ISARIC-4C Virtual Site Visit
Welcome to the ISARIC-4C study virtual site visit. Thank you very much for supporting recruitment to this study.
- Obtain local R&D approval
- Contact email@example.com to register site: provide contact details for local Principal Investigator, lead Research Nurse and R&D contact
- Confirm recruitment tier:
- Tier 0 - data only (no 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)
- If recruiting to Tier 1 or 2, provide contact person and postal address that sample kits can be sent to.
- Request access to REDCap for data entry by e-mailing firstname.lastname@example.org - separate sites within same institution should request separate access.
- Create GCP-compliant site file stored in a secure location
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
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.
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).
Generate patient study number and enter into REDCap: 5-digit site code + 4-digit patient number
Obtain informed or proxy consent. The copy of the consent form signed by the participant will 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.
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
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
Package samples appropriately and arrange safe transport to site laboratory
Liaison with site laboratory for sample processing
Arrange onward transport to receiving study laboratory. Separate arrangements exist for English and Scottish sites - detailed in the logistics guidance document.
Complete the Case Report Form:
- Day 1: core form
- Alternate subsequent days: daily form
- Death/discharge: outcome form
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.
If proxy consent was obtained from a patient lacking capacity, plan a review date to assess for regained capacity.
Sample processing in site laboratories
|Sample||Processing & storage|
|Clotted blood||Centrifuge 1500g for 10 mins (ideally +4C).
→ serum (3x 1mL aliquots; store -80C)
|EDTA blood||Centrifuge 1500g for 10 mins (ideally +4C).
→ plasma (3x 1mL aliquots; store -80C)
→ cell pellet (leave in tube, store -80C)
|Blood in RNA tube||No processing required.
Freeze -20C for 24h then transfer to -80C.
|Viral throat swab
Urine & stool
|No processing required. Do not open bag.
Freezr at -80C.
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 email@example.com
REDCap date entry: firstname.lastname@example.org
Operationalising recruitment: Clark Russell email@example.com