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WP 9-10 GRACE Online System

WP 9-10 GRACE Online System. G RACE O nline S ystem WP9-10 Frank Leus 14 September 2007 Stockholm. WP 9-10 GRACE Online System. Visit codes Labels GRACE packs Study flows Survey tasks and human tasks. WP 9-10 GRACE Visit Codes. Visit codes Patients

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WP 9-10 GRACE Online System

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  1. WP 9-10 GRACE Online System GRACE Online System WP9-10 Frank Leus 14 September 2007 Stockholm

  2. WP 9-10 GRACE Online System Visit codes Labels GRACE packs Study flows Survey tasks and human tasks

  3. WP 9-10 GRACEVisit Codes Visit codes Patients V1 = Visit 1  Inclusion of patient V2 = Visit 2  4 weeks after inclusion of patient Controls V0 = Inclusion of control

  4. WP 9-10 GRACEYellow labels for forms • Yellow labels for patients • 15 labels per patient for V1 and V2 • Labels provided for 350 patients per Network • Labels consist of Patient Study Number followed by ‘Pt’  e.g. L0213 Pt • Same labels should be used for V1 and V2

  5. WP 9-10 GRACEYellow labels for forms • NNF attaches yellow patient labels to the following forms: • Informed Consent form 2x, • Patient registration form 1x • CRF 1x • Diary 1x • X-ray requisition form 1x • Spirometry requisition form 1x • Investigator requisition form 2x (V1 + V2) • Local lab requisition form 2x (V1 + V2) • Sputum results 1x • And to the blue patient pack 1x    

  6. WP 9-10 GRACEYellow labels for forms • Yellow labels for controls • 10 labels per control • Labels provided for 350 controls per Network • Labels consist of Patient Study Number followed by Ctr  e.g. L0214 Ctr • NNF attaches labels to the following forms: • Informed Consent form 2x, • Patient registration form 1x • Control CRF 1x • Investigator requisition form 1x • Local lab requisition form 1x • And to the white control pack 1x

  7. WP 9-10 GRACEWhite labels for samples • White labels • Patients • 10 labels provided per patient for V1 • 5 labels provided per patient for V2 • Controls • 5 labels provided per control for V0 For each visit (V1,V2 and V0) there will be 75 numbers provided

  8. WP 9-10 GRACEWhite labels for samples • White labels • Labels consist of : • ‘GRACE’ • Patient Study number • Visit Number •  e.g. GRACE L0213 V1 • GP/Nurse attaches white labels to samples • The remaining labels will be send together with samples to local lab

  9. WP 9-10 GRACEGRACE packs • To be prepared by NNF • Patient packs (blue): • All forms to which yellow labels should be attached • Patient Information Leaflet • TempaDot disposable thermometer (use new ones) • Stamped self adressed envelope for return of patient diary • Sample packs V1 and V2, including besides sample material: • Requisition forms (GP and Local Lab) • Only for V1  sputum result form • White labels

  10. WP 9-10 GRACEGRACE packs • To be prepared by NNF • Control packs (white): • All forms to which yellow labels should be attached • Patient Information Leaflet • Sample pack, including besides the sample material: • Requisition forms (GP and Local Lab) • White labels

  11. WP 9-10 GRACE Online System Inclusion flow (for patients and controls)

  12. WP 9-10 GRACEInclusion of Patient or Control (1)

  13. WP 9-10 GRACEInclusion of Patient or Control (2)

  14. WP 9-10 GRACEInclusion of Patient or Control (3)

  15. WP 9-10 GRACE Online System Patients flow - Visit 1

  16. WP 9-10 GRACE Patient: Visit 1 (1)

  17. WP 9-10 GRACE Patient: Visit 1 (2)

  18. WP 9-10 GRACE Patient: Visit 1 (3)

  19. WP 9-10 GRACE Patient: Visit 1 DIARY

  20. WP 9-10 GRACE Patient: Visit 1 DIARY/ShortQc

  21. WP 9-10 GRACE Patient: SAE

  22. WP 9-10 GRACE Patient: SAE

  23. WP 9-10 GRACE Online System Patients flow - Visit 2

  24. WP 9-10 GRACE Patient: Visit 2 (1)

  25. WP 9-10 GRACE Patient: Visit 2 (2)

  26. WP 9-10 GRACE Online System Controls flow - Visit 0

  27. WP 9-10 GRACE Patient: Visit 0

  28. WP 9-10 GRACE Online System Samples flow - Visit 0, 1 and 2

  29. WP 9-10 GRACESamples: Local lab

  30. WP 9-10 GRACESamples: Central lab

  31. WP 9-10 GRACESamples: analyses

  32. WP 9-10 GRACE Online System Surveys and tasks - Visit 0, 1 and 2

  33. WP 9-10 GRACESurveys and human tasks on GOS

  34. WP 9-10 GRACESurvey tasks on GOS: Visit 1

  35. WP 9-10 GRACE‘Human’ tasks for NNF: Visit 1

  36. WP 9-10 GRACESurvey tasks on GOS: Visit 2

  37. WP 9-10 GRACE‘Human’ tasks for NNF: Visit 2

  38. WP 9-10 GRACESurvey tasks on GOS: Visit 0

  39. WP 9-10 GRACE‘Human’ tasks for NNF: Visit 0

  40. WP 9-10 GRACENew Survey listing • Make your selection • Click on ‘Search’

  41. WP 9-10 GRACENew Survey listing (2) • Surveys with status ‘new’ will not be shown in survey listing • Print/view possibility will soon be available

  42. WP 9-10 GRACERemember • Always include subjects to the correct GP •  Each GP should have their own account • After re-opening a ‘closed’ survey  always ‘finalise’ the survey • When training with GOS use: • The ‘Demo’ network • Subject numbers preceeded with an ‘X’ • Trial medication numbers in the range X001- X999 • Please, delete your test subjects when you are finished • Keep up with your tasklist!

  43. WP 9-10 GRACETasklist NNF Direct after inclusion of a Patient

  44. WP 9-10 GRACETasklist NNF 1 week after inclusion of a Patient

  45. WP 9-10 GRACETasklist NNF 6 weeks after inclusion day of a Patient

  46. WP 9-10 GRACECommunication • In case of GOS related questions: • e-mail to Jan-Willem Maaskant (J.W.Maaskant@UmcUtrecht.nl) • e-mail to Frank Leus (F.R.Leus@UmcUtrecht.nl) • Call the GRACE phone (+31627744069)

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