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 to operationalise CCP

Tier and sub-study record template

Basic info 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 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.

Study master file check-list

Site capacity checklist

Ethics application example

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.

CCP training for site staff

How to operationalise CCP Global

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.

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/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.)

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.

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

Ghana Flag

ALERRT (Ghana)

Malawi