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4.3.4 Validation
(a) The responsible party is responsible for the validation status of the system throughout its life cycle. The approach to validatio… +
4.3.8 User Management
(a) Access controls are integral to computerised systems used in clinical trials to limit system access to authorised users and… +
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4.4 Compliance with the protocol
The investigator must agree and sign the protocol ( or another legally acceptable document mentioning the agreement w… +
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EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4 +
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 record… +
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.4 +
4.4. Trial management
Monitoring
Monitoring activities should focus on preventing or mitigating important and likely sources of error in the conduct, … +
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4.5 Information for subjects and informed consent
[…]
Information should be given in both oral and written form in a language understandable to the su… +
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4.5 Interim Analysis and Early Stopping
An interim analysis is any analysis intended to compare treatment arms with respect to efficacy or safety at a… +
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EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOA +
4.5. 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 CCEAT +
4.5. ALCOA++ principles
[...]
Complete
To reconstruct and fully understand an event, data should be a complete representation of the observation made.… +
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5 +
4.5. Trial documentation
Content of the Trial Master File (TMF)
[…]
Examples of how risk-adaptation could affect the TMF include the following:
- comb… +
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4.6 The investigational product
The investigator must be thoroughly familiar with the properties, effects and safety of the investigational pharmaceut… +
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EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6 +
4.6. Criticality and risks
For systems deployed by the investigator/institution specifically for the purposes of clinical trials, the investigator sh… +
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4.7 Site of the trial, facilities and staff
Clinical trials must be carried out under conditions which ensure adequate safety for the subjects.
The s… +
4.8 Notification of the trial or submission to the drug regulatory authority
As governed by national regulations, the investigator, sponsor, or invest… +
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EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8 +
4.8. Electronic signatures
Whenever ICH E6 requires a document to be signed and an electronic signature is used for that purpose, the electronic signa… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5-001 +
5. A performance study as referred to in paragraph 1 may be conducted only where all of the following conditions are met:
(a) the performance study… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5-002 +
5. A performance study as referred to in paragraph 1 may be conducted only where all of the following conditions are met:
(a) the performance study… +
5. In the case of PMCF investigations referred to in Article 74(1), the provisions on vigilance laid down in Articles 87 to 90 and in the acts adopt… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 5 – 6 +
5. In the case of PMPF studies referred to in Article 70(1), the provisions on vigilance laid down in Articles 82 to 85 and in the implementing acts… +
5. Irrespective of the outcome of the clinical investigation, within one year of the end of the clinical investigation or within three months of the… +
