- Who initiated the LEOSS project?
- What are the goals and visions of this project?
- What happens with the data and who governs it?
- I have heard of other surveys on SARS-CoV‑2. Why should I contribute to LEOSS?
- Who can participate in the LEOSS project?
- Which patients can be included in LEOSS?
- How long does it take to enter a patient case?
- At what point do I document the case of a positive tested SARS-CoV‑2 patient?
- Where can I document my patients and how can I get an access to the eCRF?
- How is the data collected and stored?
- How should I proceed with already completed cases in the context of on-going modifications of the eCRF?
- Who is responsible for data security?
- Who can get access the dataset and for what purposes can the data be used?
Who initiated the LEOSS project?
The EITaF and the German Society for Infectious Diseases have joined forces to establish a clinical patient registry for patients infected with SARS-CoV‑2.
What are the goals and visions of this project?
The goal of LEOSS is to establish a quick and simple register that allows anonymous documentation of patients, in order to get more in-depth knowledge about the epidemiology and clinical course of patients infected with SARS-CoV‑2.
What happens with the data and who governs it?
All survey results will be regularly published to the scientific community for crowd-based analysis. The survey will be self-governed by a Board of Investigators consisting of the contributing centers, with Country Coordinators and ESCMID representatives giving additional input.
I have heard of other surveys on SARS-CoV‑2. Why should I contribute to LEOSS?
At the beginning of March, the German Society for Infectiology (DGI) approached us to establish a European case registry for patients with SARS-CoV‑2 infection with a broad-based team of experts, supported by the Emerging Infections Task Force of ESCMID. We decided to do this because there have been repeated calls for free, anonymous data entry, e.g. also for patients who are unable to give their consent. The result was the Lean European Open Survey for SARS-CoV‑2 Infected Patients (LEOSS). We chose an open, anonymous documentation approach, without patient consent, in order to be as time efficient and comprehensive as possible.
We invite you to contact us if you would like to establish a collaboration between LEOSS and other SARS-CoV‑2 related cohort studies.
Who can participate in the LEOSS project?
LEOSS is a European case registry for SARS-CoV‑2. However, LEOSS is an open access for the research community and non-European countries are also welcome to participate.
Which patients can be included in LEOSS?
Patients with confirmed SARS-CoV 2 infection by PCR can be included. In outpatient settings additionally to medical history and known outcome laboratory values and vital signs should be determined at least once.
How long does it take to enter a patient case?
At what point do I document the case of a positive tested SARS-CoV‑2 patient?
Data collection is best to be performed retrospectively after a patient case has been completed (treatment is finished or patient’s death). But due to the necessity to fight this ongoing pandemic, also the documentation of on-going patient cases is viable.
Where can I document my patients and how can I get an access to the eCRF?
The eCRF will be accessible through www.clinicalsurveys.net. Partner sites wishing to contribute need to request account-details for login via email. Please contact email@example.com. Please be aware that all investigators can only view and modify their own contributions. You can create a joint account for your ward or clinic by using one email address.
How is the data collected and stored?
The data will be collected via an electronic case report form (eCRF) provided by using the ClinicalSurveys.net online platform of the University Hospital of Cologne (UHC). ClinicalSurveys.net is hosted by QuestBack, Oslo, Norway on servers in Cologne, Germany as part of a software-as-a-service agreement. All data transmissions are encrypted via TLS 1.2 with an AES 256 GCM bit key and ECDHE RSA key exchange; certificate provided by COMODO RSA Domain Validation Server. Data is documented anonymously; no directly identifying data are stored on QuestBack servers. Regular data-backup, hierarchic management of rights and authentication protocols ensure the protection of data from unauthorized access and loss.
How should I proceed with already completed cases in the context of on-going modifications of the eCRF?
The eCRF is modified in cooperation with medical societies and partners according to their expertise and updated information. We do not expect any subsequent documentation of an already completed case. The patient’s documentation is complete considering the survey at the respective point of documentation.
Who is responsible for data security?
Contracts between the University Hospital Cologne and QuestBack regulate ownership and responsibility for data, security and eCRFs. Regular on-site audits of security and data protection measures are performed at QuestBack Cologne by the University Hospital of Cologne.
Who can get access the dataset and for what purposes can the data be used?
For all collaborators an anonymised data set will be available, protected by a password. There will be no limit for collaborators to requesting access to the anonymised data set and the analyses made with the data set. This allows analysis of the data set for research purposes and public health interests in the context of the SARS-CoV‑2 pandemic. All use for other research questions or for financial gain of individuals or corporations will be prohibited.