Guidance for ISARIC Partner Analyses
ISARIC promotes the generation of high-quality evidence to advance understanding of infectious disease and improve patient outcomes. Staff of the sites and networks who have contributed data to the ISARIC Data Platform; collectively called ISARIC Partners; are invited to lead and participate in collaborative analyses of the ISARIC global data platform. Details on how to request, receive, analyse, publish, present, and protect data from the ISARIC Data Platform are described below.
- Review the list of existing analyses to be sure your idea is novel.
- Submit a Statistical Analysis Plan (SAP) and agree a draft SAP with ISARIC Global Support Centre (GSC).
- Invite Partners to input and participate on SAP, including a co-lead based at an LMIC institution.
- Finalise SAP based on Partner input.
- Sign an agreement to access data.
- Download the data and support documentation from the secure link sent by GSC.
- Execute the analysis using the tools provided.
- Choose an appropriate journal.
- Send a list of subject IDs included in the analysis to GSC. Define authors and collaborators.
- Share the draft manuscript with collaborating Partners. Finalise the manuscript based on feedback.
- Submit to journal. Inform GSC when it is accepted and published. Send the author accepted manuscript to GSC.
- Follow the data security guidance to destroy the data.
- Participate in an Evidence Forum at any point.
- Get support from the GSC at any time for any of these steps.
For further details of steps above, see 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 email@example.com. The ISARIC Global Support Centre (GSC) will review the SAP for completion, feasibility with existing data, duplication with other analyses, and scientific validity. The GSC 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 the GSC agree that a SAP is ready to progress, the GSC will post the SAP on a shared web platform and invite all ISARIC Partners to review and provide input. ISARIC promotes broad participation in Partner Analyses. As such, SAP authors are encouraged to invite participation from other Partners. This may be as a part of a working group that supports the analysis and manuscript writing. All SAPs must include a lead or co-lead from an institution in a low- or middle-income country. The GSC can assist in connections to appropriate experts. All input from Partners, co-leads and working groups (if applicable) should be considered before sending a final version of the SAP to the GSC.
5&6 - Receiving data
All individuals who require access to data should be listed in the appropriate section of the SAP. The GSC 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 the GSC for co-execution. GSC 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
COVID-19: Details of the database purpose, origins and contents are available in the ISARIC Value of Data 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.
8 - Choosing a journal
Manuscripts must be published with open access, in a journal that meets the open access requirements of ISARIC funders. You can check that the journal you select meets these criteria at https://journalcheckertool.org/ 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, or if listing the first author’s institution in the INSTITUTION field yields the same result.
9 - Defining authors and collaborators
A list of all subject IDs (USUBJID) included in the final analysis must be sent to the GSC. The GSC will generate a list of collaborating Partners, based on the subject IDs, to be appended to the manuscript.
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” should be listed as either first or last author, linked to the list of collaborating Partners provided by GSC.
10 - Finalising the manuscript
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.
On completion, the draft manuscript is sent to the GSC, 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 arrange funding for open access fees if 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). Forward the journal invoice to the GSC 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.
Inform the GSC when the manuscript is accepted. Send a copy of the author accepted manuscript (the final version submitted to the journal) to the GSC. Inform the GSC 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, GSC will retain a copy of the dataset shared. On request, GSC 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. GSC should be informed when data are permanently deleted.
The GSC team 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
The GSC are available to provide administrative, scientific, statistical, and technical support for all the steps outlined above. Contact firstname.lastname@example.org with any questions, clarifications, suggestions, or requests. We are here to help.