Release Notes Version 1.4.5

July 8, 2006

Expand/Collapse Changes Impacting PIs and Study Teams

Form Changes

The following sections of the application have changed:

  • The first page now includes a text box explaining that all questions with red asterisks are required.
  • Question 8-3.6 (Subject Recruitment) regarding requirements for IRB number on recruitment materials includes new clarifying text.
  • A new question, 16.2.24 (FDA Approved Device), allows investigators to upload supporting documents.
  • Question 29.4 (Survey Detail) now alerts those using electronic survey instruments of special instructions for informed consent documents.
  • Question 32-1.2 (Data and Safety Monitoring Plan) includes an updated link to IRBMED adverse event reporting requirements.

Scheduled Continuing Review (SCR)

  • The Jump To tool in the top navigation bar of the SCR form has been updated. The new functionality displays only the pages required to complete the renewal application, rather than all possible pages. It also differs slightly in appearance from the Jump To tool in the initial application or amendment form.
  • Section 2-2 (Subject Enrollment Status) includes a new question, 2-2.1.1. This allows study teams to explain any discrepancies between projected and actual enrollment numbers.


The title field on the amendment cover sheet now indicates that there is a 255 character limit.

Withdraw Activity for Amendment and SCR

The Withdraw activity for amendments and SCRs now clarifies that the amendment or SCR (and not the parent study) is being withdrawn.


Improved validation has been added to the following sections of the application. The system requires users to enter data in fields based on previous answers in the application. Applications submitted following this update, and applications returned for contingencies or questions following this update will be subject to these new validation rules.

  • 3-2.2, 3-2.3
  • 10-1.2
  • 11.2
  • 11.3.1
  • 18.1
  • 32-1.2
  • 32-2.1, 32-2.2, and 32-2.3
  • 42-1.5
  • C1.2 (Conflict of Interest)

Online Help Changes

The following sections of the online help have been updated:

  • Section 8-1.2 (Estimated Number of Consented Subjects) now includes instructions for longitudinal studies.
  • The GCRC budget now includes information about and a link to the Michigan Diabetes Research and Training Center (MDRTC) application.
  • Section 1.10 (Estimated Dates) now clarifies that these dates refer to estimated length of the entire study, and not to the actual start and end dates.
Expand/Collapse Changes Impacting GCRC Reviewers and Staff
  • A new ancillary committee, GCRC Biostats, has been added. All GCRC applications will be routed to this ancillary committee for review prior to proceeding to GCRC review.
  • In the GCRC Application Summary Report, quick links to specific documents have been added to the top of the report.
  • There is now a GCRC Application Summary Report for amendments.
  • Validation has been added to the Create/Edit GCRC Info activity to prevent the entry of duplicate GCRC IDs.
Expand/Collapse Changes Impacting Ancillary Committees
  • A Staff Notes column now appears in the home workspace for ancillary committee members. This area contains auto-generated information about the submission.
  • A new Edit Inbox Staff Notes activity allows Ancillary committee members to edit the staff notes text.
  • Ancillary committee members can now search for specific studies in their home workspace.
Expand/Collapse Changes Impacting Core Staff
  • There is now a Single Member Review Report for adverse events. IRB staff create these reports via the Generate AE-ORIO Single Member Review Report activity in the meeting workspace. After the IRB staff have created a report, it can be viewed under the Reports tab in the meeting workspace.
  • Section 2.0 of the SCR (SCR Summary Report) now includes a link at the bottom of the page to allow users to navigate to the originally approved application.
  • Section 2.0 of the SCR (SCR Summary Report) no longer lists consent documents from section 10-1 of the initial application. Instead, the list of currently approved (finalized) documents appears, which includes the informed consent document (if applicable) and all other finalized documents.
Expand/Collapse Changes Impacting Reviewers
  • The Request Change or Clarification activity page now indicates that when the activity is completed, the submission will leave the reviewer's Inbox and return to Core Staff for processing.
  • Email notifications are now sent to reviewers when a study transitions from Core Committee Staff Contingency Review to Full Committee.