Confidentiality Section
SPIRIT 2025 calls for protocols to explain how personal information about potential and enrolled participants will be collected, shared, and maintained to protect confidentiality before, during, and after the trial. This is a protocol-reporting intent, not a universal legal checklist. Privacy, data-protection, ethics, sponsor, institutional, and jurisdictional requirements determine the exact safeguards and wording.
A Confidentiality section explains the safeguards used when collecting, storing, accessing, transferring, and retaining identifiable or re-identifiable participant information.
Key details
Important caveats
Scope Boundary
This is a protocol-reporting intent, not a universal legal checklist. Privacy, data-protection, ethics, sponsor, institutional, and jurisdictional requirements determine the exact safeguards and wording.
Further guidance
Content
Describe identifiers or coding where relevant, access controls, storage and transfer protections, authorized recipients, retention or destruction arrangements, and any material re-identification process needed for the trial.
Purpose
Make the privacy protections around participant information concrete enough to understand how confidentiality will be maintained.
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.