Phidisa: Regulatory and Ethics Operational Team Report

1
PhidisaRegulatory and Ethics Operational Team
Report

• Col. Xolani Currie, Chair
• Laura McNay, Co-Chair
• Ezekiel Emmanuel
• Patty Price-Abbott
• Anita Lessing
• William Monene
• Lotty Ledwaba
• Representing the Phidisa Regulatory and Ethics
  Operational Team

2
Presentation Objectives

• To summarize the accomplishments of the
  Regulatory Operational Team
• To identify the goals of the team for the
  upcoming year
• To identify obstacles to attainment of goals and
  strategies to overcome obstacles
• To identify needed resources to accomplish goals
• To summarize the draft budget proposal

3
Regulatory Operational Team Mission Statement

• The mission of the Regulatory Operational Team
  is
• to facilitate human subjects research through
  comprehensive regulatory oversight
• to ensure compliance with SA and US regulations
• to support and guide the clinical sites and
• to conduct site monitoring to ensure compliance
  with the protocols.

4
Accomplishments

• Regulatory Approvals
• Medicines Control Council (South Africa)
• Registration of SANDF Institutional Review Board
• Office for Human Research Protection (U.S.)
  Federal Wide Assurance
• Protocol Activities
• Assistance with protocol development
• Assistance with case report form and Manual of
  Operations development
• Performance of regulatory review of protocols
• Provision of text for Frequently Asked
  Questions
• Provision of ongoing regulatory guidance
• Translation of consents and questionnaires into
  South African languages

5
Accomplishments (cont.)

• SANDF Institutional Review Board (IRB)
• Assembled and trained
• Developed IRB SOPs
• Training
• Presentation of GCP and regulatory topics at
  December training
• Assistance in the development and coordination in
  June NIH training for 5 South African physicians
• Presentation of regulatory/ ethics topics at this
  training
• Phidisa Personnel Development
• Assistance in the development of position
  descriptions
• Clinical Research Organization Establishment
  Activities
• Developed Statement of Work
• Reviewed and rated applicants
• Selected Clindev/ Holisizwe

6
Accomplishments (cont.)

• Monitoring Activities
• Pre-study, Site Initiation and Routine Monitoring
  Visits
• Assistance with development of regulatory files,
  creation of source documents, and creating
  patient research files
• 1 Mil
• Mtubatuba
• Adverse Event Reporting Activities
• Training for Medical Monitor
• Created and implemented process for reporting
  adverse events to the DMCOC
• Received and reviewed adverse events
• Provision of updates to the EC
• Training of sites on event reporting
• Created booklet of expected side effects for site
  staff
• Responded to clinical queries from sites

7
Accomplishments (cont.)

• Policy Development Activities
• Travel Policy and Procedures (No 1/2004)
• Patient Travel Reimbursement Policy (No 2/2004)
• Cellular Telephone Policy (No 3/2004)
• Internet Access Policy (No 4/2004)
• Vehicle Management Policy (No 5/2004)

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Goals and Obstacles for Upcoming Year

• Phidisa I and Phidisa II
• Submit continuing reviews
• Provide amendment suggestions
• Phidisa III
• Perform regulatory review
• Obtain MCC approval
• Submit to both IRBs
• Ensure patient travel reimbursement policy is
  enacted and followed
• Obstacle having cash on base is a security issue
  (slide 11 discussion)
• Conduct pre-study visits (completed) and site
  initiations
• 2Mil
• Umtata
• Conduct pre-study visits and site initiations
• 3Mil
• Phalaborwa

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Goals and Obstacles for Upcoming Year (cont.)

• Draft/revise an informed consent operating
  procedure
• Collaborate with Data Management Operational Team
  to enhance monitoring of events
• Review expedited reporting procedures
• Obstacle need more training for site staff
• Establish an Endpoint Review Committee
• Review relevant position descriptions
• Regulatory Oversight Manager
• Medical Monitor
• Train the SANDF Data Safety Subcommittee (DSS)
• Draft SOPs for the DSS
• Propose timeline and schedule first DSS meeting
• December 2004 in conjunction with continuing
  review by SANDF IRB
• Twice yearly meetings December and June
• Phidisa II must evaluate unblinded pooled
  results after 1000 patients enrolled for one year
• Tentatively schedule for December 2005 or June
  2006

10
Goals and Obstacles for Upcoming Year (cont.)

• Ensure NIH training for DMCOC Regulatory
  Oversight Manager
• Update informed consent authorized official list
  and submit to the IRBs
• Continued provision of regulatory mentorship
• Collaborate with Training Operational Team to
  provide regulatory training
• Specific areas of focus
• Informed consent provision
• Adverse event reporting
• Provide continued safety and monitoring functions
• Review existing policies
• Draft and review new policies
• Mentally incompetent (1st draft completed)
• Training
• Grievance and Disciplinary Procedures
• Develop Document Control Policy (slides 12-14)

11
Patient Travel Reimbursement
Obstacles Potential Solutions
Transfer of funds to sites Open a site bank account
Security Voucher system or security guard/ safe
Creating a mechanism for voucher payment Agreements with local grocery stores
12
Document Control Proposal

• All draft policies submitted to the DMCOC
  Regulatory Oversight Manager (DMCOC ROM)
• DMCOC ROM to assign version number and date (i.e.
  v0.1 27-07-04)
• DMCOC ROM to circulate to DMCOC Director, Section
  Heads and Phidisa PIs
• DMCOC Director, Section Heads and Phidisa PIs to
  distribute as necessary to appropriate parties
• 2 week timeframe for comments
• Comments returned to the DMCOC ROM
• DMCOC ROM sends comments to policy initiator
• Final draft returned to DMCOC ROM

13
Document Control Proposal (cont.)

• DMCOC ROM to re-circulate to DMCOC Director,
  Section Heads and Phidisa PIs to distribute as
  necessary to appropriate parties
• 1 week timeframe for comments
• DMCOC ROM to incorporate revisions and/or seek
  assistance from policy initiator
• DMCOC ROM to circulate to Executive Committee
  (EC)
• 2 week timeframe for comments
• DMCOC ROM to incorporate EC comments

14
Document Control Proposal (cont.)

• Final document assigned new version number and
  date (i.e. v1.0 27-07-04)
• Final document posted on the web site
• Historical index of final documents
• Email alert to DMCOC Director, Section Heads and
  Phidisa PIs

15
Additional Resources Required

• Due to loss of member to Training Operational
  Team, request to supplement Regulatory
  Operational Team with one additional member from
  the NIAID with IRB experience

16
Regulatory Operational TeamBudget Proposal
Year Ending July 31, 2005Total Estimate R
3,975,716
Activity Area Budget
DMCOC Auditing R 249,642
SANDF IRB/ DSS R 256,496
Endpoint Review Committee R 36,086
DMCOC Regulatory Training/ Education R 75,612
Clindev/ Holisizwe R 3,357,882
Total proposal does NOT include patient travel
reimbursement, NT Ngidi, or labor/fringe costs