Outline of the data sharing process for the EDIT Collaboration: individual participant data

If you require additional ethics approval or have any other local requirements for data sharing and transfer (e.g. data sharing agreements) please commence this process as soon as possible, as from our experience these processes can be lengthy.

Our team is able to assist with completing any required request forms. Please send these to edit.study@sydney.edu.au.

Ethics approval and data sharing agreements

Ongoing trials

If you are not yet able to release your data (e.g. your trial has not been completed or published), please inform us when you expect to be able to release your data, so we can factor this into the EDIT timeline. You may choose to provide your data in-confidence prior to publication so that it can be included in the primary cycle of EDIT analyses. In this case, we would formulate an explicit written agreement for EDIT to not release any combined analyses including your data before your trial has been published. Please let us know if you would like to pursue this option, or if you have any questions or concerns about this.

Format of individual participant data

You will be able to provide your data to us using the following two options:

1) Ideally, we will ask you to recode your data to match the pre-specified variable names and categories as outlined in the data provision form. If for any of the requested variables you have only collected a similar variable, we will ask you to provide this variable with a separate name and explanation. Please clearly indicate where a variable has not been collected.

2) If you do not have the capacity to recode your data into our preferred format, you will be able to provide your raw data to us. We will ask you to provide a data dictionary, Case Report Form and/or similar to enable us to understand the variable names and category codes so that we can recode them into the EDIT format. The more information about your data you can provide, the easier it will be for us to understand and process the data correctly.

We will ask you to provide your data in .csv format if possible. However, we are also able to process data in most standard formats such as R, EXCEL, SPSS, STATA, or SAS.

Individual participant data

Data provision form

The Data Provision Forms seek information about the design of your trial, and the definitions of key variables used in your trial. Please complete this and send it back to us.

You can download the relevant forms here:

Data Provision Form for adult trials

Data Provision Form for adolescent trials

Data transfer

There are several ways you can provide your data/materials securely to EDIT:

1)     Via email, using zip files with a password sent in a separate email (preferred option). You can find more information on how to prepare zip files here.

2)     Any data transfer options your university provides (e.g. SharePoint, secure dropbox)

3)     We can set up a secure data transfer platform via our university for you if required

Please let us know which option you prefer, and if you need any assistance with the data transfer.

Data storage

All data will be stored in secure, password-protected folders within the NHMRC Clinical Trials Centre Network, following the University of Sydney’s Research Data Management Policy.

Data ownership

You will remain custodian of your data. We will ensure to involve you in the data processing, and any inconsistencies in your data will be resolved with you directly. The statistical analysis plan will be agreed on by the whole collaboration (which includes you) before conducting any analyses.

Questions?

If you have any further questions, please click here to access our FAQs.

Please do not hesitate to contact the EDIT Study Team if you have any additional questions, or to inform us about your anticipated timeline for data sharing.