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Contents of a patient archive
Each CRF page in a patient archive can contain the following data:
- Form and item comments.
- Signature history.
- Item audit trail.
The CRF page includes links to the following types of detailed information:
Click this link |
Link location |
To display the |
|---|---|---|
Association Summary |
Right column of repeating form instance |
Summary of repeating form instances associated with the instance where the link appears. From the association summary table, you can navigate to either association audit history or each of the individual associated pages. |
Audit Trail |
Right column of item |
Audit trail of data changes and query activity for the item. |
Comments |
Right column of item |
Audit trail of comments made on the item. |
eCRF Audit Trail history |
Top of form |
Audit summary for the entire form showing data changes and query activity for each item in the form. |
Form Comments |
Top of form |
Audit trail of comments made on the form. |
Initial Entry |
Right column of item |
Record of the initial entry of data on the item. This link is visible only if no activity has occurred since the initial entry. If the item data has changed or includes query activity, the initial entry is included in the Audit Trail of the item. |
Repeating Pages |
Right column of repeating form instance |
Snapshot of current data values in the repeating form instance. |
Deleted items
Within the InForm application, items that are deleted appear crossed out. If you create an archive for a form that contains a deleted item, the item appears with the word DELETED in bold above it.
Repeating forms
Repeating forms are displayed individually and in summary form. The summary page shows only the data for the first key items in a single table. The details of each form appear in following tables. For example, for the Adverse Events section, a summarized version of the form appears first, with a list of all the adverse events entered. The details of each instance follow the list.
