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NORIG SOP Part I: Clinical Center Operations
6.7.
6. Study procedure
Follow-up Medical History (FH form)
Who
• Complete for all NORIG patients
• Study Physician and Clinical Coordinator sign the form
What
• The form queries/reviews
– Change in patient’s symptoms
– Medical history diagnoses
– Emergency room visits, hospitalizations, and procedures since the last visit
– Medication use since the last visit
– Gastroparesis symptoms inventory including the global overall relief and the clinical
global patient impression questions
When
• Visits f03, f06, f09, f12, f15 and f18
How
• Mix of interview data and data obtained by chart review
• Questions on the FH form can be answered by interview with the patient – i.e., use all sources
to get the most accurate information that you can
• Attach a preprinted MACO label to page 5, Gastroparesis Symptoms Inventory, before
separating and giving the questionnaire to the patient for completion
• Clinical coordinator should check the returned page for missing items or other problems for
resolution before the patient leaves the clinical center
• Page 5 should be re-attached to the FH form.
GPCRC/NORIG/NORIG_SOPI\M anall_47
10:39 am Thursday, August 18, 2011/klc
NORIG SOP – Part I
Confidential, not for citation
Instructhi