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