PI Signature for Casebook

Principal Investigators have the ability to sign-off on a subject’s casebook once review of all data for the subject is complete.

PI Signature Status

The status of the PI’s signature is available in the PI Signature tab within a subject.  

A blue ‘X’ indicates PI signature is not complete:

A green burst indicates PI signature is complete:

ECDH Key

To sign off on a subject’s casebook, the Principal Investigator must create an ECDH key.  An ECDH is a public/private key signature using the latest elliptical curve technology. The private key is password protected.

Note:  Once the key is established, it will be used to sign-off on all subjects for all sites and protocols that the Investigator is associated with.

Applying PI Signature

1.  The total number of records available for signature is displayed on the PI Signature screen.  Clicking on the icon next to the records will display a scrollable list of all individual records:

2. Once all data has been reviewed, the PI can apply signature by entering the EDCH key and acknowledging review of the data.

3. Once signed, a confirmation will appear, including the total number of records that have been signed.

Signed/Unsigned Records Types

Next to each individual record is a code that corresponds with the type of record displayed:

• V:  Visit
• VP:  Visit Procedure
• SL:  Subject Log
• E:  Exception

Note:  The date time next to the record shows the last update time for the record.