Ancillary and Post-Trial Care Section
SPIRIT 2025 item 34 asks protocols to state provisions, if any, for ancillary and post-trial care and for compensation to participants who suffer harm from trial participation. The ethical and legal obligations for ancillary care, post-trial access, injury care, and compensation vary by trial, sponsor, intervention, institution, ethics body, and jurisdiction; report the applicable plan rather than inventing a universal entitlement.
An Ancillary and Post-Trial Care section states what care or follow-up will be available beyond immediate trial procedures and what compensation arrangements apply for trial-related harm, when relevant.
Key details
Important caveats
Scope Boundary
The ethical and legal obligations for ancillary care, post-trial access, injury care, and compensation vary by trial, sponsor, intervention, institution, ethics body, and jurisdiction; report the applicable plan rather than inventing a universal entitlement.
Further guidance
Content
Describe planned ancillary care, post-trial follow-up or access where applicable, management of trial-related harm, and compensation arrangements or governing processes, with relevant limits and responsible parties.
Purpose
Make post-participation responsibilities and trial-related care commitments transparent before enrollment and conduct.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (opens in a new tab)BMJ / SPIRIT-CONSORT Group · Primary SPIRIT 2025 explanation and elaboration for trial protocols, including trial monitoring and data monitoring committee roles and reporting structure.