COVID-19 CCP Global Toolkit
Where to start?
Download the inclusion criteria and a brief explanation of the different tiers, along with a quick reference checklist of core resources required in order to implement the study.
Download the inclusion criteria PDF
Next step – how do I operationalise COVID-19 CCP Global?
This page provides an overview of the main steps for implementation of tiers 1, 2 and 3. It is important that the study is not seen as a separate activity in the facility’s response strategy to COVID-19. A Principal Investigator must be appointed; They will be responsible for all aspects of the study, following the main steps outlined below.
Please explore our toolkit, click on the six buttons to download documents e.g. the protocol, checklists, Standard Operating Procedure(s) (SOPs), example templates etc.
Determine site capacity
Adapt and amend the Clinical Characterisation Protocol (CCP) to local context/capacity.
Conduct a review to assess the resources required to carry out the CCP locally.
obtain ethics approval
Review ‘Site Capacity: Points to consider’, to assist with determining the tier level for your site.
Organise a Study Master File (electronic/paper); A File, which contains key documents and procedures.
Develop standard operational procedures (SOPs) to be used by the study team e.g. Adapt ISARIC templates as required i.e. ISARIC Data Platform, Data Entry Guides.
Decide on electronic versus paper-based data collection; Register to use the free ISARIC data collection portal: firstname.lastname@example.org.
Master file example template
RAPID data entry guide
CORE data entry guide
Ensure staff are trained in research e.g. collecting patient data, processing and labelling samples.
Ensure staff have access to PPE for delivering research.
Where to start
Where to start
ISARIC Video tutorials
The patient’s journey
Consider the different groups of patients e.g. Children, and/or, Illiterate adults, and/or, adults who are unable to give informed consent due to mental or physical status.
Consider conducting a study walk-through.
Ensure documents i.e. Informed Consent/Sensitive Data are stored safely and securely.
Community & public engagement
Ensure all facility staff are familiar with the concept of the study; gather input from community/patient-led groups.
Public engagement; Creation of patient and family education materials (NB other facilities/groups may be interested in participating e.g. public health/epidemiologists etc.)
Screening & study enrollment
Ensure all correct staff have read the required documents and received appropriate training.