Evidence packet — ICH E6(R3)

One row of this record, assembled so it can be taken somewhere else: what the publisher published, where this record read it, what it hashed, and what changed between two readings it retained. Generated 2026-09-18. It carries no assessment of what the document requires and no reading of what any change means.

The packet, in three formats

Each is the same object. /packet/ich-e6r3.json carries every field; /packet/ich-e6r3.md is the same content as plain text; and /packet/ich-e6r3.zip is an archive of those two together with this row’s slice of the published leaf file and the published root. Every byte in the archive is served at its own address as well; it originates nothing.

Source

Identity as this record holds it for ICH E6(R3)
Field	Value
Identifier	`ich-e6r3`
Title	ICH E6(R3) — Good Clinical Practice
Jurisdiction	International
Address requested	https://ich.org/page/efficacy-guidelines
Address answered	https://ich.org/page/efficacy-guidelines
Observed cadence	quarterly
Row	`/r/ich-e6r3`

 
The address a request ANSWERED at is this record’s address for the
    row. The address it aimed at is testimony and is carried beside it, because
    a redirect is a publisher’s own statement about what supersedes what.
 Publisher
  The body, and the origin that answered Field Value
  Authority  International Council for Harmonisation
 Origin host  —
 Origin read from  —
 Standards body  —
 Standards body read from  —
 
 
 No origin host is recorded for this row. The authority named above is the body; the host is a fact about which origin answered, and this row does not carry one.
 Type
  The class the publisher states, and the kind of record this is Field Value
  Class, as the publisher states it  —
 Read from  —
 Source kind, recorded here  document
 Source type, recorded here  document
 Record tier  core
 
 
  No class statement by the publisher is recorded for this row, so this packet states none. That is an absent reading rather than a document without a class. 
 Status, and the dates it is held with
  The status this record holds for this document, with its dates Field Value
  Status  final 
 Stated as of  2022-02-21
 In effect from  —
 Last changed  —
 Status read from  —
 Status withdrawn  —
 Decay class  live 
 
 
 
These are the dates this record holds for the document’s own status.
    They state nothing about which products or activities the document reaches;
    that is a judgment, and this record does not make one.
 Verification
  The act behind the status above, where one is recorded Field Value
  State  ●  verified
 What the state states  checked against the primary source by a person
 Checked by  human
 Check date  2026-07-29
 Last verified  2026-07-29
 
 
 Terms
  What this record does with the text of this document Field Value
  Licence class  open
 Text retained here  no
 A quotation appears in this record  yes
 Snapshot retained here  no
 
 
  Readings with retained text
 None. The sentence below says which absence this is.
 
Digests on this row: 0. With retained text:
 0. Without:
 0. Series state:
 no-digest.
 This row has been observed and no observation produced a digest, so there is no reading to place on a series and nothing to compare. That is an absence of a digest in this record, not an absence of change in the document.
  
A digest is over the NORMALISED text of a reading, not over the bytes
    served: scripts, comments, navigation and page chrome are removed and tags
    are stripped before hashing. Hashing a source as served will not reproduce
    these digests. The full digest for every reading is in the packet; the
    column above is shortened for width.
 Changes
 One entry per consecutive pair of retained readings, in the order this record first saw each digest. Every entry carries a measured difference or the first condition that refused one. A refused entry was never tested against the conditions after it.
 
No transition. The sentence above says which absence this is. 
 
A difference here is a difference between two readings this record retained.
    It is not a statement about what the document requires, about what changed
    in substance, or about whether anything follows from it.
 Integrity
  The root this packet was generated against Field Value
  Root  fd0980cf7ca42518ff7457b92b075df16163772d48d6f75e546b4869fe7bedab
 Leaves the root covers  5,393
 Algorithm  SHA-256 over sorted `id|date|content_hash` lines, pairwise; an odd final node is promoted, never doubled.
 Fixed on  2026-09-18
 Root published at  /integrity/root.txt
 Leaves published at  /integrity/leaves.txt
 The commands  the verification page
 Leaf lines for this row  0
 
 
 The root is over every leaf line the record holds, not over the lines below. Reducing it needs the published file, which is served whole at the address named here together with the command that reduces it. These lines are this row's own slice of that file, copied verbatim.
  
This row contributes no line to the published leaf file. A leaf is one
          distinct row, day and digest, so a row that has recorded no digest
          contributes none.
 What this packet does not carry
   the words that differ
 A count of a difference is in this packet; the words are not. They are a publisher's text, and this record checks borrowed text only on the surfaces it enumerates — a packet carrying spans under a key those checks do not read would be borrowed text nothing verifies. Each change names the comparison entry for the same pair, and says which of the two is at that address: the words, where a difference was measured and is inside the word ceiling; otherwise the same condition this entry names, with no text of the document.
  this records own prose
 The row's summary and its account of an unresolved address are this archive's own voice. They are leads and not evidence, however accurate, because a faithful paraphrase is indistinguishable from evidence while remaining ours. They are published on the row's page and are not here.
  any field that would characterise a change
 No score, no rank, no ordering by judgment, no reading of what a change means and no word for how much of it counts. A packet is evidence taken elsewhere, and a field characterising it would be an opinion with digests attached.
  a recomputed root
 The integrity block states the root this record published and the leaf lines for this row. It computes no root of its own: two numbers this record produced, compared with each other, check nothing.
  
 The conditions, in the order they are evaluated
 
A change names the FIRST condition that fired and was never tested against
    the ones after it, so a condition naming no change here is not a condition
    this row passed. Not reached is not none:
 This row holds fewer than two readings with retained text, so no pair was formed and no condition was evaluated at all. Every condition is unreached here, which is a different fact from a condition that was evaluated and did not fire. 
  Each condition, how many of this row’s
 0 transition(s) it refused, and what it
      states  Condition  Changes  What it states  
  licence-restricted  not reached  No text from this document appears on this site, so no difference between two readings of it is shown either. The digests, the dates and the addresses are the record for this row.  
 licence-unread  not reached  No reading of the terms this source states is recorded for the row. That is an absent reading rather than an absent term, and the row is handled here exactly as a restricted one until a reading is recorded.  
 date-not-observed  not reached  No observation of this row on that day holds retained text.  
 date-not-unique  not reached  That day holds more than one distinct retained digest for this row, so a date alone does not name one observation. The addressed form — the day and the sequence within it — does.  
 one-point  not reached  Both dates resolve to the same observation.  
 referent-unclassified  not reached  The class of one of these observations could not be read, so neither was shown to be an observation of the document itself.  
 referent-class  not reached  One of these observations is not of the document. A listing page that names the document and the document are different subjects, and a difference between them is not a difference in the document.  
 referent-normalisation  not reached  These two digests were taken over different kinds of text — one over markup, one over prose extracted from a file — so the words they yield differ for a reason that is not the publisher’s.  
 referent-address  not reached  These two observations answered at different addresses. A difference between them is at least in part a difference between two pages.  
 text-not-retained  not reached  No normalised text is held here for one of these observations, so there is nothing on this side to compare.  
 snapshot-unreadable  not reached  Normalised text is recorded for one of these observations and could not be read from this record.  
 span-unverified  not reached  A span this comparison would have shown could not be found, word for word and in that order, in the retained text it was drawn from. The comparison is withheld rather than shown: a phrase assembled out of words a publisher did not write next to each other is a fabricated measurement of what the publisher wrote.  
 over-ceiling  not reached  A faithful difference is longer than the word ceiling this site publishes under. It is withheld whole rather than cut to fit: a shortened quote is a fabricated measurement of what a publisher wrote. The figures below are counts of the difference, not the difference.

The body, and the origin that answered
Field	Value
Authority	International Council for Harmonisation
Origin host	—
Origin read from	—
Standards body	—
Standards body read from	—

The class the publisher states, and the kind of record this is
Field	Value
Class, as the publisher states it	—
Read from	—
Source kind, recorded here	`document`
Source type, recorded here	`document`
Record tier	`core`

The status this record holds for this document, with its dates
Field	Value
Status	`final`
Stated as of	2022-02-21
In effect from	—
Last changed	—
Status read from	—
Status withdrawn	—
Decay class	`live`

The act behind the status above, where one is recorded
Field	Value
State	verified
What the state states	checked against the primary source by a person
Checked by	`human`
Check date	2026-07-29
Last verified	2026-07-29

What this record does with the text of this document
Field	Value
Licence class	`open`
Text retained here	no
A quotation appears in this record	yes
Snapshot retained here	no

The root this packet was generated against
Field	Value
Root	`fd0980cf7ca42518ff7457b92b075df16163772d48d6f75e546b4869fe7bedab`
Leaves the root covers	5,393
Algorithm	SHA-256 over sorted `id\|date\|content_hash` lines, pairwise; an odd final node is promoted, never doubled.
Fixed on	2026-09-18
Root published at	`/integrity/root.txt`
Leaves published at	`/integrity/leaves.txt`
The commands	the verification page
Leaf lines for this row	0

Each condition, how many of this row’s 0 transition(s) it refused, and what it states
Condition	Changes	What it states
`licence-restricted`	not reached	No text from this document appears on this site, so no difference between two readings of it is shown either. The digests, the dates and the addresses are the record for this row.
`licence-unread`	not reached	No reading of the terms this source states is recorded for the row. That is an absent reading rather than an absent term, and the row is handled here exactly as a restricted one until a reading is recorded.
`date-not-observed`	not reached	No observation of this row on that day holds retained text.
`date-not-unique`	not reached	That day holds more than one distinct retained digest for this row, so a date alone does not name one observation. The addressed form — the day and the sequence within it — does.
`one-point`	not reached	Both dates resolve to the same observation.
`referent-unclassified`	not reached	The class of one of these observations could not be read, so neither was shown to be an observation of the document itself.
`referent-class`	not reached	One of these observations is not of the document. A listing page that names the document and the document are different subjects, and a difference between them is not a difference in the document.
`referent-normalisation`	not reached	These two digests were taken over different kinds of text — one over markup, one over prose extracted from a file — so the words they yield differ for a reason that is not the publisher’s.
`referent-address`	not reached	These two observations answered at different addresses. A difference between them is at least in part a difference between two pages.
`text-not-retained`	not reached	No normalised text is held here for one of these observations, so there is nothing on this side to compare.
`snapshot-unreadable`	not reached	Normalised text is recorded for one of these observations and could not be read from this record.
`span-unverified`	not reached	A span this comparison would have shown could not be found, word for word and in that order, in the retained text it was drawn from. The comparison is withheld rather than shown: a phrase assembled out of words a publisher did not write next to each other is a fabricated measurement of what the publisher wrote.
`over-ceiling`	not reached	A faithful difference is longer than the word ceiling this site publishes under. It is withheld whole rather than cut to fit: a shortened quote is a fabricated measurement of what a publisher wrote. The figures below are counts of the difference, not the difference.


Word ceiling: 14. Where a faithful difference is longer
    than that, the verdict is withheld and no words are published
    for it: a shortened span is a fabricated measurement of what a publisher
    wrote, so it is withheld whole rather than cut to fit.
 How this record is built.

Last updated: 18 September 2026