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EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 2.1 +
2.1 Background
The majority of medicinal products or chemical substances administered to a pregnant woman could have effects on the foetus either befo… +
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DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.1 +
2.1. Definition einer Anwendungsbeobachtung
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Bei Anwendungsbeobachtungen handelt es sich um Untersuchungen, die dazu bestimmt sind, Erkenntnisse … +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.1. +
2.1.1. Adverse Event (AE or Adverse Experience): Any untoward medical occurrence associated with the use of a drug in humans, whether or not considere… +
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.14. +
2.1.14. Hospitalization (or prolongation of hospitalization): NCI defines hospitalization for expedited AE reporting purposes as an inpatient hospital… +
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2.1.2. Cette durée de conservation connaît des aménagements
L’article R. 1112-7 du code de la santé publique prévoit divers aménagements des dur… +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.2 +
2.1.2. Attribution: An assessment of the relationship between the AE and the medical intervention. After naming and grading the event, the clinical in… +
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.21. +
2.1.21. Life-Threatening Adverse Event: Any SAE that places the subject, in the view of either the investigator or the sponsor (NCI), at immediate ris… +
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.28 +
2.1.28. Serious Adverse Event (SAE): Any adverse drug event (experience) occurring at any dose that results in ANY of the following outcomes:
1. Death… +
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.32 - 2.1.34 +
2.1.32. Suspected Unexpected Serious Adverse Reaction (SUSAR): An adverse event that occurs in a clinical trial participant, which is assessed by the … +
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2.1.8 Proportionate, efficient and reliable capture of data
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Disproportionate data collection wastes time and resources. It places an unnecessary… +
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2.10 Investigational Product Management
2.10.1 Responsibility for investigational product(s) management, including accountability, handling, dispensi… +
2.11Randomisation Procedures and Unblinding
The investigator should follow the trial’s randomisation procedures, if any, and, in the case of an inves… +
2.12 Records
2.12.1 In generating, recording and reporting trial data, the investigator should ensure the integrity of data under their responsibilit… +
2.12.10 When using computerised systems in a clinical trial, the investigator/institution should do the following:
(a)For systems deployed by the inv… +
2.12.11 The investigator/institution should maintain the trial records as specified in Appendix C and as required by the applicable regulatory require… +
2.12.5 The investigator should ensure the accuracy, completeness, legibility and timeliness of the data reported to the sponsor in the data acquisitio… +
2.2 Resources
2.2.1 The investigator should be able to demonstrate (e.g., based on retrospective or currently available data) a potential for recruit… +
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DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2.1 - Start +
2.2.1. Anzeigeinhalte gegenüber den Bundesoberbehörden
Anwendungsbeobachtungen sind nach § 67 Absatz 6 AMG gegenüber der zuständigen Bundesoberbehörd… +
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2.2.Ethical considerations
Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical A… +
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2.3 Design Techniques to Avoid Bias
The most important design techniques for avoiding bias in clinical trials are blinding and randomisation, and thes… +
