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(t) Independent ethics committee (IEC) means an independent review panel that is responsible for ensuring the protection of the rights, safety, and we… +
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1. For the purposes of this Regulation, the following definitions shall apply:
(a) ‘cosmetic product’ means any substance or mixture intended to be … +
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (p) +
1. An application document including the following information or, in each case, an explanation of why that information is not being provided—
[…]
(p… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (i) +
1. An application document including the following information or, in each case, an explanation of why that information is not being provided—
[…]
(i… +
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1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
[…]
1.1 Submission and Communication
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1.2 Responsibilities
[...]
1.3 Composi… +
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DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-002 +
1. Nichtinterventionelle Studien (NIS)
1.1. Definition einer nichtinterventionellen Studie
[...]
Dokumentationssystematisierende und den Arzt-Patiente… +
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-001 +
1. Nichtinterventionelle Studien (NIS)
1.1. Definition einer nichtinterventionellen Studie
[...]
Dokumentationssystematisierende und den Arzt-Patiente… +
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1. The voluntary consent of the human subject is absolutely essential.[…]
2. The experiment should be such as to yield fruitful results for the good … +
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1. Where read-only user role is not a feature of the EHR system, there is a risk that Monitors (or Auditors) could enter/edit/delete data or informati… +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 1.12 +
1.12. if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the compa… +
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DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.2 +
1.2. Anzeigepflichtige nichtinterventionelle Studien
Bei Durchführung von nichtinterventionellen Studien gelten gegenüber den zuständigen Bundesoberb… +
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1.2.7 If minors are to be included in a trial, the IRB/IEC should review the assent information considering the age, maturity and psychological state … +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.3 +
1.3 Investigator Responsibility
• Clinical investigators and ultimately the protocol Principal Investigator (PI) have the primary responsibility for A… +
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DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.3 +
1.3. Abgrenzung von nichtinterventionellen Studien gegenüber klinischen Prüfungen
Die Landesbehörden sind zuständig für die Einstufung einer Studie a… +
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1.3.3. différentes catégories de decrets
[…]
Les décrets en conseil des ministres
[…]
Les décrets en Conseil d’Etat
[…]
Les décrets simples
[…]… +
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1.4 Investigator and site(s) of investigation
Each investigator should have appropriate expertise, qualifications and competence to undertake a propos… +
1.4 Persistent challenges to clinical trial enablement
There is an urgent need to avoid wasteful procedures and make clinical trials more efficient so… +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4 +
1.4 Sponsor Responsibility
• It is the responsibility of the sponsor to submit an IND/IDE for clinical trials conducted with investigational agents/in… +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - 1.5 Regulatory requirements +
1.5 Regulatory requirements
Countries in which clinical trials are performed should have regulations governing the way in which these studies can be c… +
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10 Responsibilities of the principal investigator
10.1 General
The role of the principal investigator is […]… +
