1-6 removed "CPC information" from header

4-1 updated link to Research Using Publicly Available Data Sets

5-3.6 updated validation

7-1.9 question updated to Will the study involve human embryonic stem cells (hESCs)? [Require Section 19]

7-2.1.1 updated logic for BEU routing

9-1.1 and 9-2.1 Validation added

Branching logic from 9-1 to 10 updated

10.1 and 10.2 Removed the selection;Exempt Research with or without informed consent/assent

Smartform logic updated so if study team selects; Request for waiver of informed consent/parental permission; they are routed to 10-3 (not 10-1)

11-4 Section has been revised to better accommodate study teams that are not creating a data repository

19 changed section name to "Human Pluripotent Stem Cells“ from current "Stem Cells“

Questions 19.2 and 19.1 flipped and selection values for the new 19.1 have been updated

19.3 and 19.4 questions deleted

21-1.1 Study team detail for RDRC/SHUR

25-1 the text that explains the responses that routed the application to 25-1 have been updated to 7.3 and 25.1

29.1 system validation added

32-1.1 and 32-2.1 questions updated so study teams can not contradict themselves regarding AE reporting

2.6 updated so information from 32-1.1 and 32-2.2 will populate in 2.6

Amendments

44.2 if a study team entered text for this question in the original application, and the text is not updated upon submitting the amendment, the study team will receive a warning message

SCRs

2-2.1 language updated

2-3.1.2 new question for withdrawal reason

"This letter also serves to acknowledge any AEs or ORIOS reviewed in conjunction with this SCR" removed from the 3 SCR approval letter templates.

IRBMED letter templates have been updated to reflect the new IRBMED address

Only the original (and identifying) link to the original version will be the original HUM number, in AME forms the HUM number will not display

The department title “BO Surviv, LTD, Cobra Dep, Fellow” has been changed to display “other”

A new activity, Remove from Ready to Submit Inbox, will allow study team members to remove submissions from the Ready to Submit section

Non-committee members will no longer be able to submit reviews

Reviews in the state Review Contingences will now display on the All Reviews tab

Voluntary holds will move to the state expired on the study expiration date, and for SCRs there will be a contingency on the staff review to remind them to put the study back on voluntary hold if appropriate

Staff notes for Amendments were being overwritten when the study team submitted changes

Removed "Confirmed" from member attendees and non-member attendees on Meeting Minutes (staff need to update for no-shows)

Approval activity will check that all required ancillary approvals have been issued

The parent review type will display on the summary view for child submissions

MCRU

GCRC Reviewer Summary Report will display when review is in the finalized state

Additional GCRC to MCRU name change updates

Ancillary Committee

New activity Assign Ancillary Owner, the owner name will display on AMEs

New correspondence activity “For Ancillary and IRB only” the correspondence will display on the Ancillary tab on the submission workspace

Interested Party

The Interested Party role will now have access to view and post correspondence