Site Management and Clinical Care Resource Committee

1
Site Management and Clinical Care Resource
Committee

• Carol A. Vincent
• Chairperson
• George McSherry
• Vice Chair

2
SMCCRC Mission Statement

• To provide expertise to IMPAACT CTUs/CRSs in the
  area of site management and clinical care.
• To collaborate with NIH AIDS funded networks to
  identify issues across networks and work toward
  effective resolution of these issues.

3
Committee Membership

• Total of 8 members
• Chair-Carol Vincent-Philadelphia (USA)
• Vice-Chair-George Mc Sherry (USA)
• OPS Support Joanne Espanol (USA)
• Membership
• Domestic Lourdes AngeliLinda Bettica Andrea
  Jurgrau
• International Carol Onyango Fabiana Kakehashi
  Nishi Suryavanshi

4
Committee Liaisons

• Linda Draper-DMC
• Donna Germuga-DAIDS
• Priscilla Chittum-PPD representative
• ICAB-TBN

5
Specific Areas Of Activity

• Collaboration with IMPAACT leadership
• Establishment/Maintenance of Policies and SOP
• Collaboration with IMPAACT Committees and
  Resource Committees
• Cross Network Collaboration
• Field Representative Protocol Assignment and
  Support

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Identification of Issues

• Communication
• CRS PIs and Staff
• IMPAACT Leadership
• Resource Committee Leadership
• DAIDS
• ICAB
• OPS
• DMC
• Site Monitoring Group (PPD)

7
Resource Committees

• SMCRC
• QA/QC
• Data Management
• Training and Education
• Pharmacy
• Performance Evaluation
• ICAB

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Priorities for the Short Term

• New CRSs
• Ensuring sites are ready to enroll
• Ensure that staff have what they need to do this
• Existing and Moving Forward Sites
• Helping existing sites to keep enrolling
• Transitioning/De-funded Units
• Helping sites transition
• Units doing both- transitioning and moving forward

9
Priorities for the Long Term

• Tracking Issues and Resolutions
• Identifying Training Needs
• Continued Collaboration with CRSs
• -Establishing a forum to discuss issues
• -Clearinghouse for issues

10
Visions for the Future

• Website for communication
• Site Monitoring
• - Feedback from reports
• Assisting sites to proactively prevent problems
  and manage identified issues
• Support of Dissemination of Results to the Field
  and Subjects

11
Field Representatives

• Current field rep pool
• Reassigning field reps
• Assigning field reps
• Mentoring field reps
• Pairing Domestic and International
• Other ideas?

12
Current Issues

• Phase Out of Sites
• Transitioning to new networks-NICHD applicants
• Second Wave transition (NIAID and NICHD that are
  not successful in their applications)
• New Site-getting the sites up and running
• Network Expectations
• Continuing Protocols-What is the plan?
• Enrolling 20 and beyond

13
Current Issues (continued)

• Data Base Clean up
• Lab sample shipment
• Storage of CRFs
• IRB study closures
• Site Monitoring-Close out visit

14
DAIDS Expectations

• Essential Contact List
• Clinic Assessment
• Site and Pharmacy Establishment Plans
• SOPs
• Creating and Sharing

15
Other Issues to Discuss

• Website or Other means of communication
• Cross Committee Collaboration
• Identifying issues and communicating them
• Clinical Care Issues
• DAIDS planned Grand Rounds
• Others

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Committee Email

• Impaact.smcc_at_fstrf.org