NIH | National Cancer Institute | NCI Wiki  

WIKI MAINTENANCE NOTICE

Please be advised that NCI Wiki will be will be undergoing maintenance on Monday, June 24th between 1000 ET and 1100 ET.
Wiki will remain available, but users may experience screen refreshes or HTTP 502 errors during the maintenance period. If you encounter these errors, wait 1-2 minutes, then refresh your page.

If you have any questions or concerns, please contact the CBIIT Atlassian Management Team.

Error rendering macro 'rw-search'

null

Versions Compared

Old Version 12

changes.mady.by.user Frost, Ruth (NIH/NCI) [C]

Saved on

compared with

New Version 13

changes.mady.by.user Frost, Ruth (NIH/NCI) [C]

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: Moved statements up into the table.

...

FactorDescription
Who can amend a trial?Only the trial owner. A trial may have more than one owner. To request ownership of a trial, contact your Site Administrator. (If you are a Site Administrator, refer to Managing Trial Ownership.)
What types of trials can be amended?Only National, Externally Peer-Reviewed, and Institutional trials that have been registered with the CTRP previously. For information, refer to CTRP Trial Categories, Study Sources.
At which trial processing statuses can a trial be amended?Only trials that have reached the Abstraction Verified Response or Abstraction Verified No Response processing status. For information, refer to Trial Processing Statuses. The CTRO reviews and abstracts amended trial data just as it does with original submissions.
At which trial statuses can a trial be amended?Only trials that have reached the In Review or Approved trial status. You can not amend trials in the Complete, Administratively Complete, Withdrawn, or Terminated statuses. For information, refer to Trial Status Values in the CTRP and ClinicalTrials.gov.
Which parts of a trial record can be amended?

Any part except:

  • NCI trial identifier number
  • NIH grant number
  • IND/IDE serial number

The CTRO reviews and abstracts amended trial data just as it does with original submissions.

...

titleThe ability to amend a trial is restricted by its trial status

...

Most of the information, including documentation, that is required for original submissions is also required in amendments. To ensure that these requirements are met, you can review, edit, and print your amended data using the Registration features prior to submission.

...