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Site Initiation

Site initiation is the process by which the sponsor is assured that the Principal Investigator as delegated (via agreement) is trained in the protocol and sponsor instructions and everything is in order (supported by evidence) for the site to commence the study.  

The requirements for site initiation /investigator training should be considered at the protocol development/funding application stage (so costs can be considered).  Noclor will assess the requirements for site initiation during the initial/bespoke risk assessment and where this is considered a requirement (as is most likely for clinical trials) this will be documented in study-specific monitoring plan.

Records of initiation including attendance logs, correspondence, what was covered (agenda, slides, documents covered) and reports should be retained in the Study/Trial Master file (S/TMF) and at the relevant sites in the Investigator site File (ISF).

Methods of site initiation

Although a Site Initiation Visit (SIV) is the most common method for initiating sites (and this is mandated for CTIMPs sponsored by a Noclor partner according to Noclor’s Site Initiation and Activation SOP (Noclor/Spon/S05)) other methods of initiation and investigator training are acceptable (the method should be proportionate to the complexities and risk associated with the research) such as joint investigator/training meetings, webinars, teleconference’s etc. 

For CTIMPs, site initiation visits (SIVs) must take place in accordance with Noclor Site Initiation and Activation SOP (Noclor/Spon/S05); when contracts and all relevant approvals are in place (REC, CTA and host site approval) and ideally when trial supplies have been sent to sites (study documentation /ISF/data capture tools/IMP etc).  Principal Investigator attendance is required; the SIV should not go ahead without confirmation of his/her attendance.   The SIV must be reported (and reviewed) by the Noclor Sponsor Representative prior to Noclor issuing (on behalf of sponsor) a study activation notice to site - no study procedures should be undertaken by sites until they have received this is notice.

 
Who should conduct site initiation?

Site initiation should be conducted by someone who is familiar (trained) in the protocol and all other applicable documents, procedures and the relevant regulatory requirements where applicable.

Site Initiation will usually be the responsibility of the Chief Investigator / dedicated trial manager, however Noclor may outsource these activities to a third party (such as a CRO or freelance monitor).

 
What to cover at site initiation

The following should be considered for review during site initiation process:

  • the protocol (and any amendments)-obtain the Principal Investigator’s signature on the protocol signature sheet (where applicable)
  • the data capture tools (pCRF/eCRF) – instructions on how to handle and complete  
  • randomisation procedures and code breaking (if applicable)
  • IMP handling, accountability and storage (CTIMPs)
  • interactions with internal support department/external departments (e.g. imaging facilities, labs etc.)
  • laboratory sample handling procedures including sample storage, processing and despatch
  • study supplies and documentation (ISF) 
  • delegation of responsibilities. The Authorised Delegation Log should be completed as part of the initiation process and signed by the Principal Investigator and a copy collected for the Trial Master File (original should be retained at site in the Investigator Site File (ISF)).  
  • study timelines, recruitment requirements and strategies
  • source document verification procedures and access to source data (source data location logs completed)
  • monitoring plan, audit and inspection 
  • safety and incident reporting procedures 
  • protocol deviations and reporting non-compliance
  • review of facilities and equipment
  • close-out, archive and publication