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Standard Operating Procedures (SOP)

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

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Standard Operating Procedures (SOP)

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  1. Standard Operating Procedures (SOP) Julie Mook-Kanamori Clinical Research Coordinator

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

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

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

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

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

  7. 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

  8. 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

  9. Case – Control Linking • Linking log sheet • Subject ID • Age • Sex • Ancestry

  10. Questions • Are there any questions?

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