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Summary of Government Shutdown Impact on Clinical Research Trials

(Update as of Monday, October 7, 2013)

CTEP Trials & NCI Cooperative Groups (Alliance, ECOG etc)

  • Enrollment to open trials may continue
  • Participants on study should continue to be treated, monitored and followed
  • No changes to SAEs reporting
  • CTEP is maintaining a core staff to handle essential services related to patient safety for those patients enrolled on these clinical trials, including drug shipments for CTEP IND studies
  • Concepts, protocols, and protocol amendments can be submitted to the DCP PIO, but they will not be reviewed until the government reopens

 
DF/HCC Investigator Initiated Trials

  • Enrollment to open trials may continue
  • Participants on study should continue to be treated, monitored and followed
  • No changes to SAEs reporting
  • IND approvals may be delayed
  • Activation will occur according to standard procedures


See also: Government Shutdown Impact on Clinical Research Trials: Clinicaltrials.gov Update

For questions, contacts: Alyssa K. Gateman, MPH CCRP  Director Quality Assurance Office for Clinical Trials, DFCI, DF/HCC