SITE CAPACITY

Points to Consider Checklist

This checklist helps assess whether a site has the necessary infrastructure, resources, and staff to apacity to take part in the ISARIC CCP, and consider which module their site can recruit patients .

Items ticked ✓ are considered to be the minimum requirements for each module.

For more information, please refer to the ISARIC Global Clinical Characterisation Protocol .

Requirement	Module 0	Module 1	Module 2	Module 3
	Data and clinical samples only	Simple and stable samples	Samples requiring local laboratory	Local specialist laboratory required
Infrastructure
Access to a computer	✓	✓	✓	✓
Access to a printer	✓	✓	✓	✓
Access to internet	✓	✓	✓	✓
Access to a health facility	✓	✓	✓	✓
Access to Personal Protective Equipment (PPE)	✓	✓	✓	✓
A secure office space for storing study documents	✓	✓	✓	✓
A designated area for group meetings
Scales for assessing patient body weight	✓	✓	✓	✓
Measuring tape for assessing patient height	✓	✓	✓	✓
Consumables (e.g. blood collection tubes, RNA tubes, etc.)		✓	✓	✓
Diagnostic tests and reagents required for analysing the samples			✓	✓
Appropriate biological sample shipment containers		✓
-80°C freezer (or at least -20°C Freezers)		✓	✓	✓
Serological testing equipment		✓	✓	✓
Sufficient sample kits for stool, urine, and blood samples		✓	✓	✓
Local laboratory processing (spinning and aliquoting blood samples)			✓	✓
Specialist laboratory facilities				✓
Additional Logistical Considerations
Clinical laboratory close to hospital/patient ward
Established transport link between hospital and lab	✓	✓	✓	✓
Tracking system for samples		✓	✓	✓
Human Resources/Staffing
Adequate number of doctors, nurses, and clerks	✓	✓	✓	✓
Staff available to recruit patients and obtain consent	✓	✓	✓	✓
Clinicians or nurses with sufficient time to collect blood, urine, and stool samples	✓	✓	✓	✓
Resources to support the sampling protocol		✓	✓	✓
Data Management
Appropriate mode of data collection (paper vs. electronic)	✓	✓	✓	✓
A data platform to capture the clinical data	✓	✓	✓	✓
If data hosted locally
Staff enable to set up a database
If data hosted by ISARIC
Institutional agreement to Terms of Data Submission
Credentials for data entry
Staff trained to use REDCap
Site number allocation
Staff with sufficient time to enter data	✓	✓	✓	✓
Staff with sufficient time to monitor data	✓	✓	✓	✓
Staff Training
Clinical staff awareness of the study	✓	✓	✓	✓
Consent training for staff obtaining consent	✓*	✓	✓	✓
Briefing of data collection team on protocol	✓	✓	✓	✓
Training on filling out the case report form	✓	✓	✓	✓
Practical training in ‘Sampling’ for team members		✓	✓	✓
Sharing the sampling protocol with healthcare workers	✓	✓	✓	✓
Regular meetings to discuss study progress
Research Ethics Requirements
Check appropriate local/national guidelines	✓	✓	✓	✓
Study protocol approval by ethics boards		✓	✓	✓