- Who initiated the LEOSS project?
- What are the goals and visions of this project?
- What happens with the data and how is data access regulated?
- 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?
- When do I start documenting the patient’s case?
- Where can I document my patients and how can I get 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?
- How does the data use and access process look like?
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 how is data access regulated?
Data will be available for research purposes in different variations. A public use file as a condensed data set is already available on our website. For more in-depth research a larger data set can be requested which is subject to several further anonymization processes. Data use and access is governed by the Board of Investigators (BoI) and the Global Scientific Council (GSC). For more details see our Data Use and Access Policy.
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 on 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 was meant to be a European case registry for SARS-CoV‑2. However, LEOSS has spread worldwide and non-European countries are very welcome to participate
Which patients can be included in LEOSS?
Patients with confirmed SARS-CoV‑2 infection by PCR diagnosis from nasopharynx, oropharynx, bronchoalveolar lavage, stool, or blood. Rapid tests are an acceptable alternative. Basic medical information including medical history, known outcome and at least an initial blood sample and assessment of vital signs should be available.
How long does it take to enter a patient case?
When do I start documenting the patient’s case?
To prevent double documentation, data collection should be performed retrospectively after a patient case has been completed (treatment is finished or patient’s death)
Where can I document my patients and how can I get 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 firstname.lastname@example.org. 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. You can check for changes in the eCRF on our Documentation ChangeLog.
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?
A public data set is available on our website. It includes data from the LEOSS cohort after a data cleaning and an anonymization process using our data protection concept. For all collaborators we provide the local anonymized data set and all scientists are invited to register to get access to the more extensive scientific data set. Data Use and Access Policy has been developed within the community and with the involvement of several experts. This allows analysis of the data set for research purposes and public health interests in the context of the SARS-CoV‑2 pandemic.
How does the data use and access process look like?
After having registered via our online registration process indicating the interest in using LEOSS data for research you will receive the necessary documents for a request for data use specifying your aim, methods, and required data. This request will be checked for formal issues by the LEOSS project coordinators and then be forwarded to the governance organs, namely the Board of Investigators (BoI) and Global Scientific Council (GSC). After having revised and voted on your proposal, we will inform you about the decision via email and you will get details regarding the data transfer process.