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Summary

The Sample Processing report gives an overview of the different processing steps a specific sample went through during the duration of a study. This report gives insight in what steps occurred when, deviations, staff and comments as applicable for each collection.

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 for the study for a given sample path and selected subjects

As an end user, I should see all samples collected for the study

Include all samples collected for the output selected

3

If a sample collection form is cancelled it is not included in the sample processing report

As an end user, I should only see samples that marked complete in data collection

Cancelled samples should not be included

4

When more than one sample path is selected, all sample path details will be on one excel tab for the processing report

As an end user, each time a report is generaI want to generate a sample processing report for more than one sample path in a given study

Multi-select option for sample paths when generating a report

5

When no subjects are selected prior to generating the report, all subjects are included. Allow users to select more than one subject at a time for narrowing output

As an end user, I want to select all subjects or some subjects when generating a sample processing report.

Multi-select option for subjects when generating a report

6

Sample steps that are cancelled should not be included in the processing report

As an end user, I do not want to include cancelled sample tasks

Sample tasks that have been cancelled are not reported

Design

This report includes sample processing data for the study selected and will be generated as an XLS file with one tab of data. Data is only generated when samples have been collected and form(s) are in a conformant status.

Data Mapping

Volunteer

Unique number assigned to a volunteer. (Volunteers > Manage)

Gender

Gender of the volunteer. (Volunteers > Manage)

Race

Race of the volunteer. (Volunteers > Manage)

Age

Age of the Volunteer. (Volunteers > Manage)

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 > Epoch Details > Cohort Details)

Randomization Number

Cohort subject action to assign subjects their randomization number. (Study > Configure > Epoch Details > Cohort Details)

Lead-In Number

Cohort subject action to set the subjects lead-in number. (Study > Configure > Epoch Details > Cohort Details)

Source Barcode

The sample collection barcode number. If there is a suffix included on this barcode, it will be included on the report for any step that is not a pool or aliquot step. (Samples > Manage)

Transfer Barcode

Upon the transferring a sample, a new barcode will be associated and reported. (Samples > Manage)

Timepoint

Timing relative to segment reference activity plan. (Samples > Manage)

Sample Path

The sample path assigned to the form and used for processing the sample. (Samples > Manage)

Sample Path Step

A sample task configured within a sample path. (Samples > Manage)

Material

The name of the transfer material otherwise defaulted to be Source. (Samples > Manage)

Device

If a device is used during sample processing, the name of the device will be included. (Samples > Manage)

Acquire Date

The date of the sample collection. (Samples > Manage)

Acquire Time

The time of the sample collection. (Samples > Manage)

Start Step Date

When a sample task is configured to be a batch, the start date for the batch will be reported. (Samples > Manage)

Start Step Time

When a sample task is configured to be a batch, the start time for the batch will be reported. (Samples > Manage)

Step Date

The date of the sample task or the end date for a batch task. (Samples > Manage)

Step Time

The time of the sample task or the end time for a batch task. (Samples > Manage)

Deviation

If deviation pre or post windows are configured for a sample task and the step is completed outside the configured windows, the deviation will be reported. (Samples > Manage)

Skipped

If a sample task is marked skipped a ‘y’ will be reported within the skipped column. (Samples > Manage)

Time from Aquire

The calculated time from collection to the start of each task. (Samples > Manage)

Shipment

When samples are added to a shipment, this is the name of the associated shipment (Samples > Packaging)

Shipment Date

The date of creation for the shipment. (Samples > Packaging > Shipments)

Sample Container

The container that samples have been added to. (Samples > Packaging)

Specimen Container

The container(s) configured for the sample path and/or sample tasks. (Samples > Manage)

Staff

The staff member who processed the sample task. (Samples > Manage > Audits)

Comments

When a user annotated on a sample task. (Samples > Manage)

Example Report

You can download an example spreadsheet to get a feel for the output of this report:

Report Generation

Report Type = Sample Processing

Select Desired Sample Path(s).

Select no subject to include all subjects or alternately narrow output to selected subject.

Image

The default icon representing this report. (Study > Report)

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