. All are welcome to attend.

Clinicaltrials.gov Part 1: Registration
NIH policy, FDA and ICMJE require clinicaltrials.gov registration. Learn how to register your study on CT.gov and maintain your registration through the duration of your study. The presenters will walk you through the registration requirements, steps for maintaining the record and will provide advice on how to avoid common registration problems. Thursday, Dec. 13, noon to 1 p.m., Mackenzie Hall, room 2201.

Clinicaltrials.gov Part 2: Maintenance and results reporting
Clinicaltrials.gov requirements don’t end at registration.  Learn how to maintain your CT.gov record(s) and report your study results per NIH and FDAAA 801 requirements. Presenters will walk you through the requirements, steps for maintaining records/reporting results and provide advice on how to avoid common problems. Thursday, Jan. 17, 2019, noon to 1 p.m., Mackenzie Hall, room 2201.

For information and guidance about ClinicalTrials.gov, please contact John Hicks and hickjo@ohsu.edu.