DATA STANDARDS
Interoperability-ready by design
The Registry is an independent, participant-powered observational registry. It is not affiliated with FDA, HHS, VA, NIH, the White House, or an official federal Coordinated Registry Network.
Why this matters now: FDA's 2026 public hearing asks about Coordinated Registry Networks, common data elements, adverse-event reporting, interoperability, privacy protection, and longitudinal follow-up. Executive Order 14401 separately calls for data sharing and real-world evidence generation regarding psychedelic drugs. The Registry is therefore documenting its variables in a way that can support future mapping to authoritative standards if such standards emerge.
Registry common-data-element layer
Interface wording can change. Research variables should not. Each data element below has a stable Registry ID, domain, storage location, datatype, timepoint, source, instrument/provenance information where applicable, and a reserved field for a future reviewed external mapping.
PER_PARTICIPANT_IDParticipant
Pseudonymous participant identifier
- Storage
- participants.participant_id
- Datatype
- string
- Timepoint(s)
- registry enrollment
- Source
- system-generated
- External mapping
- Not assigned — requires authoritative standard and review
PER_COUNTRY_TERRITORYParticipant
Country or territory
- Storage
- participants.country_or_territory
- Datatype
- coded/string
- Timepoint(s)
- registry enrollment
- Source
- participant-reported
- External mapping
- Not assigned — requires authoritative standard and review
PER_RESEARCH_CONSENTConsent
Research participation consent status
- Storage
- participants.research_consent + consent_events
- Datatype
- boolean + event log
- Timepoint(s)
- enrollment, withdrawal/change
- Source
- participant action
- External mapping
- Not assigned — requires authoritative standard and review
PER_EPISODE_IDExperience episode
Pseudonymous episode identifier
- Storage
- episodes.episode_id
- Datatype
- string
- Timepoint(s)
- episode creation
- Source
- system-generated
- External mapping
- Not assigned — requires authoritative standard and review
PER_EXPOSURE_CLASSExposure
Reported psychedelic substance class
- Storage
- exposures.substance_class
- Datatype
- coded categorical
- Timepoint(s)
- episode
- Source
- participant-reported
- External mapping
- Not assigned — requires authoritative standard and review
PER_EXPOSURE_NAMEExposure
Reported substance identity/name
- Storage
- exposures.substance_name
- Datatype
- string
- Timepoint(s)
- episode
- Source
- participant-reported
- External mapping
- Not assigned — requires authoritative standard and review
PER_IDENTITY_CERTAINTYExposure
Certainty of reported substance identity
- Storage
- exposures.reported_identity_certainty
- Datatype
- coded categorical
- Timepoint(s)
- episode
- Source
- participant-reported
- External mapping
- Not assigned — requires authoritative standard and review
PER_ROUTE_CATEGORYExposure
Route category
- Storage
- exposures.route_category
- Datatype
- coded categorical
- Timepoint(s)
- episode
- Source
- participant-reported
- External mapping
- Not assigned — requires authoritative standard and review
PER_SETTING_CATEGORYContext
Experience setting category
- Storage
- pre_experience_assessments.setting_category
- Datatype
- coded categorical
- Timepoint(s)
- pre-experience
- Source
- participant-reported
- External mapping
- Not assigned — requires authoritative standard and review
PER_INTERPERSONAL_SAFETYContext
Perceived interpersonal safety
- Storage
- pre_experience_assessments.perceived_interpersonal_safety_0_10
- Datatype
- integer 0–10
- Timepoint(s)
- pre-experience
- Source
- participant-reported
- External mapping
- Not assigned — requires authoritative standard and review
PER_ACUTE_SAFETY_EVENTSafety
Acute or delayed safety event
- Storage
- safety_events
- Datatype
- event record
- Timepoint(s)
- acute, post-experience, follow-up
- Source
- participant-reported
- External mapping
- Not assigned — requires authoritative standard and review
PER_FU_OVERALL_WELLBEINGOutcome
Overall wellbeing rating
- Storage
- followups.overall_wellbeing_0_10
- Datatype
- integer 0–10
- Timepoint(s)
- 24h, 7d, 30d, 90d, 180d, 365d
- Source
- participant-reported
- External mapping
- Not assigned — requires authoritative standard and review
PER_FU_MOODOutcome
Mood rating
- Storage
- followups.mood_0_10
- Datatype
- integer 0–10
- Timepoint(s)
- 24h, 7d, 30d, 90d, 180d, 365d
- Source
- participant-reported
- External mapping
- Not assigned — requires authoritative standard and review
PER_FU_ANXIETYOutcome
Anxiety rating
- Storage
- followups.anxiety_0_10
- Datatype
- integer 0–10
- Timepoint(s)
- 24h, 7d, 30d, 90d, 180d, 365d
- Source
- participant-reported
- External mapping
- Not assigned — requires authoritative standard and review
PER_FU_FUNCTIONOutcome
Functioning rating
- Storage
- followups.functioning_0_10
- Datatype
- integer 0–10
- Timepoint(s)
- 24h, 7d, 30d, 90d, 180d, 365d
- Source
- participant-reported
- External mapping
- Not assigned — requires authoritative standard and review
PER_WHO5_TOTALValidated outcome
WHO-5 total score
- Storage
- instrument framework / future scored response table
- Datatype
- numeric score
- Timepoint(s)
- baseline, 7d, 30d, 90d, 180d, 365d
- Source
- participant-reported
- Instrument / provenance
- WHO-5; version/license must be documented
- External mapping
- Not assigned — requires authoritative standard and review
PER_PCL5_TOTALValidated outcome
PCL-5 total score
- Storage
- instrument framework / future scored response table
- Datatype
- numeric score
- Timepoint(s)
- baseline where applicable, 30d, 90d, 180d, 365d
- Source
- participant-reported
- Instrument / provenance
- PCL-5 with LEC-5 and Extended Criterion A; 29 Aug 2023 version selected
- External mapping
- Not assigned — requires authoritative standard and review
PER_MEQ4_SCOREAcute experience
MEQ-4 score
- Storage
- instrument framework / future scored response table
- Datatype
- numeric score
- Timepoint(s)
- acute
- Source
- participant-reported
- Instrument / provenance
- MEQ-4; provenance/rights documentation required before exact item embedding
- External mapping
- Not assigned — requires authoritative standard and review
PER_CEQ7_SCOREAcute experience
CEQ-7 score
- Storage
- instrument framework / future scored response table
- Datatype
- numeric score
- Timepoint(s)
- acute
- Source
- participant-reported
- Instrument / provenance
- CEQ-7; provenance/rights documentation required before exact item embedding
- External mapping
- Not assigned — requires authoritative standard and review
PER_PROMIS_DOMAIN_SCOREValidated outcome
Selected PROMIS domain score
- Storage
- instrument framework / future scored response table
- Datatype
- T-score or form-defined score
- Timepoint(s)
- baseline, 7d, 30d, 90d, 180d, 365d
- Source
- participant-reported
- Instrument / provenance
- Selected fixed PROMIS short forms; form-specific terms and scoring must be documented
- External mapping
- Not assigned — requires authoritative standard and review
Interoperability rules
- Use stable internal variable identifiers independent of interface wording.
- Record source, datatype, permissible values, timepoint, instrument/version, and missingness explicitly.
- Preserve provenance and version history when definitions change.
- Map to external common data elements only when an authoritative standard exists and the mapping has been reviewed.
- Do not imply federal endorsement, certification, or participation in an official Coordinated Registry Network.
Federal context
FDA Docket FDA-2026-N-7542
FDA requested input on Coordinated Registry Networks, common data elements, adverse-event reporting, interoperability, privacy protection, and longitudinal follow-up.
Primary source ↗Executive Order 14401
Calls for federal-state collaboration, data sharing, and real-world evidence generation regarding psychedelic drugs, including collaboration with the private sector when appropriate and lawful.
Primary source ↗Schema version 1.0 · Registry release 4.1.10 · Last updated 2026-09-05. This page describes Registry architecture; it does not represent a federal data standard or government endorsement.