Summary of changes in eResearch Regulatory Management version 9.0.
Regulatory Management
Overview
Study team members, except Principal Investigators and those with an Administrative Staff role, must access eResearch Regulatory Management and accept their role before an application can be submitted, unless the study is Not Regulated or Exempt.
Exceptions:
Overview
Proposal Approval Forms (PAFs), Unfunded Agreements (UFAs), Awards (AWDs) and/or Internal Sponsors (including department or PI discretionary funding) associated with the study can be added when the Application is in an editable State (e.g., Pre Submission). At least one of the support sections must be answered. Multiple forms of funding or support must be added one at a time.
This procedure covers how to add a related PAF and Internal Sponsor.
Overview
In addition to the Principal Investigator, other Study Team Members can be included on the application. Each Study Team Member can be granted rights to edit the application and be included in future correspondence related to the study.
Study team roles include:
Co-Investigator
Faculty Advisor
Study Coordinator/Project Manager
Administrative Staff
Research Staff
Biostatistician
Consultant
Other
Individuals assigned to these roles:
Overview
The Administrative Withdrawal activity is used primarily as a “housekeeping” tool to remove submissions that no longer need to be stored in the system (e.g., when a submission has sat in a State of Changes Required for an extended period of time with no progress).
The Administrative Withdrawal activity is only available for submissions in the following States:
Overview
COI and CRAO Ancillary Committee members can advance a submission to the next required reviewing body prior to completing ancillary committee review by executing the Advance for IRB Review activity. This pauses the COI or CRAO committee's review and engages the IRB to begin their review of the submission. Ancillary Committee review and approval is required before the submission can be approved.
Overview
When an Adverse Event (AE) is reported by the study team, IRB Staff will assign it to the appropriate reviewer(s). Once an AE is assigned to you for review, it can be found under My Reviews in the Inbox of your Home Workspace.
Navigation
Role: Committee Member > Home Workspace
Overview
Anyone with access to a study can run an Adverse Event (AE) Summary Report or Other Reportable Information and Occurrence (ORIO) Summary Report to see how many and what types of AEs/ORIOs have occurred.
Navigation
Role: PI/Study Team Member > Home Workspace > Study Workspace
Overview
Core Committee Staff can set the order of meeting agenda items using the Set Agenda Order activity.
Tip A best practice is to set the agenda order as late as possible prior to the meeting date so that any agenda item changes will not impact the sort order.
Navigation
Role: Core Committee Staff