The Ripple Screening form is a tool that can be used to screen potential participants based on study requirements. This takes the manual work out of identifying whether a participant meets the designed study requirements. After a participant is screened, their status is updated automatically based on whether they pass or fail the screening criteria. The study administrator can determine in advance what status participants who pass or fail the screening criteria should be moved to. For example, if a participant passes the screening criteria (e.g., female, age 18-25, no previous drug use), he or she is automatically moved to the status set in the “Screen Pass Status” setting (see picture below). If a participant fails the screening (female, age 18-25, previous drug use), he or she is automatically moved to the status set in the “Screen Fail Status” setting. Ripple will also save the participant information to the registry in case the participant meets the requirements for other or future studies.
The screening tool is very flexible allowing any number of questions, pages, instructions, etc. The inclusion criteria can be set on any number of variables, and the status which participants should move to based on pass/fail can be defined.
The steps to create a screening form are as follows:
Creating a screening form:
In Study Settings, select the “Screening Form” tab from the menu on the left and choose “Add New Form”:
Forms can be created from scratch or copied from existing forms. To create a new form, select the “Add New Form” button and begin to create your form. By default, your form will be called “Form 1”. You can change the name of the form by simply highlighting the title “Form 1” and typing your own title. After you give your form a title, you can begin to add Questions, Instructions, Headings, Separators, and Pages. The form creation was designed to give you flexibility to create the form with the look and feel you desire. Any time during the form creation you can click the “Open as a live form” button to see a preview of what the form will look like during use.
Questions can be written in any way that you choose, but the answer must be linked to one of the participant requirement fields that appear in the drop-down list. The drop-down list is populated with general requirements (First Name, Last Name, Global ID, Family ID, birthday), contact requirements (Contact Name, Relation to Participant, Email, Phone, Address), group requirements (race, ethnicity, sex), and custom requirements (custom variables created in Ripple). If you plan to ask questions related to custom requirements those custom variables must be created within the study (or globally) prior to building the form.
When a participant enters information (web-to-lead) or a participant is screened live (internal screening by your team), the data that is entered into the form will be entered into the variable of the profile card to which the question is linked. For example, if a participant enters (or a Ripple user enters for a participant) their age, the age field in their profile card will be populated with the number they enter after the form is submitted.
You can create as many questions as you’d like in the form.
Instructions are text blocks that aren’t tied to a question. They can be used as instructions:
or they can be used in conjunction with a longer question:
In the live screening form, pages are navigated using the “Next” button:
At the very bottom of the Requirements page there is a section called “Inclusion Criteria”. Any number of criteria can be defined here. Each set of criteria relates directly to a general requirement, contact requirement, group requirement, or custom requirement that is defined on the same page in the sections above.
Simply click on “Add a criterion” to add inclusion criteria.
Give the criterion a name and use the drop-down menus to select a requirement and an operator:
Continue to add as many criteria as are required for the study. In the example below criteria are set for a minimum age of 5, a maximum age of 65, and no previous interventions:
There is no limit to the number of criteria that you set. Within a screening form, you will only reference the criteria that applies to a given form.
Once criteria are created, you can return to the screening form to apply the logic:
Click on “Add Inclusion Criteria Logic”. Only those criteria that apply to requirements that are referenced in form questions will appear in the inclusion criteria window. The logic that was created will also be displayed:
Type the names of the criteria that will be used to evaluate a participant in the text box that says “Logic”. You can use “AND” and “OR” criteria to evaluate multiple criteria. In the example above we are looking for participants older than 5 and younger than 65 that have not had a previous intervention.
Screen Pass/Fail status:
Ripple needs to know what status participants should be assigned to once they pass or fail the screening criteria. You select the status by clicking on screen pass status as shown below.
You can screen participants in one of two ways:
1. Screen a participant that is already in Ripple by clicking “Screen This Participant” within the participant profile.
Once you click on “Screen This Participant”, Ripple will ask which screening form you’d like to use to screen them:
Upon selecting the form, any data already in the profile card will populate the form. If data is missing or it is incorrect it can be added or modified in the form. Any changes to data will update the profile card:
Upon pressing “Submit”, the participant is screened and Ripple will either show a pass or fail screen with options to “Cancel and return to form”, “Cancel and close form”, or “Save participant data to Ripple”. These options are the same with a pass or a fail. The participant will then be moved into the status that the form dictates. For example, failed participants can be moved to an “Ineligible” status and passed participants can move into the “To be contacted” status.
If the participant fails the criteria, a new message will be displayed asking whether you want to save the participant data.
Soon we will be expanding the functionality of this screening feature including:
- The ability to add skip rules and flow
- The ability to add inclusion criteria and screen directly from and into the Registry (i.e., not study-specific)
- The ability to convert the screening form into web-to-lead that will allow potential participants to complete the form online and be automatically added to Ripple