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Agenda

Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage: Correlation with Subsequent Post-Closure Deep Wound Infection ( Bioburden Study ) Research Coordinator Training - August 18, 2011 PI: Michael Bosse (Carolinas Medical Center). Agenda.

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Agenda

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  1. Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage: Correlation with Subsequent Post-Closure Deep Wound Infection (Bioburden Study) Research Coordinator Training - August 18, 2011 PI: Michael Bosse (Carolinas Medical Center)

  2. Agenda • Review regulatory and administrative procedures • Reporting Requirements • IRB Procedures • Certification Procedures • Invoicing • Study Materials • Study Contacts • Timeline • Tissue collection during hospital readmission • Overview • Site presentations • Discussion

  3. Regulatory and Administrative Procedures

  4. Reporting Requirements

  5. IRB Procedures • Submit master protocol to local IRB • Includes required DoDlanguage • Includes consent form with required DoD language • Submit IRB approved documents to HRPO for review and approval • Must include PI biosketch/CV, description of roles and responsibilities, human subjects training certification, and conflict of interest statements for PI and AIs.

  6. IRB Procedures • Continuing review approvals must be submitted to DoD HRPO • Bulletin Board on the METRC website will list IRB FAQs and provide an area for Research Coordinators to communicate with each other and post study related questions

  7. Certification Procedures • Use these forms as a guide to assemble the information required by DoD HRPO. • Complete certification forms and submit electronically to the MCC Study Manager. • Training • IRB approval • REDCap access • Biospeciman shipping certification (must be compliant with 49 CRF 172.704(a) and IATA DGR Subsection 1.5) • Must receive approval from MCC before patient enrollment can begin

  8. Invoicing • Core sites will be paid up to $500 and satellite sites will be paid $1000 for each patient enrolled. • On a quarterly basis the METRC Coordinating Center (MCC) will run an enrollment report from the REDCap system for each site.  • The MCC will send the report to the site for signature and verification.  • The site  will be required to sign this report and send it back to the MCC as a PDF document via email or through the mail.  • Once the signed document is received by the MCC it will be processed for payment.

  9. Study Materials • Protocol • CRF Binders (for each patient) • CRF Guidance Document • Manual of Operating Procedures (will be available on line) • Patient Enrollment Materials (English & Spanish) • Brochures • Tissue Collection Kits

  10. Study Contacts • For questions about eligibility: • Michael Bosse (PI)- pager # included in the CRF Guidance Document • For technical (REDCap) assistance: tech@metrc.org • For questions related to all other study procedures: • Post questions to METRC Bulletin Board • If you have questions specific to your site, contact the MCC Study Manager, Marcie Maichle (mmaichle@jhsph.edu)

  11. Timeline and Next Steps • Master protocol pending final DoD IRB approval • Distribute final study materials by the end of August for submission to local site IRBs (will be posted on the METRC website) • Materials should be submitted to local IRBs by early to mid September • Upon certification, materials will be distributed • 9 month patient enrollment period • 1 year follow-up

  12. Tissue Collection During Hospital Readmission

  13. Overview • Tissue samples will be obtained prior to definitive wound closure and during the first readmission for surgical treatment of a deep infection, non union, flap failure, or amputation • Four tissue samples obtained during the index hospitalization; two tissue samples obtained during first readmission • Two different tissue sample collection kits

  14. Capturing readmissions is going to be a challenge! • Only the first readmission matters!! • How will you track readmissions at your site? • At night • On the weekends • How will you ensure that tissue samples are obtained during the readmission procedure?

  15. Tissue collection plans at METRC sites • How will participants generally be readmitted? • How will participants be identified if readmitted during a) normal business hours, b) in the middle of the night, c) on the weekend • Who will be responsible for ensuring that tissue samples are obtained a) normal business hours, b) in the middle of the night, c) on the weekend • How will attendings and residents be educated about the study? • Where will samples be stored until they can be shipped? • If the primary coordinator is unavailable, what is the backup plan? University of Mississippi (Lori Smith) BAMC, TX (Mary Fan) Hennepin County Medical Center, MN (JR Westberg) Carolinas Medical Center, NC (Rachel Seymour)

  16. DISCUSSION

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