As of January 17th, 2018 the new NIH penalties for non-compliance with Clinicaltrials.gov registration and reporting went into effect. The potential penalties are financial, at over $11,000 per day of non-compliance, and may impact continued funding of both existing and future NIH awards.
What you need to know to achieve compliance:
Understanding the Date & Deadline requirements
When registering a study in ClinicalTrials.gov, specific dates must be provided – if the PI is uncertain about an exact date, the best anticipated date must be provided until an actual date is available. Dates cannot be left blank.
What are the dates that must be provided?
*A primary outcome measure is the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one. For more information see, ClinicalTrials.gov Outcome Measures & Statistical Analyses Module.
- In some cases the primary completion date and study completion dates are the same.
- In other cases, the primary outcome measures may be collected much earlier than the secondary. And yes, results for the primary outcome measure must be posted within 1 year of this date.
Other deadlines to remember –
- Records must be updated every 12 months.
- Records must be updated within 30 days of Recruitment Status changes or amendments that affect information in ClinicalTrials.gov record, especially recruitment status, location and contact information.
- Records must be updated within 30 days after the completion date (last data collection).
- After initial submission of registration data, the ClinicalTrials.gov Quality Assurance team may respond with queries. The PI has to respond within 15 days (yes, this includes weekends).
- After initial submission of Results, the ClinicalTrials.gov Quality Assurance team may respond with queries. The PI has to respond within 30 days.
All unmet dates and deadlines trigger errors in ClinicalTrials.gov and a status of “non-compliance” in ClinicalTrials.gov.
Questions? Please open a ticket via the ORS Research 411 Portal’s ClinicalTrials.gov Assistance form.