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?

It depends on the com­plex­ity of the case. For uncom­plic­ated patients it takes about 10–25 minutes to enter a full 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 registration@leoss.net. 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. 

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