Reopen Request Form - Site
Use this form for all sites that closed in error in order to reopen a study site and resume IRB oversight and research activity. Please wait for formal correspondence from Quorum Review before conducting research activity at your site.If your site has not missed its expiration date, please submit this form. If your site’s expiration date is within the next 3 months, please also submit a Site Status Report.
If your site missed its expiration date (anniversary date) please submit this form and a new Site Information Questionnaire (SIQ). Quorum Review forms and additional information regarding Study Closure or Site Periodic Review is available at http://www.quorumreview.com / For Quorum Internal Use Only
Site Information:
Sponsor / Protocol Number
Investigator / Quorum Review Number
Site / Center Name / Phone Number
Report Date (Today’s Date) / Date of Site Closure
Description of the error
1. What events triggered site closure?
2. Please describe your corrective action plan for ensuring that these events will not occur in the future.
3. Did any study activity occur while the site was closed (e.g. subject visits, change in staff, protocol or IB revisions)?
a. *If yes, what type of activity occurred? / No *Yes
4. Were any participants consented while the site was closed?
a. *If yes, how many? / No *Yes
5. Did any Serious Adverse Events, Major Protocol Deviations, or Unanticipated Problems occur while the site was closed that have not been reported to Quorum Review? / No *Yes
(if yes, please attach)
For Quorum Internal Use Only:
Site Expiration: / Yes No / AMAP IND Model AD
Date / Rescind Yes No
Submission Options:
Electronically via
Quorum’s OnQ Portal at www.QuorumReview.com
or
By hard copy to
Quorum Review, Inc.
1601 Fifth Ave. Ste. 1000
Seattle, WA 98101
Or
By fax to:
(206) 448-4193
F-048.02, Reopen Request Form - Site, 09.07.2010 Page 1 of 1