How Can Document Management Simplify Your Study?

Streamline data-capture by using Vision’s built-in documents manager. You can keep all of your data and communications in one, easy-to-navigate place. Not only will assigned users have instant access to communications and updates, but you will be able to track who has viewed or edited what. No more unresponsive team members claiming, “No, I didn’t see that last update!” when really, they just forgot to respond to it (you know who you are).
Simply navigate to the applicable patient or site where you intend to upload a file or attach a note. Typically, the last or second-to-last form under each patient and site is labelled Notes/Comments/Errors or Comments/Errors. Under this file group will be a notes form. This can be used to append documents like medical histories or previous labs results to a specific patient or signed forms to a specific site. Team members can also add short comments as necessary throughout the study. Prelude offers this form group as part of every contract, but it can also be customized to suit your unique study’s needs.
There is also a form where users can upload transcribed CRF’s, making it easier than ever for sites to keep a thorough record of all essential documentation for their subjects. This basic form includes a place to record the date and time uploaded, the name of the electronic version of the form where the data was transcribed, as well as a link to that form within the system, the reason for transcription, and checkbox where the monitor can indicate that they reviewed the transcription. But don’t forget: this form can be customized to include any extra details your study requires.
Ask your Prelude Project Manager about even more ways to tailor your study’s forms to meet all your document management needs!

 
 

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How Can the Dynamic Drop-Down Menu be Utilized in a Study?

VISION’s user-friendly tools for customizing forms includes a handy tool known as the dynamic drop-down. This deceivingly simple field packs a lot of punch. While you can leave the drop-down menu as just that, a menu and nothing more, did you know that you can also use this menu to populate other fields or even populate it from other fields?

A great place to use this tool is on the Adverse Events and Concomitant Medications forms, so that the two can communicate with each other. If a con med gets administered to a subject due to an adverse event, both need to be documented. Using a dynamic drop-down menu on each form for the relevant subject saves a great deal of time and streamlines documentation. Once it is noted on the con med form that a medication was administered after an adverse event, then a menu appears with all previously entered adverse events for that subject. Simply select the correct event, and now the medication and adverse event are linked. Vice versa, If an adverse event required the administration of a medication in a subject, then you can select from a drop-down menu on the adverse events form all previously entered con meds.

This tool opens the door to many more opportunities for customization and, therefore, simplification of data-entry. Signature drop-down menus can either be populated from another field, i.e., from a list of names, or be role-based, meaning the names of every user who has been assigned a specified role will appear as an option. The menu for the reason a subject was withdrawn can be pre-populated conditionally, e.g., only if the subject was euthanized. This would save the investigator time as there would be no need to answer a slew of unnecessary questions to close out a patient. The transcribed CRF form features a drop-down menu that can be based on all forms or form groups, or it can include or exclude specific forms or form groups. Dynamic drop-downs can even communicate between subjects and sites, e.g., when updating con med and adverse event dictionaries.

Do you have a need for any other dynamic features? Let us know!

 
 

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VISION™ Tips & Tricks: Viewing Subject Form State Details

Do you know you can view a Subject’s (or Site’s) forms and their status (aka. Form state) at a glance? Navigate to the Subject List Page. For any given Subject, click on the plus/minus (+/-) icon next to the Subject ID field (see Figure 1). The above is also applicable for Site-level forms!

Figure 1. Displays expanded list of Subject ATL-012-IUM Forms.

This will show this Subject’s listing of applicable forms, if any of those forms have Queries (and the status of those queries), and the *Form State of the forms. Additionally, hover over any of the form icons to view the specific form’s title, form state/status (see Figure 2).

Figure 2. Displays tool tip for the first form within the “Screening” form group. Vitals/Phys Exam has a form state of In-Work and has errors that the user should resolve.

*Form States are used to determine the state of the form. The form icon is color-coded to indicate the status of that form.

  • Blue = In-Work
  • Orange = Submitted for Review (User has signed the form)
  • Yellow = Reviewed (User with appropriate privileges has reviewed the data on the form)
  • Green = Finalized (User with appropriate privileges has finalized the form- edits can no longer be made to the form unless a user with appropriate privileges revers the finalized status)
  • No color indicates that the form is “new” and no data has been entered.
  • A Red form icon indicates that there is an error(s) on the form that must be resolved before the user can Submit for Review.

VISION™ Tips & Tricks: Running Reports on On-Demand Forms

Ever wonder how to run reports for *on-demand forms? Wonder no longer! Navigate to the Subject List Page (or Site if running the report from there), click the Reports (see Figure 1) button towards the bottom of the page.
Reports

Figure 1. Reports button

Select the forms and fields you would like to see in the Report. In this example, I am pulling the Subject ID and the Unscheduled Visit date(s). Figure 2 displays the on-demand Unscheduled Visit forms- this example has two of them.

Figure 2. on-demand Unscheduled Visit forms

For an on-demand form (Unscheduled-Vitals/Phys Exam), you will see an extra field appear next to the form name- this is for the form “number.” You can enter 1 to x, depending on which on-demand form you’d like to view data from. Conversely, you can leave it blank which will pull data from all available on-demand forms.

When pulling from all on-demand forms, if more than one form exists, the data will list out within one cell (see Figure 3).

Figure 3. The Visit Exam Date fields from ALL of the Unscheduled Vitals/Phy Exam appear for Subject ATL-003.

*What’s an on-demand form?

On-demand forms are those forms that can be added as required. The first form is always available and subsequent, identical forms can be added as needed. Common examples of these are unscheduled visits, daily assessments, and serious adverse events forms.