1 / 7

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

nen
Télécharger la présentation

CCAF Meeting Spring 2011 Charleston, SC

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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.

More Related