Guidance for ISARIC Partners

ISARIC Partners are invited to lead and participate in collaborative analyses of the global data platform.

ISARIC Partners include staff of the sites and networks who have contributed data to the ISARIC Data Platform. Details on how to request, receive, analyse, publish, present, and protect data from the ISARIC Data Platform are described below.

 

 

Key steps:

  1.   Review the list of existing analyses to be sure your idea is novel.
  2.   Submit a Statistical Analysis Plan (SAP) and agree a draft SAP with ISARIC.
  3.   Invite Partners to input and participate on the SAP.
  4.   Finalise SAP based on Partner input.
  5.   Sign an agreement to access data.
  6.   Download the data and support documentation from the secure link sent by ISARIC.
  7.   Execute the analysis using the tools provided.
  8.   Choose an appropriate open access journal.
  9.   Send ISARIC a list of subject IDs included in the analysis. Define authors and collaborators.
  10. Share the draft manuscript with collaborating Partners. Finalise the manuscript based on feedback.
  11. Submit to the journal. Inform ISARIC when it is accepted and published. Send the author accepted manuscript to ISARIC.
  12. Follow the data security guidance to destroy the data.
  13. Participate in an Evidence Forum at any point.
  14. Get support from ISARIC at any time for any of these steps.

For further details of the steps above, see the sections below:

1&2 - Initiating an ISARIC Partner Analysis

Before developing a new analysis, please review the list of existing analyses. Any ISARIC Partner can initiate a new analysis of data on the ISARIC Data Platform by submitting a Statistical Analysis Plan (SAP) to data@isaric.org. Please note, in the context of an active outbreak, data access and analysis will prioritise the involvement of individuals from the sites that collected the data. If you wish to submit a SAP for an active outbreak that your site did not contribute data for, please get in touch with us to connect you with those who are collecting data. ISARIC will review the SAP for completion, feasibility with existing data, duplication with other analyses, and scientific validity, and will provide feedback with the aim of supporting all viable analyses to progress.

3&4 - Participation of other Partners in the analysis

When the SAP author and ISARIC agree that a SAP is ready to progress, ISARIC will post the SAP on a shared web platform and invite all Partners to review and provide input. ISARIC promotes broad participation in Partner Analyses. When useful, we can assist in connections to appropriate experts across our network. All input from Partners, co-leads and working groups (if applicable) should be considered before sending a final version of the SAP to ISARIC.

5&6 - Receiving data

All individuals who require access to data should be listed in the appropriate section of the SAP. ISARIC will send data security requirements and an agreement to these individuals for signature, enabling their access to data under the ISARIC data governance framework. Signed agreements must be sent to ISARIC for co-execution, and we will send a secure link to a folder where data, support documentation, the fully executed agreements, and the data security requirements will be available for download.  

7 – Executing the analysis and writing the manuscript

Analyses using COVID-19 data: Details of the database purpose, origins and contents are available in the ISARIC Value of open source clinical science paper and Data Descriptor Paper. Processing code is also available in the Data Descriptor Paper. Detailed guidance on the structure of the data can be found at https://wiki.iddo.org in the section under Implementation Manual. To access the manual, you are required to register a username and a password via https://www.iddo.org/user/register.

 

Analyses using data other than COVID-19: Details of the datasets will be provided with the data.

8 - Choosing a journal

Manuscripts must be published open access, in a journal that meets our funders’ open access requirements. You can check that the journal you select meets these criteria here, by entering: JOURNAL [the name of your target journal], FUNDER [Wellcome], INSTITUTION [University of Oxford, United Kingdom (ROR:052gg0110)]. If the result is FULL OPEN ACCESS, it is appropriate. If the result is TRANSFORMATIVE AGREEMENT, you may submit if the first author lists “ISARIC, Pandemic Sciences Institute, University of Oxford, UK” as an affiliation.

9 - Defining authors and collaborators

A list of all subject IDs (USUBJID) included in the final analysis must be sent to ISARIC. Based on the subject IDs, ISARIC will generate a list of collaborating Partners to be included as cited collaborators under group authorship.

Authors of the SAP and manuscript decide who is listed as an author of the paper. The ICMJE have guidance on authorship requirements and the CRediT ontology is recommended for attribution of roles. The “ISARIC Clinical Characterisation Group” must be listed as either first or last author, linked to the list of collaborating Partners provided by ISARIC.

10 - Finalising the manuscript

Analyses using COVID-19 data: The Value of Data paper and Data Descriptor Paper should be cited in all outputs to provide background and reduce reiteration of detailed database construction methods. Other Partner Analyses that may also be useful to cite are available in this list.

All analyses: On completion, the draft manuscript is sent to ISARIC, who are responsible to circulate the draft to all collaborating Partners for their input. A minimum of 7 days will be given for Partner input via a shared web platform. Partners will additionally be invited to list any acknowledgements that should be included in the publication.

Following the review period, feedback from Partners should be considered and incorporated as appropriate into a final manuscript. It is preferred, but not required, to respond to Partner comments posted on the shared web platform.

11 - Submitting to the journal

The final manuscript can be submitted to the selected journal for open access publishing. All funding and acknowledgements submitted by collaborating Partners should be included in the submission. ISARIC can support open access fees if the following requirements are met:

  • the first author includes ‘ISARIC, Pandemic Sciences Institute, University of Oxford, UK’ as an affiliation (in addition to any other affiliation(s) they may have), and
  • the corresponding author lists ‘University of Oxford’ as their primary institution on the journal submission system (this is to ensure that the charges are billed to University of Oxford), and
  • the journal invoice is sent to ISARIC for payment.

All authors and collaborating Partners should have a citation retrievable through the National Library of Medicine MEDLINE. It is the responsibility of the corresponding author to ensure that the journal fulfils this requirement. 

Please be sure to:

  • inform ISARIC when the manuscript is accepted, and
  • send a copy of the author accepted manuscript (the final word version submitted to the journal) to ISARIC, and
  • inform ISARIC when the manuscript is published.

12 – Ensuring data security

Following publication, the data must be permanently deleted as per the data security guidance. For archival purposes and in case of future need, ISARIC will retain a copy of the dataset shared. On request, ISARIC can retain a copy of any processed data generated by Partners who executed the analysis. Data may not be held outside of Oxford University servers beyond the termination date of the data access agreement. Inform ISARIC when the data are permanently deleted.

ISARIC will endeavour to address any queries regarding the data, to review draft outputs, and to provide support to the analysts.

13 – Participate in an ISARIC Evidence Forum

To engage partners in the use of their data, ISARIC organises intermittent Evidence Forums where Partners present SAPs and the results of analyses. When feasible, Partners will be invited to present in these open, online teleconferences. The key objectives of the Forums are to gain insights into the data, to leverage the expertise across the Partners to improve the design of the analyses, and to ensure that all ISARIC Partners can participate in the outputs of their hard work. Participation is encouraged.

14 – Getting support

We available to provide administrative, scientific, statistical, and technical support for all the steps outlined above. Contact data@isaric.org with any questions, clarifications, suggestions, or requests. We are here to help.