Toolkit for Operationalising the Clinical Characterisation Protocol
Toolkit for Operationalising the Clinical Characterisation Protocol
The Clinical Characterisation Protocol (CCP) is a standardised approach for studying anhy severe or potentially severe infections of public health concern. It allows rapid collection of data and biological samples in a globally coordinated way.
ISARIC has worked with global experts to adapt its Clinical Epidemiology Platform, supporting research on emerging infectious diseases to improve patient care and guide health policies. This platform provides tools to help researchers set up studies, analyse outbreaks, and inform clinical trials. It also enables collaboration across different variants, countries, and time periods.The ISARIC-WHO CCP and Clinical Epidemiology Platform offer free, standardised tools to support research, including Case Report Forms (CRFs), databases, and statistical analysis. ISARIC provides guidance while ensuring researchers retain control of their data and samples
The CCP enables a structured approach to studying emerging health threats. Researchers can tailor it to their needs by adding specific research questions, adjusting procedures, and modifying investigations based on available resources.
To start before implementing the CCP:
Disease-Specific Research Response Guidance
(Currently available for mpox,H5Nx and Dengue)
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.
Depending on local resources, interest 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 ✎
For module 1 and above (where consent is required), refusal to participate by patient, parent or appropriate representative.
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.
The sampling method refers to how participants are selected for a study , aiming to ensure representativeness and minimise bias in the analysis.Each site has its own requirements, abilities, and limitations to participant recruitment and should select the sampling approach that fits best.
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
Organise a Study Master File (SMF). This file (electronic/paper)should contain key documents and procedures.
Download the Study master file Stucture template ✎
Use 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 patients information sheet and consent form (PISC) to be used by the study team to enrol participants when consent is required Patient Information Sheets templates ✎
Submit your protocol and study documents and liaise with the responsible committees / authorities to gain approval. Ethics application example ⓘ
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 the design of clinical trials.
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 our 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 ⓘ
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.
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.
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
Instructions on How to get started with VERTEX
Instructions on How to create additional visualisations for the VERTEX dashboard