eBridge Support

EmailEmail    |   Bookmark Page Bookmark  |   RSS Feeds RSS  |   Print Page Print  

Guide for Managing Project Team Members

Effective September 7, 2013, how and where project team members of Human Subject Research Projects are added, removed, and reviewed in eBridge has been updated.  This redesign is based upon requests from Principal Investigators and project team members to make the management of project team members more accessible and streamlined in eBridge.
 

Enhancement Summary

  • The list of all project team members, except for the Principal Investigator (PI), is now located in one table within the redesigned Section 2 of the PRO SmartForm. Previous questions 1.4, 1.5, 2.1, 2.2, 2.3, and 39.1 have been eliminated.
     
  • Project team members and their information can now be added, updated and removed from an approved project through one activity, Update My Approved Project, even when an Amendment or Conversion CPR is open.  These types of changes will no longer occur within the Amendment or Conversion CPR.

 

Principal Investigator Information - Protocol SmartForm, Section 1

The Principal Investigator’s information now includes any Significant Financial Interest for the PI, and immediate family members (questions 1.3.1 and 1.3.1.1).  Also, the PI is automatically assigned edit access and to receive emails related to the project.
 

Question 1.5 is new, asking whether there are other project team members in addition to the PI.  If the response is “yes”, then eBridge continues to Section 2 where the project team members (other than the PI) are entered into one table.  If the response is “no”, then eBridge continues to Section 3 and automatically adds the PI as the Primary Contact. In this example, you will see one name displayed on the Study Workspace listed as the PI and the Primary Contact.

 

Project Team Members Information - Protocol SmartForm, Section 2 - New Table

All information on the Project Team Members is now maintained in one table in the PRO SmartForm, Section 2.  This table replaces previous questions 1.4 (identifying the study coordinator), 1.5 (identifying co-investigators and study staff), 2.1 (identifying edit access), 2.2 (identifying email recipient), 2.3 (identifying any Significant Financial Conflicts of Interest), and 39.1 (identifying individuals eliciting informed consent).

 

To add a project team member in Question 2.1, select the “Add” button.  An “Edit Team Member” window displays where information for each team member is completed.  A new piece of information requested is the team member’s role on the project as one of Key Personnel, Other Administrative or Project Staff, or Community Partner.  The definitions for each role can be viewed by selecting the new question mark icon.

Any changes to the Principal Investigator still require an amendment to be created and submitted for IRB approval.  There have been no changes made to this process.

eBridge allows only one Primary Contact (previously known as “Study Coordinator”) on a project.  If there is no Primary Contact indicated in the table, or if there are no team members other than the PI, then eBridge automatically assigns the PI as the Primary Contact. 

 

New Activity to Manage Project Team Members Information - Update My Approved Study

If the project is in the State of “Approved”, then changes to Project Team Members can be made only through the “Update My Approved Project” activity by either the PI or a project team member with edit access.  This new activity replaces the previous two SmartForm Update activities, and is available regardless of whether an Amendment or Conversion CPR is open. 

When the “Update My Approved Project” activity is submitted, eBridge either automatically applies the change into the Approved SmartForm or automatically routes the change for IRB Staff Review. Changes to Key Personnel, Significant Financial Interest (SFI), and the Project End Date must be reviewed by the IRB Staff.  Other changes such as adding or deleting Other Administrative or Project Staff, or Community Partners, updating the Primary Contact, who has edit access, who receives email notifications, or who will consent subjects, are automatically applied into the Approved SmartForm without IRB Staff review.  If the proposed changes require IRB Staff review, then the “Update My Approved Project” activity is not available again until the IRB Staff completes the review.

 

History Log Enhanced with New Activity - Update My Approved Study

The History log now provides more detailed information regarding the changes submitted in the “Update My Approved Project” activity. For example, when selecting the “Update My Approved Project” activity, making any change, and clicking OK, the History log displays the change you made and indicates if the change is applied immediately or if the change is routed for IRB Staff review.  Please review the example below.

 

How Do These Changes Impact My Current Protocols in eBridge?

As of September 7, 2013, most existing responses to questions that have been replaced by the new Question 2.1 in the PRO SmartForm will automatically be migrated into the new table/Question 2.1.  The information will be migrated for every PRO in eBridge.  If your PRO is in Pre Submission, the information will be migrated but you will also be required to provide responses to any incomplete information. We anticipate minimal impact of these changes on the Project Teams.  Below is what you can expect to see happen to any of your PROs:

Existing Response As of September 7th Notes to the Project Team

1.3 PI Name

No change - the name of the PI remains in Question 1.3.

None

1.4 Study Coordinator

Name now displays in the new 2.1; the "Is Primary Contact" column displays a checkbox; the "Can Edit" column displays a checkbox.

You may wish to update the role of this individual, as you see appropriate.

1.5 Co-Investigators and Student Staff

Name now displays in the new 2.1; the "Role on Project" column displays Key Personnel.

You may wish to update the role of this individual, as you see appropriate.

2.1 Study Staff with Edit Access

Name now displays in the new 2.1; the "Can Edit" column displays a checkbox.

If the name is only in the old 2.1 and not the old 1.5, then the "Role on Project" column displays "Other Administrative or Project Staff".

None

2.2 Study Staff Receiving Email Communication

Name now displays in the new 2.1; the "Receives Emails" column displays a checkbox.

If the name is only in 2.2 and not 1.5, then the "Role on Project" column displays "Other Administrative or Project Staff".

None

2.3.1 Study Staff with SFI

The "SFI" column is unchecked or displays a checkbox.

Response to new 1.3.1 will be yes or no appropriately.

None

39.1 Eliciting Informed Consent

The "Consenting Subjects" column is unchecked and set to "no" for all names in the new 2.1 if the PRO SmartForm Question 38.1 is checkbox #2 or #4.

The "Consenting Subjects" column will be unanswered for names in the new 2.1 if the PRO SmartForm Question 38.1 is checkbox #1 or #3, or if the PRO is in the state of Pre Submission.

If the "Consenting Subjects" column is unanswered, then you are required to provide a response the next time you update information for this existing individual using the "Update My Approved Project" activity.

 

 

Contact Information

eBridge Help Desk:

Phone:  (414) 955-8476

Report an Issue:  Service Request

Hours:  8:00 a.m. - 5:00 p.m. Monday through Friday

 

This right column provides helpful tips that relate to the detailed information on the left.  Scroll down to view all tips.

 

 

Helpful Tips

SmartForm-Section 1

  • PI is automatically assigned edit access and to receive emails related to the project.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Helpful Tips

SmartForm-Section 2

  • eBridge automatically adds creator name to 2.1 with edit access, if creator is not the PI.
     
  • eBridge allows for only one Primary Contact (previously known as Study Coordinator) on a project.
     
  • New question mark icon provides definitions for new team member roles.
     
  • eBridge will not allow you to remove yourself from the team members list nor remove your edit access.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Helpful Tips

Update My Approved Project

  • Changes to Project Team Members on approved protocols can be made only through the "Update My Approved Project" activity.
     
  • Can access and submit the "Update My Approved Project" activity regardless of whether an Amendment, CPR, or Conversion CPR is open.
     
  • The "Update My Approved Project" activity is hidden when proposed changes are being reviewed by the IRB Staff.
     
  • Changes to the PI still require an amendment to be created and submitted for IRB review and approval.

 

 

 

 

 

 

 

 

 

 

 

 

 

webmaster@mcw.edu
© 2014 Medical College of Wisconsin
Page Updated 04/02/2014