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Release Notes

Recent Updates

Version 1.4.6 - August 11, 2006

Changes Impacting Core Staff
  • A new activity, Generate Printable Meeting Minutes, is now available on the Meeting workspace. Executing the activity generates a static report of the meeting minutes. The View Printable Meeting Minutes button will only appear after the activity has been completed.
  • A new activity, Generate Expedited-Exempt Report, is available on the Meeting workspace. The Expedited-Exempt report is now a static report. The View Expedited-Exempt Report button will only appear after the activity has been completed.
  • A new button, View AE/ORIO SMR Report, will now display after the Generate AE-ORIO Single Member Review Report activity has been completed.

Version 1.4.5 - July 8, 2006

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.

Amendment

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Withdraw activity for amendments and SCRs now clarifies that the amendment or SCR (and not the parent study) is being withdrawn.

Validation

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.
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.
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.
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.
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.

Version 1.4.4, June 14, 2006

Form Changes - New Application

In Section 18, removed the Tissue Procurement Service option from the Use of Existing Banked Specimen detail page, question 18.1.17. The Tissue Procurement Service option has been added to the Direct Collection Non-Blood Specimen detail page, question 18.1.7.

Ancillary Committee Reviewer Functionality

The No Review Required activity for Ancillary Committees is no longer generating an error message.

Contining Reviews for Converted Studies

AE calculations for converted studies on section 3-4 are now working correctly.

Version 1.4.3, May 24, 2006

Form Changes
  • The Orders Management Project (OMP) has been integrated with eResearch. The OMP is a Health System project for online management of orders for medication, lab tests, and x-rays. Question 14.1 regarding UM facilities includes new facility options, some of which participate in the OMP. Selecting one or more participating facilities will redirect the user to a page with a link to the OMP website and contact information.
  • Questions in sections 21, Ionizing Radiation, and 21-1, 21-2, and 21-3, RDRC/SHUR Information, have been expanded to include more clarifying text.
  • Section 21-2 now includes a new required question, 21-2.4.1, regarding the source of preclinical toxicology studies. If an application was submitted prior to this change, study teams will be required to answer this question if any other changes are requested to the application.
  • Section 25-3.3 now includes a link to the Data Use Agreement form for the UMHS Privacy Board.
  • The IND (Investigational New Drug) number now displays in the table in sections 15.3.1 and 15.3.14.
Workspace Changes
  • Pending contingencies can now be viewed under the Pending Contingencies tab in the Adverse Event workspace.
Core Staff Functionality
  • Expedited categories have been updated to match the current regulations. For more information, refer to the OHRP website.
  • Amendments in the states In Administrative Review and Validate Administrative Review now appear in the core committee staff inbox.
  • Continuing Reviews in the states In Administrative Review and Validate Administrative Decision now appear in the core committee staff inbox.
  • In the Full Committee and Edit Agenda Information activities, users may now select conflicted committee members from a list of all users in the system.
Terminology Changes
  • For regulatory reasons, the states and activities for Adverse Events that previously used the term "Expedited Review" are renamed "Single Member Review."
Ancillary Committees
  • The Issue Ancillary Committee Approval and No Review Requested activities now display an error message if the user does not select the ancillary committee.
  • The No Review Required activity now displays an error message if the study team has not submitted changes requested by that ancillary committee.

Version 1.4.2, May 12, 2006

Letters and Notifications
  • Default signatures and banner images on the emailed version of approval letters are no longer broken images.
  • If a study expires, but a Continuing Review has been submitted at the time of expiration, the study team will receive a notification that the study expired and a Continuing Review is in progress.
Continuing Reviews
  • Studies that expire with a Continuing Review in progress at the time of expiration now transition to the state Expired - Continuation in Progress.
Amendments
  • If an amendment's parent application is in the state Exempt Approved-Initial, the Approve and Change to Exempt activity no longer changes the state of the amendment's parent.
Performance Enhancements
  • The printer-friendly version of the application now loads more quickly.
   

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