Release Notes Version 2.1

Released July 12, 2009


IRB Merger

The system was updated to support the IRB Health Science and IRB Behavioral Science restructuring. More information...

Subject Fee Payment Initiative

Modifications have been made to support the new M-Pathways Subject Fee Payment initiative which will eventually be the system that processes subject fee payment requests. Study Teams that are paying their subjects will need to respond to one additional question on the human subjects application (13.3.1).

RM/PM system integration

Study teams will be able to associate their PAF entered in Proposal Management with their human subjects application in Regulatory Management. This is the first step in integrating the Regulatory Management and Proposal Management systems.

IBC Renewal Form

A renewal form and workflow has been added to IBC rDNA registrations.

Additional Changes

Expand/Collapse Application Form Changes
  • Conditional logic has been added to additional questions in the application
  • 1.10 Estimated Study Start Date, the error message now references the correct question
  • For not regulated studies, references to “classroom activities” have been changed to “class activities”
  • Conflict of Interest – C1 validation updated to prevent selection of a conflict checkbox and no known conflict checkbox
  • 2.2.4 Question asks if a PAF is associated with this application. If yes, search PAFs and select the appropriate PAF to associate with the application.
  • 3-2.1 & 8.2 Years have been removed from the enrollment table
  • 5-3 & Section 12 now reference 1-1.2
  • 8-1.5 and 8-1.5.1 Race and Ethnicity tables have been removed
  • 9-1.1 validation with 5.6 (under 18) has been added
  • 10-3 validation has been added to require text in the Explain fields
  • 12 Document upload functionality is no longer associated with Section 44
  • 12-2.5 Examples have been moved to Help to model the new question/help format
  • 25-3 will now state completion of this section is required based on the response provided to 4-1.1 and/or question 25-1.3.2
  • Section 26 has been removed from the Jump To
Expand/Collapse AE/ORIO Form Changes
  • The naming convention for AE/ORIOs will default to what type of report is being submitted
    HUM00013327_Adverse Event - Fri Jun 12 11:28:39 EDT 2009
    HUM00013327_ORIO - Fri Jun 12 11:28:39 EDT 2009
  • For follow-up reports that are initiated while the original AE is in progress, links to original AE will be available as soon as the original AE is approved
Expand/Collapse Amendment & SCR Form Changes
  • Section 2-3 Race and ethnicity tables have been removed and the question has been reworded
  • Data in 5.2.1, How many subjects are represented in the data or specimens to be analyzed?, will populate in the SCR
  • New section 4: Additional Supporting Documents
  • New question, 1.5, on Amendment cover sheet: If the amendment includes a revision to the informed consent document or process, specify which subjects, if any, you intend to re-consent [*Required for clinical interventions for which subjects have already been consented and all IRBMED studies]. If you will re-consent no subjects, provide rationale (e.g., no subjects at this site assigned to affected group) in the box below.  If you will re-consent only certain subjects (e.g., those still undergoing study intervention/interactions, those in the experimental arm), enter the criteria and justification in the box below.
Expand/Collapse Letters & Notification Changes
  • Broken link in final outcome notices has been corrected
  • Exempt category will display on AME and letter
  • An approval letter template has been added for Umbrella applications
  • Text added to Not Regulated Case Studies Clinical letter:
    If this case study is about a UMHS patient's healthcare, journals are now requiring authorization from the patients in order to publish. If the patient is deceased submit your application to the IRB (changing any questions regarding decedents that you may have mis-answered). If the patient is living the Patient Authorization form can be found on the IRBMED forms page at <update link>.
  • The MCRU letter template has been revised
  • CRBU notifications have been updated to capture cancer center submissions
Expand/Collapse PI & Study Team Process and Workspace Changes
  • New Help tab will display Help Desk and IRB office contact information
  • The approved submission snapshot will display on the Main tab
  • Completed amendment activity record will display on the Main tab
Expand/Collapse Review Committee Process & Workspace Changes
  • Reviewer checklist has a new question on the Submit Review page: Are you ready to submit your review? Y/N
  • Checklists have been updated to reflect changes to the submissions
Expand/Collapse Core Staff Process & Workspace Changes
  • Primary and Secondary reviewers can be assigned to Expedited submissions
  • Reviewers must submit their reviewer checklists in order for staff to issue a final approval
  • For HUD submissions, terminated letter will display and study will change to terminated
  • Administrative Withdrawal/Termination has been renamed Administrative Withdrawal
  • Core and Ancillary committees added when an application or an amendment is in changes requested will now route to the added committee for review

Protocol Review Committee

  • PRC Priority Score field will accept decimals
  • Disapproved activity will now function like the Deferred activity

Expand/Collapse Ancillary Committee Process & Workspace Changes
  • The status meter for submissions sent back ancillary review will reflect the correct status
  • A change to the number of subjects will now require a review for IDS for amendments where the application was origionally reviewed by IDS
  • The GCRC Biostats committee has been removed
Expand/Collapse Institutional Biosafety Committee (IBC)
  • Submission routing to Section 5 has been updated
  • Correspondence will display on the Main tab