Site Set-up and Conduct Caroline O’Leary and Carrie Bayliss.

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Presentation transcript:

Site Set-up and Conduct Caroline O’Leary and Carrie Bayliss

HRA – new process Sites within England no longer require SSI (Site Specific Information form) Pre-approved HRA documentation will be sent to Site R&D Local CRN contact will be copied in on application HRA Approval Letter Statement of Activities Schedule of Events Participating Site Agreement (Addenbrooke’s) Plus usual documentation – protocol, PIS/ICF, GP letter etc. Legal and ethical review by local R&D is not required Local review is to ensure capacity and capability of running the study

High level proposed process with HRA Approval Applicant identifies sites Applicant sends local package to site team Joint arrangement capacity and capability Organisation confirms capacity and capability Applicant completes IRAS Form Applicant submits IRAS pack to HRA HRA issues outcome of initial assessment HRA issues HRA Approval to CI Applicant sends HRA Approval to site Applicant adds initial HRA letter to local package This presentation is designed to provide general information only. Our website Terms and Conditions apply Site team = R&D team + research delivery team (PI, research nurses, etc) + LCRN team (for portfolio studies) See contactswww.rdforum.nhs.uk 28 December 2015

SIMPLIFIED process with HRA Approval Applicant completes IRAS Form Applicant submits IRAS pack to HRA HRA issues outcome of initial assessment HRA issues HRA Approval to CI Applicant sends HRA Approval and local package to site Site team = R&D team + research delivery team (PI, research nurses, etc) + LCRN team (for portfolio studies) See contactswww.rdforum.nhs.uk 28 December 2015 SIMPLIFIED already approved by REC and MHRA. Approved documentation forwarded to HRA along with SoA and SoE Organisation confirms capacity and capability

Site Initiation Participating Site Agreement to be signed and returned Site file preparation and provision Delegation of Responsibility & Signature log CVs and GCP training certificates Provision of patient-specific documents (PIS/ICF, GP letter, Patient Card) Site initiation meeting conducted, initiation form and checklist completed and signed Site activated on Simplified web portal Site activation letter sent to PI and CRN

Investigator Responsibilities Patient accruals – consent, registration and randomisation ISF (investigator site file) maintenance Ensuring & delivering continual trial team training (GCP and protocol) Delegation & signature log maintenance Responding to data queries in a timely manner On-going safety and pregnancy reporting Escalating conduct issues and protocol deviations immediately to the Simplified Trial Office Continual oversight of trial conduct at your site

Site Monitoring Remote monitoring in the first instance Conducted annually Completion of Remote Monitoring Form Complete and return within 4 weeks Triggered On-Site Monitoring Triggered by: Poor patient accruals or data returns High number of SARs / SUSARs reported High number of protocol deviations, trial conduct issues or a reportable serious breach Visit scheduled and conducted by the Simplified Trial Coordinator, Sponsor Monitor or Sponsor Auditor as appropriate