Menstrual status, contraception, and cycle characteristics change over time, and a single intake response does not record that change. Arcametric stores these items as dated observations linked to a De-Identified Patient Reference, independent of any treatment session.
Cohen and Blest-Hopley (2025) recommend menstrual phase tracking and hormonal assays in psychedelic trials and observational studies, noting that these "can reduce data variability, support individualized care, and improve informed consent practices."
Each episode records a start date, an end date, or both, each with its date precision.
The data structure, validation rules, and access controls are in place in Arcametric's database.
A practitioner entry screen for these observations is planned and not yet built.
Observations link to a De-Identified Patient Reference, not to a session, and can be recorded before, between, or after treatment.
Each date present is marked Exact or Approximate, and a missing date can be marked Unknown, so an approximate date is not read as exact.
Records cannot be edited or deleted. A correction or withdrawal is a new entry linked to the original, which remains in the history.
Each observation records its source. The date it describes is stored separately from the time it was entered.
Data handling: each record holds a De-Identified Patient Reference, site and entering-account identifiers, dates, numbers, and coded answers, but no name or free-text field. Read access is limited by role at each site.
| What is recorded | Standard | Match |
|---|---|---|
| Contraception method answers | LOINC answer codes from the Birth control methods list (LL4578-2) | Exact |
| Contraception method question | LOINC 8659-5, Birth control method - Reported | Partial |
| Bleeding episodes, contraception use, cycling status, regularity, and typical cycle length | No standard code assigned | Local |
Regularity and cycle length are stored as reported, not scored against the FIGO definitions of normal and abnormal uterine bleeding (Munro and colleagues, 2018). For study design, PhenX offers related protocols, Menstrual History (101101) and Current Contraception Use - Female (100303); these observations are not PhenX protocols.
A reported cycle is not a verified hormonal phase or a confirmed ovulation, and no hormone results are recorded.
A recorded bleeding episode or irregular cycle is an observation, not a diagnosis.
The schema includes no menstrual symptom questionnaires or scales.
Unknown and missing answers are kept as recorded, not inferred.
This brief supplements the Researcher Brief, which covers the de-identified data model, current capabilities, and what to review.
This material contains content from LOINC (https://loinc.org). LOINC is copyright Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at https://loinc.org/license.
Observation names are the labels stored in the database, and the database checks the value and date rules below when a record is saved. These fields are not yet in a research export. The wider variable dictionary is at arcametric.com/data-taxonomy.
| Observation | Value and allowed answers | Dates | Standard |
|---|---|---|---|
| Menstrual bleeding episode | No value; the dates are the observation | Start, end, or both; start on or before end | Local |
| Contraception use status | Using contraception; Not using contraception; Unknown | At least one observed, start, or end date | Local |
| Birth control method - Reported | One of the 22 methods below per record | At least one observed, start, or end date | LOINC 8659-5 (Partial) |
| Current menstrual cycling status | Currently cycling; Not currently cycling; Unknown | Observed date only | Local |
| Reported cycle regularity | Regular; Irregular; Unknown | Observed date only | Local |
| Reported typical cycle length in days | One positive number, or a positive minimum and maximum, with the minimum not above the maximum | Observed date only | Local |
| Withdrawal of prior observation | No value; names the earlier record, which cannot itself be a withdrawal | None | Local |
The list's "None" is recorded as the use status "Not using contraception," and "Decline to answer" is not recorded.
Questions about this brief: hello@arcametric.com