Posted October 30, 2007 (1 Item)
Email Notification Links:
The links to view a specific protocol, amendment, or CPR from within an email notification sent from eBridge are working beginning October 29, 2007. Links in email notifications sent prior to October 29, 2007 are not functional. These links can not be fixed because the email has already been sent from eBridge. To view submissions prior to October 29, 2007, log into eBridge and locate the submission within one of the tabs on your My Home page.
Posted October 29, 2007 (1 Item)
Viewing Decision Letters from the Workspace:
Decision letters (AME, CPR, PRO, RE) are now viewable from clicking on the "View Decision Letter" within the history tab of that submission. The workaround - accessing decision letters on the "IRB Letters" tab in the Study Workspace - is no longer necessary.
Posted August 6, 2007 (2 Items)
Attaching Documents:
In order for IRB to edit uploaded documents, (i.e. edit approval dates for paper consents), attachments for electronic submissions need to be in a Word document format.
Specific Language for Approval Letters:
Be sure to insert the desired language for your approval letters in Questions #1.1 and #1.2 in the Study SmartForm (i.e. sponsor-specific language, including words such as "Addendum, Revision or Version" in the title) and Question #1.3 in the Amendment SmartForm. The eIRB System is unable to generate 2nd approval letters if sponsor-specific language needs to be changed.
Posted May 18, 2007 (1 Item)
Entering Numbers in Study SmartForm:
One of our end users discovered that when entering numbers with a comma (for example 12,000) in Question #12.3 of the Study smartForm, the system recorded "12" versus "12,000" after clicking the "Continue" button. At this time, it is recommended users enter the number without a comma (for example "12000") and should proofread specifically where any numbers are entered in the system. Our IT team has added this "fix" to their list of changes the next time the eIRB system is unfrozen.
Posted May 7, 2007 (1 Item)
Study Regulatory Files:
Good Clinical Practice (GCP) guidelines require the PI to maintain a copy of the study protocol in his/her regulatory files. When the coordinating center has not provided a writen study protocol, the IRB application itself (the SmartForm) serves as the study protocol, so the PI must maintain a paper copy in his/her regulatory files.
Posted March 22, 2007 (1 Item)
Editing SmartForms:
The eIRB System allows more than one person with edit permissions to view, update or modify the same SmartForm at the same time. However, the eIRB System will not allow more than one person to save their updates/modifications to the same SmartForm at the same time. If this happens, you will receive an error message upon clicking "Save" or "Continue" within the SmartForm.
To resolve this issue, it is a recommended practice for all individuals with edit permissions to the same SmartForm to coordinate (outside of the eIRB) who will be making updates/modifications and when.
Posted March 16, 2007 (3 Items)
Changes to the SmartForms:
As of March 16, 2007, all submissions that previously would have gone to the DSMB first will now go directly to the IRB. With this change, you will notice changes to two SmartForms. For the Study SmartForm, the branching to skip Question #37 has been removed. Question #37 will now be completed for all studies. Help Text on Questions #36 & 37 have been updated. For the CPR SmartForm, Question #3.2.1 has been removed along with the Help Text.
CPR Deadline Reminders:
The "CPR Deadline Reminder" issue has been resolved. Some CPR reminders were being sent out incorrectly and some CPR reminders were not sent. If you experience further problems, please contact the eIRB Help Desk at 456-8476.
Study Workspace - Owner Column
The "Owner" column in the Study Workspace has been removed and replaced with the "PI" column.
Re-posted March 14, 2007 (1 Item)
Legacy Study Process Instructions
Posted February 15, 2006 (2 Items)
Good Practice to Assure Work is Not Lost:
In order to assure your work is not lost, it is good practice to save and exit any SmartForm and return to the Study, Amendment, etc. . . Workspace when leaving your office or working on other projects. When you return to the SmartForm,you may not be aware you were timed out by the system until you try to save your additions. Please add this additional activity to your current practice of "saving often".
Editing an Approved Consent in Consent Builder
When you need to make changes to your approved consent in Consent Builder, you must make those modifications by opening an Amendment and selecting the consent from the list under Consent Builder Consents-For Editing. Once in the Consent Builder Workspace, select Begin Consent Form Edit Process button and then select Edit Consent Builder.
Posted November 13, 2006 (1 Item)
Clinical Consent Language Change (Question 21d., Section #88):
Clinical Consent language change was made. Old language: How can I stop my health information from being used for other purposes? [Secondary Use]. Do not sign this consent form. This means you cannot participate in this study. It wll not change your current or future health care or benefits. New Language: How can I stop my private medical information from being used for other purposes? [Secondary Use]. The way to stop my private information from being used for other purposes is to not sign this consent form.
Posted October 12, 2006 (1 Item)
eIRB Survey Results:
In July 2006, the eIRB Working Committee surveyed investigators, study coordinators, and IRB members to learn more about what users thought about eIRB. The findings are organized by response group – one report for Principal Investigators and research staff, another report for IRB members.
eIRB Survey Results
Posted September 25, 2006 (1 Item)
Paper Consent Changes:
Instructions on how to create and edit paper consents and where to find the paper consents are available.
Paper Consent Changes
Posted September 21, 2006 (1 Item)
Frequently Asked Questions now available:
Based on information obtained from the recent survey, we have created a Frequently Asked Questions page.
Posted September 18, 2006 (2 Items)
Creating PDF in eIRB:
Updated instructions for creating a PDF in eIRB are available. Changes are highlighted in yellow.
PDF Instruction File
eIRB Workflows
Based on information obtained from the recent survey, eIRB workflows are now available to assist Principle Investigators and Study Staff in understanding where their submission is in the eIRB workflow process. The workflow diagrams can be found on the eIRB Training Materials page under eIRB Workflows PDF Files. If you have any questions, please contact the eIRB Help Desk at 414-456-8476 or help-eirb@mcw.edu.
Posted September 8, 2006 (1 Item)
View All Studies With Their Expiration Dates:
In response to a PI's request, a new feature has been added to the eIRB System. Principal Investigators and study staff can now view all their studies with expiration dates on a summary page versus having to review each study separately. The summary page can be found by clicking on My Home > Studies tab.
Posted June 15, 2006 (1 Item)
Uploading Documents When Receiving an Error Message:
Some users were not able to upload Word documents into the eIRB SmartForms. They were receiving an error message "File transfer not possible due to insufficient permission on save option." Instructions to correct this error message are now available:
Upload Document with Security Warning
Posted May 11, 2006 (1 Item)
Rich Text Box Copy & Paste Guidelines
In response to users' requests, guidelines for copying and pasting into the eIRB rich text boxes have been developed and were updated on May 10, 2006
Rich Text Box Copy and Paste Guidelines