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8. CAUSALITY ASSESSMENT
The relationship between the use of the medical device (including the medical - surgical procedure) and the occurrence of each… +
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8. GLOSSARY
Parental (legal guardian) consent/permission:
Expression of understanding and agreement by fully informed parent(s) or legal guardian to … +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Electronic data handling +
8. RECORD KEEPING AND HANDLING OF DATA
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In the event of electronic data handling, confidentiality of the database must be secured by safety procedu… +
8. RECORD KEEPING AND HANDLING OF DATA
[…]
All steps involved in data management should be documented in order to allow step-by-step retrospective ass… +
8. RECORD KEEPING AND HANDLING OF DATA
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A basic aspect of the integrity of data is the safeguarding of “blinding” with regard to treatment assign… +
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8.2 Suspension or premature termination of the clinical investigation
8.2.1 Procedure for suspension or premature termination
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8.2.2 Procedure fo… +
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8.3 Archiving of data
As required by national regulations, the investigator must arrange for the retention of the subject identification codes for a s… +
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8.3 Routine close-out
[…]… +
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9.1 Experimental design
The scientific integrity of a clinical trial and the credibility of the data produced depend primarily on the design of the tr… +
9.2 Randomization and blinding
In case of a randomized clinical trial, the randomization procedure must be documented. Where a sealed code for each in… +
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9.2.2 Preparation of documents and materials
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e) provide insurance covering […]… +
9.2.4 Monitoring
9.2.4.1 General
Monitoring shall [...]
9.2.4.2 Qualifications of the monitor
Monitors shall be
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9.2.4.3 Assessment of the inv… +
9.2.5 Safety evaluation and reporting
The sponsor is responsible for […]… +
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9.3 Statistical analysis
The type(s) of statistical analyses to be used must be specified in the protocol, and any other subsequent deviations from th… +
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EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.1 +
A risk based quality management system for clinical trials should include the following steps:
- critical process and data identification
- risk ident… +
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A.17 Publication policy
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A.3 Contents of the Investigator’s Brochure
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A.3.4 Physical, Chemical and Pharmaceutical Properties and Formulation
A description should be prov… +
A.5 Objectives and hypotheses of the clinical investigation
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The objectives of the clinical investigation shall […]… +
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-001 +
A.6.3 Subjects
a) Inclusion […]… +
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-002 +
A.6.3 Subjects
a) Inclusion criteria[…]… +
