1.3 The search for PI filter has been updated

1-1.1 wizard “question” removed (1-1.1 Some types of projects do not require an eResearch application and others (e.g., secondary data analysis and exempt projects) have shortened, specialized applications available. A Wizard is available to help choose the correct application type, or determine if your project requires an application at all.) Section renumbered and help updated

1-2.2: Are you or any students working on this project being paid from a federally funded training grant?  Added “you or”

1.9 – IRB: Validation updated for 7-1.7 (drugs), 7-2.1 (devices), and 7-2.3 (Organ tissue transfer) – routing updated so that, for devices, only those with Dental school listed in 1-2.3 will be required to select IRBMED

Section 2, searching for PAF – error if title had an “&” in it has been fixed

10. 1 Two values added

10.1.1 New question added (conditionally displays): Waiver of Assent is request because

Section 31 Audio-visual materials, document uploader fixed

Added “The information provided must be consistent with the information in Section 6.” to the following questions:

33.4  Permitted Categories of Research: The federal policy and regulations governing human subject protections specify that research involving children must fall into one of the following permitted categories. Check all categories of permitted research that apply to this study.  The information provided here must be consistent with the information in Section 6.

35.1 Permitted Categories of Research: The federal regulations governing human subject protection specify that research involving pregnant women or fetuses may be conducted in only the following permitted categories.  The information provided here must be consistent with information provided in Section 6.

35-1.1 Permitted Categories of Research: The federal regulations governing human subject protection specify that research involving pregnant women or fetuses may be conducted in only the following permitted categories.  The information provided here must be consistent with the information in Section 6.

ORIO Summary report added

ORIO PFV will now display 1-4.1

Study team members will be able to notify Co-Is via The Ready To Submit activity that an AE/ORIO is ready to submit

Some AEs should have been available for follow-up reports but were not, this has been fixed

For AE/ORIOs, detail pages will now display on the submission review and the PFV

Amendments

No changes

SCRs

2-1.1.1 new question: Please describe the discrepancies between projected and actual number of subjects

View Study and PFV display for response to 1.1 (Characterize the ongoing study activity) will no longer be truncated Documents uploaded in Section 4 will now display on the documents tab

An error was displaying on the bottom of the SCR PFV, this has been removed

1-2.2 HUD SCR, validation updated

On the Submit Contingencies activity, validation updated to the question: Indicate the changes you have made in response to the identified issues

The non-serious AE Reporting Form instructed the user to add a new event in Section 2.2 instead of Section 3.2.

The letter template header has been added to the Not Regulated self determination letter template

The ITS Help Desk information has been updated in letters and notifications

Renewal deadline reminder issue fixed

Original version and snapshot will now display on the Main tab for terminated studies

An IRB Approval Date column has been added to the Amendment, Continuing Review, and Adverse Event tabs on the study workspace

The project creator buttons (for example Amendment, Continuing Review) will display above the activity options

For closed applications, shared supporting documents will now display on the documents tab

AE Supporting documents will display on the documents tab

An Is Friend account column will display on the Study Team Member information

If Reviewer selects Approved or Approved with Contingencies they must respond to a Y/N Question on approval period page of the reviewer checklist

For Reviewers and IRB Only activity, any committee member or core staff can be selected to receive email notification

Reviewer Allocation information is available on the committee member details tab

A new activity, Manage Action Items, is available to add or edit action items associated with a study

On the Full Committee activity, Compassionate Use and Emergency Use have been added to the list of agenda item type values and will display on the meeting agenda when selected

Changes made by super admins and site admins will be executed and tracked through an activity

For SCRs, an auto-contingency will be created on the staff checklist when the study has ceased enrollment

Typo fixed in Edit Committee Member Details from Currently Active? to Currently Inactive?

An Issues tab has been added to the original version so the initial set of issues can be viewed

Expedited category descriptions that had incorrect CFR references have been corrected

Typo in staff checklist 10-1, item 21

Status meter updated to display correct state when sent back for Ancillary review

PRC & MCRU

Expedited approval and full committee approval letter have been updated

All letters updated with new PRC address

Additional GCRC to MCRU clean-up

Updated routing on changes requested resubmissions to ensure required core committees receive submission

 

Registration form updates made to the following questions:

5.2	Revised question text: "Will you be administering recombinant DNA or cells containing recombinant DNA to animals? [ Yes or No] If yes, please choose which: (checkbox)  I am administering rDNA directly to animals.  (checkbox)  I am administering cells containing rDNA to animals.  Please also respond to the following three questions:"
5.2.1	Revise wording to: "What species of animal?"
5.3	previously was 5.4
5.4	previously was 5.3
5.4	Wording changed to "Can your recombinant DNA (other than an integrated transgene) replicate in the animal host?"
8.7	Added note to the question: "Even though your virus may be replication defective, it is still an infectious particle to which lab personnel may be accidentally exposed.  Please consider this in answering this question."
9.4	Changed main question to read "How will your virus be grown?"  Added text:  "Important:  One biosafety concern that arises during the growth of recombinant retroviruses and lentiviruses is the possible generation of replication competent retrovirus (RCR) or lentivirus (RCL).  In general, transient transfection techniques such as those used by the UM Vector Core do not produce RCR or RCL, while other techniques may or may not.  Please review the protocol details for production of your particular retrovirus/lentivirus so that you fully understand the potential for RCR or RCL generation, and check the applicable boxes:  (checkbox) The UM Vector Core is producing my virus.  (checkbox)  I am growing the virus in my own lab using transient transfection.  (checkbox)  I am growing the virus in my own lab by creating a stable producer cell line. (checkbox) I am receiving the virus from another lab (inside or outside UM) that produces the virus using transient transfection.  (checkbox) I am receiving the virus from another lab that produces the virus from a stable producer cell line."
9.5	Updated text after radio button, "If you checked 'no,' please explain what features your system for growing virus has such that replication competent virus will not be produced. How will you assay for the presence or absence of replication competent virus?"
9.8	Added note to the question: "Even though your virus may be replication defective, it is still an infectious particle to which lab personnel may be accidentally exposed.  Please consider this in answering this question."
10.7	Added note to the question: "Even though your virus may be replication defective, it is still an infectious particle to which lab personnel may be accidentally exposed.  Please consider this in answering this question."

All people with core IBC staff role will receive staff notifications

Updated dates set on Summarize Reviews activity

Added reminder notifications for registrations in the state Changes Requested

Added reminder notifications for registration in the state Renewing Registration

Updated security settings so any study team member with edit rights can initiate an amendment