Interval Summary (Report)

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

#	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 interval summary details when ClinSpark base forms are used for interval collections
3	If an interval does not contain any interval containers, the start and stop time should still export	As an end user, I should see all interval start and stop times for the study	Include all interval start and stop date/times with blank interval details
4	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
5	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)

Target Item Identifier should be an alias associated with an item

Interval Start Time (PCDTC)

Alias Name = Interval
Alias Context = Start Time

Interval Stop Time (PCENDTC)

Alias Name = Interval
Alias Context = Stop Time

Collection Time

Date/time of each void corresponding to an interval container. (Study > Data)

Target Item Identifier should be an alias associated with an item

Void Collection Time (PCVOID)

Alias Name = Interval
Alias Context = Void Time

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)