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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.
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
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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 Options include Active, Completed, Terminated, and Withdrawn.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.
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