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Timings and Default Behaviour
In the Timings and Default Behaviour section, you may define some settings pertaining to the data collection screen.
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Subject Number Settings
In this section you may define the defaults for Subject Numbering in ClinSpark. In each Study, a Subject may have various numbers, that will help you track them: Appointment Number in the Volunteers > Calendar module, Screening, Lead-In, Randomization Numbers in Study > Configure > Epoch > Cohort.
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Click here to read more about Subject Numbering.
Eligibility Options
In this section, you may define the options that appear to the user, when they are evaluating the Subject Eligibility in the Study > Subjects module.
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Unspecified - there is no confirmed eligibility status.
Pending - the Subject has some information, but the final eligibility decision is still pending. For example, this can be used whilst the Labs are still pending or whilst the Subject is pending another eligibility reevaluation during Lead-In, etc. So you may have several “phases” added to this pending period, by introducing “Pending Laboratory Results”, “Eligible for Day -1 evaluations”, or similar.
Eligible - the Subject has all of the necessary information in order to reach an eligibility decision. You may want to rename it to something that is more intuitive, for example “Eligible for Dosing”.
Ineligible - the Subject has been rejected from the Study, which could occur for various reasons. You could create an Eligibility Option of this Type that is called “Rejected at Screening”.
Adding an Eligibility Option
Click on the “Add” button in the Eligibility Options section.
Define the Name of the Eligibility Option. Define the underlying type of the Eligibility.
Provide optional Help Text to explain to the user what this Eligibility Option means.
Click “Save”.
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The underlying eligibility types can then be used in Cohort setup, in order to determine which Eligibility statuses are allowed to enter any given Cohort:
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Archiving an Eligibility Option
If you decide to stop using one of the Eligibility Options you have previously created, you can always archive it:
Click the Action menu and select “Edit”
Tick the “Archive” checkbox and provide the “Reason for change”.
Click “Save”.
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Default Comments
This is an opportunity to establish a Comment Library that the users could use in various situations during Data Collection and Sample Processing:
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Most of these default comments can be modified, when users click on them (text can be amended, deleted), except for the “Reason for Change”. Users can still add details, when they modify data, even if they cannot modify the “Reason for Change”.
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Adding a Comment
To add a new Comment, simply click the “Add” button:
Define the Type of the Comment
Enter the text of the Comment
Click “Save”
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Deleting a Comment
You can delete the Comments at any time, by simply clicking the “Delete” button.