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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 sufficiently trained in the following protocol, understands the instructions and the site is ready to commence the study.  

The requirements for site initiation should be considered at the protocol development/funding application stage so study costs can be taken into account. Noclor will assess the requirements for site initiation during the initial/bespoke risk assessment. Where risk assessment is considered a requirement (e.g. for clinical trials) this will be documented in study-specific monitoring plan.

Records of site initiation including attendance logs, reports, correspondence and meetings content (e.g. agenda or slides) should be retained in the Study/Trial Master file (S/TMF) or the Investigator Site File (ISF).

Methods of site initiation

Although a Site Initiation Visit (SIV) is the most common method for initiating participating sites, other methods of initiation and investigator training are acceptable. For instance, joint meetings, webinars, teleconference’s or online trainings. Any chosen method should be proportionate to the complexities and risk associated with the research. 

For CTIMPs, site initiation visits (SIVs) must take place in accordance with Noclor Site Initiation and Activation Standard Operating Procedures. Contracts and all relevant approvals (e.g. REC, CTA and Host Site approvals) must be in place. Ideally, trial supplies (e.g. study documentation, data capture tools, Investigational Medicinal Product etc) should be sent to the site.

Principal Investigator attendance is required; the SIV should not go ahead without confirmation of their attendance. The SIV must be reported (and reviewed) by the Noclor Sponsor Representative prior to Noclor issuing 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 with the protocol; all other applicable documents, procedures and all relevant regulatory requirements where applicable.

Site Initiation will usually be the responsibility of the Chief Investigator or 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 ths site initiation process:

  • Study timelines, recruitment requirements and strategies
  • Instructions how to handle data capture tools (e.g. pCRF/eCRF)
  • 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) 
  • Obtain PI’s signature on the protocol (if applicable)
  • Complete authorised delegation log that should be signed by Principal Investigator.  Original copy should be retained in the Investigator Site File (ISF) at the site and a copy collected for the Trial Master File. 
  • 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 non-compliance reporting
  • Review of facilities and equipment
  • Closing, archiving and publications