What are the primary and study completion dates?
The primary and study completion dates are the dates that the final participant was examined or received intervention for the purposes of final data collection for the primary and secondary outcome measures, respectively.
Why is the completion date different from the IRB closure date?
Completion dates refer to participant enrollment and study visits.
CTgov does not take data analysis into account for completion dates.
CTgov does not take IRB closure date into account.
When will my study become non-compliant?
A study becomes non-compliant when the record is not updated and posted within 30 days of the start date or completion date on CTgov;
If a study is not updated at least every 12 months;
If results are not posted within one year of completion dates.
How do I add study contacts to study records?
Study contacts can be added by submitting a ticket. CTgov permits the listing of up to 2 central contacts and 2 contacts per site.
Can Co-Pis be added?
There are no restrictions on the number of study officials (Study Chair, Director, or PI) that can be listed.
PIs can only be listed as PI or sub-PI for each site/location. There is no co-PI option.
Where can I request updates for my study?
Study updates can be requested by submitting a ticket.
What are the consequences of a study falling out of compliance?
Non-compliance studies are escalated to the Dept Chair and to the Dean’s office.
Possibility of losing current or future funding for NIH studies for the institution.
Monetary penalties to be paid by the department.
How can I interpret the status of a clinical trial (e.g., "Recruiting," "Completed," "Terminated") and what do these statuses mean?
Overall recruitment status information can be found under “study status” in the definitions section of the CTgov site here.
How can I create a ClinicalTrials.gov account?
The ORS team creates a CTgov account for Principal Investigators upon study submission.
Who is the Responsible Party (RP)?
The RP is the PI:
Responsible for conducting the study;
Has access to and control over the data from the study;
Has the right to publish the results of the study;
And has the ability to meet all of the requirements for submitting and updating clinical study information.
Who can release the record for the Principal Investigator (PI) or lead researcher of a clinical trial?
Only the Responsible Party (e.g., Principal Investigator) can release the record.
Can I set Mount Sinai as the sponsor for a clinical trial?
During registration, there are 2 choices for sponsor, Principal Investigator or Sponsor-Investigator (when PI holds the IND). On the public record. It will show the record is listed under Sinai’s account.