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Evidence Authority

Issue register

The AlphaCitation Standard · Version 3.0

Every proposal and open question recorded since version 2.1, with its status: 54 issues.

To raise one, write to analyst@alphacitation.com. How proposals are recorded and decided is on the governance page.

Open (15)

Not yet decided. Each is open for comment and targets the version named.

  • EA-040Shortage registers

    Whether a regulator's register of medicine shortages settles a claim about stock (P5, the stock form), for the market and the dates the register covers.

    Status
    Open
    Section
    Section 4, P5; Annex B, C6
    Target
    Next major version
    Opened
    Raised in
    Version 3.0, section 10, question 1
    Related
    EA-026

  • EA-041Claims that a medicine is no longer studied

    Whether a sponsor's dated statement that it has stopped developing a medicine for a use settles a claim that development stopped (P3 negative), which a registry record, speaking for its own study only, never settles.

    Status
    Open
    Section
    Section 4, P3 and P3d; Annex B, C10
    Target
    Next major version
    Opened
    Raised in
    Version 3.0, section 10, question 2
    Related
    EA-027

  • EA-042Suitability

    Whether a statement that a medicine is "unsuitable" or "not suitable" for a group is a contraindication or warning (P8a), a statement of who may receive it (P2), or, where its subject is the medicine's use in practice, no proposition (X1).

    Status
    Open
    Section
    Annex B, C2, C4 and C14
    Target
    Next major version
    Opened
    Raised in
    Version 3.0, section 10, question 3: the classification study's blind adjudication, core test item CT-037

  • EA-043What a medicine does, stated without a result

    Whether an effect stated as what a medicine does or is used to do, with no study, magnitude or population, is an effect on an endpoint (P7) or a description of its mechanism or use (X1).

    Status
    Open
    Section
    Annex B, C13 and X1
    Target
    Next major version
    Opened
    Raised in
    Version 3.0, section 10, question 4: the classification study's blind adjudication, confirmatory field item FC-052

  • EA-044A regulator's clinical hold

    Whether a statement that a regulator placed a medicine or its study on clinical hold states that the study is not ongoing (P3d negative) or only entails it, whether the hold is an event (T6), and how the reason given for it is classified.

    Status
    Open
    Section
    Annex B, C11, U5, T6 and C14
    Target
    Next major version
    Opened
    Raised in
    Version 3.0, section 10, question 5: the classification study's blind adjudication, confirmatory field item FC-061

  • EA-045Tense in other languages

    Whether T6 reads tense by its form or by its function in the answer's language, where a present perfect in form (the French passé composé, the German Perfekt) is the ordinary narrative past.

    Status
    Open
    Section
    Annex B, T6
    Target
    Next major version
    Opened
    Raised in
    Version 3.0, section 10, question 6: the classification study's blind adjudication, confirmatory field item FC-137

  • EA-046The dates of an answer change

    Which date an answer-change claim takes when the sentence states only the earlier of the two times it compares.

    Status
    Open
    Section
    Annex B, C18 and T1 to T7
    Target
    Next major version
    Opened
    Raised in
    Version 3.0, section 10, question 7: the classification study's blind adjudication, confirmatory field item FC-140

  • EA-047Drug interactions

    Whether a label's statement of a drug interaction is a warning (P8a), a term of dose (P2) or, where it states neither a risk nor a dose, no proposition (X1).

    Status
    Open
    Section
    Annex B, C2 and C14
    Target
    Next major version
    Opened
    Raised in
    Version 3.0, section 10, question 8: the classification study's blind adjudication, confirmatory field item FC-216

  • EA-048A "Yes" that is not bare

    When a "Yes" or "No" is bare, and whether a statement of uncertainty about the question's proposition in the same sentence hedges it.

    Status
    Open
    Section
    Annex B, U9 and E5
    Target
    Next major version
    Opened
    Raised in
    Version 3.0, section 10, question 9: the classification study's blind adjudication, confirmatory field item FC-244

  • EA-049The tense of a reported result

    Where a sentence states a study's result with no word that reports it ("in the trial, it reduced the risk"), whether the tense of the result's own predicate is the tense of the report, which T6 makes an undated event in the past tense, or the result is a state on the answer's date.

    Status
    Open
    Section
    Annex B, T6, with C11, C13 and E7
    Target
    Next major version
    Opened
    Raised in
    Version 3.0, section 10, question 10: the classification study's blind post-run check of the reference's P3c date kinds, 12 units of the confirmatory set

  • EA-050"Its market step (M1 to M7)" in Annex B's opening paragraph

    Annex B's opening paragraph calls its market rules, M1 to M7, "its market step", while B1 and M7 record the step that fixed a claim's market as one of M1 to M5 for every unit; the proposed wording is "Its market rules (M1 to M7)", which changes no rule.

    Status
    Open
    Section
    Annex B, opening paragraph, with B1 and M7
    Target
    Next patch version
    Opened
    Raised in
    The classification study's answer format, which offered M7 as a market step (DEVIATIONS-AND-DISCLOSURES.md, D4)

  • EA-051What a sentence "continues" (M1)

    M1 lets a heading or an earlier clause the sentence continues state the claim's market, but does not define "continues"; labellers divided where a sentence opens with a connective or a reference back to a clause that names the market. The items were decided as M1 under the text as written; a definition that states that reading would remove this class of disagreement, and changes no rule and no item's record.

    Status
    Open
    Section
    Annex B, M1 and E8; section 2, the claim's market
    Target
    Next major version
    Opened
    Raised in
    The classification study's confirmatory adjudication record, pattern 1

  • EA-052Bodies and terms that state no market (M1)

    M1 lists the regulators, payers, HTA bodies and instruments that state a market; a public-health agency or an approval pathway is none of these, so it states no market, but one labeller took such words as stating the United States. A sentence in M1 saying that other bodies and terms state no market would prevent it and changes no rule.

    Status
    Open
    Section
    Annex B, M1
    Target
    Next major version
    Opened
    Raised in
    The classification study's confirmatory adjudication record, pattern 2

  • EA-053Unit boundaries in label lists (U1, U2, U6)

    U1, U2 and U6 decide how many units an entry of a label list makes, but labellers divided in both directions across five items; a worked example in U6 would make the rule easier to apply and changes no rule.

    Status
    Open
    Section
    Annex B, U1, U2 and U6
    Target
    Next major version
    Opened
    Raised in
    The classification study's confirmatory adjudication record, pattern 3

  • EA-054"Recommended dose" without authorisation language (C2, C4)

    A statement of the recommended dose with no status word makes no P2 claim under C2, C4, U5 and U7, but labellers were inconsistent across three items; an example in C4 would settle it and changes no rule.

    Status
    Open
    Section
    Annex B, C2, C4, U5 and U7
    Target
    Next major version
    Opened
    Raised in
    The classification study's confirmatory adjudication record, pattern 4

Adopted in 3.0 (39)

Decided, and written into version 3.0 of the standard.

  • EA-001How the claim's market is fixed

    Most sentences state no market, so the standard must say in what order the answer, the question and the deploying system's configuration fix the claim's market.

    Status
    Adopted in 3.0
    Section
    Section 2 (the claim's market); Rule 5; Annex B, E4
    Target
    Version 3.0
    Opened
    Raised in
    Version 2.1, section 10, question 1
    Resolution
    Adopted in 3.0 as the market step (EA-013): the answer, then the question, then configuration, otherwise unresolved; the verdict records which step fixed the market.
    Related
    EA-013

  • EA-002Named groups and places below the country

    Whether named groups such as the Gulf states, the EU and Europe are markets, and how a sub-national place or payer is expressed when ISO 3166-1 codes cannot express it.

    Status
    Adopted in 3.0
    Section
    Section 2 (the claim's market)
    Target
    Version 3.0
    Opened
    Raised in
    Version 2.1, section 10, question 2
    Resolution
    Adopted in 3.0 (EA-013): the GCC or the Gulf states are its six members, the EU is its 27 member states, and Europe with no EU body named is unresolved. Decided in 3.0 before release (EA-031): a place below the country is recorded by its ISO 3166-2 code, and Annex B, M6 says which sources speak for it.
    Related
    EA-013, EA-031

  • EA-003The scope of a coverage decision (P6)

    A payer's decision, a health technology assessment body's recommendation and a formulary listing are not equivalent, so P6 may need to be divided.

    Status
    Adopted in 3.0
    Section
    Section 4, P6
    Target
    Version 3.0
    Opened
    Raised in
    Version 2.1, section 10, question 3
    Resolution
    Adopted in 3.0 (EA-015): P6 is divided into P6a (reimbursed or covered), P6b (HTA recommendation) and P6c (formulary listing).
    Related
    EA-015

  • EA-004Emerging safety signals and confirmed findings (P8b)

    A claim that a regulator is assessing a safety signal differs from a claim that an association is established, yet only a systematic review settles P8b.

    Status
    Adopted in 3.0
    Section
    Section 4, P8
    Target
    Version 3.0
    Opened
    Raised in
    Version 2.1, section 10, question 4
    Resolution
    Adopted in 3.0 (EA-016): a new proposition, P8c, for a safety signal, settled by the body's signal record or safety communication; a signal record supports P8b and never settles it.
    Related
    EA-016

  • EA-005The jurisdiction of an answer-change claim

    Section 4 leaves open which market an answer-change claim concerns, and whether answers that differ at one time, between engines or framings, are the answer change.

    Status
    Adopted in 3.0
    Section
    Section 4, the answer change
    Target
    Version 3.0
    Opened
    Raised in
    Version 2.1, section 10, question 5
    Resolution
    Adopted in 3.0 (EA-019): preserved observations speak for the markets they observed, and the answer change is settled per market under the market step. Decided in 3.0 before release (EA-032): a difference at one time between engines or framings is not the answer change.
    Related
    EA-019, EA-032

  • EA-006Date rules

    How a stated date carries to later clauses, how an undated earlier time is read, whether an event's date is the claim's date, when a record reporting an earlier event is in force, and in which time zone dates are read.

    Status
    Adopted in 3.0
    Section
    Annex B, B6 (dates); Rule 7
    Target
    Version 3.0
    Opened
    Raised in
    Version 2.1, section 10, question 6
    Resolution
    Adopted in 3.0 (EA-018): rules T3, T4 and T7, which also fixes the time zone in which a pharmacy listing's date is read. Decided in 3.0 before release: T6, event claims and their time test (EA-024), and the record of an earlier event (EA-033).
    Related
    EA-018, EA-024, EA-033

  • EA-007P5 claims outside the two claim forms

    Availability claims with no word of breadth, about one named supplier or channel, about stock, or that the medicine is not available across the market fit neither claim form.

    Status
    Adopted in 3.0
    Section
    Section 4, P5
    Target
    Version 3.0
    Opened
    Raised in
    Version 2.1, section 10, question 7
    Resolution
    Adopted in 3.0 (EA-014): a claim with no word of breadth takes the first claim form, as its negation does. Decided in 3.0 before release (EA-026): the named channel, stock and "not available across the market".
    Related
    EA-014, EA-026

  • EA-008P3 with no use named, or no label in the market

    Where the answer names no use, or the medicine has no authorised label in the market, no source can settle P3's P2 part.

    Status
    Adopted in 3.0
    Section
    Section 4, P3
    Target
    Version 3.0
    Opened
    Raised in
    Version 2.1, section 10, question 8
    Resolution
    Not decided by the design of 3.0, and carried as EA-027. Decided in 3.0 before release: see EA-027, which records the rule.
    Related
    EA-027

  • EA-009Label content outside P2

    The legal category of supply, the dose and the route appear in the authorised label but map to no proposition.

    Status
    Adopted in 3.0
    Section
    Section 4, P2
    Target
    Version 3.0
    Opened
    Raised in
    Version 2.1, section 10, question 9
    Resolution
    Not decided by the design of 3.0, and carried as EA-028. Decided in 3.0 before release: see EA-028, which records the rule.
    Related
    EA-028

  • EA-010Claims about a class

    Whether a claim that a class of medicines is authorised, available, effective or recommended makes a proposition, and how it would be settled.

    Status
    Adopted in 3.0
    Section
    Section 4; Annex B, E11 and C17
    Target
    Version 3.0
    Opened
    Raised in
    Version 2.1, section 10, question 10
    Resolution
    Not decided by the design of 3.0, and carried as EA-025. Decided in 3.0 before release: see EA-025, which records the rule.
    Related
    EA-025

  • EA-011Reported results of studies that are not trials (P3c)

    Whether P3c, a trial's reported result, covers observational studies, and which classes then settle it.

    Status
    Adopted in 3.0
    Section
    Section 4, P3c and P7
    Target
    Version 3.0
    Opened
    Raised in
    Version 2.1, section 10, question 11
    Resolution
    Not decided by the design of 3.0, and carried as EA-029. Decided in 3.0 before release: see EA-029, which records the rule.
    Related
    EA-029

  • EA-012Guidelines named only by their issuer, or not named

    Whether "the ADA recommends" names a guideline for P4, and whether "guidelines recommend" is the answer's own recommendation or maps to no proposition.

    Status
    Adopted in 3.0
    Section
    Section 4, P4 and P10
    Target
    Version 3.0
    Opened
    Raised in
    Version 2.1, section 10, question 12
    Resolution
    Not decided by the design of 3.0, and carried as EA-030. Decided in 3.0 before release: see EA-030, which records the rule.
    Related
    EA-030

  • EA-013The market step

    The claim's market is fixed by the answer, then the question, then the deploying system's configuration, and is otherwise unresolved; the verdict records the step and any conflict.

    Status
    Adopted in 3.0
    Section
    Section 2 (the claim's market); Rule 5
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, item 1, after the external review of version 2.1
    Resolution
    Adopted in 3.0. The answer's market governs over the question's, configuration never overrides a stated market, and no market is inferred from an IP address, language, spelling, currency, units or time zone. The API's claim takes market, questionMarket and configuredMarket, and its response gives market as codes, basis and conflict.
    Related
    EA-001, EA-002

  • EA-014P5 claim forms

    An availability claim with no word of breadth ("available in the UAE") takes the first claim form, the same as its negation.

    Status
    Adopted in 3.0
    Section
    Section 4, P5
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, item 2, after the external review of version 2.1
    Resolution
    Adopted in 3.0. The reference implementation's default for a claim whose form is not recorded stays the narrower reading, across the market.
    Related
    EA-007

  • EA-015P6 divided into P6a, P6b and P6c

    Reimbursement, a health technology assessment recommendation and a formulary listing become three propositions, each settled only by its own record.

    Status
    Adopted in 3.0
    Section
    Section 4, P6; Annex A
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, item 3, after the external review of version 2.1
    Resolution
    Adopted in 3.0. P6a is settled only by a payer's coverage decision within its stated reach; P6b only by the assessment body's published appraisal (hta_appraisal, a new class); P6c only by the formulary's own listing (formulary_listing, a new class). P6b and P6c support P6a and never settle it.
    Related
    EA-003

  • EA-016P8c, a safety signal

    A claim that a regulator or pharmacovigilance body has identified or is assessing a safety signal is a proposition of its own.

    Status
    Adopted in 3.0
    Section
    Section 4, P8; Annex A
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, item 4, after the external review of version 2.1
    Resolution
    Adopted in 3.0. P8c is settled by the body's signal record (safety_signal_record, a new class issued only by an authority) or its safety communication, from any market, and never settles that the medicine causes the effect. P8a and P8b are unchanged.
    Related
    EA-004

  • EA-017Hedged claims are recorded

    A hedged statement is recorded with its proposition, its polarity and hedged: true, reported as a hedged claim, and never judged or counted as an error.

    Status
    Adopted in 3.0
    Section
    Annex B, E5
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, item 5, after the external review of version 2.1
    Resolution
    Adopted in 3.0. In 2.1, E5 set hedges aside as making no claim; the change reclassifies sentences 2.1 classified, so it belongs to a major version.

  • EA-018Date rules T3, T4 and T7

    A stated date governs its clause and any clause that continues it, an undated earlier time leaves the claim's date not determinable, and the answer's date is read in the market's local time.

    Status
    Adopted in 3.0
    Section
    Annex B, B6 (dates)
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, item 6, after the external review of version 2.1
    Resolution
    Adopted in 3.0. Under T3, a later clause in the present tense, or marked currently, now or today, takes the answer's date. Under T7, where the market spans time zones or is unresolved, the answer's date is read in UTC.
    Related
    EA-006, EA-024

  • EA-019The answer change's jurisdiction

    Preserved observations speak for the markets they observed, and the answer change is settled per market under the market step.

    Status
    Adopted in 3.0
    Section
    Section 4, the answer change
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, item 7, after the external review of version 2.1
    Resolution
    Adopted in 3.0. Whether observations speak for engines or framings they did not observe is interpretation, recorded as a limitation.
    Related
    EA-005, EA-032

  • EA-020Governance and stability

    Proposed: that section 7 state the versioning rules, the release history, a 90-day stability window, the public issue register and the proposal process.

    Status
    Adopted in 3.0
    Section
    Section 7
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, item 8, after the external review of version 2.1
    Resolution
    Adopted in 3.0, with stability stated as a policy for the stable version rather than a dated window: it changes only by corrections that change no rule and by fixes to security issues in the published implementation or API, and any other change waits for the next major version. External reviewers are named only with their consent, and an invitation to review implies no endorsement.

  • EA-021Classification validation

    The 3.0 classification test set is measured by three blind machine readers, one flagship model each from Anthropic, OpenAI and Google, and the measured results are deposited and stated in section 9.

    Status
    Adopted in 3.0
    Section
    Section 9; Annex B
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, item 9, after the external review of version 2.1
    Resolution
    Adopted in 3.0. Reported: precision, recall and F1 per proposition, item exact match, attribute agreement, Cohen's kappa between readers per proposition, and every failure. The readers' errors may be correlated, and the labels were written by AlphaCitation, so they are not independent.

  • EA-022The developer entry point

    The standard's address becomes a five-minute guide to the API, the reference implementation and the conformance test vectors.

    Status
    Adopted in 3.0
    Section
    Section 7 (machine-readable files and conformance); the guide at /standards/evidence-authority
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, item 10, after the external review of version 2.1
    Resolution
    Adopted in 3.0. The quickstart is verified from a clean directory before release.

  • EA-023Positioning

    The standard's page compares it with GRADE, HL7 FHIR and W3C PROV by their intended functions.

    Status
    Adopted in 3.0
    Section
    The full text's page (/insights/which-evidence-settles-which-claim)
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, item 11, after the external review of version 2.1
    Resolution
    Adopted in 3.0, without a claim that no other work addresses the question.

  • EA-024T6, event dates

    Whether an event's date ("approved in June 2026") is the claim's date, given that the rule that a source is in force throughout the stated period (T2) answers a different question.

    Status
    Adopted in 3.0
    Section
    Annex B, B6 (dates); Rule 7
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, left open; continues Version 2.1, section 10, question 6
    Resolution
    Adopted in 3.0 before release (Annex B, T2 and T6; Rule 7). A date the answer gives for an event dates an event claim, whose claim's date is the stated time at its precision, even a period that contains the answer's date. A past-tense event with no time, a time with no year, "recently" or "initially" is an undated event claim, dated the answer's date. Either is judged against the record of the event issued on or before the answer's date, which still settles if its force later ended unless it was annulled, retracted or corrected as to the event by then; whether its date for the event falls within the claim's date is adjudication.
    Related
    EA-006, EA-018

  • EA-025Claims about a class

    Whether a claim about a class of medicines makes one of the propositions P1 to P3 or P5 to P10, and how it would then be settled.

    Status
    Adopted in 3.0
    Section
    Section 4; Annex B, E11 and C17
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, left open; continues Version 2.1, section 10, question 10
    Resolution
    Adopted in 3.0 before release (Annex B, E11; section 4). A claim about a class makes the proposition it would make about a medicine, with the class as its product. For P1, P2, P5, P6a, P6c and P8a it is about the class's members in the market, and a member's record settles it as to that member; for the other propositions only a source that speaks of the class itself settles it. P10 covers a recommendation of a class.
    Related
    EA-010

  • EA-026A named supplier or channel, stock, and "not available across the market" (P5)

    How a claim about one named supplier or channel, about stock, or that the medicine is not available across the market is settled.

    Status
    Adopted in 3.0
    Section
    Section 4, P5
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, left open; continues Version 2.1, section 10, question 7
    Resolution
    Adopted in 3.0 before release (Annex B, C6; section 4, P5). A named channel is the third claim form: a regulatory access route is settled only by the market regulator's decision or label that provides the route for the medicine by name, an import permit included, and the regulator's published rules for a route only support; a named supplier is settled by its own supply record. Stock is the fourth form, which no class settles. "Not available across the market" is the negation of the across-market form. A negative claim about a channel named only by kind is not determinable. Whether a shortage register settles a stock claim stays open (EA-040).
    Related
    EA-007, EA-014, EA-040

  • EA-027P3 with no use named, or no label in the market

    Which source, if any, settles P3's P2 part when the answer names no use or the medicine has no authorised label in the market.

    Status
    Adopted in 3.0
    Section
    Section 4, P3
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, left open; continues Version 2.1, section 10, question 8
    Resolution
    Adopted in 3.0 before release (Annex B, C10; section 4, P3). Where "investigational" or "experimental" names no use, P3 is read through P1: a study is ongoing (P3d) and the medicine holds no marketing authorisation in the market (P1), a part that a register read finding nothing never settles (Rule 3). "Being studied" with no use named is P3d alone. Whether a sponsor's statement settles that development stopped stays open (EA-041).
    Related
    EA-008, EA-041

  • EA-028Label content outside P2

    Whether a proposition is wanted for the legal category of supply, the dose and the route stated in the authorised label.

    Status
    Adopted in 3.0
    Section
    Section 4, P2
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, left open; continues Version 2.1, section 10, question 9
    Resolution
    Adopted in 3.0 before release (section 4, P2; Annex B, C2, C4 and C7). P2 covers the legal category of supply, a dose, route or form stated as what the authorisation permits, and a restricted programme the authorisation requires for every supply; the authorisation decision also settles the legal category and a restricted programme where it states them (in the EU, Annex II to the Commission's decision). A statement that a group must not receive the medicine is a contraindication or warning, P8a.
    Related
    EA-009

  • EA-029P3c and studies that are not trials

    Whether P3c covers the reported results of observational studies, and which classes then settle it.

    Status
    Adopted in 3.0
    Section
    Section 4, P3c
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, left open; continues Version 2.1, section 10, question 11
    Resolution
    Adopted in 3.0 before release (Annex B, C11; section 4, P3c; Annex A). P3c covers the reported result of a study, interventional or observational, settled by results posted to a registry or the study's publication of record.
    Related
    EA-011

  • EA-030Guidelines and formularies named only by their issuer, or not named

    Whether a guideline named only by its issuer is named for P4, how "guidelines recommend" is classified, and whether "on the formulary", naming none, is a coverage claim (P6a).

    Status
    Adopted in 3.0
    Section
    Section 4, P4 and P6; Annex B, C9 and C12
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, left open; continues Version 2.1, section 10, question 12
    Resolution
    Adopted in 3.0 before release (Annex B, C9 and C12; section 4, P4 and P6c). A guideline named by its issuer, or by a back-reference, is the issuer's guideline for the use; a recommendation attributed to guidelines the claim does not identify is a P4 claim that is not determinable; "experts recommend" maps to no proposition; a recommendation attributed to a body that assesses medicines is classified by C9. "On the formulary", naming none, is a P6c claim that is not determinable, not a coverage claim.
    Related
    EA-012

  • EA-031Whether a national source settles a sub-national claim

    Whether a national regulator's or payer's record settles a claim about an emirate, a state or a region.

    Status
    Adopted in 3.0
    Section
    Section 2 (the claim's market); Rule 2
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, left open; continues Version 2.1, section 10, question 2
    Resolution
    Adopted in 3.0 before release (Annex B, M1 and M6; Rule 2). Places below the country are recorded by ISO 3166-2 codes, and a place with both codes by its ISO 3166-2 code. A source of a class only an authority issues, an HTA appraisal or a formulary listing that speaks for a country speaks for each of its subdivisions, and one whose reach is a subdivision never settles a claim about the country. A launch statement or a supply record speaks for its own place and every place that contains it. A payer's reach uses the same codes; a decision for part of a place's population is one plan's decision.
    Related
    EA-002, EA-013

  • EA-032Answers that differ between engines or framings at one time

    Whether a claim that answers differ at one time, between engines or between framings of a question, is the answer change.

    Status
    Adopted in 3.0
    Section
    Section 4, the answer change
    Target
    Version 3.0
    Opened
    Raised in
    Design of version 3.0, left open; continues Version 2.1, section 10, question 5
    Resolution
    Adopted in 3.0 before release (Annex B, C18; section 4, the answer change). A claim that answers differ at one time, between engines or framings of a question, states no change over time: it is not the answer change and maps to no proposition. An evaluation of reported answers makes no claim of the answer's own.
    Related
    EA-005, EA-019

  • EA-033Records that report an earlier event

    Whether a record that reports an earlier event, such as a launch statement giving an earlier launch date, is in force from that event or from its own date.

    Status
    Adopted in 3.0
    Section
    Rule 7; Annex B, B6 (the evidence's dates)
    Target
    Version 3.0
    Opened
    Raised in
    Version 3.0, section 10, question 2; continues Version 2.1, section 10, question 6
    Resolution
    Adopted in 3.0 before release (Rule 7; Annex B, B6, the launch statement). A launch statement is in force from its own date, also where it reports an earlier launch; for an event claim about the launch it is the record of that event, and the launch date it gives is compared with the claim's date in adjudication.
    Related
    EA-006

  • EA-034A class member named only in the ground of a recommendation

    Whether a member of a class, named only in the ground of a recommendation about the class ("do not treat online peptide products as alternatives: retatrutide and similar compounds are not ..."), gets its own recommendation unit (P10).

    Status
    Adopted in 3.0
    Section
    Annex B, E11 and C17
    Target
    Version 3.0
    Opened
    Raised in
    Classification validation of version 3.0, test item CT-025
    Resolution
    Adopted in 3.0 before release (Annex B, E11 and C17). A member named only as an example of a class, or only in the ground of a recommendation about the class, gets no unit; a member of which the sentence states a predicate gets its own.
    Related
    EA-025

  • EA-035A product entered under a heading that offers options

    Whether a product entered under a heading that offers treatment options is recommended (U7) when the heading itself states no predicate (E10).

    Status
    Adopted in 3.0
    Section
    Annex B, U7 and E10
    Target
    Version 3.0
    Opened
    Raised in
    Classification validation of version 3.0, test item CT-101
    Resolution
    Adopted in 3.0 before release (Annex B, U7). A heading or lead-in that names its entries as options, alternatives or choices makes each product entered under it a P10 unit; a class entered under it is one P10 unit for the class. A status word in it also supplies its predicate to each entry, recorded as a ground. A heading that only names a topic or a class supplies no predicate.

  • EA-036A list of adverse effects

    Whether a list of adverse effects ("drops in white blood cell counts, rashes and gastrointestinal issues") makes one safety-finding claim (P8b) or one for each effect.

    Status
    Adopted in 3.0
    Section
    Section 4, P8b; Annex B, U1
    Target
    Version 3.0
    Opened
    Raised in
    Classification validation of version 3.0, test item CT-029
    Resolution
    Adopted in 3.0 before release (Annex B, U1 and U7). A unit has one adverse effect: coordinated adverse effects, and the entries under a heading of risks, are one unit each.

  • EA-037A market attached to a noun

    Whether a market attached to a noun in one clause ("a UAE-licensed clinician") states the market of a coordinated clause.

    Status
    Adopted in 3.0
    Section
    Annex B, M1
    Target
    Version 3.0
    Opened
    Raised in
    Classification validation of version 3.0, test item CT-028
    Resolution
    Adopted in 3.0 before release (Annex B, M1). A market attached to a noun of the clause ("a UAE-licensed physician", "a Saudi patient") states the market of that clause's claim.
    Related
    EA-001

  • EA-038Coordinated uses

    Whether an authorisation "for weight management and cardiovascular risk reduction" makes one indication claim (P2) or one for each use.

    Status
    Adopted in 3.0
    Section
    Section 4, P2; Annex B, U1 to U3
    Target
    Version 3.0
    Opened
    Raised in
    Version 3.0, section 10, question 15; the larger 3.0 test set, item CT-141
    Resolution
    Adopted in 3.0 before release (Annex B, U1). A unit has one use: coordinated uses or conditions under one predicate are one unit each, while coordinated populations or qualifiers of one use stay one unit.
    Related
    EA-036

  • EA-039A regulator's warning reported by the answer

    Whether "the regulator has warned that the medicine can cause" a stated effect is the regulator's safety statement (P8a) or, classified by its content, a safety finding (P8b).

    Status
    Adopted in 3.0
    Section
    Section 4, P8a and P8b; Annex B, C14 and E7
    Target
    Version 3.0
    Opened
    Raised in
    Version 3.0, section 10, question 16; the larger 3.0 test set, item CT-292
    Resolution
    Adopted in 3.0 before release (Annex B, C14). A statement that a regulator has warned of a risk is that regulator's safety communication, P8a, for the regulator's market; the risk it reports is not also a P8b unit unless the sentence states it in the answer's own voice.