Samples and data generated during the PredictTB project may be shared with external investigators.

What type of samples and data may be shared?

Samples to be shared include any biological specimen obtained directly, or generated from material obtained directly, from participants of the PredictTB study. These specimens include sputum, blood, urine, saliva as well as nucleic acids, proteins, biochemicals, other biological materials human or bacterial, or bacterial isolates obtained from any of these body fluids.

Data to be shared include information collected from participants of the PredictTB study in the clinical research forms, metadata, imaging data (DICOM format) and data from end-assays.

All shared data and samples will be de-identified and presented using the assigned participant identifier (PID).

Please note that only samples that have not already been claimed by the internal PredictTB Trial investigators will be available for sharing with external investigators.

Who can request sharing of samples and/or data?

A sample request can only be submitted by the principal investigator of the project for which the samples are being requested. A data request can only be submitted by an experienced data manager and analyst or if the requesting team has an experienced data manager and analyst.

For which purpose may samples and/or data be shared?

Samples and data may only be shared in the context of non-commercial studies which are relevant to the advancement of TB or related research and for which any forthcoming products will adhere to the Bill & Melinda Gates Global and Open Access Policy. Seeking direct financial benefits for the samples and/or data that have been shared is not permitted.

The shared samples and the shared data may only be used towards completion of primary and secondary project aims as described in the sample and/or data sharing request. Any additional/new involvements needing the use of these samples and/or this data will require a new sample and/or data sharing request to allow for expansion of the Material and Data Transfer Agreement (MDTA) extending the use of the samples and/or the data to other projects.

How can sharing of samples and data be requested?

Requests for sample or data sharing can be submitted by filling out the “PredictTB sample or data sharing request form” and submitting it via email to the Secretary of the Sample Management Committee (predictsamples@linq-management.com).

The Sample Management Committee will require up to 6 months to return a decision to all requests, unless some reasonable urgency is implied.

In the case of sample sharing, an MDTA will be signed between each site that sends samples and the requesting party. After the MDTA is completed and signed, samples will be shipped within 90 calendar days provided all regulatory approvals are in place for shipping of the samples.

After a data sharing request has been granted, an MDTA will be signed between each site that sends data and the requesting party. After the MDTA is completed and signed, the data will be provided through locked or public databases.

Please note: The requesting party must state that they have the funds available for conducting the proposed work when submitting a sample and/or data sharing request.

We encourage the requesting research team to communicate with the PredictTB study team prior to submitting a formal request to better understand the nature of the provided samples/data. Any communication should be directed to the Secretary of the Sample Management Committee (predictsamples@linq-management.com), who will then put the requestor in direct contact with the appropriate study team member.

For further information please refer to the details of the sample and data sharing.