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Site initiation considerations

 

It is the responsibility of the chief investigator to ensure initiation considerations are in place for all study sites. This will help provide continued support for the duration of the study and its ongoing conduct.

The following is not an exhaustive list of site initiation considerations:

  • Study protocols, patient information sheets, informed consent forms and related documents must be up-to-date (future amendments should also be disseminated)
  • Study specific procedures (may need amending for local sites)
  • Ethics approvals
  • Medicines and Healthcare products Regulatory Agency (MHRA) approvals (where applicable)
  • Authorisation letter covering University Hospitals Birmingham NHS Foundation Trust (UHB) or external sponsorship
  • UHB Research and Development (R&D) site approval
  • Site file has been set up
  • Site agreements are signed
  • Investigational medicinal products (IMP) supply
  • Local R&D approval
  • Local delegation of duties log is ready to be signed off by the chief investigator and local principle investigator
  • Applicable training certificates for local principle investigator and research associates
  • Copies of up-to-date CVs of staff listed in the delegation of duties log

A delegated monitor will also need to be appointed to carry out site initiation and plan future monitoring visits.

Last reviewed: 29 April 2021