Project status terms explained

Status Comment
  • RMT have not started the C&C checks.
  • Study has not yet been assigned an R&I reference.
  • Study has been assigned an R&I reference.
  • This is the initial status of a new project and means it is undergoing Capacity and Capability (C&C) checks by R&I and has not yet received Confirmation of C&C.
In set-up
  • Confirmation of C&C has been issued.
  • Waiting for formal confirmation of Sponsor Green Light to be issued.
  • Confirmation of C&C and Sponsor Green Light have been issued.
  • Study open to recruitment at site.
Closed – In follow up
  • The study is on-going at the site (that is, participants are being treated or examined), but recruitment is complete.
Closed – Follow up complete
  • The study has concluded normally at the site: participants are no longer being examined or treated (i.e. last participant’s last visit has occurred).
Closed – Archived
  • The study has concluded normally at the site, no further data cleaning required by the sponsor and site has completed Close Out Visit.
Cancelled prior to approval
  • Cancelled during set-up – that is, prior to the study receiving Confirmation of C&C and/or Sponsor Green Light.
  • Recruitment of participants to the study at the site has halted, but may resume.
  • Trial recruitment stopped prematurely and permanently by sponsor.
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