Versions, protocol reading and study responsibilities

2026.10.12-versionnage · 2026-10-12

Delivered build : 61f96c9775dcfa57019013d33ad888a7590d56a0

Changes

• An inactivity lock uses the organisation’s configured timeout: work in progress remains in memory, data access is suspended and resuming requires fresh authentication, with TOTP when required.
• An Application version page shows the loaded client and server builds, whether their identities match, and links to public release notes and history.
• Protocol history retains successive states. A published version freezes its content and retained files; approval requires a reviewer distinct from its author and submitter.
• Protocol reading can be assigned and tracked for each published version. Each person acknowledges reading through fresh signing bound to the exact content; opening a protocol does not sign anything.
• Administrators have a role permissions matrix. Study plans and amendments can be frozen and approved by a Study Director assigned to the study; Director and QA report signatures remain distinct.
• An optional DocuSign workflow per organisation prepares requests for an exact PDF and provides for tracking, reconciliation with provider status, and retention of the signed PDF and certificate. Use requires configuration and connection of the organisation’s account.

Known limitations

• Independent retention of a complete client, API and database release, and a laboratory’s choice of its update date, are unavailable on the shared service.
• This delivery does not connect DocuSign. Provider configuration and an authorised organisation account are still required; no live provider signature is claimed. DocuSign does not replace internal Director and QA business signatures.
• Older versions with incomplete retained packages remain viewable, but cannot support a new signed reading acknowledgement bound to exact content. Existing historical evidence remains readable and is not reconstructed.
• Reading acknowledgement does not establish training or competence and does not automatically block protocol execution.
• After activation, a rollback must retain the compatible code delivered with this update (C1) and the schema supporting retained evidence.
• Matching build identities and file hashes do not validate the laboratory’s configuration or certify scientific computations.