Abstract moved to first page of the form, question 1.4, from page 11. Further, the text of the question has been slightly modified for clarity and to encourage brevity.
Waiver of HIPAA authorization and partial waiver of HIPAA authorization have been split into two seperate detail pages.
22d.1. the question has been altered to "Describe how you will communicate with non-English participants" and now has checkboxes for common answers. An "other" option is available for plans that differ from the options available.
22e.1. The justification for involving minors now has checkboxes for common reasonable answers to the question. "Other" is also available to explain further or for cases that do not fit the other options.
Page 28a, Incidental Findings, will now show up for studies that indicate MRIs at HSC. Previously, this page was limited to UPC and CHLA.
The Facilitated and Collaborative review forms have been updated to use the current form pages of the main study application. This both keeps these forms up to date and makes the absolute numbering more consistent between submission types.
The text appearing after 13.1 (Decedents) has been altered for clarity.
Dept /Div Reviews:
For studies, every time the PI / study staff submit the study back to the IRB (e.g. Submit Response to Contingencies, etc.) it will now check to see if any further departments or divisions need to sign off and will first go to them for pre-review before coming back to the IRB.
On Amendments, changes made indicating new dept / div review (e.g. a new co-investigator from a department that has not previously signed off on the study) will send the amendment to pre-review. Following sign off of the Amendment by the dept / div, it will come to the IRB.
Continuing Review Form:
A question asking whether the funding indicated on the study is current was added.
The question on participant complaints has been replaced by an instruction to submit any complaints in iStar as a new type of reportable Event -"Participant or Other Complaint".
Reportable Events:
There is a new Reportable Event type, "Participant or Other Complaint" that allows the complaints made about a study to be tracked in iStar. Previously, this all was done outside of iStar or as a text box on the continuing review form where the investigator is asked to summarize any complaints. Complaints submittted to the IRB can also be initiated by the IRB Director.
The Serious Adverse Event form now supports CTCAE 4 in addition to CTCAE 3.
Study Approval and Expiration dates can be altered on the Approval action for studies. Further, a new question asking whether the study is clear to proceed is asked. This serves two purposes:
(1) HSC and UPC are now following the updated OHRP and FDA guidance that allows for the study's "Effective Approval Date" to be the date that the study can begin (all contingencies met, contract executed, etc.). This means that studies found to be approvable by the full committee but awaiting contract finalization will be approved for a year following the completion of the contract or contingencies. Previously, the date the committee found the study approvable was the approval date, and the time that it took to be able to start was lost to the study.
(2) There is now an easier way to indicate that while the study has been found approvable by the IRB, it cannot yet start. Typically, this occurs when the contract is not yet executed.
The approval documents that get set on the Approval letter can now be seen and updated by the IRB administrator prior to sending the approval letter. This allows for minor changes made to documents since the committee decision to be reflected in the documents that get sent with the approval letter.
NHSR Submit button: On the last page of the Not Human Subjects Review form there is a "submit" button that models what we have done on other last pages of forms in iStar.
Staff Verified Contingencies: The full committee or designated reviewer can now indicate that the study, amendment or continuing reviewunder review can be approved by staff verifiable contingencies, which indicates that the changes are minor and need not return to the board or committee member for verification.
Studies that are approved under the Flexibility policy as Exempt will retain their complete formset and the type of review will show up as "Exempt - Flex" instead of just exempt. Previously, when they were approved as exempt the formset would change to the exempt forms, which are much more brief and would thus hide much of the information submitted.
Amendments now will correctly indicate whether they are amendments to studies that underwent facilitated or collaborative review.
Certification icons for personnel on open amendments now appear correctly on the continuing review form.
GCP expiration reminders for CHLA will now be sent out, similar to human subjects expiration reminders have been sent.
IRBAs now have access to directly edit the answers on studies and amendments. This allows for IRB required changes and corrections to be made more efficiently, since the IRB can make the change and have the study staff confirm instead of writing instructions to the study staff to make the changes.
The IRB now has an ability to internally indicate whether a study is a clinical trial.
Reportable Event review by committee member is much more efficient and now allows for the review of Participant or Other Complaints.
The Committee and Meeting sections in iStar have been reworked to make them faster and more easy to use.
Minutes - now create snapshots to keep a version of the minutes accessible that is fast and efficient.
Assigning Reviewers has been completely reworked to fix bugs and make it much more efficient.
A number of actions have been reworked to allow for easier audit and review of actions.
The icons now reflect the current iStar iconography.
Many changes have been made to the technical plumbing to increase speed and efficiency of the system.
IACUC Changes: The IACUC system (Institutional Animal Care and Use Committee) on iStar has undergone a large number of changes to support the IACUC electronic system going live in Q1 2013.
Protocol Form: redesigned and implemented to handle a number of different animals without having to maintain different pages for each type of animal. It also have been updated to reflect the current needs of the IACUC.
Amendment and Renewal Forms have been created with the current policies and procedures in mind.
The workflow for each (Protocol, Amendment, and Renewal) has been completely reworked to support IACUC procedures and needs.
New actions to support assigning items for pre-review, reviewing items, creating amendments and renewals, submitting changes, sending letters, conflict of interest review, to name a few.
New Agenda and Minutes forms for IACUC meetings have been created with the ability for any member's review to show up for the agenda item.
