Novel Coronavirus (COVID-19) Case Report Form
All information on how to start collecting data via the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) Case Report From (CRF), as well as a pdf template, can be found on the ISARIC website. On this website you will find not only the COVID-19 CRF, but also the COVID-19 Clinical Characterisation Protocol (see Figure 1 below).
Figure 1. ISARIC website with COVID-19 Resources tab highlighted in orange.
Through the COMBACTE/PREPARE networks, you have been asked to participate in the COVID-19 tool, which is NOT considered a clinical study. Should you wish to participate in a clinical study and want to endorse the Clinical Characterisation Protocol (CCP), please contact the ISARIC Global Support Centre.
What is the role of COMBACTE/PREPARE in the collection of clinical data of patients with novel coronavirus (2019-nCoV)?
The COMBACTE and PREPARE clinical networks are supporting ISARIC, based at the University of Oxford and hosting the Novel Coronavirus (NCoV) Data Platform (NCoVDP), in their goal to collect clinical data in a rapid and coordinated fashion. COMBACTE and PREPARE are committed to informing their network members on the need for, and possibility of, standardized data collection during the course of an emerging infection, through using the thoroughly validated and WHO recommended ISARIC 2019-nCoV case report form (CRF). The CRF is not a study in itself, but a tool to facilitate the collection of standardised clinical data on patients hospitalised with suspected or confirmed infection with novel coronavirus (2019-nCoV). This data can be used for individual sites, or upon agreement, by sites to take part in combined analysis to facilitate disease characterisation and inform clinical management and control. For any detailed questions on the CRF tool, please contact the ISARIC Global Support Centre.
Can I only participate in data collection via the CRF if I also participate in the ISARIC COVID-19 Clinical Characterization Protocol (CCP)?
No, the ISARIC COVID-19 CRF can be used separately. The CRF is an international tool to facilitate the collection of standardised clinical data on patients hospitalised with suspected or confirmed infection with novel coronavirus (COVID-19). The COVID-19 Clinical Characterisation Protocol (CCP) is developed as a tiered protocol with the option to also include research sampling. This will require IRB approval of the study protocol. The COVID-19 CRF is aligned with the CCP CRF. The CCP is designed to be used for any emerging and novel pathogen of public health interest, including COVID-19.
We would like to participate in data collection via the ISARIC CRF. What are the next steps?
Hospitals that want to participate in data collection via the ISARIC COVID-19 CRF should check the need for EC/IRB approval of the anonymized data collection. If you expect EC/IRB approval is necessary, a Frequently Asked Question (FAQ) on this topic is outlined below.
The data for the CRF will be entered into the central electronic REDCap database, hosted by the University of Oxford. An account can be requested via an email to email@example.com. Via this account a Data Sharing Agreement (DSA) can be filled out. After submittal of the Data Sharing Agreement, you can start data entry in the electronic CRF.
Where can I find the Data Sharing Agreement?
A pdf version of the Data Sharing Agreement can be found on the ISARIC website. As stated above, if you want to participate in data collection an account can be requested via email, after which the DSA can be filled out in the REDCap database.
We want to use the CRF but we do not want to share our data, is this possible?
Sites keep ownership of the data they enter and can access and download their data directly from the REDCap database. Sites can use their data for independent observational studies. University of Oxford only hosts the database. The data will not be accessed by any other party without prior agreement and permission. For further information see the Data Sharing Agreement.
We need EC/IRB approval for the collection of anonymized data into the ISARIC CRF. What documents are available?
On the ISARIC website there is an ‘Ethics approval request template letter’. For the ISARIC CRF only there is no study protocol available, as it is a standardized data collection tool. Sites who wish to set up the CCP protocol with the option to scale up and add research specific samples, can download the protocol directly here.
This website provides template consent forms which can be downloaded and adapted as appropriate.
Why is there a separate UK-CCP?
In the United Kingdom (UK) the CCP has been pre-approved across all NHS sites, for immediate activation across all participating UK NHS sites in the event of an emerging or novel incident or outbreak of public health interest. It is the same protocol, it is just coordinated via another centre.
Do we need a contract with ISARIC before we can start data collection?
The COVID-19 CRF is an international, free, open-access tool to facilitate the collection of standardised clinical data on patients hospitalised with suspected or confirmed infection with novel coronavirus (COVID-19) in a rapid fashion. No financial agreements or site contracts are needed for using this data collection tool. The eCRF can be downloaded directly from the ISARIC website. To enter data onto the electronic database, download and sign the Data Sharing Agreement.
Is there financial compensation for participating in data collection?
There will be no financial compensation for entering data in the COVID-19 CRF.
What should I do if I have any other questions?
For other questions about the data collection or further information on how to use the ISARIC COVID-19 CRF or CCP, please email the ISARIC Global Support Centre.