• ISARIC4C Virtual Site Visit
• Site set-up
• Documentation
• Recruitment procedure
• Sample processing in site laboratories
• Contact details for questions

ISARIC4C Virtual Site Visit

Welcome to the ISARIC4C study virtual site visit. Thank you very much for supporting recruitment to this study.

Site set-up

1. Obtain local R&D approval
2. Contact ccp@liverpool.ac.uk to register site: provide contact details for local Principal Investigator, lead Research Nurse and R&D contact
3. Confirm recruitment tier:
   • Tier 0 - data only (consent required)
   • Tier 1 - data + single biological sample on recruitment day (day 1)
   • Tier 2 - data + serial biological samples (days 1, 3, 9 and 3-months)
4. If recruiting to Tier 1 or 2, provide contact person and postal address that sample kits can be sent to.
5. Request access to REDCap for data entry by e-mailing ccp.REDCap@liverpool.ac.uk - separate sites within same institution should request separate access.
6. Create GCP-compliant site file stored in a secure location

Documentation

The following documents should be kept in the site file:

• ISARIC/WHO Clinical Characterisation (CCP) UK Protocol
• Patient information sheets, consent/assent forms
• Approvals: ethics, R&D, amendments
• Research team
• UK CCP Case Report Form
• Logistics guidance document
• Completed consent forms - these should be kept indefinitely

Recruitment procedure

Further details are provided in the logistics guidance document (separate Scottish & English versions). An example SOP providing step-by-step instructions for operationalising this process is available here.

1. Receive recruitment pack from Liverpool. This will contain a blood RNA tube, nasal SAM strip, Oracol oral swab and barcode stickers (barcodes will be sent separately to Scottish sites).

2. Generate patient study number and enter into REDCap: 5-digit site code + 4-digit patient number

3. Obtain informed or proxy consent. Depending on the condition or infection, the copy of the consent form signed by the participant might be considered contaminated, therefore ask an independent healthcare worker to witness the signed form and then complete the witness section of a fresh copy outside the isolation area.

4. Label sample collection containers before entering isolation room/cohort zone:
   • patient study number
   • “ISARIC research”
   • unique barcode sticker (not clotted or EDTA blood tubes - see below)
   • biohazard sticker
5. Obtain required biological samples whilst wearing appropriate PPE
   • see this video for correct use of SAM strip
   • note the Oracol swab should be swabbed around the gum-line for 1-2 minutes
   • specific sampling requirements and timepoints are detailed in the logistics guidance document

6. Package samples appropriately and arrange safe transport to site laboratory

7. Liaison with site laboratory for sample processing

8. Arrange onward transport to receiving study laboratory. Separate arrangements exist for English and Scottish sites - detailed in the logistics guidance document.

9. Complete the Case Report Form:
   • Day 1: core form
   • Alternate subsequent days: daily form
   • Death/discharge: outcome form

10. If recruiting at Tier 2, in addition to recruitment day samples (day 1), obtain serial biological samples on days 3 and 9, and arrange for convalescent sampling at day 28.

11. If proxy consent was obtained from a patient lacking capacity, plan a review date to assess for regained capacity.

Sample processing in site laboratories

• The serum (‘S’), plasma (‘P’) and cell pellet (‘C’) should be labelled with the patient study number, “ISARIC research”, a unique barcode (one per aliquot) and S/P/C (to identify the sample type).

• Samples may be stored at +4°C out of hours and at weekends prior to processing and freezing. If -80C storage not feasible, -20C is an alternative.

• Up-to-date PHE guidance on handling SARS-CoV-2 positive specimens is available here. Currently, blood from COVID-19 patients can be spun and aliquoted in BSL2 laboratories.

Contact details for questions

Site registration and recruitment packs: Hayley Hardwick ccp@liverpool.ac.uk

REDCap date entry: ncov@isaric.org