eSignature Consent Made Easy

How to e signature consent

welcome in this video we're going to look at the red cap PDF Auto archiver and the optional be consent framework that you can use to help consent your your participant via an electronic survey to do this we're first going to go to the online designer and then to survey settings for our consent survey the PDF photo archive we found at the very bottom of the survey settings page under survey termination options what the PDF Auto archive err is is a compact PDF copy of the survey response that gets stored in the project's biorepository where you can download the archive PBS at any time by default this feature will be disabled you can enable it or you can choose to use the auto archive err plus II consent framework this includes an end of survey certification and the archival of the PDF consent form beyond this video the red cap has included a link that will take you to an explanation of how that you consent framework works the e consent is a platform for consenting patients and research subjects either on-site or at a home computer based on a computer-based survey consent form instead of our traditional paper document you can use this on a computer mobile phone or tablet but this is something that you must discuss with your IRB boy to make sure that it's appropriate for your study before implementing it what the extra e consent framework adds to the Auto archiver is when a participant completes the survey there's an extra certification page at the end of the survey which displays an inline PDF copy of the survey responses so that they can confirm all the information in the document is correct once they've confirmed that the survey gets marked as complete and they must certify for the survey to be marked as complete and then like with the standard PDF Auto archiver a copy of their responses with the consent specific PDF will be stored in the file repository this is considered a framework because you still have to create the consent form it just provides a scaffolding to let you provide the can send to your patients or subjects patients and subjects can sign their consent forms by typing their name or by using the redcap signature field type on the survey you can also assign pin numbers to eight respective participants in the signature process setting up the signature process is your responsibility as a researcher you also get have any consent version and type which are freeform text fields whose values are inserted in the footer of each page of the PDF this allows you to version the form where you can give it a numeric or alphanumeric designation to represent the current version of the consent or the form that you're using this is useful if you have multiple consent forms within a project or for some reason your consent form changes over the course of your study so first I'm going to put in our econsent version then we're going to select our first name field and our last name field as some optional fields we can put in the consent type and select the date of birth field then we're going to Save Changes when you look at the instrument in the online designer you can see that nothing here has particularly changed you can send framework will show up when we're filling the information out by a survey we go to survey distribution tools and open this as a public survey so here we can see that we're asking the basic inside question and then we're going to fill in the first name and the last name and provide an email we put a date of birth in our date of birth field consent and add a signature this means consent and signature fields are both optional just saying that I have added that you may want to have in your consent survey if you remember from the view in the online designer this was only a one-page survey but here we have the next page button this takes us to our econsent framework we can see that we have an inline PDF that the participant would be able to review before finalizing their survey we see that it's clearly labeled as a consent form with our descriptive text do you consent first name last name email date of birth consent and signature and then at the bottom in the footer we have the participants name date of birth our version and our type that we entered in earlier now we have this check box where the participant certifies that the information and the consent attachment is correct and that this is the same assignee aesthetical document you notice that the submit button is grayed out and the participant will not be able to submit their survey until they have checked that box now we can submit and it takes us to the next survey in the project to see where the PDF has been Auto archived then we go to the file repository under applications on the sidebar here we can see that there is a section for the PDF survey archive and we have our record so it tells us the survey completion time what record it is what the survey name is if it's a repeating instance the identifying information it captures an IP address gives us a version the type and it's PDF we can download so here is our PDF of the consent form that we can download and have stored as a paper copy if we want it also makes very quick and easy way to find all the consent forms for all the participants in the project and if we want to we can jump straight to the record and here we can see all the information again and we can see that the survey responses marked as read only because it was completed by the econsent framework this will prevent anyone from going back in and changing the information the PDF auto archiver in the econsent framework are a wonderful way of conducting an online consent that captures the identifying information you need and make certain that the participant has had the opportunity to thoroughly read the consent for themselves having the PDF appear within the survey also gives the participant the option to download their consent form or to print it for themselves if you want to be certain that your participant does get a copy of the consent you can go to the survey settings and send a confirmation email after they've completed the survey here you could choose to include a PDF of the completed surveys in attachment however email is not a secure form of communication so the PDF option is not recommended the survey contains question asking for identification like you can send survey must it is therefore much safer to have the PDF presented to the participant in the survey itself where they can choose to download or print it at the time they would find that information in the inline survey itself where if they mouse over they can rotate it download it or print it thank you for watching this video on how to use the PDF Auto archive for any consent remember that if you're going to be using these features of redcap you should run them by the IRB board before implementing them but they're a wonderful way to gather consent electronically that helps you store and track all the information and gives the participants an easy chance to keep their own records on their consent to your study thank you