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

Dr. John Amuasi facilitating training at the Ga East Municipal Hospital, a CCP project implementation site.

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

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.

6 Steps

Tier record

Readme

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 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: ncov@isaric.org.

Master file example template

Capacity checklist

Example response

RAPID data entry guide

CORE data entry guide

3

Planning resources

Ensure staff are trained in research e.g. collecting patient data, processing and labelling samples.

Ensure staff have access to PPE for delivering research.

Site staff

Where to start

Where to start

ISARIC Video tutorials

4

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.

5

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.)

6

Screening & study enrollment

Ensure all correct staff have read the required documents and received appropriate training.

Adults

Adult Serial Serology

Adult Extra Convalescent

Parent or Guardian

Consultee

Young (12 to 16 years old)

Child (under 12 years old)

ISARIC cartoon information for children

Case studies

Dominican Republic

Hoja De Información Para Pacientes Adultos

Hoja De Información Para Padres/Tutores

Protocolo de Caracterización Clínica del COVID-19 en la República Dominicana

Hoja Dibujos Cartoon

Hoja De Información Para Jóvenes De 12 A 18 Años De Edad

Hoja De Información Para Niños Menores De 12 Años

Malawi

CCP Global Case Study, Malawi

Information Sheet For Parent/Guardian

Information Sheet For Children Younger Than 12 Years Old

Information Sheet For Consultee

Information Sheet For Adult Patient

Information Sheet For Young People Age 12 To 16 Years Old