UK Virtual Site Visit

SIV and site training

Thanks for obtaining approval to recruit to the GenOMICC study! This virtual site visit describes the key next steps you need to take in order to get started with recruitment.

Before you start, you should:

• be appropriately trained to conduct clinical research in patients in your clinical area
• have ethics and local R&D approval for GenOMICC
• have access to the REDCap CRF at redcap.clinicaltrials.ed.ac.uk
• have a supply of our specimen kits - see below
• watch our virtual site initiation visit below, or directly on YouTube.

Site file

You will need to create a GCP-compliant site file and store it in a secure location accessible only to trained staff working on the study. The site file should contain:

Study Documents

• Current
• Superseded

Approvals

• Ethics
• R&D
• Amendments
• Contracts
• OID

Research Team

Safety

• Safety reporting
• Protocol Violations
• Protocol Deviations

Participant Documents

• Consent forms

Sample collection kits

The GenOMICC team will supply you with return postage-paid UN3373 specimen transport kits, containing:

• Sticky ID labels for each patient
• Sample bag and absorbent material
• EDTA tube