Stamped consent forms will no longer be given an expiration date. The header at the top of the consent form will only reference the date the consent was approved and the context (e.g. at initial review, amendment, etc.). Going forward, consent forms will only be stamped on initial approval and if the consent is revised. Study teams are instructed to continue to use the most recently approved consent.
IRB studies Continuing/Final Review workspace now displays 'Continuing Reviews' and 'Reportable Events' tabs giving access to all of these sub-projects related to the study.
Optimization of IRB Reportable Event application completed May 27, 2015. Investigators will notice enhancements to the RE workspace that include the RE description and additional tabs for Amendments and REs for easy access to related sub-projects. Questions are updated and clarified, new document uploads added, and branching is simplified. A new notice is configured to email study team members when an RE is scheduled for a board meeting.
Optimization of IRB Continuing/Final Review application completed May 13, 2015. A major update to the CR/FR form removes some questions, clarifies others, and displays more helpful information from the approved study to assist in completion of the application. Highlights:
Status of IRB Certification of all study team members displays on first page of application.
Revised the options for Status of Research Activities including language addressing record reviews.
Added question about adverse events and serious adverse events. Provided document upload for AE/SAE log and a link to the log template.
New link to protocol deviation log template.
Added section numbers to Jump-To menu to aid navigation.
Will show approved number of records and specimens (in addition to participants) for reference.
New certification dates for human subject protection courses are established:
Courses completed before April 1, 2015 are certified for a period of two years.
Courses completed on or after April 1, 2015 are certified for a period of three years.
To align withUSF HRPP Policy on IRB Exempt Reviews, amendment creation and submission is no longer available for Certified Exempt studies.
Unveiled the Personnel Change Request (PCR) sub-project on approved IRB studies for updating study team members (other than PI). The PCR form and approval process is designed for a quick turn-around. Read the details in the Personnel Change Request Introduction.
A snapshot of the application smartform will be recorded upon approval for all projects and will be posted to the project's History tab
New activity on IRB Amendment workspace, Upload Study Team Education Certification. New study team members can now upload current proof of human subjects protection education right from the amendment workspace.
A new policy for ARC Portal passwords will go into effect on December 1, 2014. Users who login into ARC Portal with their USF NetID will not be affected by this change. Users who do not use NetID for ARC Portal access will be prompted to change their password if it is more than 180 days old.
New passwords must be at least 8 characters long and must contain at least 3 of the following 4 character groups:
Upper case letters (A-Z);
Lower case letters (a-z);
Special characters (such as !, $, #, %).
New passwords may not match any of the previous 5 passwords used.
Added the 3 year study expiration date to the approved IACUC study workspace.
IRB PIs will receive an email notice when all study team members have completed the Agree to Participate activity and the study is ready to submit.
See left side menu on this page for IRB Optimization Summary of Changes document.
Investigators with a COI Interest Inventory or COI Disclosure that is pending recommended changes will receive automatic weekly reminder emails.
Created a link to this ARC Updates page on the My Home page for Study Staff.
Extended the time frame for studies in state 15 to be returned to IACUC with changes and removed the automatic transition to the ‘Withdrawn’ state. Investigators will receive monthly reminder notices about the study for six months.
eIRB Optimization is here! Applications are being optimized to facilitate submission and review. Investigators may notice clarified questions, enhanced help text, simplified branching, and redundancies reduced.
USF NetID sign-on is now available for ARC Portal. This allows users whose ARC username matches their active NetID to access ARC via USF single sign-on.
The new IRB Exempt study application is live! The revamped Exempt smartform delivers a streamlined workflow with less required pages and elimination of redundant questions.
ARC Portal 6.0 (major platform update) provides a better look and feel across popular internet browsers, displays a more informative progress bar when processing information, and better positions the site for future enhancements.
New ‘Upload IRB Education Certificate’ activity available on Researcher Profile page – updates certification status on all studies.