Two new reports are now available for PROTECT users
ID
20PT2329PT23
“All Single Patient Expanded Access Studies (NIH)”
and
“All Studies (NIH)”
Any system user can run these Custom Reports by logging into PROTECT, Clicking IRB tab > Reports tab > Custom Reports tab. Click on the name of the report you want to run. Use the filters on the report window to search for the studies you wish to yield. The report will show all of the studies that you have access to in the system.
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Change to Consent Form Stamp in PROTECT
ID
21PT2330PT23
Two important changes to consent forms and approval letters in PROTECT have been made effective 12/01/2023.
The consent form stamp in the footer will be changed from “IRB APPROVAL DATE” to “IRB EFFECTIVE DATE”.
The NIH IRB Approval letter will include the Effective Date in the table, which will correspond with the IRB Effective date in the consent form stamp.
These changes are to rectify the consent version date potentially being after the approval date when the IRB requires modifications to the consent document(s), which is not ideal for auditing and monitoring purposes.
Please note – A MOD or MODCR should NOT be submitted to get the new consent form stamp with the Effective date on it. The IRBO does not have the bandwidth for an influx of administrative MODs that do not have any substantial changes associated with them.
Should you have any questions, please reach out to the IRBO inbox at irb@od.nih.gov
