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Optimizing the Use of Data Standards

The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published a new response to a question regarding SDTM/ADaM IG Nuances. View the team's response to the following question here

'Please confirm instances that would define the OCCDS analysis dataset to be the Adverse Event sub-classification.'

Do you have a SDTM ADaM Implementation question? You can send your questions to the team by emailing workinggroups@phuse.global. 

Data Transparency

The Good Transparency Practicesproject has published a new Guideline. Good Transparency Practice (GTP) is a guideline developed by the Data Transparency Working Group to create a set of best practices to govern the anonymisation of clinical trial data, for external sharing or disclosure. Although there are transparency initiatives across the globe, with differing guidelines, the common goal is to uphold patient privacy and data utility to the highest standards.

Data Transparency

The Rare Disease/Small Population Data Sharing project within the Data Transparency Working Group has published a new White Paper. The purpose of this White Paper is to review potential barriers to the sharing of rare disease data, such as risk of re-identification and invasion of privacy (balanced against maintaining data utility), to understand if and how these barriers apply to controlled access data sharing under specific contextual assumptions.

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Emerging Trends & Innovation – Calling for Feedback 

The Cloud Adoption in the Life Sciences Industry project within the Emerging Trends & Innovation Working Group has produced a White Paper 'Cloud Services, A Framework for Adoption in the Regulated Life Sciences Industry'.

This paper sets out guidance on developing effective cloud exit strategies in the regulated life sciences industry. It explores how organisations can safeguard data security and integrity, maintain business continuity, meet compliance requirements, manage risks, and prevent vendor lock-in. By planning ahead, companies can stay resilient, flexible, and prepared for both planned migrations and unexpected provider changes.

Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 10 October

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