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Compliance

Compliance. Enrollment Notifications and Monthly Logs. Overview. Compliance Track Record Enrollment Notifications Monthly Logs. Compliance Track Record. Compliance Goals. Our 2012 goal is 100 % compliance. Today we are at less than 30%. Enrollment Notifications.

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Compliance

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  1. Compliance Enrollment Notifications and Monthly Logs

  2. Overview Compliance Track Record Enrollment Notifications Monthly Logs

  3. Compliance Track Record

  4. Compliance Goals Our 2012 goal is 100 % compliance. Today we are at less than 30%.

  5. EnrollmentNotifications

  6. EnrollmentNotifications • Study Coordinators Responsibilities • Create an Enrollment Notification each time a patient is enrolled in a study.

  7. EnrollmentNotifications • Study Coordinators Responsibilities • Create an Enrollment Notification each time a patient is enrolled in a study. • Completed notifications must be faxed or emailed to OCR within 24 hours of enrollment.

  8. EnrollmentNotifications • Study Coordinators Responsibilities • Create an Enrollment Notification each time a patient is enrolled in a study. • Completed notifications must be faxed or emailed to OCR within 24 hours of enrollment. • Scan the signed Informed Consent into EPIC. When scanning in the signed consent form, remember to use a RESEARCH COVER SHEET and the Patient’s Label.

  9. Enrollment Notifications Enrollment Notifications inform the OCR of Patient Enrollment. All information on this Form is very important and must be completely filled out. If the MR is not available please provide Date of Birth or Social Security Number. As billing becomes more involved, the Subject Initials and Subject Number are becoming more and more important . They must be reported as well. (Provide Complete IRB #)

  10. EnrollmentLogs

  11. EnrollmentLogs • Study Coordinator’s Responsibilities • Fax or Email copy of Enrollment Log for current month only

  12. EnrollmentLogs • Study Coordinator’s Responsibilities • Fax or Email copy of Enrollment Log for current month only • Due on the last work day of the month no later than the 10th of the following month

  13. Monthly Enrollment Logs Common Errors Month /Year- this field refers to the Month you are reporting. Most often it is left blank or the wrong month is entered. IRB- incomplete IRB’s are being provided. Please report the complete IRB#. Moving forward , if there is no enrollment to report for the month please enter “ No Enrollment ” in the Patient Name column . Example: March 2012- No Enrollment Please utilize the Remarks/Screen Failure Notation.

  14. Super Stars The following coordinators are 95% to 100% compliant. They are quick to respond and correct errors found on logs. • Dr. Salihu’s Group: Chiaka Nwoga, Lindsey King and Ronee Wilson • Rachel Karlnoski • Laurie Joughin • Paula Cairns

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