Page 465 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
Research Administration
• Enrol/Randomize
• Consent
• Source Documents
• Complete/enter CRF’s
• SAE/AE reporting/Med watch
• Query resolution
• Lab Orders
• Specimen Collection
• Specimen Processing
• Vitals signs, weight, EKG, etc
• Drug Administration
• Family Education: requiring license
• Family Education: non-license
• Shipping
• Study Manager
• Other (specify)
5. SPECIFIC PROCEDURE
1. Put together a study report of information about the study such as:
a. Feasibility Analysis with Team Lead (ensure TL is added in Velos and eIRB as Other Study Personnel)
b. Laboratory Questionnaire
c. CTS and SOA
d. EPIC RBR tracking and management
e. PI/Sponsor/CRO/Industry vs. Investigator Initiated
f. Type of study
i. Inpatient and/or Outpatient
ii. Observational vs. Treatment
iii. Retrospective chart review vs. Prospective
iv. Safety/Efficacy
v. Randomization, Stratification, etc.
vi. system, training
vii. Expected study start date
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SOP No: R-Com-101 SOP Title: P.A.C.T