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.
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.
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.
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.
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 questions specific to your project!
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.
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”.
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)