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Protocol Deviations. MTN protocol deviation policy. MTN has recently revised their policy on PDs- this policy will be made available on the MTN website The Manual of Procedures for the MTN has also been updated to reflect this change

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Protocol Deviations

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    1. Protocol Deviations

    2. MTN protocol deviation policy MTN has recently revised their policy on PDs- this policy will be made available on the MTN website The Manual of Procedures for the MTN has also been updated to reflect this change Goal is thorough reporting of all deviations from the protocol

    3. Identification of deviations Protocol deviations may be identified through any of the following mechanisms: Site internal QA/QC procedures PPD assessment visits SCHARP notification through data review Study management team assessment visits

    4. Reporting of deviations Report deviation by completing and faxing a MTN-020 Protocol Deviations Log CRF If someone other than site staff initially identifies the PD, the site staff will be notified immediately so that they can report the PD Goal is to fax PD Log within 7 days of site awareness (like other non-AE CRFs)

    5. PD Log CRF Completion • Page: assign page numbers like other log CRFs, starting with 01 and increasing sequentially for each ppt • Site Awareness Date – date site became aware this was a PD requiring reporting • Deviation date – date deviation occurrerd or start date if deviation lasted >1 day

    6. PD Log CRF - continued • Item 3. Has or will this PD be reported to local IRB/EC? • Mark “yes” if planning to send to IRB at some point, “not required” if the particular PD does not need to go to IRB/EC • May not use “no” often – just included if PD should have been reported but was not • Item 4. Has or will the PD be reported as to DAIDS as a critical event? • Mark “not applicable” if policy is not final at time of PD report

    7. PD Log CRF - continued • Item 5 – type of deviation • Mark only one reason • Examples of some categories are provided on the back of the forms • Let’s discuss questions you have about items 5a – 5t

    8. PD Log CRF - continued • Item 6 – brief description of the actual deviation • Item 7 – describe your corrective action for the deviation • Item 8 – describe your preventative action plans (do not need to be final or completed at time of report) • Needs to be specific and applicable to the deviation • “will not do it again” – not good • Discuss re-training plans, plans for system modifications, etc.

    9. PD Log CRF - continued • Item 9 – record Staff Code number assigned to staff member reporting the deviation • Create staff codes if not already in place • Staff Initials/Date still needed in right-hand corner

    10. What is reported on PD Log CRF If you are unsure if the event should be reported as a deviation, contact the MTN Regulatory department Remember – 1 deviation per PTID per CRF For off-site visits where multiple procedures are not done (as planned), use “other” category to explain/document missed procedures

    11. PDs Not Reported on PD CRF 1. Missed visits 2. Participant non-adherence to study product use 3. Participant failure to return ring • These deviations are captured via other CRFs • Missed Visit, Ring Adherence, Ring Collection/Insertion • For items 2 and 3, chart notes or other source must document corrective and preventive action for the event

    12. After a PD CRF is faxed… If more information is needed, MTN Regulatory Department will follow-up with the site ‘Next steps’ or other follow up related to implementation (or prevention of further deviations) will come from the study management team

    13. Does this go on a PD Log CRF? HIV test results were given to a ppt, but HIV post-test counseling was not done A ppt misses the 2nd part of a split visit On the way to the lab, a blood tube breaks and cannot be used for Month 9 safety labs You forget to fax in the ppt’s Pelvic Exam form at Month 18 You discover a stored specimen is not correctly labeled You conduct a Month 6 visit off-site, and pelvic exam/pelvic specimen collection not done

    14. Network Oversight & PD Policy MTN Regulatory Department will regularly review PDs with Protocol Management Teams Safety Physicians Other network groups as necessary NEC DAIDS/OCSO PD listings to sites can be required as requested

    15. ASPIRE PD philosophy Deviations from the protocol are expected No one is perfect! However, we need to learn from our mistakes and major deviations will be looked at critically It is critical that the team is aware of what would be considered a major deviation and how to prevent these from occurring

    16. Questions?