Signing a CRF or case book
The procedures for signing a CRF or a case book are the same, with the following exceptions:
- To sign a case book, you sign the form designated as the form on which a signature represents a signature on the entire case book.
- The buttons and controls used to sign a form and a case book are labeled differently; you can access the form signature page from a Sign button or link, but you access the case book signature page from a Sign Book button or link.
Before you can sign a CRF, the following conditions must be true:
- The CRF is set up as a signing form.
- You have the right to sign CRFs.
- You are in the same signature group as the CRF.
- No other user in the signature group has already signed the CRF.
- The CRF has at least one data item entered.
Before you can sign a case book, the following conditions must be true:
- A CRF has been set up as the form used to sign case books.
- You have the right to sign case books.
- You are in the same signature group as the case book.
- No other user in the signature group has already signed the case book.
- At least one data item is entered in the final CRF of the case book.
To sign a CRF or case book:
- In the Navigation pane, click Signatures.
The Required Signatures page appears.
- Use the drop-down lists at the top of the page to select the CRF or case book signing information you need. The following table summarizes the criteria you can select. In addition to these selection criteria, you can select All to display all forms or case books in the category.
To display forms or case books for a …
Select from the …
Site.
Site list. This list is visible if you have rights to view information for more than one site.
Patient.
Patient list.
CRF or case book signature.
Type list.
Signing status (signed or unsigned).
Status list.
Form or case book completion status (All, All Signatures Complete, Not All Signatures Complete, With Queries, With Missing Values, Missing & Queries, Frozen, Locked, Ready for SV, Completed SV, SVed and Complete, Complete, Not Done, Deleted).
CRF/Book status list. Note that the InForm application ignores filters that do not apply to the selected Type. For example, if you select case book from the Type list and select Ready for SV in the CRF/Book status list, the InForm application ignores the Ready for SV filter, since SV readiness applies only at the CRF level.
Note: Use the page indexer control to navigate through multiple pages of the Required Signatures page.
- Click the Sign or Sign Book link for the form you want to sign.
The signing affidavit appears.
- Read the affidavit. In the User name and Password boxes type your InForm application username and password.
Note: You need to enter both username and password only the first time you sign the form during an InForm session. If you need to re-sign a form because of intervening activity that causes the form to become unsigned, enter only your password.
- Click Submit.
The InForm application updates the signing status on the Required Signatures page, on the Signature Status Details page, and on the CRF.
Note: Another way to access the signing affidavit for a signing CRF, without going through the Required Signatures list, is to click Sign CRF on the signing CRF. Another way to access the signing affidavit for the CRF designated for signing case books is to click Sign Book on the Time and Events Schedule or on the form.