Data from clinical studies for co-developed products approved on or after Jan 1, 2010, and from clinical studies for products which development has been terminated on or after January 1, 2010 that are not listed on the portal can be requested by completing the Vivli Enquiry Form as described below. These requests will be reviewed and a decision made on a case-by-case basis.

• • Study Participant ID: Replaced with a new random study participant ID that cannot be linked back to the original study participant.
  • Site ID: Replaced with a new random site number that cannot be linked back to the original site ID, however, can be still used to link information within anonymized study dataset.
  • Investigator ID: Removed.
  • Dates: Replaced by study days relative to a “baseline/ reference date”.
  • Date of birth: Only AGE is kept and converted into classes.
  • Date of death: Removed; relative day of death is converted to relative WEEK of death.
  • Geographic information: Grouping of countries until all combinations of GENDER * RACE * GROUPED_COUNTRY are >= 3 study participants.
  • Demographic Information: Ethnicity is removed. Races aggregated with few study participants under “Other” race group until all combinations of GENDER * RACE * GROUPED_COUNTRY are >= 3 study participants.
  • BMI, weight and height: Classified and/or removed.
  • Free Text, Verbatim, Comments: Removed

Specifications for anonymization may vary depending on a per study basis and are subject to adjustment according to guidance from e.g. Phuse and TransCelerate methodology.

More information about the anonymization of data prior to sharing can be found in the Sanofi Anonymization Standards.

• for products that have been approved on or after January 1, 2010, by both the US and EU Health Authorities, or by the US or EU Health Authorities when regulatory submissions are not planned in both regions;
•  for products which development has been terminated on or after January 1, 2010 (i.e. formally confirmed as excluded from any further internal or external development activities).

Within the product scope defined above, a clinical trial (interventional study) will be listed as available for request through the portal when the trial meets the following criteria:

•  the trial has been completed (or terminated after patients were enrolled);
• and the primary trial results have been accepted for publication and in exceptional circumstances assessed by study sponsor, only after key secondary results have been accepted for publication;
•  or, in the absence of a publication, when the trial results have been made publicly available.

• Sanofi believes that the privacy and confidentiality of research participants cannot be protected through anonymization, e.g. single site studies, or studies in rare diseases.
• There are legal or contractual agreements in place that would limit our ability to list the study and share the data with a third party, such as when the medicine has been out-licensed to another company, the data are the property of another organization, the data originate from third party databases under license agreements which prevent Sanofi from providing access.
• There are ongoing regulatory or legal constraints on data sharing that would limit our ability to list the study. Requests for such studies will be considered on a case-by-case basis.
• There are substantial practical/technical constraints to providing anonymized data. Examples include: data are not available in electronic format or data are images (e.g., X-Ray/MRI scan) or genetic/genomic data.
• The data labels and/or supporting documents are not in English (e.g. local studies).

Sanofi will regularly update this list to add trials meeting the criteria. An enquiry can be submitted for studies that are not yet listed.

In exceptional circumstances, access to data may be declined by the study sponsor, for example, where there is a potential conflict of interest or an actual or potential competitive risk.

• Raw dataset. This is the raw data collected for each patient in the clinical trial.
• Study Data Tabulated Model (SDTM) dataset. This is the dataset Sanofi used for submission.
• Analysis Data Model (ADAM) datasets. This is the dataset Sanofi used for analysis & submission.
• Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial.
• Blank case report form. This is a blank case report form.
• Statistical methods. This describes methods of analysis and procedures for data handling.
• Dataset specifications. This is the meta-data which describes the datasets, e.g., variable labels, variable descriptions, code lists, formats.
• Anonymization report. This describes the method of anonymization.
• Clinical study report. This is the report of efficacy and safety data from the trial. It forms the basis of submissions to Health Authorities. Appendices which include patient level data are not included as these data are provided in the anonymized datasets.

• The requested studies are for a product that has been approved by the Health Authorities, or for a product which development has been terminated.
• The studies are completed (or terminated after patients were enrolled) and the primary study results (and in exceptional circumstances key secondary results) have been accepted for publication, or, if a publication is not feasible, the results have been made publicly available.
• Sanofi believes that the privacy and confidentiality of research participants cannot be protected through anonymization, e.g. single site studies or studies in rare diseases.
• There are legal or contractual agreements in place that would limit our ability to list the study and/or share the data with a third party, such as when the medicine has been out-licensed to another company, the data are the property of another organization, the data originate from third party databases under license agreements which prevent Sanofi from providing access.
• There are ongoing regulatory or legal constraints on data sharing that would limit our ability to list the study and/or share the data.
• There are substantial practical/technical constraints to providing the data. Examples include: data are not available in electronic format or data are images (e.g., X-Ray/MRI scan) or genetic/genomic data.
• The data labels and/or supporting documents are not in English.

Please be aware that the feasibility assessment for older compounds/studies may require additional lead times due to legal and operational constraints.