iStar Version 6.8 | 10/4/2024- Form Changes
Added guidance to Section 1.5 for clinical trial guidance.
(DEV00002226) 
Study Personnel Question "2.4 Does your study include specific aims or endpoints that relate to cancer risk factors . . ." will now be required on all CHLA studies. The study team will not be able to advance to the next section unless the question is answered.
(DEV00002044) - Add "Promotional Activities" attestation/question to section 39 of iStar that triggers COI review (DEV00002093)
- Added new section 50c.2.9.1 for CHLA. Answering "Yes" will route study to ACCM ROC for divisional review.
(DEV00002075)
- CHLA Ceded applications has newly added question 1.8 requesting information regarding FDA association.
(DEV00002189)
- Changes for Committee / Staff
- Update the CIC contact information contained in section 2.4 of the iStar application.
(DEV00002269)
- iStar reminder notification for the chair to review overall minutes for a meeting now contains a link to the meeting minutes that require review.
(DEV00001552)
- Added checklist of study documents to send to Scientific Reviewers assigned to the study
(DEV00002261)
- Added a new activity called "Send Request for Scientific Review Assessment" which will allow Scientific Review Coordinators to request the Chair's determination on whether a protocol requires scientific review from USC.
(DEV00002258)
- Enhancements
- Add USC Arcadia Hospital as option in USC sites and provide mechanism for review. This allows any ancillary that has been selected to review to review and get email.
(DEV00002294)
- Subinvestigators who have left USC can now be administratively removed from all studies by the iStar Help Desk.
(DEV00002215)
The monthly hospital reports show new studies approved in the prior month. However, if there were no new studies, the user may click the report link and log into the system, only to find that the report contains no data which wastes the administrator's time. The system-generated letter will now include language indicating that there were no new studies in the previous month, and in such cases, it will no longer include a link to the report.
(DEV00002329) - Enhancements were made to the ROB Review activity, including new sections for comments and attachments on the activity form. Additionally, a checkbox was added, allowing the user to choose to send an email to the study team once the activity is completed.
(DEV00002293)
- IRB Analysts can now send unassigned studies that are in the IRB cart for Scientific Review. Once the CTSI has completed their review, the study will get returned back to the IRB queue and the state will revert back to Awaiting IRB Administrator Assignment.
(DEV00001611)
- Multiple reviewers can now be assigned for Expedited-Exempt Reviews.
(DEV00001274)
- The "Send PI Assurances Instructions" activity is now available whenever the PI is changed in the IRB submission process.
(DEV00002214)
- Added Study Information section to Assign Scientific Reviewers activity
(DEV00002260)
- Scientific Reviewers can now send messages to investigators from the study page in iStar.
(DEV00002259)
- Added a new activity called Feasibility Review which can be executed by Scientific Review Coordinators.
(DEV00002173)
- Scientific Review Coordinator can now send messages and attachments to scientific reviewers within iStar.
(DEV00002263)
- Bug Fixes
- Fixed an issue where committee review comments were visible to study teams on reportable events. These are now visible only to IRB staff.
(DEV00002273)
- For approval letters, the header/footer is now easily editable by the RTS staff. Additionally, CHLA studies will now always use the CHLA footer.
(DEV00002257)
- The CR summary section for enrollment numbers now reflects the correct numbers in all project states.
(DEV00002265)
- Users are no longer able to submit NHSRs outside of the main IRB application.
(DEV00002312)
- Fixed an issue preventing Study Smartform views from saving (Validation Failed: Object doesn't support this property or method).
(DEV00002240)
- Corrected issue where Amendments may display the "MCA Required" flag after being cleared. Additionally, when using the "Agreement or MCA Review" function on Amendments, the "Changes Required" text will only appear red when "Clear to Proceed" is not true.
(DEV00002241)
- Section 10 now only errors when the sum of target accruals for all multi-sites exceed the projected total target subject accrual.
(DEV00002352)
- Approval letters will now use hrpp@usc.edu instead of irb@usc.edu.
(DEV00002249)
- The links to the instructions for completing the HIPAA authorization form have been updated. These links are contained in the summary area and underneath the Documents tab on the study workspace.
(DEV00002355)
- Determination letters now output funding agency name instead of "n/a" and will output Cayuse imported award information if KC information is unavailable.
(DEV00002250)
- The IRB of Record now correctly displays in question 1.3 of reportable events for ceded review studies.
(DEV00002317)
- Fixed an issue where the change history of protocol documents on ceded reviews (section D1.2) was not tracking correctly.
(DEV00002285)
- The "MCA Required" flag will no longer appear on studies that were reviewed prior to the separation of MCA Review from Contract Review.
(DEV00002252)
- Properties Removed from Internal IRB Email Message Template (DEV00002233)
- Misc
- Locations Enhancements (DEV00002357)
- Section 2a now references 45d instead of 6d in guidance text.
(DEV00002251)
- Fix amendment approval notifications for HUD applications (DEV00002307)
- Fix Ancillary access for USC/CHLA when location is added to 45d (DEV00002366)
- Close Studies and send custom letter (DEV00002325)
- Study Approval Activity error: studyLocations is null or not an object (DEV00002266)
- Ensured that scientific review coordinator can send the collated review to the chair to confirm. The chair can then either approve or send it back for changes.
(DEV00002262)
- Form Changes
- Protocol Section 5 for COI is updated to be consistent with IRB Studies. Submit Protocol and Agree to Participate activities also have been updated to ask the Possible Conflict of Interest questions.
(DEV00001294)
- Species Section 14 for Radiation Materials now automatically pulls RUA information from the RSC system if there is only RUA selected.
(DEV00002349)
- For new protocols and 3rd year renewals, IACUC applications must link only 1 unique RUA in Section 4.3 on protocol and/or Section 14.1 on species subform.
(DEV00002054)
- Changes for Committee / Staff
- DMR Summary Emails now also emails Ex-Officios members
(DEV00002309)
- Mentors can now be added to NCRs to provide communication with the IACUC.
(DEV00000850)
- Enhancements
- When suspending IACUC protocols, IACUC coordinators can select USC research deans to notify.
(DEV00002306)
- Bug Fixes
- IACUC Staff does not see Internal Notes/Docs section in User Profile (DEV00002234)
- Removing project personnel will remove them from both parent project and amendment authorized submitter sets.
(DEV00002338)
- AE Assign to Sub Committee Agenda Item Type dropdown blank (DEV00002274)
- Updated Footers for Email Templates in the system.
(DEV00002275)
- Fixed an internal server error on the Non-Compliance Report summary page.
(DEV00002235)
- Misc
- Update Monitoring Notices contact information (DEV00002335)
- Form Changes
- Updated Section 7 Link for NIH Guidelines Section III to the current version.
(DEV00002369)
- 1.10.1 Language updated to include reference to pathogens.
(DEV00002271)
- New Section 3.7 regarding "Other Delivery Vectors" added.
(DEV00001797)
- Language change to Section 1.14. For USC, Section 1.12.1 and 1.12.2 removed (added as Section 16.2.1). For USC, Section 1.15. removed.
(DEV00002295)
- Section 2.10 now has distinct options differentiating solid and liquid chemical waste.
(DEV00001766)
- 1.13. language update to indicate HGT clinical trials for USC.
(DEV00001897)
- Changes for Committee / Staff
- The motion of disapproving a BUA in committee member review shows up as red text in the history log.
(DEV00002323)
- IBC Staff can now take ownership of BUAs in any state other than Approved, Approval Withheld, Archived, Expired, Withdrawn, or Pre Submission.
(DEV00002256)
- Modify CHLA iStar generated Agenda (DEV00001648)
- Enhancements
- The validation to enforce either 1.10.1 or 1.10.3 to be "yes" now exists on the page instead of being checked upon submission of the BUA.
(DEV00002270)
- Two new sections were added to the Generate Lab Inspection Report activity for BUAs which show rDNA data and Live Animal data.
(DEV00002300)
- Bug Fixes
- Section 1.10.1 should now all be answered “Yes” if there previously was any entries in Section 13.1.
(DEV00002305)
- "Forward to Admin Review" activity not available in "Staff Review of Changes" state (DEV00002287)
- Misc
- IBC Master Protocol Log Report Request (DEV00002315)
- Form Changes
- New question added to HD1. Radiation Producing Devices that automatically calculates how many research-related administrations there are. If less than 1, users must revise their answers.
(DEV00001423)
- Enforce unique linking between RUA and IACUC protocol.
(DEV00002350)
- Changes for Committee / Staff
- Enhancements
- Added ability to create a copy of an RUA that can be modified to submit for review for the RSC
(DEV00002264)
- Users can now only add 1 IACUC protocol to Section 1.5. The title and PI from the selected IACUC protocol will populate section 1.2 and 2.1 of the RSC application, respectively.
(DEV00000565)
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