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Clinical Trial Registration Data Elements

Data Element

Deadline for Updating
(i.e., not later than the specified date)

Study Start Date 

30 calendar days after the first subject is enrolled (if the first human subject was not enrolled at the time of registration).

Intervention Name(s)

30 calendar days after a nonproprietary name is established.

Availability of Expanded Access

30 calendar days after expanded access becomes available (if available after registration); and 30 calendar days after an NCT number is assigned to a newly created expanded access record. [1]

Expanded Access Status

30 calendar days after a change in the availability of expanded access.

Expanded Access Type

30 calendar days after a change in the type(s) of available expanded access.

Overall Recruitment Status

30 calendar days after a change in overall recruitment status. [2]

Individual Site Status

30 calendar days after a change in status of any individual site.

Human Subjects Protection Review Board Status

30 calendar days after a change in status.

Primary Completion Date

30 calendar days after the clinical trial reaches its actual primary completion date.

Enrollment

At the time the primary completion date is changed to "actual," the actual number of participants enrolled must be submitted.

Study Completion Date

30 calendar days after the clinical trial reaches its actual study completion date.

Responsible Party, by Official Title

30 calendar days after a change in the responsible party or the official title of the responsible party.

Responsible Party Contact Information

30 calendar days after a change in the responsible party or the contact information for the responsible party.

Device Product Not Approved or Cleared by U.S. FDA

15 calendar days after a change in approval or clearance status has occurred.

Device Product Not Approved or Cleared by U.S. FDA

15 calendar days after a change in approval or clearance status has occurred.

Record Verification Date

Any time the responsible party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time.

[1] If expanded access to an investigational drug product becomes available after a clinical trial of that drug product has been registered and an expanded access record has not yet been created, a responsible party who is both the manufacturer of the investigational product and the sponsor of the applicable clinical trial must also, not later than 30 calendar days after expanded access becomes available, submit the data elements in accordance with 42 CFR 11.28(c) to create an expanded access record.

[2] If Overall Recruitment Status is changed to "suspended," "terminated," or "withdrawn," the Why Study Stopped data element must be submitted at the time the update is made.