Roche is committed to delivering on the principles of clinical trial transparency as set out in the joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing including sharing patient level data in compliance with global legal and regulatory requirements.

• Patient identifiers (subject number): Replaced by a new patient ID, consistently across all datasets to keep the patient-record relationship.
• Further unique identifiers: Removed (e.g. kit number) or scrambled (e.g. sample IDs).
• Site ID: Removed.
• Date of birth: Removed.
• Age: 5, 10, or 20 year Age Banding to be applied on age variables. Above 89 are aggregated into a single category of 90 or older.
• Country: Aggregation to continent level.
• Dates/Times related to study subject: Date shift by random shift factor. Same factor for all dates of a patient, however different factor per patient. Time remains unchanged. (NOTE: in some studies dates are replaced by a relative study day)
• Comments, free text, variables containing personally identifiable information (PII), e.g. names, initials: Removed.
• Verbatim term of adverse events, medical history and concomitant medications: Free text verbatim term replaced by coded dictionary terms.

More information can be found in the  Anonymization of Clinical Trial Datasets , also an “anonymization orientation document” is provided with each set of data. Some studies may require alternative data transformations based upon datasets properties and re-identification risks.

18 months after completion of the study report (to enable publication to be submitted).

In the event that you cannot see a specific study in the Roche list, an Enquiry Form can be submitted to confirm the availability of the specific study (see section Questions or enquiries).

Publication datasets for limited number of studies: Roche is committed to sharing the data generated from our clinical studies used in publications to enable external researchers to validate, contextualize, and expand upon our findings, thereby supporting broader scientific progress. As part of a pilot program with Vivli biomarker data supporting a limited number of studies used in Roche publications will be listed on the Vivli platform. Requests to access these datasets will be subjected to an accelerated review process by Vivli to ensure data minimization principles are practiced and data access and use is in compliance with relevant regulations.

Restrictions on datasets combination and usage will be provided during the review process.

Phase 4 clinical studies conducted for non-registrational purposes or local affiliate studies.

Studies or data records within a study, where data sharing is prohibited by the consent, legal, regulatory, or contractual constraints on data sharing.

Where there is a potential conflict of interest, data is to be used for a commercial purpose or there is an actual or potential competitive risk.

• Images
• Genomic data
• Exploratory Biomarker data, PK data

If individual patient data from the same study is made available outside of Vivli, this cannot and should not be linked to data on the Vivli platform by researchers external to Roche due to a potential increase in risk of patient re-identification. Requests to merge patient-level data for a study with additional data from the same study hosted on another platform (e.g. European Genome Archive) is not possible.

Where available, the following anonymized patient level data and information is provided for each clinical study.

• Raw dataset. This is the dataset collected for each patient in the clinical study.
• Analysis-ready dataset. This is the dataset used for Roche’s analysis.
• Annotated case report form (If available). This is a blank case report form with descriptions of the data collected and how they are described in the dataset.
• Dataset specifications (If available). This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats. 

The following will be provided if readily available.

• Protocol (If available)
• Reporting and analysis plan (If available)
• Clinical study report (If available)

Alternatively, Researchers can request these clinical study documents via the following link:

Roche Clinical study documents request form 

Additionally, published Clinical Document Packages per Health Canada’s Public Release of Clinical Information and European Medicines Agency’s Policy 0070 on the respective agency-controlled websites and databases may be accessed.

www.clinicaltrials.gov

EU Clinical Trial Register 

Health Canada

For the publication dataset pilot (see Studies listed for sharing), these data (data only included in package) will be handled separately from the CSR datasets and cannot be combined and used alongside each other.

Roche will assess whether it is feasible to anonymize the data without compromising the privacy and confidentiality of research participants.

If Roche incurs significant costs to retrieve data from repositories and archives for older studies in particular, these costs can be substantial which may lead Roche to decline certain requests.

Requests for the LORELEI (GO28888) study may be additionally reviewed by an independent study specific steering committee.