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CCAF Meeting Spring 2011 Charleston, SC

What the @#$% is Summary 4 and Why Do We Need It?. CCAF Meeting Spring 2011 Charleston, SC. Lauren Hackett, MPA Lisa Gaynes , CCRP. Report on Portfolio: Accrual Types of trials Programmatic Tool for Reviewers: How well you close trials Competing trials

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CCAF Meeting Spring 2011 Charleston, SC

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  1. What the @#$% is Summary 4 and Why Do We Need It? CCAF Meeting Spring 2011 Charleston, SC Lauren Hackett, MPA Lisa Gaynes, CCRP

  2. Report on Portfolio: Accrual Types of trials Programmatic Tool for Reviewers: How well you close trials Competing trials Length of time for accrual What is Summary 4

  3. How to Put it All Together: Simply a catalog by Group/Sponsor/Funding Source What is an Institutional vs IIT vs Industry Sponsored Trial vs Peer Reviewed?

  4. How to Put it All Together:Definitions • Type • Sponsor/Source – II vs. Industry • Agent/Device aka Therapeutic • Other Intervention • Prevention • Non-therapeutic with an intervention • Supportive care • Screening / Early detection, diagnosis • Ancillary or Correlative • Non-interventional • Database • Tissue Banking

  5. Answers to FAQ’s • Does not need to match Summary 3 • Target accrual must be at or higher than total accrual – ‘no range’ • All trials must have a program, even unaligned • Target number for multi-center trials must include both IF you are the coordinating center • ‘To Date’ = as of day you run report! • Multi-center trials – if initiated at your center, only include your accruals and those of your affiliates, NOT accrual at all sites

  6. Pitfalls • Target accrual lower than accrual • Competing trials • No closure for non or low accrual • Ensure you have consistent counts between 12 Months and Center To Date • Too many unaligned trials • IRB target accrual may include screen failures

  7. Helpful Hints • Ask for program designation on your PRMC application • At your site visit, have an annotated version that includes reasons for no/low accrual, why open, competing, etc.

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