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?