Page 76 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
Research Administration SOP No: R-Reg-005 SOP Title: Securing Reimbursement for Your Study
Confirm/Complete the first two columns (Procedures & Visit) with quantity and occurrence./ The appointed QS will complete the SOW. You can use this guide to inform your review.
Lab Manual:
• Central/Local Processing • Bundling
• Timing/Occurrences
Don’t forget the Fine Print!
* Visit 103-120/203 220 are combination of in-person and phone visits.
** For the participant who participates in the 2nd PK/PD dose, Visit 299 and 301 may occur on same day (part 2). 2 Vital signs at 11hrs, 12hrs, and 18hrs are optional unless the patient stays on site. 24hr vitals will be done if the patient stays on site or returns the next day. Subjects < 6yrs: weight measurement every 3 months Subjects ≥ 6yrs: weight measurement every 6 months
4 Must be performed within 1 month of Visit 1 (Part 1) or Visit 301 (Part 2). 5) Serum pregnancy test for positive urine pregnancy test
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