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2.3 Investigational Product Management
Various approaches to investigational product management (i.e., supply, storage, dispensing, administration, r… +
2.3 Responsibilities
2.3.1 The investigator may delegate trial-related activities to other persons or parties.
The investigator may be supported by t… +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIII Part A Section 2.3 +
2.3. Methods for clinical performance studies
2.3.1. Clinical performance study design type
Clinical performance studies shall be designed in suc… +
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2.3.2 Certain documentation and processes already used in the institution/healthcare centre may be sufficient for the management of the investigationa… +
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2.3.7. The written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of all the da… +
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2.4 Communication with IRB/IEC
[...]
2.4.2Before initiating a trial, the investigator/institution should have a documented and dated approval/favoura… +
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2.4 Good clinical trials are designed to be feasible for their context
[…]
Clinical trials should be tailored to be practicable given the available in… +
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2.4 In emergency situations, where consent cannot be obtained prior to trial participation, consent should be obtained from the participant or their l… +
2.4 Investigator Oversight
[…]
2.5 Safety Assessment and Reporting
For the safety monitoring of individual trial participants (see Annex 1, section 2.… +
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DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.4 +
2.4. Änderungsanzeigen nach § 67 Absatz 6 AMG
Da sich die Anzeigepflicht nach § 67 Absatz 6 Satz 1 AMG auf das „Durchführen“ von Untersuchungen bezieh… +
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2.5 Compliance with Protocol
2.5.1The investigator/institution should sign the protocol or an alternative contract to confirm agreement with the spons… +
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2.5 Good clinical trials manage quality effectively and efficiently
The design and conduct of a high-quality trial require competent decision-making … +
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EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-002 +
2.5. Personnel
Points to consider:
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• Relationship of the Investigator with the Sponsor company.
[…]… +
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-001 +
2.5. Personnel
Points to consider:
• SOP for minimum staffing levels during clinical conduct and medical supervision on dosing days.
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• Basic, imme… +
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2.7.1 Medical Care of Trial Participants
(a) A qualified physician or, where appropriate, a qualified dentist (or other qualified healthcare professi… +
2.7.1 Medical Care of Trial Participants
(a) A qualified physician or, where appropriate, a qualified dentist (or other qualified healthcare professi… +
2.7.2 Safety Reporting
(a) Adverse events and/or abnormal test results required for safety evaluations (as outlined in the protocol) should be report… +
2.7.2 Safety Reporting
(a) [...]
Unfavourable medical events occurring in participants before investigational product administration (e.g., during sc… +
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DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.3 +
2.7.3. Qualitätssicherung
Die für epidemiologische Studien üblichen Qualitätsanforderungen gelten auch für Anwendungsbeobachtungen. Ziel der Qualität… +
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.4 +
2.7.4. Patientenaufklärung und -einwilligung
In der Regel müssen Patienten vor dem Einschluss in eine Anwendungsbeobachtung über die Anwendungsbeobac… +
