Release Notes Version 2.9.1
Release Date: November 26, 2012
The following changes apply to Study Teams:
- Section 1-2 (Standard Study Information): New question (1-2.8) identifies whether research results should be "blinded" from study subjects per study design.
- Remember: the implementation of the UMHS patient portal (i.e. electronic medical records) will "unblind" results unless this question is answered "Yes."
- This question conditionally appears in the application if IRBMED is selected in question 1.9.
For an updated list of all HUM application questions, see the eResearch Questions spreadsheet.
Amendment fixes applied:
- When you change the PI on a study via an amendment, the conflict of interest (COI) data for the new PI now appears. You no longer need to manually remove the information for the previous PI.
- For consistency with other submission types, and to avoid confusion, the modified HUM number has been removed from the top right corner in section 45 (End of Application) when editing the study with an amendment.
Adverse Event/ORIO change:
- Section 01-5 (RDRC/SHUR Adverse Events or ORIOs): Two new questions indicate if the Adverse Event (AE) occurred due to use of a radiopharmaceutical in the study and if the administration of the radiopharmaceutical resulted in a "medical event" as defined by NRC regulations.
These questions display for AE/ORIO types of:
- UM Serious Adverse Event
- UM Non Serious Adverse Event
- Protocol Deviation
- Notification of audit/inspection/inquiry
Note: Section 01-5 only appears if RDRC/SHUR approved the parent application, as a result of answering "Yes" to question 7-2.2 and either question 21-1.2 or 21-1.3.
IBC Registration changes:
- Section 3 (Research Goals) has two new questions (3.4 and 3.4.1) to identify if the research is performed with synthetic nucleic acids and to enter a description of the experiments associated with the research. These questions were added to comply with NIH regulations.
- In the following sections/questions, the question text updated to improve clarity and provide additional directions to help you complete the question correctly.
- Section 5 (Use of Animals)
- Section 8 (Adenovirus) - question 8.7
- Section 9 (Retrovirus/Lentivirus) - question 9.8 (includes a link to the Lentiviral Vectors: a Biosafety Primer resource on the ORSP web site)
- Section 10 (Adeno-Associated Virus) - question 10.7
- Section 11 (Baculovirus) - question 11.5
- Section 12 (Biosafety Levels): Reminder text and instructions to schedule an OSEH inspection of laboratory space (depending on biosafety level requirements) have been added to assist you in the IBC Registration approval process.
The following changes apply to Core Staff & Core Committees:
Activities available: Core IRB staff can now execute the Project Hold and Lift Project Hold activities. Previously these activities were limited to the "Core Staff Super Admins."
- All submission types:
- eRRM will now check PEERRS certification information each time the Submit activity is performed.
- The submission state now appropriately changes to Core Committee Staff Contingency Review and the "Submitted - Edited Contingency Review" activity is recorded in the History tab when a secondary reviewer complete the activity. These system actions are now consistent for both the primary and secondary reviewer.
- Application: The "Time Tracker" is now reset when the Correct Required Core Committees activity is used to display the time information accurately for the new committee(s).
- Amendment: the issue of an amendment with a recorded change of review Committee being incorrectly routed to the original committee when the study team submits requested changes to the Core Staff.
The following changes apply to Ancillary Committees:
- RDRC/SHUR: To reduce the number of AE/ORIO email notifications, RDRC/SHUR will only recieve notifications when section 01-5 is required in the adverse event.
See the Adverse Event/ORIO change item in the Study Team section for question details.
- Fixes applied:
- Going forward, when the application state transitions from Changes Required by Core Staff to Ancillary Committee Review only those applicable Ancillary Committees that have not yet reviewed the application will receive the system notification.
- A coding change was made to ensure that all people listed in Ancillary Notification set receive the system-generated email upon approval of the submission type (e.g., application).