Download Standard Operating Procedures

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NORIG SOP Part I: Clinical Center Operations
6. Study procedure
6.5. EGG with satiety testing (ST form)
You may elect to start a study for a new patient in one of two ways:
•
Select the icon for a new file, from the toolbar just under the top menu.
•
Select File from the top menu, then select New Study, and then select New Patient.
De-identifying patient data:
–
For EGG recordings in the NORIG trial, do not enter patient addresses, phone numbers, or
social security numbers into the Patient Demographics screen. This will prevent protected
health information (PHI) from being displayed, printed, or transferred to Dr. Kenneth Koch
at Wake Forest University or the DCC for central reading. It is the responsibility of the
clinical center staff to ensure that system protections are utilized to meet HIPAA
requirements followed at your institution and implemented by the Gastroparesis Clinical
Research Consortium Steering Committee.
–
Do not follow the guidelines outlined in the 3CPM User Manual for entering patient
demographic for NORIG trial research purposes. Instead, enter the participant's information
as shown in the figure below:
GPCRC/NORIG/NORIG_SOPI\M anall_47
10:39 am Thursday, August 18, 2011/klc
NORIG SOP – Part I
Confidential, not for citation
ST