Metanoia's Minimum Common Data Element Set for Psychedelic Exposure Records

Minimum Common Data Element Set for Non-Clinical Psychedelic Exposure Records

Records of human exposure that arise outside clinical trials. "Non-clinical" in this title does not refer to nonclinical (animal or laboratory) studies.

Version: 1.1, draft for public comment

Version date: 25 September 2026

Status: A draft specification released for comment. It is not yet an implementable standard. Section 4 lists what is not yet done, including a machine-readable data dictionary and the mappings to other standards.

Comments close: 2 December 2026

Prepared by: Metanoia

Copyright: © 2026 METANOIA

License: Creative Commons Attribution 4.0 International (CC BY 4.0), https://creativecommons.org/licenses/by/4.0/

Suggested attribution: Metanoia. Minimum Common Data Element Set for Non-Clinical Psychedelic Exposure Records, version 1.1 (draft for comment), 2026. CC BY 4.0. https://metanoia-ca.org/common-data-elements-nonclinical-exposure.html

This set does not incorporate items drawn from any proprietary instrument. The license does not extend to third-party standards and terminologies this document refers to, including MedDRA and ISO code systems, which remain subject to their own terms, or to the text of State rules and federal documents quoted in it. Names of third-party standards, terminologies and guidelines are used only to identify them, and their use does not imply that their owners endorse this document. Metanoia charges no fee for the use of this set.

Version history

1. Context

Metanoia is a California 501(c)(3) public charity advancing the science of natural psychedelics for personal growth and human flourishing in healthy adults. Not treating illness. Expanding potential.

In its written comment to the Food and Drug Administration on Docket No. FDA-2026-N-7542 (Topic 4, Best Practices for Data Collection and Standardization), submitted on 22 September 2026, Metanoia recommended that any Coordinated Registry Network or comparable repository require a minimum set of common data elements, and stated that it was preparing a draft of that set for non-clinical exposure records. This document is that draft.

The problem it addresses is practical. Records of psychedelic exposure now come from State programs, naturalistic surveys, clinical registries, adverse event reports and electronic health records. They define adverse events on different clocks, report counts against different denominators, and record the reason for use in different words or not at all. For supervised psilocybin services, a three-phase e-Delphi of 36 experts has defined consensus process, outcome and structure measures (Korthuis et al., 2024). Those measures assess supervised services. This set is a cross-source element set for records that arise outside clinical trials. The two are meant to be mapped to each other, not merged, and element-level mapping is planned for a later version, after that study has been read in full text. Among the sources we have read, which are listed in section 8, we have not identified a shared minimum element set for psychedelic exposure in adopted use across the kinds of source listed above. This statement does not rest on a systematic search. Pooling such records without a shared set produces numbers that look comparable and are not.

The set has 23 elements in six groups. The first groups follow the categories for which the hearing notice seeks common data elements across data sources: "drug, dosage, indication, setting, and patient characteristics (e.g., comorbidities)" (91 FR 43097). The notice names these categories and does not publish a list of elements. The elements are Metanoia's proposal, and outcome and provenance groups are added. Each element below gives a definition, data type, permitted values or units, when it is captured, whether it is required, the external source it is aligned to, and a short rationale. Each element is a composite that holds several sub-fields. An atomic data dictionary, with one identifier per sub-field, will follow with the machine-readable dictionary (section 4).

Three design choices run through the whole set.

1. Record, never recommend. Every quantity field records what was reported or observed. Nothing in this set is guidance on how much of anything to take, how to take it, or whether to take it.
2. The status of every field is recorded, and no answer is ever compelled. Every person-level field can record that the person declined to answer (code DE, below). A declined answer is a recorded value. It is kept distinct from an item the source never asked (NR), from an item the source collects but this record does not hold (NH), and from an answer of "unknown" (UK).
3. Missing is not a value. The missing-data codes are kept separate from each other, because collapsing them corrupts denominators.

Terms used in this set

Scope

In the Agency's final guidance on clinical investigations of psychedelic drugs, "psychedelic drug" covers classic psychedelics, "typically understood to be 5-HT2A receptor agonists such as psilocybin and lysergic acid diethylamide (LSD)", as well as entactogens or empathogens such as MDMA. This version of the set is written for records of adults (18 or older) exposed to classic psychedelics in that sense, including natural materials that contain them, such as psilocybin-containing fungi. Annex B lists the substances and materials the set treats as in scope, as a proposal for comment. Most elements are not specific to any substance. SUB-04 and OUT-04 are limited to classic psychedelics. Whether the set should extend to entactogens, or to records of minors, is an open question for comment (section 6).

Capture timing codes

Follow-up schedule

Every period and window is counted in days from the start of the index exposure (SUB-03), which is day 0. The schedule is shared by the outcome elements, so that every source refers to the same intervals.

Each assessment records the actual number of days since exposure, so an assessment made outside the accepted range is still usable and is visibly out of range. Window 30 begins at day 30 because the persisting-effect case definition cannot be met earlier. The 72-hour boundary and the accepted ranges are proposals for comment. A source's own reporting period, for example Oregon's 72 hours from the client's release from an administration session (OAR 333-333-1010(59)), is recorded with each event in OUT-01 and is a different quantity from these standard periods.

Missing-data codes and what "required" means

Every element, and every sub-field within it, accepts five set-level codes in place of a substantive value.

Where an element lists "prefer not to say" or "unknown" among its permitted values, these are the codes DE and UK. The codes PU-98 and PU-99 of version 1.0 are withdrawn, and PUR-02 uses these set-level codes like every other element.

"Required" means that the element is present in every record and holds either a substantive value or one of these codes. It does not mean that every source must be able to supply a substantive value. A blank is never a valid entry.

Conformance. A record conforms to this version when every element is present and holds a substantive value or one of these codes, and every conditional sub-field whose condition holds is filled in the same way. A source that does not collect an element conforms by recording NR for it. The set does not rank sources by how many substantive values they supply.

Obligation

All 23 elements are required at the element level, as recommended in the comment. Within an element, a sub-field may be conditional (required only when a stated condition holds) or recommended (collected where the data source can support it). Sub-fields, permitted values and scoping choices that go beyond the text of the comment are proposals for comment, and each is marked as one where it appears.

Record model and identifiers

A record describes one index exposure of one person. It has a record header, a value or code for each of the 23 elements, and repeating sub-records where an element says so: one per adverse event (OUT-01), per symptom and window (OUT-02), per window (OUT-03, OUT-04), per healthcare contact (OUT-05), per supervising or attending person (SET-02) and per setting phase (SET-01). A later exposure of the same person is recorded in OUT-04 and may also open a record of its own, with its own index exposure. The record model is a proposal for comment.

Record header (proposal for comment)

Source record (proposal for comment). Each source supplies, for each cohort and reporting period: the source type (State program / naturalistic survey / registry / adverse event reports / electronic health records / other), the number enrolled with the enrolment definition (consented / completed baseline / other, specify), the number completing each window, and the reporting conventions it operates (see OUT-01). Records link to it by Source ID and Cohort ID. For a source with no defined cohort, such as spontaneous adverse event reports, the denominators are NA, and records from that source are counts without a rate.

Versioning and change control

Element identifiers (for example PUR-02) and code values (for example PU-03) are stable. A later version may add or withdraw elements, sub-fields and codes, but will not reuse an identifier or a code for a different meaning. A withdrawn item keeps its identifier and is marked as withdrawn. New codes are added at the end of a list, so the order of codes is not a ranking.

Metanoia maintains the set. Changes are proposed through comments (section 5) or by Metanoia, and Metanoia decides on them after each comment period. Every version carries a change log, and the version after a comment period is published with a summary of how each comment was handled. A machine-readable version manifest will follow with the data dictionary.

2. The elements

Group 1. SUBSTANCE

SUB-01 Substance identity: as reported and as verified

SUB-02 Preparation form, quantity consumed with units, and route

SUB-03 Date and time of exposure

SUB-04 Prior exposure history

Group 2. PERSON

PER-01 Age band, sex and gender identity

PER-02 Comorbidities and risk-relevant history, from a closed list

PER-03 Concomitant medications and concomitant psychoactive exposure

PER-04 Reproductive stage and hormonal status

PER-05 Concurrent non-drug intervention and its timing

Group 3. PURPOSE

PUR-01 Clinical indication present

PUR-02 Purpose of use

Group 4. SETTING

The setting fields decompose a definition of setting given in the review cited in OUT-03 (the culture, place and situation of use, including the other people present) into recordable values. They are a recording schema for non-clinical records. They are designed to map to the Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) guidelines, an international Delphi consensus of 89 experts from 17 countries that specified 30 setting variables in four categories: physical environment, dosing session procedure, therapeutic framework and protocol, and subjective experiences (Pronovost-Morgan et al., 2025). ReSPCT is a reporting standard for trials, and these fields are designed to map to it and not to compete with it. In this version the correspondence is at the level of the four ReSPCT categories only. Item-level mapping will follow in a later version, once the full ReSPCT item checklist has been read against each field.

One exposure can carry more than one setting record. Each setting record states the phase it describes (SET-01).

SET-01 Physical environment category

SET-02 Supervision: presence, role, and licensure

SET-03 Solitary or group, and number of persons present

SET-04 Preparatory contact before exposure

SET-05 Pre-exposure screening

Group 5. OUTCOME

OUT-01 Acute and subacute adverse events

OUT-02 Persisting effects at fixed observation windows

Case definition CD-1.1 (proposal for comment). Every count of persisting adverse effects derived under this set names the case definition and its version. Two analysts who apply the same version to the same records obtain the same count.

1. Eligible record. A record with the start of exposure (SUB-03) at date precision or better, and a pre-exposure status for the symptom.
2. Criteria. The definition of a persisting adverse effect above, new or worsened.
3. Window. An assessment in window 30, 90 or 365, within the accepted range (section 1).
4. Case status. "Case" when the criteria are met. "Not a case" when the symptom was assessed and the criteria are not met. "Not assessable" when the pre-exposure status is NR, NH, UK or DE, when a symptom present before exposure has no baseline severity, or when no assessment falls in the window.
5. Re-exposure. The case status in each window is reported together with the OUT-04 status for that window, and the re-exposure rule in OUT-04 applies.
6. Basis. Cases whose baseline rests on recall at follow-up are reported separately from cases whose baseline was assessed before exposure.
7. Convention. Composite counts and single-category counts are reported separately and are never interchanged.

OUT-03 Outcome referenced to the recorded purpose of use

OUT-04 Re-exposure during the follow-up window

OUT-05 Healthcare contact attributable to the exposure

Group 6. PROVENANCE

PRV-01 Capture mode, reporter type, and retention denominator

PRV-02 Jurisdiction and primary language of capture

3. Summary table

4. What this set does not do

• It gives no guidance on use. No field suggests an amount, a route, a preparation or a setting. The quantity field records what was consumed.
• It does not endorse, oppose or evaluate any use, any substance, or any State or local program. It describes what their records contain.
• It is not a clinical instrument, a screening tool or a diagnostic tool.
• It is not a validated outcome instrument. OUT-03 names the element that an outcome instrument fills.
• It does not replace MedDRA, the ReSPCT guidelines, ICH E2A, or analytical method standards for the material. It refers to them.
• It is not an agency standard. It has not been adopted or endorsed by FDA, by any other federal agency, or by any State program.
• It makes no claim of interoperability with any other standard. That claim waits for the mappings listed below.
• It is not itself a data collection. Publishing it is not a request for anyone's exposure data, and comments on it (section 5) should contain none.
• Metanoia is developing an anonymous intake channel, with a report form derived from this set, for accounts of exposure that would otherwise go unrecorded. Its design principles, no direct identifiers, aggregate-only publication with small-cell suppression, and no collection of cultivation or sourcing methods, will be set out in a separate policy before the channel opens. The channel is not part of this document and is not yet accepting reports.
• It does not set privacy, consent or data-governance rules. Any collection under this set must follow the consent terms and the law that apply to the data source.

Privacy and re-identification

This set describes sensitive information. A record under it can describe conduct that is unlawful where it occurred, health conditions, pregnancy, medication use, and religious or spiritual practice. A few fields together can identify a person without a name: an exact date (SUB-03), a subdivision code (PRV-02), an age band with sex and gender identity (PER-01), a rare substance (SUB-01), and the supervising roles of a small program (SET-02). A record can also describe people who are not its subject, such as a facilitator or a companion.

This section is not a de-identification standard, and following it does not make a data set de-identified under any law. The set does not set rules for privacy, but it recommends the following to any source or repository that uses it.

• Hold records in three layers. A restricted layer holds free text, full dates, and anything that describes a person other than the subject. A coded layer holds coded values, with dates as offsets. An aggregate layer holds counts only.
• Limit access to the restricted layer to named staff of the source, under the source's own rules.
• Store dates as offsets or shift them, and carry no full dates in a de-identified release.
• Suppress or combine small cells before any aggregate release, and state the threshold used in the release.
• Record the roles of other people, never their identities (SET-02, PRV-01).
• Link records across sources only under a written agreement that names the fields used for linkage.

Retention periods, key management and the legal role of each party are governed by the law and the consent terms that apply to each source, and this set does not specify them.

Not yet done in version 1.1

• Item-level mapping to the ReSPCT guidelines, and mapping to the consensus measures for supervised psilocybin services (Korthuis et al., 2024), which will follow a reading of that study in full text.
• Publication of the supplementary adverse event list for OUT-01. The substance list in Annex B is provisional.
• Coding rules for "other condition" in PER-02 and for the medication list in PER-03, to standard terminologies for conditions and medications.
• An atomic data dictionary with one identifier per sub-field, published in machine-readable form with a version manifest.
• Mapping to CDISC standards and to the format of the NIH Common Data Elements Repository, and a check of the missing-data codes against the HL7 NullFlavor code system.
• An assessment of the set against the Agency's guidance Data Standards for Drug and Biological Product Submissions Containing Real-World Data (December 2023).

These are planned for later versions.

5. How to comment

Send comments to main@metanoia-ca.org with "CDE v1.1" in the subject line, by 2 December 2026. Comments that arrive later will still be read and considered for later versions. Please cite the element ID (for example PUR-02) and, where you propose a change, the reason and any source. We are also interested in comments from people who hold or work with records like these outside supervised or State-regulated programs, under the same terms as any other comment in this section.

We are particularly interested in comments from State program staff, registry operators and investigators on four questions: whether the permitted values for SET-02 and PRV-01 map cleanly onto the roles your program uses, whether the proposed code systems in PRV-02 work for your jurisdiction, whether the follow-up schedule and the case definition CD-1.1 can be operated with your follow-up resources, and whether the record model in section 1 fits the records you hold. Section 6 lists further open questions.

What happens to comments. We read every comment. With the next version we will publish a summary of the comments received and of how each point was handled. The summary names no commenter unless the commenter asked to be acknowledged.

How we may use your comment. We read every comment and reflect each point in the published summary, in our own words. If you want us to be able to quote or incorporate your wording, mark your message "contribution" at the start. For a contribution you grant Metanoia a worldwide, royalty-free, non-exclusive and perpetual license to reproduce, adapt and incorporate the text in this set and in its later versions, and to publish the result under the Creative Commons Attribution 4.0 International license (CC BY 4.0), including the right to license the incorporated text to the public under CC BY 4.0 and nothing beyond that. You keep the copyright in your text and may use it anywhere else. You may withdraw a contribution by writing to us within 30 days of sending it. After that, or once the text appears in a published version, the license for the incorporated text continues, because a CC BY 4.0 license granted to the public cannot be withdrawn. Text that is not marked as a contribution is not reproduced. Please send only material you wrote yourself or have the right to share. Do not include items or text from proprietary instruments, information about any other identifiable person, or accounts of your own or anyone else's use of any substance. This process collects comments on a specification. It does not collect exposure data.

Acknowledgment. We name contributors only when they ask us to. If you would like to be acknowledged, tell us how your name, and your affiliation if you wish, should appear.

Privacy. We use your name, email address and message only to review and respond to comments and to prepare later versions. We do not publish email addresses. You may ask us at any time to delete your name and email address, and any comment or contribution that has not yet appeared in a published version. We will delete them from our comment records, except where the law requires us to keep them. Text already published under CC BY 4.0 stays published. Our Privacy Policy: https://metanoia-ca.org/privacy

6. Open questions for comment

1. Whether the 72-hour boundary between the acute and subacute periods, and the accepted ranges of the windows (section 1), can be operated.
2. How aggregate reports, such as quarterly State counts, should report against a set that is specified for person-level records. Oregon, for example, requires service centers to submit aggregated counts of adverse reactions and of post-session reactions each quarter (OAR 333-333-4910(5) and (6)).
3. Whether the fourth reporter value in PRV-01 should be split further, for example into family member, friend and bystander.
4. Whether OUT-05 needs levels for an emergency services contact without transport and for other outpatient care.
5. Whether the set should extend formally to entactogens such as MDMA, and to records of persons under 18.
6. Whether the new values proposed in PER-02, PER-04 and PUR-02 (PU-12 to PU-14) should stay, whether Annex B lists the right substances and materials, and whether the case definition CD-1.1 and the re-exposure rule in OUT-04 are workable.

7. Disclaimer

This document is a proposed data specification, provided as is and without warranty. It is not medical, legal or regulatory advice, and it is not guidance on the use of any substance. References to the Food and Drug Administration, to ICH, to State programs and to published studies describe what their documents say. They do not imply that any agency, program or author has reviewed or endorsed this set. Metanoia does not provide, sell, or source any controlled substance, and does not provide therapy or medical services.

8. Sources

Literature

1. Hovmand OR, Poulsen ED, Arnfred S. Assessment of the acute subjective psychedelic experience: a review of patient-reported outcome measures in clinical research on classical psychedelics. J Psychopharmacol. 2024, 38(1):19-32. PMID 37969069. doi:10.1177/02698811231200019
2. Nayak SM, Jackson H, Sepeda ND, et al. Naturalistic psilocybin use is associated with persisting improvements in mental health and wellbeing: results from a prospective, longitudinal survey. Front Psychiatry. 2023, 14:1199642. PMID 37795509. PMCID PMC10545967. doi:10.3389/fpsyt.2023.1199642
3. Pronovost-Morgan C, Greenway KT, Roseman L, et al. An international Delphi consensus for reporting of setting in psychedelic clinical trials. Nat Med. 2025, 31(7):2186-2195. PMID 40461819. doi:10.1038/s41591-025-03685-9
4. Korthuis PT, Cook RR, Gregoire D, et al. Safety and mental health outcomes of Oregon state-regulated psilocybin services. JAMA Netw Open. 2026, 9(8):e2630608. PMID 42616497. doi:10.1001/jamanetworkopen.2026.30608
5. French T, Fontana AJ, LaBudde R, Brunelle SL, Sudberg S. Determination and confirmation of psychedelic and psychoactive compounds in botanical materials by UPLC-ESI-MS/MS: single-laboratory validation. J AOAC Int. 2026, 109(1):61-74. PMID 41014027. doi:10.1093/jaoacint/qsaf081
6. Foster K, Morrison I, Daniel S, et al. Toward standardized products containing biomass of Psilocybe cubensis fungi. J AOAC Int. 2026, 109(1):51-60. PMID 40802522. doi:10.1093/jaoacint/qsaf072
7. Korthuis PT, Hoffman K, Wilson-Poe AR, et al. Developing the Open Psychedelic Evaluation Nexus consensus measures for assessment of supervised psilocybin services: an e-Delphi study. J Psychopharmacol. 2024, 38(8):761-768. PMID 38888164. doi:10.1177/02698811241257839

Regulatory and other sources

1. Metanoia. Written comment on Docket No. FDA-2026-N-7542, Topic 4, submitted through Regulations.gov on 22 September 2026.
2. Food and Drug Administration. Considerations for Potential Future Therapeutic Use of Psychedelic Drugs; Public Hearing; Request for Comments. 91 FR 43095-43098 (July 14, 2026). FR Doc. 2026-14155. Docket No. FDA-2026-N-7542.
3. Food and Drug Administration, Center for Drug Evaluation and Research. Psychedelic Drugs: Considerations for Clinical Investigations. Guidance for Industry. July 2026. Docket No. FDA-2023-D-1987.
4. Food and Drug Administration. Data Standards for Drug and Biological Product Submissions Containing Real-World Data. Guidance for Industry. December 2023. Docket No. FDA-2021-D-0548.
5. Oregon Administrative Rules, OAR 333-333-1010 (Definitions) and OAR 333-333-4910 (Required Reporting of Data), Oregon Health Authority, Public Health Division. Both last amended by PH 21-2025, effective January 1, 2026.
6. Colorado Department of Regulatory Agencies, Office of Natural Medicine Licensure. Natural Medicine Licensure Rules and Regulations, 4 CCR 755-1, Rules 6.22 and 6.23. Version effective December 5, 2025. This version is recorded by the Colorado Secretary of State as an Emergency Rule, adopted December 5, 2025.
7. Colorado Department of Revenue, Natural Medicine Division. Colorado Regulated Natural Medicine Rules, 1 CCR 213-1, Rules 3015 and 8035. Version effective July 1, 2026.
8. International Conference on Harmonisation. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, E2A. Step 4 version dated 27 October 1994.
9. Creative Commons. Attribution 4.0 International Public License, legal code.

Verification note. PubMed records for literature sources 1 to 7 were retrieved on 22 and 23 September 2026. The statements attributed to sources 1, 3, 5, 6 and 7 were checked against their abstracts on 23 September 2026. Source 7 is cited from its PubMed record, and its full text has not yet been read. The figures attributed to source 2 were checked against its full text in PubMed Central on 24 September 2026. The figures attributed to source 4 were checked against its full text on 15 September 2026. The totals of 5,736 endorsements, the averages per person, and the rates of 4.5% and 1.6% are arithmetic performed on counts reported in those articles. The passages quoted from sources 9 and 10 were read in the published documents on 23 and 24 September 2026. The definitions quoted from OAR 333-333-1010 and the text of OAR 333-333-4910 were read in the Oregon Secretary of State's Administrative Rules database on 23 and 24 September 2026. The Colorado rules quoted were read in the Code of Colorado Regulations published by the Colorado Secretary of State, in the versions marked as current, on 22 to 24 September 2026. Source 15 was read in the text published by ICH on 24 September 2026, and source 16 on the Creative Commons site on the same day. Source 11 is listed as a document the set has not yet been assessed against, and its content is not relied on here. Characterizations of the 14 September 2026 public hearing rest on the hearing webcast as transcribed by automated captioning. No official transcript was listed on the Agency's page for the hearing when it was checked on 24 September 2026.

Annex A. Provisional crosswalk of two cohorts' reason categories to PUR-02

The category names are those reported in the two cohorts (sources 2 and 4). The mapping is provisional and is offered for comment. Where one source category could fall under more than one code, both are given. These cohort-level categories cannot be resolved into one code without person-level data on whether a clinician had diagnosed the condition (PUR-01) and whether that condition was the reason for the exposure. That ambiguity is itself the case for recording PUR-01 and PUR-02 separately.

Naturalistic cohort (Nayak et al., 2023), seven motivation categories

Oregon supervised program (Korthuis et al., 2026), eleven reason categories

Annex B. Provisional substance list for SUB-01

The list names substances and materials, not products or suppliers. It is Metanoia's reading of the scope in section 1, it is not exhaustive, and it is offered for comment. The form of what was consumed (dried, fresh, brewed, extract) is recorded in SUB-02, not here. Whether entactogens are added is open question 5.