Guidance for HeSANDA Nominated Trials completing the ANZCTR Data Sharing Statement

This document contains guidance for HeSANDA Nominated Trials who are updating Step 11 (Data Sharing Statement) of their ANZCTR trial registration. This guidance has been developed collaboratively by ARDC, the HeSANDA Nodes, and ANZCTR.

ANZCTR question

ANZCTR description

Guidance for HeSANDA trials

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Indicate whether there is a plan to make individual participant data (IPD) publicly available for this trial. IPD refers to raw line-by-line data collected from each participant.

Yes; IPD and related data dictionaries are/will be available
No; IPD will not be available

Note: the option of ‘Undecided’ is no longer able to be selected due to a recent decision by the International Committee of Medical Journal Editors (ICMJE).

Nominated Trials must select: “Yes; IPD and related data dictionaries are/will be available”

If you select “No”, you are indicating that you are not willing/able to share your data under any circumstances - if this is the case, then your trial is not eligible to be part of HeSANDA.

You can answer “Yes” as long as you meet one of the following criteria:

You don’t have ethics approval (or a waiver of consent) to share data, but you would be willing to seek ethics approval in some circumstances: If you didn’t originally obtain ethics approval to share data, it might not be possible to obtain approval at a later stage to share data for ‘unspecified future use’ (i.e. the broadest form of approval for data sharing). However, your ethics committee may be willing to provide approval for you to share your data on a case-by-case basis. If you are willing to review requests from others to access your data for a specific project and (potentially) seek ethics approval to share your data with that project, then you can select ‘Yes’. You should clarify what kinds of projects and groups you would be willing to do this for in the relevant sections below.
You have ethics approval to share data: This does not need to be approval to share with anyone who requests the data. It just needs to be approval to share data under some circumstances with people outside of the groups running the trial (e.g. a secondary researcher). While it is best practice to obtain consent from trial participants to share data, ethics committees may provide a waiver of consent under some circumstances - this constitutes ethics approval to share data.
There are no other restrictions preventing you from sharing your data.

No IPD sharing reason/comment (Only available when ‘No’ is selected for previous field)

Provide reasons/comments for why the IPD are not planned to be shared.

Not applicable for HeSANDA trials

Nominated Trials must respond ‘Yes’ to the previous question
If you select ‘No’ for the previous question then your trial is not eligible for HeSANDA.

What data will be shared? * (Mandatory when ‘Yes’ is selected for IPD question in Step 11)

Please describe what data will be shared e.g. all of the individual participant data collected during the trial, after de-identification; individual participant data underlying published results only, etc.

Nominated Trials should indicate at least one of the following:

All participant data collected
Participant data supporting the publication results
Participant data relating to primary outcomes
Participant safety data

Sample response

“Participant data supporting the publication results

Participant data relating to primary outcomes”

When will data be available (start and end dates)? * (Mandatory when ‘Yes’ is selected for IPD question in Step 11)

Please outline the timeframe of data availability, i.e. beginning and end dates for when the data is expected to be available, e.g. Immediately following publication, no end date; Beginning 3 months and ending 5 years following main results publication; no end date determined etc.

Nominated Trials should describe when the data will be made available. Options/examples include:

(Optional) Pick one from the following:

Data are available straight after publication
Data are available [‘x’ months] after publication

Pick one from the following:

Data are available for a finite time
Data are available for an indefinite time

Add the following information (approximate dates are ok):

Start date: [insert date]
End date: [insert date] / [if “data are available for an indefinite time” then insert “Unknown”]

If dates are subject to change (e.g. if funding ends/is extended) then your trial registration must be updated (as per the general requirements for updating ANZCTR records)

Sample response

Example 1:

“Data are available 5 months after publication

Data are available for an indefinite time

Start date: July 2023 (approx)

End date: Unknown”

Example 2:

“Data are available for a finite time

Start date: 1 July 2023

End date: 1 July 2028”

Available to whom? * (Mandatory when ‘Yes’ is selected for IPD question in Step 11)

Please specify who can/will be able to access the data, e.g. anyone who wishes to access it, only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor, etc.

Nominated Trials should specify one or more of the following:

Data are [potentially] available to (select all that apply):

Researchers from not-for-profit organisations
Commercial organisations
Other

Based in (select one):

Australia only
Any location
Other

Further information:

[insert further details about the above responses if required]
[insert further information usage permissions if required]
[insert reference to data sharing policy if required]

Sample response

“Data are potentially available to:

Researchers from not-for-profit organisations
Commercial organisations
Other

Based in:

Any location

Further information:

All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see our data sharing policy (http://www.university.edu/datasharing policy).”

Available for what types of analyses? * (Mandatory when ‘Yes’ is selected for IPD question in Step 11)

Please clarify if there is a specific type of analysis for which the data are/will be available, e.g. any purpose, only to achieve the aims in the approved proposal, for IPD me

Nominated Trials should indicate at least one of the following:

Any type of analysis
IPD meta-analysis or systematic review
Assessed on a case-by-case basis
Any approved protocol
Audit/verification of results

Sample response

“IPD meta-analysis or systematic review

Assessed on a case-by-case basis”

How or where can data be obtained? * (Mandatory when ‘Yes’ is selected for IPD question in Step 11)

Please specify how/where data are/will be shared e.g. unrestricted access via web address (provide link), access subject to approvals by Principal Investigator (provide email or other contact details), etc.

Nominated Trials should include the following statement:

“Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health ). Search for the ACTRN in the catalogue to find datasets associated with this trial.”

ARDC also recommends including a link to the data sharing policy for the trial (where available). For e.g. “For further information, see our data sharing policy: {insert URL}”

Please note that you can use your own processes handling data requests in addition to the HeSANDA platform. If so, you should provide those details in addition to the statement above.

Sample response

“Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health ). Search for the ACTRN in the catalogue to find datasets associated with this trial.

For further information, see our data sharing policy (http://www.university.edu/datasharing_policy).”

What supporting documents are/will be available? *

Select all types of supporting information that will be shared. Choose the appropriate type(s) from the list.

No other documents available†
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
Analytic code
Data dictionary
Other (please specify)††

† Note that if this option is selected, other options will not be available for selection.

†† If ‘Other’ is selected, please note that it is mandatory to specify the other type of document that is/will be available.

Nominated Trials are required to make their Study Protocol and Data Dictionary publicly accessible unless there is a legal or ethical requirement to restrict access.

Nominated Trials should tick the “Study Protocol” and “Data dictionary” options.

It is recommended that the study protocol, data dictionary and any other supportive documentation be provided in the ANZCTR record in the form of a DOI, attachment or link. This helps other users find relevant details. For further information see below.

How or where can supporting documents be obtained? * (Mandatory for each of the documents selected in the previous field)

Indicate how the corresponding document can be obtained, e.g. citation, link, email, other, attachment. Note that it is mandatory to complete at least one of these.

Attachment: It is the responsibility of the registrant to ensure that any uploaded documents comply with copyright regulations. Please note that any files attached will be publicly available via the trial ANZCTR registration record. Attached files cannot exceed the maximum size of 35MB per file.

Maximum number of attachments allowed: 20

Supporting documents must be made publicly accessible unless there is a legal or ethical requirement to restrict access. Nominated Trials should avoid using the Citation, Email, or Other options. ARDC recommends the following:

Option 1 [DOI] - ARDC strongly recommends creating a DOI for each supporting document. Your institution may be able to create this for you. Alternatively, you may consider creating a DOI by uploading your supporting documents to public/generalist repositories such as Figshare, Dryad, Zenodo, or OSF. These generalist repositories can create a DOI for you. The DOI can then be entered in the ‘Link’ option in response to this ANZCTR question. (NB. The DOIs for your supporting documents should also be listed as ‘Related Items’ (DataCite element 20) in your dataset DOI). You should speak to your institution first for advice on what options they allow and are best suited for your trial. The Library or Research Office can support with repository choice and DOI considerations.
Option 2 [Web link] - If it is not possible to mint a DOI for your supporting documents, then provide the URL for the web page where the document can be accessed into the ‘Link’ option. (NB. The URLs for your supporting documents should also be listed as ‘Related Items’ (DataCite element 20) in your dataset DOI)
Option 3 [Attachment] - If neither of the previous options are available, upload your supporting documents to ANZCTR. For study protocols please use the prefix “Study Protocol” in the filename of your attachment. For data dictionaries please use the prefix “Data Dictionary” in the filename of your attachment.