Data elements collected

These are the data elements Forte Site Benchmarks collects from OnCore to create an award-winning tool for research sites to compare their performance to other sites. As a result of years of collaborative efforts among the nation’s top research centers to develop data definitions and identify key metrics, a standardized set of site-driven metrics is used to provide a holistic view of performance. 

 

Protocols:

  • Protocol Number
  • NCT ID Number
  • Organization Unit
  • Management Group
  • Oncology Groups
  • EPRMS enabled (Y/N)
  • Treatment Type
  • Sponsor Type
  • First Active Date
  • IRB Submit Date
  • IRB Review Date
  • IRB Comments Received Date
  • IRB Response Sent Date
  • IRB Approval Date
  • PRMC Submit Date
  • PRMC Meeting Date
  • PRMC Comments Sent Date
  • PRMC PI Response Date
  • PRMC Approval Date
  • Contract Draft Received Date
  • Contract Executed Date
  • Budget Draft Received Date
  • Budget MCA Complete Date
  • Budget Finalized Date
  • First Patient In Date
  • CRO Involvement (Y/N)
  • IRB Type
  • Enrollment Goal
  • Affiliate Enrollment Goal
  • Enrollment Duration

Protocol Status Changes:

  • Protocol ID
  • Status Date
  • Status ID
  • Status

Organization Unit/Management Group/Oncology Group:

  • Name
  • Parent OU

Effort Tracking:

  • Protocol Number
  • Protocol Stage
  • Effort Category
  • Effort Date
  • Effort Minutes

Reviews:

  • Outcome ID
  • Meeting Date
  • Review Reason
  • Review Reason Category
  • Action Effective Date
  • Submit Date

Subjects:

  • Protocol ID
  • Sequence Number
  • On Study Date
  • Off Study Date
  • On Study Organization

Subject Deviations:

  • Protocol ID
  • Deviation ID
  • Deviation Date
  • Deviation Type

Subject Form Queries:

  • Subject Sequence Number
  • Protocol ID
  • Query ID
  • Form Name
  • Query Open Date
  • Query Response Date
  • Query Closed Date

Subject SAEs:

  • Subject Sequence Number
  • Protocol ID
  • SAE ID
  • SAE Date
  • SAE Types
  • Notified IRB Date
  • Notified Sponsor Date
  • Reported Date

OnCore Task Lists:

  • Protocol ID
  • Milestone
  • Target Date
  • Completed Date