Release Notes Version 1.7
December 8, 2008
Overview of Changes for Committee Members - Unanticipated Problem
Application Form Changes
AE/ORIO Form Changes
AE/ORIO Form Changes
- Documents uploaded in a follow-up adverse event report no longer overwrite the original documents in the original AE submission.
Amendment Form Changes/SCR Form Change
Amendment and SCR Form Changes
- The "Total as of Last SCR" is no longer being overwritten for the following SCR questions:
Letter and Notification Changes
- Studies approved for 2 years will receive a reminder notification after 9 months stating that they must submit an amendment to the IRB if they have received federal funding.
- References to use of a date stamped consent form have been removed from all exempt letters.
- Emergency Use letters have been revised to clarify FDA definitions and reporting responsibilities.
- The time (11:59 p.m.) had been added to all approval letters.
PI & Study Team Process and Workspace Changes
- A faster method for generating the printer friendly version of applications has been implemented. Other changes related to this issue include:
- Detail pages will now appear in the associated sections, rather than at the end of the application.
- The printer friendly view will now appear in the window in which it was launched. Click the close button to return to the previous window.
- A status window will indicate progress as the printer friendly version is being generated.
- On the Submit Application and Submit Amendment activities, the text in the investigator activities has been updated to read, "Notifying the IRB of any unanticipated problems, adverse events (AEs), or other reportable information or occurrences (ORIOs) in a timely manner in accordance with the terms of this approval and published IRB guidelines."
Review Committee Process and Workspace Changes
- Unanticipated Problem questions have been moved to a separate page in the Reviewer Checklist Form.
Meetings and Agendas Workspace Changes
- Meeting agendas and meeting minutes now display the primary staff owner and a list of the vulnerable subjects.
Core Staff Process and Workspace Changes
- The error message on the Approve activity now correctly references Outstanding Issues instead of Outstanding Contingencies.
Institutional Biosafety Committee (IBC)
PI/Study Team Changes:
- 2.3: new wording "Is this space shared by other faculty?"
- 6-1.1: A new column, Into which vector, and a new row, siRNA/shRNA, have been added.
- 6-1.2 : A new column, Into which vector, and a new row, siRNA/shRNA, have been added. The following text has been added,"...or siRNA/shRNA targeted at a specific gene(s)? (Please note your answer should be "yes" regardless of whether you are doing the cloning yourself or obtaining clones from elsewhere, and you should answer the following question to the best of your knowledge.)"
- 6-4.1: Question has been reworded to "Does your work involve the introduction of any foreign genes into an infectious agent other than standard E. coli K12 hosts or viral vectors?"
- 12.1 now references 12.1 instead of 3.1.
- The PI title has been added to all IBC workspaces.
- Reviewer notes functionality has been disabled.
- Document upload functionality has been added to the For IBC and Reviewers Only activity.