standard operating procedures (sop) julie mook-kanamori clinical research coordinator

STANDARD OPERATING PROCEDURES (SOP)Julie Mook-Kanamori

Clinical Research Coordinator

Overview• Categories of SOPs• Example SOP• Blood Sample Kits• Label coding• Case – Control Linking

SOPs Patient Visit• SOP Workflow Step-By-Step• SOP Patient Enrolment• SOP Control Enrolment• SOP Informed Consent Form

SOPs Data Collection • SOP Demographics and Clinical Questionnaire• SOP Ancestry Questionnaire• SOP Using SurveyGizmo• SOP Data Entry• SOP Data Storage• SOP Quality Control

SOPs Blood Samples • SOP Creating Labels• SOP Venepuncture• SOP Sample Processing• SOP Sample Shipment on Dry Ice

Example SOP• Purpose• Policy• Responsibility• Procedures• Post-processing• Contact for questions or injury

Blood Sample Kit• 2x EDTA tube 4.0ml, pre-labeled• 2x Cryovials 5.0ml, pre-labeled• 6x SubjectID stickers• Blood Specimen Collection form• Contact Information form

Label Coding• IRB-2011-0019 04-SubID 4001

• Each country starts with 100 kits, for example 3001 to 3100 for Lebanon• No linking codes between cases and controls linking log sheet

Site Site code Available numbers

Jordan 1 1001 – 1999

KSA 2 2001 – 2999

Lebanon 3 3001 – 3999

Qatar 4 4001 – 4999

UAE 5 5001 – 5999

Case – Control Linking• Linking log sheet

• Subject ID• Age• Sex• Ancestry

Questions• Are there any questions?