What is the proposed extension?
The NCI dictionary defines open label by knowledge of the treatment, not by a guarantee of benefit. Ask what additional research phase is proposed and how its purpose differs from the original phase. Knowing the intervention does not remove uncertainty, oversight or study procedures. Do not treat the label as a promise of personalised treatment.
Who is actually eligible to enter?
Check the extension’s own criteria and whether your centre is offering entry. As a concrete example, record NCT00868959 describes a bipolarity extension that required completion of an earlier treatment period and assessments as well as investigator suitability. This historical record illustrates study-specific conditions, not present availability or a rule for other extensions.
Which information and decision are new?
Request the extension information sheet and any proposed consent documents. Compare its purpose, activities, risks explained and information use with the earlier phase. Ask what decision is needed and which questions require a clinician. Earlier participation or an earlier signature should not be taken as a complete explanation of this new phase.
Which visits and responsibilities continue?
Use the extension’s actual calendar, including assessments, contact between visits and the proposed monitoring. Ask which activities differ and whether travel or time commitments change. The historical example has its own defined duration; that is not a duration to apply elsewhere. Keep research visits distinct from appointments with your usual care team.
What about costs and later access?
Ask who supplies any study treatment, what expenses or costs may arise and what is confirmed when the extension ends. Get the study-specific terms rather than assuming an extension provides long-term access or universal coverage. Do not change medicines to enter it. Clinical decisions and any transition belong with the responsible clinicians.
What if you decline or the extension finishes?
Ask how the team would coordinate care and any proposed final follow-up in either situation. Clarify whom to contact and what information can go to your usual clinician. Declining the extension is a different question from the practical plan for leaving an existing phase. Request that plan without assuming a further research place or treatment supply.