Reporting on clinical data

When you create reports using clinical data, keep in mind:

• Clinical data availability and organization are unique to each study; for this reason, reports that contain clinical data may not be validated to use across studies.
• Data that is entered on clinical forms can be changed several times during the course of a study. Although the InForm application captures audit trail data and stores it in the Reporting and Analysis database, the available clinical data elements in the InForm Ad Hoc Reporting tree return only the most current values and revisions for any controls in clinical forms.
• A study is likely to go through many study versions. For example, forms and items might be added to or deleted from the original study design. The Clinical Data by Form folder contains data elements for every form and item that have ever been used in any version of the study.
• Your site associations and the display override settings on items determine the way reporting elements appear to you in the InForm Ad Hoc Reporting workspace. For example, if an item is not visible to you in the InForm application, when you create a report that contains the item, the cells in the row that corresponds to the item contain the text N/A.
• When creating reports using clinical data, you must include a unique identifier for the study component on which to report. For example, to create a clinical report about a particular subject, you must use whatever identifiers uniquely identify the subject in your study. Depending on your study design, you may use:
  • Subject Number, if unique Subject Numbers are assigned for your study.
  • Subject Number and Subject Initials, if unique Subject Numbers are not assigned for your study.
  • SubjectID.
• When the same form is used in multiple visits, if a subject does not have any instances of the form, the resulting report may display extra rows that contain incomplete information. For more information, see Reporting on multi-instance forms and visits.