New Early Study Closure Confirmation Form Requirement
As of January 2, 2024, each study closure will require the completed and approved Early Study Closure Confirmation form. The Early Study Closure Confirmation form will be required for all studies, even those where no participants have been enrolled.
The Study Closure Confirmation form is required to document the Lead Protocol Organization’s (LPO) review and approval of early study closure regardless of the accrual status of the site. Approval is not guaranteed (e.g., registration trials).
- For trials with a registration intent, it is recommended you contact the LPO prior to form submission to confirm that early closure is an option.
- Studies that are terminated (i.e., FDAAA/IRB Complete) or that the LPO has determined no longer require further data submission do not require this LPO closure approval form.
- If multiple studies are being closed, a separate form should be used for each study. If the request to close the study applies to multiple sites, the additional sites should be included on the Supplemental Site List.
Once completed, save a copy of the form and submit it to the applicable LPO at the email below.
i. ALLIANCE* - email@example.com
ii. COG – firstname.lastname@example.org
iii. CCTG – CCTGStudyClosureRequest@ctg.queensu.ca
iv. ECOG-ACRIN – EAStudyClosureRequest@ecog-acrin.org
v. NRG* - regulatory-phl@NRGOncology.org
vi. SWOG – SWOGStudyClosureRequest@crab.org
ETCTN and CITN
i. Theradex – CTMS-DM@theradex.com; and
ii. LAO Leading the study (see protocol contact table); or
iii. CITN - email@example.com
i. Submit to the statistician/data manager per the protocol contact table.
If, after receiving an approved form back from the LPO, you are closing the study at all of the participating sites under your CIRB Signatory Institution, complete the Study Closure Worksheet via IRBManager.
If after receiving an approved form back from the LPO, you are closing the study at some, but not all, of the participating sites under your CIRB Signatory Institution, or if you are closing the study through your local IRB, use the Regulatory Submission Portal with the CTSU.
Please note, this new process supersedes the previous Alliance and NRG early closure processes.
Please refer to the CTSU Bimonthly Broadcast for December 22, 2023 for more information.
CIRB Operations Office