Human Research Protection Program

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Version 1 to 3 SmartForm Conversion Process

Purpose

Seating Groups

Instructions

FAQs

 

Purpose:

As part of the IRB Accreditation process, a Version 3 (V3) of the eBridge PRO SmartForm was implemented on November 19, 2011. In the V3 PRO SmartForm update, new questions and information were added in an effort to meet the accreditation criteria. It is the goal of the Human Research Protection Program (HRPP) office to have all human study protocols in the same SmartForm version. With the completion of the PRO SmartForm conversion from V2 to V3, we are now ready to begin the PRO SmartForm conversion from V1 to V3.

Principal Investigators and their research staff who have approved human subject protocols in eBridge before 11/19/2010 will need to convert their studies from V1 to V3 during a predetermined, scheduled time.

The conversion process from V1 to V3 begins August 1, 2012 with an anticipated completion date of December 2014. Because of the volume of conversions (over 1000+), HRPP has staggered the conversion process to coincide with a CPR expiration date based on the study’s original approval date. This guide provides the Conversion CPR information for converting a V1 Protocol SmartForm to V3.

 

Seating Groups:

The Seating Groups will determine when the protocols are expected to complete the SmartForm conversion.  Click on the “Seating Group” to pull up a list of the PRO assigned to each group:

Seating Groups*

Date Originally Approved CPR Expiration Dates Conversion Start Date
Seating Group #1 <= 2005, 2006, 2007, 2008 November 2012 through April 2013 August 1, 2012
Seating Group #2 <= 2005, 2006, 2007, 2008 May 2013 through October 2013 January 1, 2013
Seating Group #3 <= 2009, 2010, 2011 November 2013 through April 2014 July 1, 2013
Seating Group #4 <= 2009, 2010, 2011 May 2014 through October 2014 January 1, 2014

*Updated 07/27/2012

 

Instructions, Guides and Training:

Study SmartForm Conversion from Version 1 to Version 3

Guide (PDF) Updated 9/7/13
Conversion Overview

Quick Reference  (PDF) 7/28/12
Specific Instructions

Online Training (Link) 7/28/12
Demo of Conversion Process

Frequency Asked Questions (FAQ)

Advice from Study Coordinators who participated in Conversion testing:

  • READ ALL OF THE HELP TEXT - There are important and subtle differences in the Help Text and it is necessary to read it
  • Go slowly and read the questions carefully
  • Ask questions

What do you need to complete the Conversion?

  • Study or Sponsor Protocol
  • Regulatory or Study Binder
  • Printed copy of V1 SmartForm
  • Printed copy of the last approved CPR

Tips:
Use "Continue" button to navigate through each page of the Modified Study SmartForm
Do not use the "JumpTo Menu" because you will skip required pages which will delay the review process
Keep track of any changes made to the overall project for ease of drafting the Project Change Summary
Provide a response to any question that you have not previously answered
SAVE, SAVE, SAVE your responses in the SmartForm

 What is Conversion and why is this required?

The SmartForm Conversion process is:

• An institutionally required process that allows you to convert your project from Version 1 to Version 3 of the eBridge PRO SmartForm
• Submitted & reviewed in conjunction with your CPR (Continuing Progress Report)
• Involves completion of the CPR SmartForm along with answering new questions within the Modified Study SmartForm

All currently approved Full Committee and Expedited protocols on V1 SmartForm will complete the conversion process.  Exempt studies are not required to convert.

As part of the IRB Accreditation process, a Version 3 (V3) of the eBridge PRO SmartForm was implemented on November 19, 2011. The V3 PRO SmartForm transitioned questions from the Addenda PDF form (created to meet the accreditation criteria) into electronic questions in eBridge. It is the goal of the Human Research Protection Program (HRPP) office to have all research projects in the same SmartForm version so that the questions asked and information collected regarding all research projects at MCW are consistent. With the completion of the PRO SmartForm conversion from V2 to V3, we are now ready to begin the PRO SmartForm conversion from V1 to V3.


The conversion process from V1 to V3 begins August 1, 2012 with an anticipated completion date of December 2014. Because of the volume of conversions, HRPP office has staggered the conversion process to coincide with a CPR expiration date based on the study’s original approval date. This guide provides the Conversion CPR information for converting a V1 Protocol SmartForm to V3.
 

V1 PROs do not provide study information related to policy changes or IRB accreditation standards. It is the goal of the HRPP office to have all approved studies on the same SmartForm version so that all studies meet the current policy and IRB accreditation standards. Since new information is being introduced into the V3 SmartForm, the IRB Committee must review and approve the submission.

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 How do I complete the Conversion?

Conversion will be completed by a new eBridge activity called, ‘Start Conversion to V3’

• This activity will bring you to the Conversion CPR Workspace
• This process consists of first completing a CPR as usual and
• Modifying the Study SmartForm using the View/Edit Study button within the Conversion CPR Workspace

Questions that are the same between V1 and V3 will auto populate. In addition, new questions will now require a response.

• Please use the ‘Continue’ button to navigate through the SmartForm

Go into the CPR SmartForm - click "Continue" below to access the CPR SmartForm. Complete as usual.

Go into Modified Study SmartForm (located on the Conversion CPR Workspace) – review all information on each page of the PRO SmartForm to verify the information in each question is accurate as it currently relates to your project. Complete all new questions.

Section 53 - Project Change Summary - the IRB requires you to bring everything up to date with this conversion process. Please note changes to the project by describing each in section 53.1.1 of the Modified Study SmartForm.
 

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 When am I supposed to complete my Conversion and for which studies?

The IRB and eBridge will contact the Study Team via email when it is time to convert their PRO. Conversions have been staggered into 4 seating groups based on date of original approval and CPR expiration

If the study is ready to be closed, then the conversion is not necessary.  Instead, a Final Report needs to be completed and submitted.

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 Can the Conversion only be done at CPR time?

Yes, there are over 1,000 V1 projects that will be converted and because of this volume the HRPP has staggered the conversions to coincide with CPR submission and review for each individual project. The process of conversion in eBridge was designed to include completion of the CPR SmartForm and cannot be completed without completion of the CPR SmartForm. 

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 Does it matter which SmartForm I complete first, the CPR SmartForm or the PRO SmartForm?

No, but it will be easier and more time saving to complete the CPR SmartForm first and it takes several minutes for the modified study to be copied form the currently approved study. You will not be able to edit the PRO SmartForm until the modified study has finished copying. 

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 How many new questions are there in V3 (that are not in V1)?

There are approximately 25 -35 new questions in V3 that were not in V1. However, no single project will see all of the new questions. You will only receive question specific to your project!

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 Section 52: Why are there delete buttons here?

Delete all outdated documents that are no longer being used and add only currently used documents.

►All previously uploaded documents will be saved and available in “Archived SmartForms” under the “Project Information Links”

If you are using a Consent Builder consent or consent builder language that was copied and pasted into a Microsoft Word document, you must submit a consent form using the current consent form template language found on the HRPP website.

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 What kind of changes can be made and recorded in Section 53?

Some of the Version 3 PRO SmartForm submission may appear different to the reviewing IRB because the SmartForm asks different questions and/or because you were not as specific the first time you completed your IRB submission. These kinds of changes are expectable and allowable.
Where the project or protocol has REALLY changed (a little or a lot), the IRB requires you to bring everything up to date with this conversion process. As long as you flag all changes by describing each one in 53.1.1, you have a one-time opportunity to obtain IRB approval for changes to your research with this conversion”.
 

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 How much detail must I provide in Section 53?

The same amount of detail that you would provide in an Amendment:

- You must indicate the change (e.g., Performance of MRI before blood draw on visit 2)
- You must describe where the change was made (e.g., SmartForm Section 30.1 and consent form page 6)
- You must provide a rationale for the change (e.g., after we enrolled several subjects we realized that it was creating timing issues with the MRI schedule to draw blood first on visit 2 and easier to just send the subject to the MRI first, so we changed the order of these procedures) 

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