eCRF COMPLETION
GUIDELINES
Version 1.2; 14-July-2011 Confidential Page 6 of 55
appear after saving the form). A new window will open for additional comments
to be entered. To save the comment, click the „Save Annotation‟ button.
The types of edits that may appear in the Errors and Warnings window are
„CRITICAL‟, „ERROR‟, and „WARNING‟. These messages are color-coded to indicate
their severity and the action that is required:
1. „CRITICAL‟ messages are Red and must be addressed in order to save the
form at all.
2. „ERROR‟ messages are Dark Red and must be addressed in order to save the
form with a status of „Complete‟.
3. „WARNING‟ messages are Grey and are informational. These do not affect
the saving the form.
These Errors and Warnings provide guidance to the site on entering logical, valid,
range appropriate information as specified in the protocol.
At the end of each form you have the option of saving the form as „Complete‟ or
„Incomplete‟. You may only save the form as „Complete‟ if all „CRITICAL‟ and
„ERROR‟ edits in the Errors and Warnings window have been resolved, the data is
accurate, and the form is ready for an electronic signature. You may save a form as
„Incomplete‟ as long as all „CRITICAL‟ edits have been resolved. If the form is saved
as „Incomplete‟ the EDC system will save the most recently entered responses and
the form can be updated at a later time.
NOTE: Once the form is signed electronically, only authorized Signature Users will
have permission to modify it. All forms must be signed at the end of the survey.
1.4 Patient Data
To enroll a new patient into the registry, click the „New Patient‟ link on the main portal
page after login. You can also enroll a new patient by clicking the „Enter New Patient‟
link on the Patients tab. After you have entered the information and ensured data
accuracy, select the „Complete‟ form option. If you wish to save the data you have
entered but want to return to the form to complete it at another time, select the
„Incomplete‟ option. You will then have the option to „Save and Exit‟ the form or you
can click „Save and Continue Data Entry‟ to move to the next form. The system will
alert you to any missing patient information prior to moving to the next form. The
completed form will be saved as a „Date Link‟ on the Patient Grid. The Patient Grid is
where you will see all saved patient forms. Within the Patient Grid, you will also have
the ability to enter new forms for the patient. Refer to the „User Manual‟ link located
within the top right corner of the EDC system for further information on the Patient
Grid.
1.5 Patient Identifiers and Header Information
The patient ID will be obtained at the time of enrollment. As soon as the Anesthesia
form is saved, the patient will automatically be assigned a unique Patient ID in the
following format: #### - ####. The first part of the ID (####) represents the Site ID.
The second part of the ID (####) represents the unique patient number. The Clinic ID
and patient ID will not need to be entered at each visit and will populate automatically
at the top of the screen after initial entry at the Baseline visit.