The overall aim is to achieve a pragmatic balance, ensuring an acceptably low risk of re-identification while preserving data utility.

An anonymized SDTM data package (CDISC standard) will be provided as part of the data sharing deliverables

The following data protection procedures for personally identifiable information are performed prior to data sharing:

• Patient identifiers (subject number): Replaced by a new patient ID, consistently across all datasets to keep the patient-record relationship.
• Further unique identifiers: Removal of identifiers such as kit numbers and devices.
• Site ID: Replaced by a new site ID, consistently across all datasets.
• Date of birth: Removed.
• Age: Aggregation of Age in numeric bands.
• Country: Removed to protect patient privacy.
• Ethnicity: Removed to protect patient privacy.
• Race: Removed to protect patient privacy.
• 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.
• Comments, freetext, variables containing personally identifiable information (PII), e.g. names, initials: Removed.
• Verbatim term of adverse events and medical history: Verbatim term replaced by coded dictionary terms. Sensitive conditions/disorders blanked out from dataset.
• Verbatim term of concomitant medications: Replaced by Standardized Medication Name. Sensitive terms/conditions blank out from dataset.
• Laboratory test or examinations: Sensitive laboratory tests describing sensitive or rare events are blanked out.
• Disease scores and questionnaires: retained if the risk of subject’s reidentification is not increased.
• Weight and height: retained if the risk of subject’s reidentification is not increased.
• Other variables containing Personally Identifiable Information (PII): Redacted.

In some cases, we may be able to carry out additional work to customize the anonymization strategy to address particular research needs; this will require justification and additional time to prepare and provision the data sets.

In-scope studies are searchable in the Vivli platform.

• The requested data is subject to legal or contractual provisions which prohibit data transfer to a third party.
• Data will not be provided to Requesters with potential or actual conflicts of interest, including individuals requesting access for commercial, competitive or legal purposes.
• The data request analysis overlaps or interferes with existing or previous AL analyses/publication plans.
• Requested data is unavailable.
• The informed consent templates used in the study restrict the sharing of data, or the patient has denied consent to share data with third parties.
• The request has the potential to produce information that will enable identification of individual study participants: data anonymization is difficult due to e.g. a rare-disease therapeutic area or small sample size.
• If the request includes source data e.g. images (e.g. x-rays), genetic data and/or exploratory biomarker data.
• Datasets for which the total number of U.S. persons exceeds the bulk thresholds set by the DOJ regulations at 28 CFR § 202.205 and the requestor is a country of concern or covered person as defined by 28 CFR § 202.209 and § 202.211.

• Study is completed as per protocol.
• Summary results have been published on ClinicalTrials.gov (CT.gov) and/or the European Union Clinical Trials Register (EU-CTR).
• Primary manuscript disclosing study’s primary endpoints, key secondary endpoints, and safety data is published.
• After the first European Medicines Agency (EMA) and/or US Food and Drug Administration (FDA) approval – not applicable if development program was terminated.

• The research team is required to sign a Data Use Agreement.
• The research team must be appropriately qualified and include at least one Biostatistician.
• The applicant has certified that the stated research purpose has been declared fully and openly and that the research as described will be conducted and reported in good faith.
• The applicant is willing to declare all professional interests, affiliations, possible conflicts of interest, and all sources of support for the research as part of the dissemination of their results.
• There is a clear scientific publication/disclosure planning.
• Research team seeking any public disclosure will provide a copy to Alfasigma of any manuscript 30 days prior to submission, for Alfasigma review.
• The research question must be clearly defined and needs to have relevance to medical science or patient care.
• Pursuant to the U.S. Department of Justice Final Rule – Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern (28 CFR Part 202), we review on a case-by-case basis requests for studies that include US participants and where researchers are from Countries of Concern or are Covered Persons.

• Study Protocol
• Study data package documentation including information on the dataset structure and data dictionaries
• Statistical Analysis Plan
• Anonymized/redacted Clinical Study Report (CSR) without appendices other than protocol, statistical analysis plan, and sample case report form
• Anonymized IPD dataset

Optional:

• Anonymization Guidance
• Analytic code
• Analysis ready IPD data set
• Case report forms