Assess your site capacity

Conduct a review to assess the resources required to carry out the CCP locally. Review the Site Capacity: Points to consider Checklist to assist with determining the module(s) use, inclusion criteria and sampling strategy for your site.

Choose module(s) to use

Depending on local resources, research objectives and feasibility, chose which Module(s) to use.

You can choose to change module at a later date; The patient data recorded is the same for all modules.

The currently-active module will be recorded in the site file Module Record Form. Use the Site Module and sub-study record template ✎

Determine Inclusion and exclusion criteria

Inclusion criteria

• Confirmed or suspected infection with an emerging or high-consequence pathogen, or
• All population, adults, children, pregnant women
• Confirmed or suspected exposure to a pathogen, toxin, chemical or other exposure of public health interest, or

Exclusion criteria

For module 1 and above (where consent is required), refusal to participate by patient, parent or appropriate representative.

Choose a sampling strategy

In some circumstances, robust analysis requires methodical selection of patients for data collection. This is usually the case where the primary aim is large-scale data collection to explore the features of, and risk factors for, illness. Each site has its own requirements, abilities, and limitations to participant recruitment and should select the sampling approach that fits best.

To know more about the type of sampling

Record the inclusion criteria and sampling approach taken for each unique date range in your site level CRF.

Prepare your protocol

Adapt and amend the Clinical Characterisation Protocol (CCP) to local context/capacity and your research objectives.

Several sites have used the CCP to create their own regionally-specific versions for specific response activities. Examples are available in CCP Resources Library

Develop your Study documentation

Organise a Study Master File (SMF). This file (electronic/paper) should contain key documents and procedures.

Download the SMF Structure template ✎ and u se the SMF guide to complete and organise it.

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. Data entry guides and tools

Develop Patient Information Sheet and Consent form (PISC) to be used by the study team to enrol participants when consent is required Patient Information Sheets templates ✎

Obtain Ethics and regulatory necessary approval

Submit your protocol and study documents and liaise with the responsible committees / authorities to gain approval. Ethics application example ⓘ

Prepare the Case Report Form (CRF)

ISARIC and partners have developed a ARChetype standardised CRFs for mpox, H5Nx, Covid and Dengue.

The forms include the variables needed to efficiently characterise the natural history of the disease, regions, time and populations. It is structured to quickly identify risk factors for severe outcomes, understand the mechanisms of disease, and provide key evidence to inform clinical care, public health response, and clinical trial design.

To know more on the ISARIC ARchetype Case Report Form Creation Process ⓘ

You can use the ISARIC ARChetype CRF as designed, or tailor it to your context by adding or removing variables using CRF Generator BRIDGE .

Instructions on How to Get and Use ISARIC Approved Case Report Forms ⓘ

Instructions on How to use the CRF Generator BRIDGE, adapt ARChetype CRFs or create your own CRF ⓘ

Set up a database for data capture

After using BRIDGE to select your final CRF, BRIDGE will generate a download of the paper CRF and create a CRF completion guide. It will also generate an XML file and data dictionary to set up a REDCap database that matches your CRF.

• If your institution uses REDCap, upload the XML file and data dictionary to a REDCap project to launch a database for your study. Instructions on How to generate an ISARIC approved CRF and database using BRIDGE ⓘ
• If your institution does not currently host REDCap software, but would like to, you can find installation instructions and technical requirements on the REDCap home page ⓘ
• The data dictionary can also be used to design a database in any other data management software you prefer.

ISARIC has a REDCap database for all the ARChetype CRFs available for use by any sites that decide not to run their own data management software. Support and hosting are provided by ISARIC.

Please contact data@isaric.org for support, to launch a database, host data, map to the ISARIC data model, or anything else we can assist with.

Ensure staff are trained in research (collecting patient data, processing and labelling samples) using the Competency/Training Needs:Points to consider Checklist

Visit the ISARIC CCP resources Library

Ensure staff have access to Personal Protection Equipment (PPE) for delivering research.

Assess consumables/technology and other resources.

Consider the different groups of participants like children, illiterate adults or adults who are unable to give informed consent due to mental or physical status.

Consider conducting "The study walk-through method" to help translate your protocol into an accurate and successful study. Please visit The EDCTP Knowledge Hub via The Global Health Network for tips on conducting a ‘study walk through’.

Ensure documents like Informed Consent or other documents with sensitive data are stored safely and securely.

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.

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

Prepare your Statical Analysis Plan (SAP)

The SAP is a document outlining the planned statistical methods and procedures undertaken to analyse and interpret the data collected during the study. The SAP should be specific and highly detailed, offering a clear description of any analyses required to meet study objectives. To ensure high reliability and validity of the study, the SAP should be written and finalised before the end of the study and the start of the analysis.

An ISARIC Statistical Analysis Plan (SAP) has been developed to align with the CCP and ISARIC ARchetype CRFs. This can be tailored to your needs and used for data analysis.

Examples are available in CCP Resources Library

Use our Visualisation and analysis tools VERTEX

ISARIC also provides a set of analytic tools called VERTEX, designed to perform the analyses outlined in the SAP using ISARIC's data structures. VERTEX generates automatically tables and visualisations using Python code, and displays this information for each relevant research question or study endpoint, in a web application dashboard. All analytics can be tailored to fit the needs of your data.

VERTEX is built using reproducible analytical pipelines. It is designed to allow ISARIC partners and the broader scientific community to develop, contribute to, and share their own analytic codes so that other researchers can use and reproduce them.

Instructions on How to get started with VERTEX

Instructions on How to create additional visualisations for the VERTEX dashboard

ISARIC can support your implementation of these tools which may be downloaded at your site and/or used for aggregate analysis of multi-site datasets using ISARIC’s data governance framework.

Share your evidence widely, including with those who are making clinical and public health decisions, and those undertaking further research.