Knee Articular Cartilage Damage in Osteoarthritis

1. Knee Articular Cartilage Damage in Osteoarthritis ACRIN Data Management October24, 2006

2. Overview • Navigating the ACRIN web site • Registration • Case specific calendars • Form review • Data Management

3. Navigating the ACRIN Web Site

4. Access to Protocol page ACRIN Home Page: Protocol, Registration, Accrual

5. Protocol specific accrual updates will be projected within the Enrollment column. Clicking on the 4001 link automatically connects to the 4001 web page.

6. Protocol Resources Manuals Adverse Event [PDF] Procedure [PDF] Audit [PDF] PI [PDF] The Current Protocols screen provides links to the Protocol, protocol specific contents, participating sites, protocol resources and upon study activation PDF versions of all data forms. All documents and forms within the link are print ready.

7. If there are amendments made to a previously approved protocol version, the Summary of Changes link will detail the changes within the protocol by section

8. Registration

9. Access to all Protocol registration and data forms modules

10. Access to all active protocols and the pilot site is accessible through the Main Menu.

11. Jane_Doe Password

14. Select K-LScore

15. Registration • Appendix II • Standard demographic questions • Protocol specific questions • Message boxes appear specific to: • Required data • Validity of input • Date checks • E-mail confirmation upon successful registration • Participant stratified into 1 of 3 groups per K - L Score

16. Questions 1- 16 are the protocol specific eligibility criteria.

17. Demographic questions are 1-16 and are standard across all ACRIN Protocols. 18 Participants will be recruited into each Kellgren-Lawrence Score Required Signatures

18. Sharlene Snowdon

20. Case specific calendars

21. A participant specific calendar is generated on each case enrolled. The calendar will identify all data forms, images and reports due for submission. All forms are referenced by name, two letter ID, due date, assessed date and the received date.

23. 4001 14

24. The View Patient Calendar is static. Data entry of forms is only through the Data Collection link. The View Calendar list all data expected for submission specific to the case, i.e. data forms, images and reports when applicable. The calendar is dynamically updated upon data submission.

25. Form Review

27. The Data Collection screen only lists forms expected for submission through the ACRIN website. Upon submission of the form through the web, the received date is updated and the form is removed from the Data Collection screen. The receipt of the form is also updated within the View Calendar screen.

28. I1: On-Study Evaluation/Medical History • Records participant specific characteristics • Weight • Height • Documents detailed treatment participant received • Within the last 6 months • Continuing for the next 3 months • Dates and Signatures • Radiologist

29. Knee X-Ray must be performed within 60 days prior to registration Check box indicate multiple response capability: equivalent to a “yes” response Radiologist signature required Form ID; Current Version Date; # of Pages

30. KX: Koos Knee Survey • Participant completed questionnaire indicating how the participant feels about their knee and are able to perform daily activities • Divided into categories • Symptoms-Stiffness • Pain • Function: Daily living • Sports and recreational activities • Quality of Life • Instructions are provided before each section • Guide Participant on how to complete

31. Guidelines for proper completion of the Participant Survey

32. Remember to instruct Participant to select the best answer and to answer all questions. When entering the form on the web, only enter Participant’s initials. Remember form is to be completed on day of registration for complete accuracy. Instructions

33. Calculations are performed manually, the web site is not programmed to automatically calculate

34. M3: MRI Assessment FormLocal Reader • Form is completed at each time point • Gathers • General Imaging information • Associated Findings • When form is submitted, a copy of the MRI report for that time point must be faxed to • Data Management • 215-717-0936

35. Form is to be submitted even if imaging was not performed at that time point Military time is to be recorded

36. Boxes choose all that apply Radial buttons choose only one

37. PR: Protocol Deviation Form • Captures all occurrences that fall outside the protocol specific requirements • Inclusion/exclusion criteria • Imaging Parameters • Record only one deviation per form • Contact ACRIN Data Management when an occurrence is discovered so a form can be populated to Participant's calendar for direct data entry through the web

38. Only one deviation per form Remember to indicate time point

39. Date of actual occurrence: Registration Imaging Date you realized happening occurred

40. Data Management

41. ACRIN Data Management/Site Communications • Protocol specific conference calls • Telephone • E-mail • Data Queries • Forms Due Report • Communication Memo

42. Data Queries • Generated when: • Inconsistencies exist between data reported • Confirmation of data entered is necessary • Incomplete data fields • Request for Study Information Z1 • e-mailed to RA of record • Protocol, case, question specific • Due Date is the date query is mailed • Respond in timely manner • Reminder letters • 2 weeks from due date • 4 weeks from due date • 8 weeks from due date (final)

43. Z1: Request for Additional Information

44. Forms Due Report • Site case management tool • Request for outstanding data and future due data notification • Encourage prompt submission of data, reports, and images • Affords an opportunity to resolve discrepancies between the Institution's records and the Data Management Center • A listing of each item that has not been received by a specified deadline • Sent to the PI and RA of record for a protocol • Time specific and frequency

45. Forms Due Report

46. Forms Due Memorandum • M E M O R A N D U M • TO: PRINCIPAL INVESTIGATORS and RESEARCH ASSOCIATES • FROM: Sharlene Snowdon, AS, RT (R)(CT)(M), Senior Data Manager • DATE: XXXXXXXXXX • RE: Request For Outstanding Data/Reports/Images • Study: ACRIN 4001 • CC: Sanaa Boudhar, Biostatistical Center Coordinator • Anthony Levering, RT (R)(CT)(MR), ACRIN Imaging Research • Cynthia Olson, MBA, MHS, Project Administrator • _________________________________________________________________________ • Enclosed is a report outline of delinquent data forms, reports, pathology data and images for cases registered on Protocol 4001 through your institution. • The cut-off date of January 1, 2007 has been chosen. Any data items due to be submitted from the start of study activation, through January 1, 2007 and have not yet been received will appear on this list. The Forms/Images Due Report indicates past due forms as well as images due. Memo is sent to Study PI and RA Forms due “cut-off” date The report will identify all data listed within the report: forms, reports, images, and follow-up.

47. General Communication Memo • Communication memo is submitted to the Data Management Center for all instances in which a form is not submitted • Fax • 215-717-0936 • Mail • ACRIN Data Management 1818 Market Street Suite 1600 Philadelphia, PA 19103

48. EXAMPLE

49. Data Corrections • Corrections to data cannot be made through the web • Follow Good Clinical Practice, GCP • Revisions to data must be by mail or as directed • Corrections are noted on the original printed form • CRF or Summary Data Form • Single strike mark through incorrect data • Indicate the correct data • Initial, date