1. Online Data Management System: Navigating the ACRIN Website http:// www.acrin.org http:// www.acrin.org Page 1

2. Click Rescue: Directed to protocol specific material. Or Click Protocol Summary Table: Type in protocol number, click on 4701 and then you are directed to protocol specific material. Page 2

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7. Specific Form Instructions Page 7

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12. Data Center Login Accessing the Data Center-Web form Data Entry System Page 12

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27. View Patient Calendar Page 27

28. Select the View Patient Calendar link to view each participant calendar. The calendar lists all data expected for submission, i.e. data forms, images, and reports when applicable. The calendar is updated upon data submission. Calendar Page 28

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31. Site Operations Tool Participant Form Calendar Page 31

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36. Single: Form code that only occurs once in the database with one due date. (Ex: CR form). Multiple: Form code that occurs multiple times for a participant. The calendar will have multiple due dates. (Ex: F1 form, occurs at 6,12,& 24 months). Both: See both single and multiple occurring forms. Page 36

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39. Forms Due Report Page 39

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42. Revise-It http://www.acrin.org Data Management Research Associates: Kimberly Brown Roberta Clune Bola Shodunke Victoria Shoyelu Page 42

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49. Please read. Page 49

50. Select the correct form by matching the Form ID to the Form “Due Date”. Page 50

51. Revise to “No” Please Note: When revising incorrect data validation checks are in place (future dates, range check, etc.) Page 51

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53. Query Response: Applies to a Z1. Site Revision: Applies to queries received via excel spreadsheet. Applies to a random update to a form by the site. Audit QC Finding Correction: Applies to data revisions found during an site audit. Page 53

54. If “Query Response” is selected, a prompt will appear instructing users to select the appropriate/corresponding query. All due dates for outstanding queries for the case will be listed at the bottom of the screen. Check the due date of the query that applies to the revision. When finished, select the “Save and Submit” button. To cancel revisions, select the “Correct Form” button. Page 54

55. Once revisions are submitted/saved, a confirmation e-mail will be generated which includes two attachments: Completed revised form with a version number which will change with subsequent revisions to a form. Summary form showing only the changes that were made during that particular session. An example of the e-mail and attachments will be presented by ACRIN 6684 on the next couple of slides. Page 55

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61. Additional Information Needed: As of 26-Sep-11, sites participating in ACRIN studies are able to revise data online. Does not apply to multiple occurring forms (ex: AE, MH etc.) Revisions to these forms must be faxed to ACRIN. Remember: When revising data, make sure to correct the source document using GCP guidelines. (Line thru the error, write corrected data, date and initial the change). The corrected CRF does not need to be sent back to ACRIN. The only time the Z1 needs to be sent back to ACRIN is if there was no correction made, “Data Correct As Is”. Page 61

62. Thank you for participating in this trial. Questions? Slide presentation prepared by Kimberly Brown Page 62