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Document:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023: Difference between revisions

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<noinclude>{{#set:
{{DocumentData
|DocReference=EUΒ  EMA/INS/GCP/112288/2023
-
Guideline on computerised systems and electronic data in
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|DocName=EMA/INS/GCP/112288/2023
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Guideline on computerised systems and electronic data in
clinical trials
|DocVersion=2023
|DocStatus=Current
|DocType=Official guideline
|DocLanguage=EN
|DocDescription=EMA/INS/GCP/112288/2023
Good Clinical Practice Inspectors Working Group (GCP IWG)
Guideline on computerised systems and electronic data in clinical trials
|DocRestricted=No
|DocSubmittedBy=Florian Adragna
|DocContributors=
}}</noinclude>
Β 
{{DocumentBox
|reference=EUΒ  EMA/INS/GCP/112288/2023
|reference=EUΒ  EMA/INS/GCP/112288/2023
-
-
Line 45: Line 22:
|contributors=
|contributors=
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<noinclude>
== References ==
{| class="wikitable"
! Reference !! Scope !! Document part !! Language !! Preview
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3]] || G || Annex A
A5.3 || EN || A5.3 Electronic informed consent Ethics committees will review all material related to the informed consent process. Before the implementation of an electronic consent procedure is considered, the ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2]] || G || Annex 5
A5.2 || EN || Annex 5 Additional consideration to specific systems [...] A5.2 Interactive response technology system [...] A5.2.1.2 Stratified randomisation Where the randomisation is stratified by factors ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2]] || G || 4.2 || EN || 4.2. Responsibilities Roles and responsibilities in clinical trials should be clearly defined. The responsibility for the conduct of clinical trials is assigned via legislation to two parties, which ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4]] || G || 4.4 || EN || 4.4. Source data The term source data refers to the original reported observation in a source document. Source documents could be e.g. hospital records, clinical and office charts, laboratory notes. ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOA]] || G || 4.5
ALCOA || EN || 4.5. ALCOA++ principles A number of attributes are considered of universal importance to data. These include that the data are: Attributable Data should be attributable to the person and/or system ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEAT]] || G || 4.5
CCEAT || EN || 4.5. ALCOA++ principles [...] Complete To reconstruct and fully understand an event, data should be a complete representation of the observation made. This includes the associated metadata and audit ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6]] || G || 4.6 || EN || 4.6. Criticality and risks For systems deployed by the investigator/institution specifically for the purposes of clinical trials, the investigator should ensure that the requirements for computerised ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13]] || G || A4.13 || EN || The level of security should be proportionate to the sensitivity and confidentiality of the data (e.g. nominative data in electronic medical records are highly sensitive) and to the access rights to ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8]] || G || 4.8 || EN || 4.8. Electronic signatures Whenever ICH E6 requires a document to be signed and an electronic signature is used for that purpose, the electronic signature functionality should meet the expectations ...
|}
</noinclude>

Latest revision as of 14:15, 16 July 2026


Document information
Reference EU EMA/INS/GCP/112288/2023

- Guideline on computerised systems and electronic data in clinical trials 2023

Validity area EU
Scope(s) G
Document name EMA/INS/GCP/112288/2023

- Guideline on computerised systems and electronic data in clinical trials

Version / Revision 2023
Status Current
Document type Official guideline
Language(s) EN
Description EMA/INS/GCP/112288/2023

Good Clinical Practice Inspectors Working Group (GCP IWG) Guideline on computerised systems and electronic data in clinical trials

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors

References

 ScopeDocument partLanguagePreview
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2G4.2EN4.2. Responsibilities Roles and responsibilities in clinical trials should be clearly defined. The responsibility for the conduct of clinical trials …
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4G4.4EN4.4. Source data The term source data refers to the original reported observation in a source document. Source documents could be e.g. hospital record…
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOAG4.5 ALCOAEN4.5. ALCOA++ principles

A number of attributes are considered of universal importance to data. These include that the data are:

Attributable

Data sho…
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEATG4.5 CCEATEN4.5. ALCOA++ principles

[...] Complete

To reconstruct and fully understand an event, data should be a complete representation of the observation made.…
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6G4.6EN4.6. Criticality and risks For systems deployed by the investigator/institution specifically for the purposes of clinical trials, the investigator sh…
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8G4.8EN4.8. Electronic signatures Whenever ICH E6 requires a document to be signed and an electronic signature is used for that purpose, the electronic signa…
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13GA4.13ENThe level of security should be proportionate to the sensitivity and confidentiality of the data (e.g. nominative data in electronic medical records a…
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2GAnnex 5 A5.2ENAnnex 5 Additional consideration to specific systems

[...] A5.2 Interactive response technology system [...] A5.2.1.2 Stratified randomisation

Where t…
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3GAnnex A A5.3ENA5.3 Electronic informed consent Ethics committees will review all material related to the informed consent process. Before the implementation of an e…
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