Release Notes Version 2.6

1.1.2: new question, not required: If there are other U-M studies related to this project, enter the eResearch ID number (HUM#) or IRBMED Legacy study number. Examples of related projects...

1-2.6: Reformatted question and added check boxes for types of peer review.

Section 2: Updated sponsor table and Help links added to the agencies that have regulatory requirements above and beyond the Common Rule.

10.2.3: added text to question: If documentation of child’s assent is to be waived, provide a justification.

Section 14-1: updates to questions 14-1.1 & 14-1.2 and Help. 

Section 42 and 42-1: A warning message will display if the study team enters data in section 42 and 42 – 1, but does not select MCRU in 1-2.4.

No changes

The Amendment Audit trail should display all changes.

Submissions with an SCR approved before AME approval will record the correct expiration date.

Updated subject line for MCRU amendments when no review is required and when AME is received.

The Submission Summary link has been added to the following workspaces: Ancillary Committee Review, Terminated Application, Exempt Approved, Exempt Approved – Transitional.

Comments box added Rebut Decision and Decline Right to Rebut activities.

Short title added to Edit Website Posting Data activity.

Edit Website Posting Data: conditions list updated:

• Added “Obesity”
• Removed “Healthy Volunteer”
• Changed check box “Vision/Eye” to “Eye/Vision”
• Removed duplication check box “Mental Health Conditions”
• Removed check box “Pancreatic Cancer” (Cancer – Pancreatic is there)
• “Other” moved to end of listing

Section 5 Reviewer checklist item, added the following text:

• Is the rationale for the study clearly stated and appropriate for expected knowledge?
• Are the aims and corresponding hypothesis clearly stated?
• Are there adequate preliminary data in the literature (or from the investigator) to justify the proposed research?
• Does the question or hypothesis being tested provide important knowledge to the field?
• Is the design of the study appropriate for the questions posed?
• Is the proposed subject population appropriate?
• If applicable, are statistical considerations, including sample size and justification, estimated accrual and duration, and statistical analysis adequate to meet the study objectives?
• Are the resources necessary to conduct this study adequately addressed

Reviewer checklist item for Section 10 Informed Consent – Children updated to:

• Has the PI described adequate provisions for soliciting the assent of the children?
• Has the PI described adequate provisions for soliciting the permission of their parents or guardians?
• Is the permission of one parent sufficient for research conducted under 46.404 or 46.405?

10-4 Reviewer checklist item updated to: Has the PI provided adequate justification for a waiver of documentation of consent?

An email notification will be sent to the designated reviewer when an amendment, adverse event, continuing report and/or an application is assigned to them.

Updated CRAO auto-contingency text to: Changes were made to sections that may impact the billing calendar (application sections: 2, 5, 10, 14-1, 42 or Consent sections: 4, 5, 8). If changes made to these sections could affect the billing calendar, please contact CRAO for additional evaluation.

CRAO

Changed “Issue Ancillary Approval Pending IRB Approval” activity name on Application and Amendment to Issue Ancillary Conditional Approval.

Changed status meter text when Issue Ancillary Conditional Approval is executed to read “Review Complete – Conditional Approval”.