Summary
The Interval Summary Report includes all interval container (IC) details from Data Collection and Samples > Intervals. This report is driven from the Base ClinSpark Form ‘PK Interval Start’ and the repeating item group ‘Interval Container’.
Requirements
# | Requirement | User Story | Acceptance Criteria |
|---|---|---|---|
1 | Report should be an excel document | As an end user, I should be able to open this report in Excel | Report is manageable in excel. |
2 | Should list all samples collected interval containers used for the study and the interval summary details | As an end user, I should see all interval containers used for the study and the interval summary details | Include all urine interval summary details when ClinSpark base forms are used for interval collections |
3 | When more than one interval container is added to an interval time point, the net weight of the interval should be updated to reflect the total current volume each time the report is generated | As an end user, each time a report is generated the total net weight should be updated accordingly should there be more than one interval container added to the interval summary | Net weight updates when more than one interval container has been added to an interval time point |
4 | If an item is cancelled within the form it should not be included in the report | As an end user, I do not want to report cancelled items | If a form has a cancelled item do not report out |
Data Mapping
Study Name
Name of the study displayed to users when navigating ClinSpark. (Study > Configure)
Protocol Name
Protocol Name of the study reported during data exporting. (Study > Configure)
Cohort Name
Cohort within which subjects of interest are contained. (Study > Configure)
Study Event
A study’s data collection event assigned to form. (CRF Design > Activity Plans)
Screening Number
Cohort subject action to set a screening number for a subject. (Study > Configure > Cohort Details)
Lead-In Number
Cohort subject action to set the subjects lead-in number. (Study > Configure > Cohort Details)
Randomization Number
Cohort subject action to assign subjects their randomization number. (Study > Configure > Cohort Details)
Timepoint
Timing relative to segment reference activity plan. (CRF Design > Activity Plans)
Form
Along with Study Events forms are used to create an activity within an activity plan. (CRF Design > Activity Plans)
Void Time
Date/time of each void corresponding to an interval container. (Study > Data)
Interval Container
Associated interval container to a void time. (Study > Data)
Empty Weight (g)
Weight of the empty interval container. (Samples > Intervals)
Weight (g)
Weight of each interval container. (Samples > Intervals)
Weight Time
Time the interval collected was weighed. (Samples > Intervals)
