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: Kept, aggregation of Age >89 into a new variable.
• 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 “anonymisation orientation document” is provided with each set of data. Some studies may require alternative data transformations based upon datasets properties and re-identification risks

Roche will regularly update this list to add studies going back to January 1999. 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.

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

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

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

For future studies (2014 onwards) patients will be asked to give permission for broader research so other research may be possible with data from these studies.

A condition of providing the data is that the external requester seeks publication of their research results. Roche is to be provided with a copy of the manuscript after journal submission for information. Roche may choose to provide the requester with comments on the document as a courtesy, but the external requester is not obliged to incorporate any feedback resulting from this review.

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.

Please note: only clinical data that underlies the CSR is made available.  Therefore some data types may not be routinely provided (eg. Exploratory Biomarker data, Images, Genomic data, PK data).

If individual patient data from the same study is made available outside of Vivli this can not 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.

Protocol. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical study.

Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset.

Reporting and analysis plan. This describes methods of analysis, procedures for data handling and data displays (figures and tables) Roche used for the study.

Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats.

Clinical study report. This is the report of efficacy and safety data from the study. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices which include patient level data are not included as these data are provided in the datasets Roche provide.

Whether Roche has the legal authority to provide the data. For example, Roche may not have the legal authority because the medicine has been out-licensed to another company.

Whether Roche considers it feasible to anonymize the data without compromising the privacy and confidentiality of research participants. For example, anonymization of data from studies of rare diseases is more difficult to achieve and will be reviewed on a case-by-case basis.

Whether Roche consider that there are any practical constraints to providing access to the data. For example, imaging data, notes from patient interviews or genomic data will not be provided unless and until all relevant patients provide explicit consent.

The resources (costs) for Roche to retrieve data and documents from repositories and archives, anonymize data, and redact personally identifiable information from relevant documents. In some cases, particularly for older studies, the costs could be considerable and Roche may turn down requests on this basis.

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