Post on 11-Jan-2016
Online
Data Management System:Navigating the ACRIN Website
http://www.acrin.org
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Click Rescue: Directed to protocol specific material.
OrClick Protocol Summary Table: Type in protocol number, click on 4701 and then you are directed to protocol specific material.
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Specific Form Instructions
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Data Center Login
Accessing the Data Center-Web form Data Entry System
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View Patient Calendar
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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
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Site Operations Tool
Participant Form Calendar
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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.
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Forms Due Report
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Revise-It
http://www.acrin.org
Data Management Research Associates: Kimberly BrownRoberta Clune Bola ShodunkeVictoria Shoyelu
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Please read.
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Revise to “No”
Please Note: • When revising incorrect data validation checks are in place
(future dates, range check, etc.)
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• 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.
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• 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.
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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.
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• 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”.
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Thank you for participating in this trial.
Questions?
Slide presentation prepared by Kimberly Brown
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