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A sponsor access plan should make urgent submissions possible while showing exactly who may prepare, view and submit trial information.
CTIS sponsor access — Define the regulatory scope
The EMA handbook distinguishes administrative and business roles and organisation-centric or trial-centric approaches. Select a model that fits the sponsor structure.
CTIS sponsor access — Build the working record
Build a user-by-trial matrix showing role, organisation, justification, approver and backup. Test the intended tasks with an authorised account before a deadline; holding an EMA account alone does not establish every CTIS permission.
CTIS sponsor access — Check before release
- Separate preparation from submission authority.
- Remove departing users without losing coverage.
- Review external-provider access against current duties.
CTIS sponsor access — Record the decision and handover
Reconcile the matrix after staff or provider changes. Preserve approval and access review evidence, and identify the sponsor owner who can restore coverage when the primary administrator is unavailable.
Frequently asked questions
- Does outsourcing remove sponsor access oversight?
- No. The sponsor should retain visibility and appropriate control over delegated access.
- Should every user become an administrator?
- No. Grant permissions according to tasks and justified operational need.