ELSO DATA REQUEST FORM

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General Principles for Research with ELSO Registry data

  1. ELSO supports the use of ELSO registry data for research to improve the care of ECLS patients worldwide.
  1. Use of ELSO registry data is restricted to member centers of ELSO.A summary of ECLS outcomes are provided to the public at: Member centers can request data for purposes of analysis. In general, the data requested should be a confined to a small population defined by age, mode of ECLS, and diagnosis.
  1. All academic product resulting from investigation of ELSO Registry data must include reference to ‘the ELSO Registry’. Publications in the scientific literature should reference the ELSO Registry as ‘the ELSO Registry’ or the Extracorporeal Life Support Organization Registry’ in the published abstract.
  1. Larger data releases are possible, in rare cases where large populations are necessary for epidemiologic studies, or to answer a question common to all patients receiving ECLS.These studies will be individually reviewed by the ELSO registry committee chair(s) and if approved, will usually be conducted with ELSO participation to maintain data protection, integrity, and limitation of scope of analysis.
  1. Requests for data should be submitted in writing using the below data request sheet. All fields must be completed. A list of all variables collected by the ELSO registry is available at Data requests that propose higher levels of methodological rigor are favored.
  1. Requests for data to be used for publication will be reviewed with previous data request submissions to ensure there is no substantial overlap.Date/time of request establishes priority of the request.Data is only to be released to one investigator at a time for a particular study question.In cases where potential overlap is found with existing approved studies, both investigators will be contacted to determine if substantial overlap actually exists.Final discretion for data release is the decision of the ELSO registry chair(s).
  1. The released dataset must only be used to answer the proposed hypothesis/hypotheses.
  1. Datasets from the ELSO Registry are released after a study proposal has been submitted for Data Request review. Released data should only be used to test the hypotheses included on the study proposal. Any further analysis of the dataset needs to be resubmitted for review to ensure the data has not been released to other investigators. This process is essential to the integrity of the ELSO Registry data and is respectful of the resources and effort expended by other investigators.
  2. Data use violations are defined as use of ELSO Registry datasets to explore analyses which were not proposed as part of Data Request. Data use violations which are published in the scientific literature will result in consequences for the investigators and the center director. Initial examples of consequences include – a first warning, but if repeated infringements occur, the investigators and center director may be refused access to ELSO Registry data for a period of 12-24 months.
  3. Data use violations that directly compete with other active investigations and result in publication in the scientific literature will result in a Letter of Correspondence to the journal or editor from the ELSO President and ELSO Registry Chair which states that the investigators were not granted this data in good faith and that this work competes directly with other investigators. This letter will be in the public domain.
  1. Substantial progress should be made with analysis of data within 1 year from request of data for research purposes. Substantial progress will be defined as submission of an abstract or manuscript (regardless of acceptance) and/or submission of a report of progress in writing to the ECMO registry. Failing to do so will result in release of data to other investigators after one year following request.
  1. Any additional data required for analysis must be requested with the Data Request form. This will be reviewed by the Registry or Scientific Oversight Committee Chair to determine whether the additional data is a significant enough change to be presented at a full Data Request Review Committee Meeting.
  1. New requests for data will be limited to one outstanding and one new request per principal investigator. An outstanding request is one that has not been submitted as an abstract to a scientific conference or a manuscript to scientific journal.
  1. Investigators are invited to submit a copy of the abstract or manuscript to the protocols and research committee at ELSO to ensure accuracy of data analysis and conclusions when using registry data.After publication, investigators are required to provide a copy of the manuscript to ELSO for purposes of monitoring use and publication of ELSO Registry data.
  1. Data cannot be shared or distributed to anyone besides those listed in this document and can only be used for the sole purposes outlined in the request.

This application for ELSO Registry data constitutes my work and that of the co-investigators included on this application. I agree to work within these ‘General Principles for Research with ELSO Registry data’

Name of the director / coordinator requesting the data: /

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Electronic signature: / Click or tap here to enter text.
Date: / Click or tap to enter a date.

ADMINSTRATIVE INFORMATION

Center name /

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Center number /

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PROJECT TITLE /

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Principal investigator / Click or tap here to enter text.
Co-Investigators / Click or tap here to enter text.
Complete list of persons having access to the data file(s) / Click or tap here to enter text.
CORRESPONDING CONTACT
Name and title / Click or tap here to enter text. /
Organization / Click or tap here to enter text. /
Address / Click or tap here to enter text. /
Telephone number / Click or tap here to enter text.
E-mail address / Click or tap here to enter text. /
DATA USE
Internal purposes only / Choose an item.
For Publication / Choose an item.
Presentation at scientific meeting / Choose an item.
Meeting where data will be presented: / Click or tap here to enter text. /
Publication in peer-reviewed journal / Click or tap here to enter text. /
Anticipated journal of submission: / Click or tap here to enter text. /
I have existing data requests from ELSO
Provide updates for any released dataset from more than 12 months / Click or tap here to enter text. /

PROJECT DESCRIPTION

Primary research questionor objective / Click or tap here to enter text.
Additional research question(s) or objective(s) / Click or tap here to enter text. /
Important background information / Click or tap here to enter text.
Relevant literature references / Click or tap here to enter text.
Citations of Primary Investigator or Co-investigators’ previous use of ELSO Registry Data / Click or tap here to enter text.
Hypothesis / Click or tap here to enter text.
Specific aims / Click or tap here to enter text.
Inclusion/exclusion criteria (population, ICD-10 codes, …)
e.g. 28 days to 18 years, pulmonary, 2012-2017 who had any mention of P27.1 ICD-10 diagnoses code. / Click or tap here to enter text. /
Requested study period / Click or tap here to enter text.
If >5 years of data requested, please provide justification of requested dates / Click or tap here to enter text. /
Relevant ELSO variables / Click or tap here to enter text.
Planned statistical analysis
(include as much relevant detail as possible) / Click or tap here to enter text.
Expected time-line
(not more than 1 year) / Click or tap here to enter text. /
Institutional Review Boardapproval / Choose an item. /
Funding secured for project (specify) / Click or tap here to enter text. /

FOR ELSO USE ONLY

Reviewer names /

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Meeting date / Click or tap to enter a date. /
Overlap with existing requests? / Click or tap here to enter text.
Additional notes / Click or tap here to enter text.
Publication citation / Click or tap here to enter text.
Approval notes / Click or tap here to enter text.
Request number / Click or tap here to enter text.

Version 1.4January3, 2018

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