Platform boundaries

Disclaimer

Clinical Study Passport is an information and consent infrastructure layer. It is not a clinical decision system, a regulator, a certification body, or a substitute for any CRO or site standard operating procedure.

What Clinical Study Passport outputs actually are

Where Clinical Study Passport reports a participation interval — for example the number of days elapsed since a volunteer's last recorded dosing or study exit — that figure is derived solely from records contributed by participating CROs, sites and volunteers. It is a data point of the same order as any other screening input, and it is only as complete and as current as the records supplied to the platform.

A match score, an eligibility indicator or a washout signal in Clinical Study Passport is advisory. It expresses how supplied information compares against criteria published for a study. It does not state that a volunteer may be screened, dosed, enrolled or paid.

What Clinical Study Passport does not do

  • It does not determine volunteer eligibility for any study.
  • It does not authorise, approve or recommend dosing. Eligibility must be established by the CRO or site through physical, pathological, medical and protocol-specific assessment under their own approved procedures.
  • It accepts no role or responsibility for a volunteer's enrolment, safety, health outcome, compensation, or for the scientific or operational quality of any study.
  • It does not certify, audit, rate or guarantee any CRO, site, sponsor or investigator listed in the directory. Capability, capacity and regulatory-history figures shown in Discover are self-reported by the organisation unless a verification badge explicitly states otherwise.
  • It is not a national duplicate-participation registry and does not replace any statutory or industry cross-participation checking system a CRO is required or accustomed to use. Where such a system applies, Clinical Study Passport is used alongside it, never instead of it.

Completeness of records

A volunteer's Clinical Study Passport history reflects only participation that has been recorded on the platform and released under consent. Absence of a record is not evidence that no participation occurred. CROs and sites must continue to apply their own verification steps before screening and at each subsequent check.

Source clinical records

Clinical source documents remain the property and responsibility of the CRO or site that generated them. Clinical Study Passport holds identity, consent, permission and participation metadata — not a mirror of a site's clinical file.

No professional advice

Nothing on Clinical Study Passport constitutes medical, legal, regulatory or commercial advice. Sponsors selecting a research partner, and volunteers deciding whether to participate in a study, should carry out their own diligence and take independent advice.