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Summary
Requirements
# | Requirement | User Story | Acceptance Criteria | Jira Issue | Notes |
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1 | Display progress breakdown | As a data manager, I want to see a breakdown of data cleaning progress by subject and item group level, because this provides me with a logical breakdown of data still outstanding or under review. | Display progress of data cleaning at both subject and item group level | FHSD-942 | Subject view shows things at a ‘birds eye’ view, but doesn’t show what is outstanding. |
2 | Review progress per subject | As a data manager, I want to see the progress of data cleaning per subject, so get an understanding of how far along each subject is with data collection and data review. | Track the percentage of completed data Track percentage of locked data per subject | FHSD-942 | Alias information for the PI Signature item: |
Design
The report will be generated as an XLS file containing two tabs, containing subject level and item level details (respectively).
Filters
The Filters allow to include Randomized Subjects only or all Subjects.
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It is also possible to select one or more Subjects from the list.
Example Reports
Data Cleaning Progress Report Example:
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Role Dependencies
Certain areas of this report are dependent on strict Role definitions and make an assumption about how certain Roles are named in customer environments. Certain data may not be produced in these sections if the Role names do not match what is defined in the reporting configuration logic.
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If customers want to utilize this report but follow different or additional naming conventions for these Roles, they should reach out to Foundry Health via service desk ticket for assistance.
Data Mapping
TAB 1 - ‘Subject Level’ Tab
The subject level tab is intended to track data cleaning progress on a per-subject basis. For each subject who has participated in the trial, the following status fields help to track progress toward clean data:
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Subject status tracks the state or outcome of a subject’s participation in a trial. Options include Active, Completed, Terminated, and Withdrawn. These statuses are established within the Study > Subjects component.
ClinSpark
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Report
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Locked Subject (Y/N)
This field tracks whether data for an entire subject has been locked. Typically, subjects are locked as one of the final steps in data cleaning. Once a subject is locked, none of that subject’s data may be edited. Locked subjects are displayed with a lock icon next to the ‘subject’ hyperlink in the Study > Data component.
ClinSpark
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Report
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Existing Item Group Data
Existing item group data is a count of all item groups associated as part of a subject’s database, regardless of the status of the item group (i.e. unsaved, incomplete, complete, etc.). Within the Study > Data component, item groups are separated by light/dark shading.
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Further notes about the Form setup for PI Signature:
Name the Form / Item Group / Item whatever you like.
The Data Type for the Item can be anything you like (a Yes/No Code List, a boolean tick checkbox or any other option that you chose.
The Form does not need to contain a datetime field, the date of the PI signature will be taken from the audit trail.
The Form can be built into an Activity Plan as a scheduled activity or it can be added as an adhoc Form on the Data Collection page.
ClinSpark
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Report
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PI Signature Date
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The Report will not return the value recorded in the Item. For example, if you set it up as “PI Review” with Code listed answer “Yes” and “No”, it will not populate the column with the Yes or No value. The system will only look at the Item with the relevant Alias and if the Item has been completed during data collection, it will return PI Signature in the Report as “Yes”. Thus it is recommended to create the Item with only one possible option that reflects that the Review was done, for example, “PI Review Complete” with a boolean type checkbox for the PI to complete.
ClinSpark
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Report
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PI Signature Date
This field reflects the most recent date on which a PI completes the applicable ‘PI Signoff’ item that registers a PI’s acknowledgement of data approval. This date may be accessed by clicking on the corresponding item prompt within the Study > Data component.
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Name of the study displayed to users when navigating ClinSpark. Defined in the Study > Configure component.
ClinSpark
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Report
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Protocol Name
Protocol name of the study reported during data exporting. Defined in the Study > Configure component.
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Subject status tracks the state or outcome of a subject’s participation in a trial. Options include Active, Completed, Terminated, and Withdrawn. These statuses are established within the Study > Subjects component.
ClinSpark
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Report
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Locked Subject (Y/N)
This field tracks whether data for an entire subject has been locked. Typically, subjects are locked as one of the final steps in data cleaning. Once a subject is locked, none of that subject’s data may be edited. Locked subjects are displayed with a lock icon next to the ‘subject’ hyperlink in the Study > Data component.
ClinSpark
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Report
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Study Event
This field tracks the visit (or “Study Event”) against which each item group is associated. This helps users to quickly locate data that may require action (i.e. completion, review, or locking). Visit information is readily displayed in the Study > Configure component.
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