New Account Self-Registration capability. Users can now request their accounts directly from iStar.
CITI Integration: CITI certificates will automatically be sent to iStar and added to the requisite accounts.
IRB Study Form Alterations:
1.1 - new option to select "Ceded Review". This is a new formset designed to capture information about a study conducted at USC/CHLA that has been approved by an outside IRB
2.1 - personnel training information will now be 'hoverable' by all browsers (will show you expiration date if hover over the training icon)
Page 3: Additional Department/Division Reviews (3.a.3. for HSC and 3.c.3. for CHLA) now has a small number of options to select from. Prior it only had a place to type in the name and no help on what sorts of committees (etc.) might be added there. Further, the name of the chair of the committee/dept is no longer required
The Funding page has been moved to page 4 instead of page 8. Type of study review takes over page 5, and study locations moved to page 6.
Page 5b: Studies that qualify for the flexibility policy and are surveying minors will not be blocked from submitting by the system
The options for HSC locations (6a.1.) have been updated to remove Doheny Eye Institute (for future studies) and add Verdugo Hills Hospital and the USC Eye Institute
If it is indicated at 9.2 that the study will conduct interviews (page 19) or surveys (page 21) it is required that at least one document be uploaded in each space provided
Page 24: Exempt studies no longer must fill out the Informed Consent details questions
New Reportable Event Type: IDE Annual Report. The IRB or study staff can upload an IDE annual report into the system
Expiration warning messages now include status of the continuing review
Approval letters now contain a link to the approved consent documents
Approved documents page now also contains HIPAA forms (if applicable)
Contract/MCA activities on the study now will overwrite any open amendment to eliminate a problem where the amendment would wipe out the changes made on the study
Student submissions are notified more clearly that their faculty advisors will be signing off
Newly created study snapshots will now only have the study snapshot following the completion of an amendment (they had contained the amendment form before)
Participant complaints submitted by the IRB now will capture the date received by the IRB
IACUC Changes:
IACUC Form:
1.3 Form asks whether protocol is funded and funding questions only show up if answer yes
On Species form: Separated Analgesic and Anesthetic question so can indicate that you are doing one but not the other
Monitoring Report functionality: can designate a study to be monitored, ability to create monitoring reports added, tab for monitoring reports available to IACUC
Monitoring Status and IBC/RSC review status shows up on protocol workspace
DMR reviewers can be reassigned
DMR bug fixed that had the DMR reviewers each creating the review for the same DMR.
Annual renewal fields available to track annual renewals
Renewal reminders automated in the system
IBC and RSC have activities that allow them to easily tell the IACUC what is needed for the protocol
IACUC coordinators have an activity to alter the ID on a protocol
Reissue approval letter activity available for IACUC coordinators
IBC Changes:
Edited Role display to display Academic Title and Department in Authorized Personnel (1.1)
Revised Wording to indicate local calendar as link for safety courses in Authorized Personnel (1.1)
Added "Visiting Scholar" to list of personnel in Authorized Personnel (1.1)
Added a list of common granting agencies (NIH, NCI, CIRM, DOD, Departmental) in Project section (1.2)
Revised wording for 1.4.1.1 and included it as general question (e.g. 1.4.2) instead of a sub question in Transportation/Shipping 1.4
Revised list of chemical/toxin and revised SOP document in Chemicals 1.5
Added a new section for biosafety aspects as 2.3
Various updates to Vectors tables in Section 3 to make for a consistent look
Added additional subsection to replication competent for jusification in Vector popups
Added and updated the list of Common Hazardous Chemicals to section 1.5 and section 12
Devised a way to add Common Hazardous Chemicals and other chemicals (requiring more details)
Made text changes to Max Concentration and Max Volume and making them separate individual questions for all instances in which these questions occurred in the system
Removed "Replication Potential" in Bacterial Vector popup
Modified the single Document upload in Genetic Inserts popup to a set of Documents upload
Added "Human" to Genetic Insert and Host drop downs
Added new question about rDNA materials administered to live animals (6)
Added and updated questions related to Section III Checklist
Updated the drop down for Hosts to make species listing singular
Modified the Risk Group values and moved it from the Host Vector Gene (HVG) popup to the Vector popup page (Updated Risk Group display in HVG table to reflect the correct location reference)
Added a message to inform individuals that they must contact the BioSafety Office for Select Agent Registration if they answered No to Biologically Derived Toxins 8.1
Reordered question in Potentially Infectious Organisms popup and removed entries in checkbox list for Manipulations
Reordered and added new question in Human cell lines popup. Also, added various messages to inform based on radio button selections for the various questions.
Updated all the sections for Exposure Control Plan to include a link to the template, instruct PI to download and complete before uploading
Tab was changed from "BioSafety" to "IBC"
Various text edits (Human Gene Transfer and DURC (1.2), Experimental Procedures (2.2), Biologically Derived Toxins 4.1)
Added various link to external sites for users to get more information on specific items (Biosafety levels of organisms, DURC)
Radiation Safety: New functionality to automate the RSC business processes. Expected to go live in the Fall of 2013
