EMA CT computerised systems

EMA guideline on computerised systems and electronic data in clinical trials

Recorded status: final (basis: person-ratified)
Last person check: 1 August 2026 — a person confirmed the status this entry publishes
Last observation: 2 November 2026
Retained text: held — Prose was extracted from the retrieved bytes, so a quotation from this document can be checked against what this record retained.

Primary source (opens in new tab) ema.europa.eu
Observation series
Compare
Evidence packet
Citation

2 corrections name this row · last 2026-09-02 → history

Evidence coverage#

Of the 12 rungs of this entry’s evidence ladder: 6 held · 1 held in part · 2 read, and not there · 3 nothing held.

The 12 rungs, each with its mark

identity — held
publisher — held
jurisdiction — held
type — read, and not there
current edition — nothing held
publication date — nothing held
lifecycle signal — nothing held
publisher notices — read, and not there
observation history — held
text — held
diff — held in part
verification — held

A rung marked nothing held has no recorded reading; one marked read, and not there has a reading that ran and did not find it. Rungs stand in the ladder’s fixed order and the counts in this fixed order of marks: held · held in part · read, and not there · nothing held; neither order says anything about this entry. The counts on /coverage are counted by rules of their own, so a rung here and a count there of one name can differ. The sentence behind each mark is in the evidence ladder, under Evidence.

What this record does not establish#

No conclusion is drawn from absence. An absence here is not evidence that a document does not exist, is not in force, or does not govern.

Of the 12 rungs on this entry, 6 are held, 1 are held in part under a limit each one states, and 5 cannot be established from what this record holds. Each of those carries the reading that produced it and whose blank it is. Ordered by whose blank each names: this record’s own first, then the publisher’s, then the blanks this record cannot attribute at all.

type the publisher’s own surface the class the document calls itself, quoted from its own title The title was read and it does not call this document a regulation, a guidance or a standard, so no class is recorded.
current edition this record has not looked a statement of which edition or revision this record holds No reading of an edition or revision statement is recorded for this entry.
publication date this record has not looked a date the publisher states for this document No reading of a publication date is recorded for this entry.
lifecycle signal this record has not looked a stage, step or status wording read from a publisher surface No read of a publisher surface for a stage or status wording is recorded for this entry.
publisher notices this record cannot tell which official notices the publisher issued about this document A collection of publisher notices has succeeded and none of the records it holds attaches to this entry.

3 this record has not looked — no reading of this rung is recorded here. The blank is this record’s, and it is not evidence about the publisher · 1 the publisher’s own surface — a reading reached a surface the publisher published and what was asked for is not on it, bounded to the surfaces read · 1 this record cannot tell which — what is held does not say whether the blank is the publisher’s or this record’s. This is an absence of an attribution, not a kind of one

Established for this entry: identity · publisher · jurisdiction · observation history · text · verification. Held in part: diff.

The reading behind every one of those is stated rung by rung in the evidence ladder under Evidence, and the public evidence each was marked from is published in full on this page under Timeline, Publisher neighbourhood, Observation history and Sources.

What this record undertakes for this entry is stated in 6 terms, each answering one question, and each answered for this entry in the coverage contract under Evidence:

Observed cadence: how often this record has reached this entry’s address
Text: public, and retained: whether the publisher’s text is public, and whether prose from it is kept here
Hash: what is digested for this entry, and of what
Status verification: which check this record undertakes for the published status, and which it holds
Lifecycle tracked: which lifecycle facts this record follows for this entry
Known limits: the limits this entry’s own record declares

Overview#

Open primary source (opens in new tab) ema.europa.eu View observation 2026-11-02 · sequence 1

Document status what the publisher asserts, and the status recorded here

Publisher lifecycle field: none captured

No status read is recorded for this entry — this record has not read a publisher surface for its status, which is a fact about this record and not about the publisher. A status read is recorded for 7 of 132 tracked entries, 5 of which banked a passage.

Recorded status: final (basis: the act named under Established by)

Verification what a person or a tool has confirmed here, and when

Publisher: European Medicines Agency Last checked: 1 August 2026 Last read: 2 November 2026

Evidence state what this record holds

verified by a person — a person checked this entry against the primary source on a recorded day

How this status is recorded

Recorded: final — no as-of date is recorded
Established by: A person confirmed this entry. The record carries no separate check date; the verification date it holds is 1 August 2026.
Evidence: In Current status on this page.
Published at: This record names no separate surface for the status. The primary source it holds is the primary source (opens in new tab). This entry's record is published in machine form at /api/v1/instruments.json.

Filed core. For that label this archive undertakes to close an entry's open status question by rule on a clock, with its reason, and to re-read a ratification on record against its observation every night. The label records what this archive undertakes for a class of entries. It states no finding about this one, and it is not a ranking.

Resolution: direct document

Authority: European Medicines Agency
Jurisdiction: EU
Status: final
Effective date: — this record holds no effective date for this entry
Last changed: —
Last verified: 1 August 2026 (person-ratified: a key stands on the status this entry publishes)
Watch cadence: monthly
Crawlable: yes · renders server-side
Text licence: freely reproducible
Primary source: Primary source (opens in new tab) ema.europa.eu
Topics: computerised systems · clinical

Timeline#

The dated facts this record holds for this entry. Each line below states what one kind of dated fact amounts to here, and links to the list holding it where this entry has one; the list carries the dates, the words and the addresses they were read from. Nothing is counted twice: where a line states a number, the section it names states none.

— No publisher-dated calendar entry is recorded for this entry.
— No revision has been detected for this entry. Detection is this record’s own act rather than a publisher’s statement, so its absence says nothing about whether the document moved.
— No archived version of this entry is held.
— No difference between two versions of this entry is published.
Change history — 2 entry(ies) in this record’s own changelog, each dated by the day this record acted.
Every dated reading of this entry — the day, the address that answered, the response and the digest — is in Observation history below, which states its own counts.

What is not published. This build serves 3 address(es) holding a time-ordered list for an entry — a TimeMap in JSON, its link-format sibling and an index — each expanding to one document per tracked entry. What they list is CAPTURES of this entry’s source held at a web archive, carrying that archive’s own capture instants; this record serves no copy of a tracked document, so none of those addresses is one of this record’s, and a capture address is published only where the terms filing recorded for the source host permits it. This entry’s own is at /api/v1/timemap/ema-ct-computerised-systems.json. The route set naming them, and what each one answers, is published at /developers.

Change history#

2026-09-02 — archive metadata change (a 48-word quotation, over the 14-word cap → a 10-word verbatim sub-span of the same banked evidence) correction: the quotation here exceeded the 14-word cap. A shorter span was SELECTED from the same banked evidence, not trimmed. The evidence record is unchanged. the entry on the corrections page
2026-08-01 — status change (unknown → final) correction: the status moved unknown to final at commit 237b4a5b on 2026-08-01 and no changelog entry was written at the time. Recorded 2026-09-01 from git history. the entry on the corrections page

Publisher neighbourhood#

What sits around this entry, counted. Every figure below is drawn from a value already rendered elsewhere on this page; where a count has a list, the count is here and the list stays in the section holding its evidence.

The direct document, and the activity around it what this record’s observations of the document recorded inside a stated window, beside the official signals dated inside the same one

Each row is a window of calendar days ending 2026-11-02, the day the source-health block below counts its own window to. Every column between the window and the official signals is drawn from the 157 observation(s) of the document this entry holds in total. An observation is counted here only where the class projection places it on the document this entry names.
Window	Observations of the document	Of those, carrying a digest	Direct document	Official signals dated inside it
30 calendar days	31	25	no detected difference in window	not measured
90 calendar days	140	133	no detected difference in window	not measured
365 calendar days	157	150	no detected difference in window	not measured

A window is marked changed where at least one observation of the document inside it recorded a change against the previous one; unchanged where the window holds at least one such observation, at least one of them carries a digest of the retrieved bytes, and none recorded a change; undigested where the window holds observations and none of them carries a digest, so no observation in it could be compared with another; and unmeasured where the window holds no observation at all. The word is shorthand for the three counts printed beside it and adds nothing to them. It is a statement about the window and never about the document outside it, which is why a window reaching back before the first observation says so underneath. A mark is derived from the observations a window holds and never from the days it spans; which days inside this entry’s own window hold none is stated by the coverage sentence in Observation history below.

The first observation of the document this entry names is 2026-07-31. These windows reach back before it — 365 calendar days — so part of the span each names was never watched, and a window with no detected difference inside it says nothing about the days before that first observation.

no detected difference in window — this window holds observations of the document and none of them recorded a change — which is a statement about the window, not about the document outside it

No word is attached to the signal count beside it, and none will be. Any word for the size of a count needs either a threshold this record would have authored or a comparison against other entries that would rank the sources against one another; the count and its window are the whole claim. The document column beside it carries a word only because the rule reaching it is printed underneath and can be checked against the counts it stands for.

The last column holds no member on this entry. The zero it holds is named under “Around it” below.

Around it official signals naming this entry, by the class their publisher stated

— 88 of the 88 record(s) the store holds could be tested against this entry, and none names it. That zero is a measurement.

Related sources other entries reachable from this one by a relation a publisher states

— This record publishes no relation from or to this entry. A relation is published only where a publisher states it, so this is the absence of a statement this record has read and not a claim that none exists.

Related standards which of those entries call themselves a standard, in their own publisher’s word

— No published relation from this entry reaches an entry this record tracks, so there is nothing to place on this axis. That is a statement about what this record can read, not about what exists.

Topics record identifiers for publisher-stated values, and the voice each one is in

2 identifier(s), minted by the convention published at /conventions. The values themselves are not listed again here; what this adds is the identifier and the voice it is in. 2 come(s) from a term this document’s own publisher states about it, quoted with its citation lower on this page: topic.computerised-systems · topic.clinical.

Before, now and next where the record’s day sits among the publisher-dated facts this entry holds

— This entry holds no publisher-dated lifecycle fact, so no position can be derived. What is absent is a dated statement this record has read.

Next holds the publisher-dated facts this record already carries that fall after the day this record calls today — a stated effective date, a consultation close. Nothing is projected and no step is inferred from a lifecycle: where a publisher has stated no further date, the cell says so, and what is absent is a statement rather than a future.

Subject and class (as stated)

The words this document uses about itself, matched verbatim against its own title. Not a statement of scope, and not a judgment about which organisations or products fall under it: each value quotes the span it was read from and links to where that span was read.

subject computerised systems
EMA guideline on computerised systems and electronic data in clinical trials source (opens in new tab) ema.europa.eu
subject clinical
EMA guideline on computerised systems and electronic data in clinical trials source (opens in new tab) ema.europa.eu

This document does not call itself a regulation, a guidance or a standard, so no class is recorded. It is filed under title states no class.

Family (along publisher-stated edges)

A family forms only along a supersedes, superseded-by or document-history line a publisher prints. A shared title, number, date or prefix forms none. This records what one document's publisher lists about another and states nothing about the relationship between their requirements.

In no family. No store this record fills holds a supersedes, superseded-by or document-history field naming a second document for this entry, so whether its publisher prints such a line is unmeasured.

Shared publisher terms

Terms in the index that list this entry, each with how often its exact words occur in this entry’s retained text as read, that the text read does not hold them, or that no text of it is read here.

“audit trail” — 43 times in the text retained on 2026-10-27
“electronic record” — 3 times in the text retained on 2026-10-27

Terms retired from the index that had listed this entry. Each address says which text did not hold the words.

“electronic signature” — retired 2026-09-24
“validation” — retired 2026-09-24

contextual mapping — not a regulatory applicability determination The policy, stated once

Evidence#

Current status#

Recorded as final against the primary source on 1 August 2026.

The text that supported that record, retrieved 1 August 2026 by pdf:

Final version adopted by the GCP IWG 7 March 2023

Found at: page 1

Evidence ladder#

What this record holds for this entry, rung by rung, each mark derived from a field, a count or a stored reading. Rungs in the order the record acquires them, from what an entry is to what has been checked about it. The order is fixed; a rung’s position says nothing about any entry.

The 12 rungs, as marked for this entry

held. identity an address that describes this document rather than a list it sits in This record holds an address that describes this document, and the names it is published under.
held. publisher the body that published it The publishing body is recorded as European Medicines Agency.
held. jurisdiction the jurisdiction the publishing body belongs to The jurisdiction is recorded as EU.
read, and not there. type the class the document calls itself, quoted from its own title The title was read and it does not call this document a regulation, a guidance or a standard, so no class is recorded.
nothing held. current edition a statement of which edition or revision this record holds No reading of an edition or revision statement is recorded for this entry.
nothing held. publication date a date the publisher states for this document No reading of a publication date is recorded for this entry.
nothing held. lifecycle signal a stage, step or status wording read from a publisher surface No read of a publisher surface for a stage or status wording is recorded for this entry.
read, and not there. publisher notices official notices the publisher issued about this document A collection of publisher notices has succeeded and none of the records it holds attaches to this entry.
held. observation history a dated series of what the publisher’s address returned This record holds 157 dated records for this entry, and every one of them is of the document it names.
held. text prose retained from the retrieved bytes, against which a quotation can be checked Prose was extracted from the retrieved bytes, so a quotation from this document can be checked against what this record retained.
held in part. diff a comparison of two retrievals of this document 150 retrievals of this document carry a digest, and the store records no retrieval differing from the one before it.
held. verification a person’s check of this entry against the primary source A person checked this entry against the primary source; the day is recorded above.

✓ held — this record holds it, and the sentence beside it names what from · ✗ read, and not there — a reading ran and did not find it — an absence this record measured · — nothing held — no reading of this rung is recorded — nobody has looked, which is not the same as looking and finding nothing · △ held in part — part of it is held, or it is held under a limit the sentence states

The first rung a reading ran on and did not find: type — The title was read and it does not call this document a regulation, a guidance or a standard, so no class is recorded.

What the evidence states

This record holds an address that describes this document, and the names it is published under.
The publishing body is recorded as European Medicines Agency.
The jurisdiction is recorded as EU.
This record holds 157 dated records for this entry, and every one of them is of the document it names.
Prose was extracted from the retrieved bytes, so a quotation from this document can be checked against what this record retained.
A person checked this entry against the primary source; the day is recorded above.

What it does not state

The title was read and it does not call this document a regulation, a guidance or a standard, so no class is recorded.
No reading of an edition or revision statement is recorded for this entry.
No reading of a publication date is recorded for this entry.
No read of a publisher surface for a stage or status wording is recorded for this entry.
A collection of publisher notices has succeeded and none of the records it holds attaches to this entry.
150 retrievals of this document carry a digest, and the store records no retrieval differing from the one before it.

Evidence states#

All 8 evidence states, marked against this entry’s own fields. The axis at the top of this page publishes the first of them this entry meets; a state it meets after that is marked as met and not carried, because a state an entry meets and does not carry is not the same fact as one it fails. 7 of the 8 come from the published model and 1 was recorded here. The order, and why it is not a ranking, is stated on the observatory.

not a document not met a body, committee or programme — there is no document here to retrieve, quote or date The object model records this entry’s own type as document.
a register not met retrieved and hashed daily; the tier promises no person-verification The record tier this entry declares is core and its freeze reason is not recorded.
unstated by the publisher not met a surface was read and it states no status term this publisher’s family declares; bounded to the surfaces read This entry carries no status basis and no recorded tool reading that found none, and no status read on file for it reports a surface that states none.
verified by a person (person-ratified) carried a person checked this entry against the primary source on a recorded day This entry records the check as made by a person: checked_by reads human.
source access limited not met the publisher’s licence or its access policy limits what this record takes from the source The freeze reason this entry declares is not recorded, its licence class is open, and its record of whether the publisher excludes automated clients reads false.
publisher metadata not met what is held is metadata the publisher publishes about the document — a catalogue entry or a stage record — not the document The resolution strategy this entry declares is direct_document, what its address points at is declared as document, and no stage the publisher publishes is held for it.
observed also true the document at the address the publisher answered is retrieved and hashed here on a dated series This record holds 150 dated retrievals of the document this entry names, each carrying a digest.
not currently retrievable not met no retrieval of the document this entry names has produced a digest 150 dated retrievals of the document this entry names have produced a digest here.

◆ carried — the entry meets this test and no state before it in the order does, so this is the state its evidence axis publishes · ◇ also true — the entry meets this test as well, and the axis publishes a state that comes before it in the order · × not met — the entry does not meet this test, and the line beside it names what was read

Coverage contract#

Each term states what this record does for this entry and what it does not, derived from the entry’s own fields and its own series. It is a record of coverage, not a finding about the document.

Observed cadence how often this record has reached this entry’s address: Every interval between consecutive days holding an observation is 1 day. The term this record declares for the entry is “monthly”.
Text: public, and retained whether the publisher’s text is public, and whether prose from it is kept here: The publisher’s text is freely reproducible. Prose is retained from the retrieved bytes, so a quotation can be checked against it.
Hash what is digested for this entry, and of what: 150 of 157 record(s) classified as being of the document this entry names carry a digest of the retrieved bytes.
Status verification which check this record undertakes for the published status, and which it holds: This entry’s label undertakes to close an open status question by rule on a clock, with its reason, and to re-read a ratification on record against its observation every night. A person’s confirmation is recorded; the verification date the record carries is 2026-08-01.
Lifecycle tracked which lifecycle facts this record follows for this entry: This record follows no lifecycle fact for this entry: no effective date, no dated event, no archived version, no publisher stage record and no detected revision is held. That is what has been recorded here, not a reading of what exists. 36 of 132 tracked entries carry at least one such fact.
Known limits the limits this entry’s own record declares: None of the 8 limits this record can record is set on this entry. That is an absence of declared limits, and not a finding that the entry has none.

Why this entry is tracked#

The test an entry is admitted under is published in full, with its negative limb and its worked examples, at the inclusion rule. What this record holds about THIS entry's admission is below, each line naming the store it was read from.

Inclusion-rule limb which of the four limbs was applied: — No field in this record names which limb an entry satisfies, so none is stated for this one. Membership was closed as a human judgment on 2026-08-11, and the four-limb test is applied by a person rather than by code. This entry’s own stated subject is not read as a limb: a title word standing in for a rule would be a classification this record authored.
Admission entry the dated act that added this entry: — No admission entry is recorded for this entry. 21 of 132 tracked entries carry one, so an absence here is ordinary rather than a gap peculiar to this entry.
Declared tier-1 list a recorded judgement that this belongs: This entry is not a member of the declared tier-1 list. That list names 37 identifiers, of which 35 resolve to one of the 132 tracked entries, so most of the corpus sits outside it and non-membership says nothing about this entry on its own.
Admissions boundary the jurisdictions this record adds from: This entry’s jurisdiction is EU. It is inside the admissions boundary ruled on 2026-08-16, which names 4 jurisdictions — EU · US · UK · International — and which is one of the two admission tests this record enforces in code. The other is that a candidate carry the publisher’s own address: a mention is not a citation.

Observation history#

Observed on 157 occasion(s) since 2026-07-31. 150 produced a content hash. No observation is marked ! (digest differed).

······························×······························································································································

All 157 marks, one per observation, oldest first. On 6 of the 157 observations the server at the row's address answered a request carrying an earlier reading's validator with 304 "not modified", recorded as "checked, unchanged" on the basis "publisher-validator"; no digest was taken, and the strip draws each of them with the mark for an unchanged one. · unchanged · ! digest differed · ~ fetched but rendered client-side, no hash · × could not be fetched, no hash · / withheld by the publisher’s terms — no fetch made.

Every one of the 95 days from 2026-07-31 to 2026-11-02 holds an observation.

Each mark links to the single observation it stands for, at that observation’s own address. The whole series, with every address, is at /observations/ema-ct-computerised-systems. Any two of its retained observations can be set side by side at /compare/ema-ct-computerised-systems. The same evidence as a packet, with its refusals and its integrity reference, is at /packet/ema-ct-computerised-systems.

Every observation in this series is published, untruncated, at /api/v1/observations.json.

Of the retrievals classified as this document: same digest on 50 observed days, 2026-09-08 to 2026-10-27 (52 retrievals); the last digest before it, recorded on 2026-09-07, differs; 6 later observed days hold no digest of this document. This states what this record retrieved and normalised on those days, and nothing about the document on any other day.

First observed: 2026-07-31
Last observed: 2026-11-02 (HTTP 304)
Fetch method: direct
Current hash: ebaf707c409de6755574432f28b37e616971d7bb1601d41b43ac853f6222140c Taken on the reading of 2026-10-27. On 2026-11-02 the server answered a request carrying that reading's validator with 304 "not modified", recorded as "checked, unchanged" on the basis "publisher-validator"; no digest was taken that day.

How this series is recorded

Recorded: observations: 157 · carrying a digest: 150 · marked ! (digest differed): 0 · first observed: 2026-07-31
Method: resolution: direct document · watch cadence: monthly · last fetch method: direct
Evidence: The most recent record is addressed at 2026-11-02·1.
Published at: /observations/ema-ct-computerised-systems — every record of this row, with its address. /api/v1/series.jsonl — the same records for every row, one line each. Each observation is addressed by this row’s identifier, the date it was observed, and its sequence within that date — the same key /api/v1/series.jsonl publishes as `sequence`, counted in the order the store recorded them.

SHA-256: ebaf707c409de6755574432f28b37e616971d7bb1601d41b43ac853f6222140c This digest is a leaf of the integrity root, and the command that recomputes it is published at /verify/.

Clauses, definitions and sentences (as printed)#

Each string below is the string served for this entry at /api/v1/clause-anchors.json, /api/v1/definitions.json and /api/v1/modal-sentences.json, one block per observed text, each named by the first 12 characters of its content_hash as the JSON serves it: each clause anchor's id beside its label as the text prints it, each definition's term with its text where the derivation quotes it, and each sentence printing a listed verb that sits under the quote cap. A sentence or definition text over the cap is not cut: it is cited by the clause anchor it sits under, or by the stored reason no anchor is placed, its text withheld, and the count withheld is printed beside the count read. The block of the current text, where one is marked, is the one shown open.

Text 90f72782b398, first observed 2026-07-31

Clause anchors: no numbering read; 0 placed and 0 withheld.

Definitions: served for the current text of an entry only.

Sentences: unmeasured, the retained text opens with a PDF file signature ('%PDF-')

Text ebaf707c409d (current text), first observed 2026-09-08

Clause anchors: read; 0 placed and 86 withheld.

1 withheld: id repeats in this text
2 withheld: id repeats in this text
3 withheld: id repeats in this text
4 withheld: id repeats in this text
4.1 withheld: id repeats in this text
4.2 withheld: id repeats in this text
4.3 withheld: id repeats in this text
4.4 withheld: id repeats in this text
4.5 withheld: id repeats in this text
4.6 withheld: id repeats in this text
4.7 withheld: id repeats in this text
4.8 withheld: id repeats in this text
4.9 withheld: id repeats in this text
4.10 withheld: id repeats in this text
4.11 withheld: id repeats in this text
5 withheld: id repeats in this text
5.1 withheld: id repeats in this text
5.2 withheld: id repeats in this text
5.3 withheld: id repeats in this text
5.4 withheld: id repeats in this text
5.5 withheld: id repeats in this text
6 withheld: id repeats in this text
6.1 withheld: id repeats in this text
6.1.1 withheld: id repeats in this text
6.1.2 withheld: id repeats in this text
6.1.3 withheld: id repeats in this text
6.1.4 withheld: id repeats in this text
6.2 withheld: id repeats in this text
6.2.1 withheld: id repeats in this text
6.2.2 withheld: id repeats in this text
6.3 withheld: id repeats in this text
6.4 withheld: id repeats in this text
6.5 withheld: id repeats in this text
6.6 withheld: id repeats in this text
6.7 withheld: id repeats in this text
6.8 withheld: id repeats in this text
6.9 withheld: id repeats in this text
6.10 withheld: id repeats in this text
6.11 withheld: id repeats in this text
6.12 withheld: id repeats in this text
annex-1 withheld: id repeats in this text
annex-2 withheld: id repeats in this text
annex-3 withheld: id repeats in this text
annex-4 withheld: id repeats in this text
annex-5 withheld: id repeats in this text
annex-6 withheld: id repeats in this text
annex-6/1 withheld: follows a withheld heading
annex-6/2 withheld: follows a withheld heading
annex-6/3 withheld: follows a withheld heading
annex-6/4 withheld: follows a withheld heading
annex-6/4.1 withheld: follows a withheld heading
annex-6/4.2 withheld: follows a withheld heading
annex-6/4.3 withheld: follows a withheld heading
annex-6/4.4 withheld: follows a withheld heading
annex-6/4.5 withheld: follows a withheld heading
annex-6/4.6 withheld: follows a withheld heading
annex-6/4.7 withheld: follows a withheld heading
annex-6/4.8 withheld: follows a withheld heading
annex-6/4.9 withheld: follows a withheld heading
annex-6/4.10 withheld: follows a withheld heading
annex-6/4.11 withheld: follows a withheld heading
annex-6/5 withheld: follows a withheld heading
annex-6/5.1 withheld: follows a withheld heading
annex-6/5.2 withheld: follows a withheld heading
annex-6/5.3 withheld: follows a withheld heading
annex-6/5.4 withheld: follows a withheld heading
annex-6/5.5 withheld: follows a withheld heading
annex-6/6 withheld: follows a withheld heading
annex-6/6.1 withheld: follows a withheld heading
annex-6/6.1.1 withheld: follows a withheld heading
annex-6/6.1.2 withheld: follows a withheld heading
annex-6/6.1.3 withheld: follows a withheld heading
annex-6/6.1.4 withheld: follows a withheld heading
annex-6/6.2 withheld: follows a withheld heading
annex-6/6.2.1 withheld: follows a withheld heading
annex-6/6.2.2 withheld: follows a withheld heading
annex-6/6.3 withheld: follows a withheld heading
annex-6/6.4 withheld: follows a withheld heading
annex-6/6.5 withheld: follows a withheld heading
annex-6/6.6 withheld: follows a withheld heading
annex-6/6.7 withheld: follows a withheld heading
annex-6/6.8 withheld: follows a withheld heading
annex-6/6.9 withheld: follows a withheld heading
annex-6/6.10 withheld: follows a withheld heading
annex-6/6.11 withheld: follows a withheld heading
annex-6/6.12 withheld: follows a withheld heading

Definitions: 0 read in this text, 0 with the text quoted and 0 with the text withheld.

Sentences printing a listed verb: 557 read in this text, 90 quoted and 467 withheld.

(follows a withheld heading) This may be covered in a future Annex.
(follows a withheld heading) Responsibilities Roles and responsibilities in clinical trials should be clearly defined.
(follows a withheld heading) It should be possible to validate the correct operation of the processing.
(follows a withheld heading) Therefore, changes to data, such as compression, encryption and coding should be completely reversible.
(follows a withheld heading) Original Data should be the original first generation/capture of the observation.
(follows a withheld heading) Data should be an accurate representation of the observations made.
(follows a withheld heading) Traceable Data should be traceable throughout the data life cycle.
(follows a withheld heading) Changes should be documented as part of the metadata (e.g. audit trail).
(follows a withheld heading) Critical component parts of any system should always be addressed.
(follows a withheld heading) The interface and interdependency between systems or system components should be taken into consideration.
(follows a withheld heading) This decision should be justified prior to use in the trial.
(follows a withheld heading) Trial participants should be informed accordingly.
(follows a withheld heading) These procedures should be controlled and maintained by the responsible party.
(follows a withheld heading) The system should record changes to user roles and thereby access rights and permissions.
(follows a withheld heading) All pertinent observations should be documented in a timely manner.
(follows a withheld heading) Edit checks should be relevant to the protocol and developed and revised as needed.
(follows a withheld heading) In computerised systems, the audit trail should be secure, computer generated and timestamped.
(follows a withheld heading) The audit trail should be stored within the system itself.
(follows a withheld heading) The clarification process for data entered should be described and documented.
(follows a withheld heading) Changes to data should only be performed when justified.
(follows a withheld heading) Justification should be documented.
(follows a withheld heading) However, the database audit trail should capture the generation of data extracts and exports.
(follows a withheld heading) Data review should focus on critical data.
(follows a withheld heading) Data review should be proactive and ongoing review is expected unless justified.
(follows a withheld heading) The sponsor should seek investigator endorsement of their data at predetermined milestones.
(follows a withheld heading) National law could require specific responsibilities, which should then be followed.
(follows a withheld heading) The systems should be designed to support this functionality.
(follows a withheld heading) Copies should contain a faithful representation of the data and the contextual information.
(follows a withheld heading) Source documents and data should allow accurate copies to be made.
(follows a withheld heading) Special considerations should be taken whenever copies are to replace original source documents.
(follows a withheld heading) This should be justified and documented.
(follows a withheld heading) Any contractual agreements regarding hosting should ensure investigator control.
(follows a withheld heading) Data and configurations should be regularly backed up.
(follows a withheld heading) Such plans should be regularly reviewed.
(follows a withheld heading) Disaster mitigation and recovery plans should be part of the contractual agreement, if applicable.
(follows a withheld heading) Prior to migration, the process should be planned in detail.
(follows a withheld heading) A data verification focused on key data should be performed post migration.
(follows a withheld heading) Mapping from the old system onto the new system should be retained.
(follows a withheld heading) Arrangements should ensure that the link between data and metadata can be established.
(follows a withheld heading) If several parties are involved, agreements should be in place to ensure this.
(follows a withheld heading) Retention periods should respect the data protection principle of storage limitation.
(follows a withheld heading) Security controls should be in place to ensure data confidentiality, integrity, and availability.
(follows a withheld heading) Data should be archived in a read-only state.
(follows a withheld heading) Where a service provider is involved, this should be addressed in the contractual arrangements.
(id repeats in this text) Agreements should be maintained/updated as appropriate.
(id repeats in this text) Special consideration should be given on training and quality systems.
(id repeats in this text) The examination report should document that the vendor's validation process and documentation is satisfactory.
(id repeats in this text) This traceability may have many forms and the process may be automated by software.
(id repeats in this text) A2.5 Validation and test plans Validation activities should be planned, documented, and approved.
(id repeats in this text) Where possible, the tester should not be the author of the test case.
(id repeats in this text) Deviations encountered during system validation should be recorded and brought to closure.
(id repeats in this text) The validation report should be approved by the responsible party before release for production.
(id repeats in this text) Defects and issues should be fixed in a timely manner.
(id repeats in this text) A2.10 Change control There should be a formal change control process.
(id repeats in this text) The system should be version controlled.
(id repeats in this text) There should be timely removal of access no longer required, or no longer permitted.
(id repeats in this text) Unblinded information should only be accessible to pre-identified user roles.
(id repeats in this text) A3.5 Individual accounts All system users should have individual accounts.
(id repeats in this text) Media (e.g. hard disks) should be securely erased or destroyed before disposal.
(id repeats in this text) A disaster recovery plan should be in place and tested.
(id repeats in this text) This should be monitored.
(id repeats in this text) Methods should be determined based on the type of information in the system.
(id repeats in this text) A risk-based approach should be used to define the type of access control required.
(id repeats in this text) Depending on the level of risk, two-factor authentication may be appropriate or necessary.
(id repeats in this text) However, attention should be paid to insufficiently secured password managers.
(id repeats in this text) A4.15 Password policies Formal procedures for password policies should be implemented.
(id repeats in this text) The policies should be enforced by systems and verified during system validation.
(id repeats in this text) This should be mandated by the system.
(id repeats in this text) Upon inactivity logout, a re-authentication should be required (e.g. password entry).
(id repeats in this text) Data loss on devices should be avoided.
(id repeats in this text) There should be a procedure in place to handle failed or interrupted data transmission.
(id repeats in this text) Those should consequently be made available to the investigator in a timely manner.
(id repeats in this text) In relation to BYOD, sponsors should ensure that basic user access controls are implemented.
(id repeats in this text) Trial participant confidentiality should be ensured at all times, including in the communication process.
(id repeats in this text) Procedures for service desk, user authentication and access restoration should be implemented.
(id repeats in this text) Risks linked to known application and operating system vulnerabilities should be minimised.
(id repeats in this text) Trial participant confidentiality should be ensured if device identification information is stored.
(id repeats in this text) In some cases, the application may not be suitable for use.
(id repeats in this text) The user should be able to uninstall at any time without expertise or assistance.
(id repeats in this text) The uninstallation process should not compromise the device.
(id repeats in this text) A5.2.2 Emergency unblinding The process for emergency unblinding should be tested.
(id repeats in this text) The version of the service used, and where applicable, the seed should be maintained.
(id repeats in this text) The identity of the persons signing should be ensured.
(id repeats in this text) There should be no ambiguity about the time of signature.
(id repeats in this text) Any alterations of the document should invalidate the electronic signature.
(id repeats in this text) Secure archiving should ensure availability and legibility for the required retention period.
(id repeats in this text) The electronic signing should be captured by the audit trail.
(id repeats in this text) The copy should be available immediately to the trial participant.
(id repeats in this text) A6.7 User management Robust procedures on user management should be implemented (see Annex 3).
(id repeats in this text) Such information should only be accessible to unblinded staff.

(id repeats in this text) 3 withheld: over the quote cap
(follows a withheld heading) 178 withheld: over the quote cap
(id repeats in this text) 286 withheld: over the quote cap

Source health#

Counts and dates over a stated window. No figure here is a mark out of a hundred, no cell is ordered against another, and none of it is a statement about the publisher: a day this record did not reach is a fact about this record’s reach.

Fetch outcomes how the requests in the window answered

139 of 140 fetch records in the 90 calendar days ending 2026-11-02 carry no error. The 1 that carry one are recorded under blocked ×1. Of those, 133 produced a digest, and 6 answered 304 to a request carrying an earlier reading's validator, recorded as "checked, unchanged", on which no digest is taken.

Last fetched the most recent record in the whole series

2026-11-02 — the latest day this record holds (2026-11-02). The method recorded is direct. What that record returned is in Observation history above.

Address stability where the requests actually landed

139 record(s) in the window recorded the address that answered, across 1 distinct address(es). 1 further record(s) carry no answered address and say nothing either way. The most recent answered address is the one this entry declares.

Access posture what the publisher declares, and what the requests met

Declared: no AI-specific disallow · crawlable yes · renders server-side. Met: 1 of 140 record(s) in the window were recorded as refused. A refusal is what one request of this record met on one day; it is not a policy the publisher stated.

Expected and observed cadence the declared term, the days held, and the days holding none

The term this record declares for this entry is monthly. Over its own window, 2026-07-31 to 2026-11-02, 95 of 95 calendar days hold at least one observation. None holds none. Every interval between consecutive days holding one is 1, counted in days. Both figures are stated and the difference between them is not adjudicated here.

Days by outcome each day of the document's window, by what the store holds for it

95 calendar days expected, 2026-07-31 to 2026-11-02 · 95 observed (89 digest-bearing, 6 checked, unchanged (publisher-validator), 0 retrieval failed) · 0 withheld · 0 no request recorded.

calendar days expected — one for each calendar day from the first observation classed as the document to the last day the store holds, because the collection is scheduled once a night; not the entry’s declared watch cadence
observed — a request for the document is recorded that day, and its record does not state that it was withheld or never left this machine
digest-bearing — a digest of the document is recorded that day
checked, unchanged (publisher-validator) — observed, and no digest of the document is recorded that day: the request carried an earlier reading’s validator and the server answered 304 “not modified”, which the record keeps as its outcome and basis; stated on a row only where the row has such a day
retrieval failed — observed, and no digest of the document is recorded that day
withheld — the day’s requests for the document are recorded as withheld, because the host’s filed terms withhold collection; none was sent
not sent, name unresolved here — the day’s requests for the document are recorded as never leaving this machine, because the host’s name did not resolve on it; attributable to this record, not to the host; stated on a row only where the row has such a day
no request recorded — no request for the document is recorded that day. This states what the store holds, not that no request was sent: the corrections page names the cause of each run of such days, including runs on which requests were sent and their records were not written

API and citation#

Cite this entry

Each format carries the permalink and the date this entry was observed. The observation date is part of the citation: the underlying source may have changed since.

Plain text

GxPlex. EMA guideline on computerised systems and electronic data in clinical trials [entry record]. Observed 2 November 2026. https://gxplex.com/r/ema-ct-computerised-systems Primary source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf

BibTeX

@misc{gxplexremactcomputerisedsystems,
  author       = {{GxPlex}},
  title        = {{EMA guideline on computerised systems and electronic data in clinical trials}},
  year         = {2026},
  note         = {entry record, observed 2 November 2026},
  howpublished = {\url{https://gxplex.com/r/ema-ct-computerised-systems}},
  urldate      = {2026-11-02},
  url          = {https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf}
}

APA

GxPlex. (2026). EMA guideline on computerised systems and electronic data in clinical trials [entry record]. Retrieved 2 November 2026, from https://gxplex.com/r/ema-ct-computerised-systems

JSON

{
  "@context": "https://schema.org",
  "@type": "Dataset",
  "name": "EMA guideline on computerised systems and electronic data in clinical trials",
  "publisher": "GxPlex",
  "url": "https://gxplex.com/r/ema-ct-computerised-systems",
  "temporalCoverage": "2026-11-02",
  "observation": {
    "url": "https://gxplex.com/observations/ema-ct-computerised-systems#obs-2026-11-02-1",
    "observedDate": "2026-11-02"
  },
  "isBasedOn": "https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf"
}

observation.url addresses the single observation this citation rests on.

Every observation of this document is addressed and separately citable at the observation series.

Rights envelope — how this record handles the text of each entry listed
Entry	`text_retained`	`licence_class`	`quote_allowed`	`snapshot_available`
EMA CT computerised systems	`true`	`open`	`true`	`true`

One row, for the entry this page records.

Each value is read by the same function the API reads, and each field is defined in the published schema. None of the four is a grant.

Sources#

Primary source (opens in new tab) ema.europa.eu

Listed primary first, then the further addresses this record holds for this entry, then the route it was found by, then dated third-party copies. Repeated URLs appear once, at their first position.

Last updated: 1 August 2026