Good Clinical Practice Guide
Results 1 to 2 of 2

Thread: 24 hour cover for clinical trials

  1. #1
    Forum Member
    Join Date
    Apr 2012

    24 hour cover for clinical trials

    I was wondering if anyone can help me with a query please?
    There is an expectation that 24/7 coverage is provided for clinical trials in case of emergency - is this based on legislation or is it just a logical expectation that a Sponsor will provide this?
    Thank you!

  2. #2
    Forum Member
    Join Date
    Nov 2011
    The BARQA GCP website has the following reply to a similar question on 03Aug2011:-
    The GCP Committee are not aware of any explicit requirement in legislation stating that 24 hour medical cover should be in place. However, ICH E6 5.3 states that ‘the sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related medical questions or problems. If necessary, outside consultant(s) may be appointed for this purpose.’
    This ‘readily available’ statement has often been interpreted as meaning 24 hour cover. The basis for this being the argument that if there is a medical emergency involving a clinical trial subject, the treating physician may need immediate access to information about the trial, the investigational medicinal product and potentially the actual treatment given to the subject. Regulatory Inspectors will certainly assess sponsor and CRO systems to ensure that continuous cover is available should such advice be needed in a medical emergency. There is also an expectation that these systems should be tested by the sponsor.
    In addition, there is a general inference in US and EU legislation regarding prompt action to be taken by sponsor in relation to safety information e.g. 21 CFR 312.32 (d) ‘the sponsor shall promptly investigate all safety information received by it.’

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts