Eligibility Checklists

Transcription

1 Eligibility Checklists CRMS Support Pool Help Topic Eligibility Overview In order to enroll participants on your study, they must meet all of the eligibility requirements defined in the protocol (with rarely granted exceptions approved by the sponsor/irb). Eligibility requirements for your study are reviewed and approved by the IRB. CRMS allows you to record electronically the eligibility of participants in your study. A new study in CRMS is created with a one-question checklist for recording whether or not the participant is eligible for the study. CRMS allows you to build checklists that match your study s IRB-approved inclusion/exclusion criteria, to use when checking participant eligibility. A study may have more than one eligibility checklist, each of which can change during a study, with IRB approval. CRMS allows you to manage checklist versions and ensure that the IRBapproved version of a particular checklist is the only one being used (Active, in CRMS terms). The Eligibility Criteria Page Eligibility checklists are managed from your study s eligibility criteria page. Select Eligibility Criteria from the left side navigation bar. Here is an example eligibility criteria page: This study has one checklist, Eligibility Checklist for CRMS-7553, with two versions. The first version is active, and the second is in development, meaning it is not ready to be used. Only the version that matches the current IRB-approved criteria should ever be active. The annotations highlight these points: 1. The Checklist Status box gives you control over which checklists are visible, by checklist status. The default is Active and In Development, but here are the options:

2 2. For each checklist, status is color-coded: Active is green, In Development is orange, and Archive is gray. 3. Items 3-6 are all ways to start a new checklist or version. Reading across the table, here are the entries for each checklist/version: Status: Color-coded, as described above. Name: Each checklist should have a name that clearly identifies its use. For a checklist in development, selecting the name brings up a form for editing the name. Activation Date: The activation date is set automatically when you select the Make Active link, which you must only do when you are ready, as described below. Latest update: Set automatically whenever you change the checklist/version during the In Development phase. Definitions/Edit: The Definitions link allows you to view eligibility criteria in the format in which they were entered. The Edit link, available only on checklists that are in development, takes you to the Eligibility Checklist Edit page to edit the checklist. Preview: This link allows you to view the checklist the way someone entering an eligibility form would see it. Make Active: This link promotes a checklist from in development to the version that is in use. Make sure that the IRB has approved this version. And make sure the version correctly matches the approved criteria, because you will not be able to edit them. The version that is active when you select this link will be archived. PDF: Short for Portable Document Format, this link provides a printable checklist that can be used when determining the participant s eligibility. Responses on the form would then be entered into CRMS. Building an Eligibility Checklist There are a number of ways to start building an eligibility checklist. Every new study in CRMS is created with a default checklist consisting of a single This participant is eligible question. You can use this or create your own. All of the ways to work on a checklist start from the Eligibility Criteria page: 2. Select Eligibility Criteria from the left side navigation bar:

3 Create a New Checklist To create a new checklist from scratch: 2. Choose Eligibility Criteria from the left side navigation bar. 3. Choose New Form (annotation 3 on the example page above) to build a new Eligibility Checklist. 4. On the page that appears, create a Name for the Eligibility Checklist or use the Computer-generated name. 5. Choose Main as the type of Eligibility Form. 6. Choose Save. This will create your new checklist and take you to the Editing Form, described below. Create a New Version of a Checklist To create a new version of a checklist on your study: 3. Select the New Version link (annotation 6 on the example page above) for the checklist you want to copy. 4. On the page that appears, create a New form name for the Eligibility Checklist or use the Computer-generated name. The form type is taken from the original form. 5. Choose Save. This will create your new checklist and take you to the Editing Form, described in the next section. Copy an Existing Checklist from Your Study To create a new checklist by copying one of the checklists on your study s Eligibility Criteria page: 3. Select the Copy to New Form link (annotation 4 on the example page above) for the checklist you want to copy. 4. In the popup menu that appears, enter a New form name for the new checklist form: 5. Choose Main as the New form type. 6. Select Copy to create the new checklist form and refresh the display to show your new checklist, or Cancel close to form without creating a new checklist.

4 Copy an Existing Checklist from Another Study To create a new checklist by copying a checklist from another study: 3. Select the Copy Form from Another Study button at the bottom of the page (annotation 5 on the example page above). 4. On the page that appears, enter the Protocol Number for the study with the checklist you want to copy, and select Search to search for that study, or select Back to go back to the Eligibility Criteria page. 5. If the search was successful, you will see the checklists for that study. It has view by checklist status options, just like your own study, so you might have to change the Checklist Status to see the checklist you are looking for. If you find it, select the Copy to New Form link. 6. In the popup menu that appears, enter a New form name for the new checklist form: 7. Choose Main as the New form type. 8. Select Copy to create the new checklist form and refresh the display to show your new checklist, or Cancel close to form without creating a new checklist. The Eligibility Checklist Editing Form Build your checklist by adding eligibility criteria, each of which will be one of two types: Inclusion Criterion: questions must be answered Yes to be eligible. Exclusion Criterion: questions must be answered No to be eligible. Let's add an Inclusion Criterion to an empty checklist: 1. (Optional) Select the "Inclusion Criteria" link. This is a section header for criteria, all of which must be of the inclusion type. On the page that appears, you can enter additional information about this section of questions. 2. Click on "<add criterion>" to redraw the page with a form at the bottom for you to define each of the Inclusion Criteria for your study. 3. Under Criterion in the new form, enter (or cut and paste) the first criterion as stated in your study s protocol. The contents of this box are formatted as MediaWiki text, allowing simple options like bulleted and numbered lists. 4. Under Additional Information, add any additional information about this specific question that would be helpful to the study staff (not required). 5. All questions default to Yes/No input unless one of the following options is selected: Select Include N/A Option if you want to add N/A (not applicable) to the default Yes/No option. Select Require a date to indicate that you need a date associated with this criterion. Select Require a text field to indicate that you need a text answer for this criterion.

5 Select Insert a field for entering and checking a value to indicate that eligibility depends on comparing the response to some other value(s), e.g., age is 18 or older: 6. Select Save to save this criterion and close the add criterion form, or Close to close the form without saving. Your options at this point are to: Continue building the eligibility checklist by adding more inclusion or exclusion criteria or more sections by selecting <add criterion> or <New section> links, Edit criteria by selecting the criterion text, which is a link, Delete criteria by selecting the big red X: Rearrange criteria by clicking the up and down arrows on items you want to move: Select Preview to see what you have so far as a teammate would see it, Select Make Active to make this an eligibility checklist your team can use, but you will not be able to edit, or Select Back to List to see the list of checklists, where the status of this checklist will be In Development. You can come back and finish this checklist later. Getting More Help Clinical Research Management System (CRMS) Support Pool: crmshelp@jhmi.edu phone: CRMS Training Website: CRMS Website: