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 guidance on where to start
Dr. John Amuasi facilitating training at the Ga East Municipal Hospital, a CCP project implementation site.
Doctors at Pentecost Convention Center Isolation Unit in a training session on the use of REDCap for CCP data entry
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.
1
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.
How to operationalise the CCP
Tier and sub-study record template
ISARIC CCP - before you start
ISARIC CCP
2
Prepare documentation/
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 adapting ISARIC templates as required (ISARIC Data Platform, Data Entry Guides, etc.)
Decide on electronic versus paper-based data collection. Register to use the free ISARIC data collection portal: ncov@isaric.org.
Study master file template
Ethics application example
Site capacity checklist
Data entry guides and tools
3
Planning resources
Ensure staff are trained in research (collecting patient data, processing and labelling samples).
Ensure staff have access to Personal Protection Equipment (PPE) for delivering research.
if you need editable templates of these documents, contact gsc@isaric.org writing on the subject: CCP Global toolkit step 3 templates.
CCP training for site staff
How to operationalise CCP Global
Competency/Training Needs checklist
ISARIC Video tutorials
4
The patient’s journey
Consider the different groups of patients like children, illiterate adults or adults who are unable to give informed consent due to mental or physical status.
Consider conducting a study walk-through.
Ensure documents like Informed Consent or other documents with sensitive data are stored safely and securely.
This area is currently under development, in the meantime, please visit The EDCTP Knowledge Hub via The Global Health Network for tips on conducting a ‘study walk through’.
The study walk through is a method to help translate your protocol into an accurate and successful study. This toolkit describes the study walkthrough approach, why it might be of benefit to your study and how you can use successfully implement the method using practical examples and ‘How to’ guidance.
5
Community & public engagement
Ensure all facility staff are familiar with the concept of the study; gather input from community or patient-led groups.
Public engagement: creation of patient and family education materials (note that other facilities and groups within the community may be interested in participating, like public health professionals, epidemiologists, etc.)
This area is currently under development, in the meantime, please visit MESH public engagement guidance. Mesh is an online network for people working in community engagement with global health research, and is accessible via the Global Health Network platform.
6
Screening & study enrollment
Ensure all correct staff have read the required documents and received appropriate training. Visit ISARIC’s Clinical Characterisation Protocol page to download all relevant resources (patient informations sheets, protocol, etc.)
ISARIC CCP resources
Case studies
Dominican Republic
ALERRT (Ghana)
