Timings and Default Behaviour
In the Timings and Default Behaviour section, you may define some settings pertaining to the data collection screen.
The Warning Seconds and Urgent Seconds values determine when the clock on the Data Collection page changes colour. The clock remains in the default blue colour until the Warning Seconds window comes. The clock remains in the Warning Seconds window colour (defaulted to orange) until the Urgent Seconds come. The clock then remains in the Urgent Seconds/late colour (defaulted to red) until it is collected. The default colours can be adjusted to your desired colours by the Foundry Health Superadmins.
Default Timings? - this setting, if enabled, will fill the datetime fields with the “current date/time”, when the user opens the Form for collection. If set to no, then users will need to enter the time manually.
Default Timings to Scheduled? - if set to yes, defaults the value of each datetime Item to the Scheduled Time. If set to no, then users will need to enter the time manually.
Allow Scheduled Time Button - enables the “Scheduled Time” button for every Item. Clicking the Scheduled Time button will populate the datetime field with the date and time that the activity was originally scheduled for.
Hide Collection Time Input? - If set to no, it will display the “Collection Time” field on the data collection Form. If set to yes, this may still be accessed via Form Actions > Collection Time. This field allows to indicate the collection time for Forms that do not have a dedicated datetime Item to record it.
Disable Collection Time? - if this is enabled, then the “Collection Time” field is not available and the server automatically registers the date/time of when the user clicked the “Save” button on the Form. This can be overriden, whilst adding Forms to an Activity Plan.
Require Device Scan? - this field is used for the Device Integrated Forms. If set to no, then the user will have an “Invoke Device” button within Form in order to start data collection from the device. If set to yes, the user will need to scan the device to trigger data collection.
Required ClinSpark Agent Version - here, the acceptable versions of the ClinSpark Agent for your instance of ClinSpark. If the machine that the user is using for Data Collection does not have a matching version of ClinSpark Agent, they will not be able to print barcodes or use devices to collect data.
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.
In the General Settings you may define the most often used numbering settings. These can be overriden for each specific Study in Study > Configure > Subject Numbering.
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.
One or more options may be defined for each underlying Eligibility Type:
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”.
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:
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”.
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:
Data Annotation
Data Deviation
Reason for Change
Sample Annotation
Sample Deviation
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”.
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”
Deleting a Comment
You can delete the Comments at any time, by simply clicking the “Delete” button.