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3. Where, regarding the substantial modification of aspects covered by Part I of the assessment report, the substantial modification is acceptable o… +
3. Development of the study protocol
[...]… +
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.1 +
3. How to report a serious breach
3.1. Who should notify
The sponsor is responsible for the notification via the EU portal and EU database - part of … +
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DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.2 +
3. Nichtinterventionelle Unbedenklichkeitsstudien nach der Zulassung (Postauthorisation safety studies: PASS)
3.2. Nationale Anzeigepflicht nach § 63… +
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.1 +
3. Nichtinterventionelle Unbedenklichkeitsstudien nach der Zulassung (Postauthorisation safety studies: PASS)
3.1. Definition einer Unbedenklichkeitss… +
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.3 +
3. Nichtinterventionelle Unbedenklichkeitsstudien nach der Zulassung (Postauthorisation safety studies: PASS)
3.3. Anzeigeninhalte gegenüber den Bund… +
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FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 3. +
3. RAPPORT ANNUEL DE SECURITE
Bien que le RDM ne le prévoie pas, il est demandé pour les RIPH1 portant sur un DM se poursuivant après le 26 mai 2021 … +
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3. SPONSOR
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3.17.1Premature Termination or Suspension of a Trial
If a trial is prematurely terminated or suspended, the sponsor should promptly i… +
3. SPONSOR
[...]
3.8 Communication with IRB/IEC and Regulatory Authority(ies)
3.8.1 Notification/Submission to Regulatory Authority(ies)
In accordanc… +
3. SPONSOR
[…]
3.17.2 Clinical Trial/Study Reports
(a) Whether the trial is completed or prematurely terminated, or an interim analysis is undertaken … +
3. SPONSOR… +
3. Sponsor
3.1 Engagement and Communication
[…]
3.1.1 Engaging patients, patient advocacy groups and their communities, as appropriate, can help ensur… +
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EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3 +
3. Trial master file structure and contents
3.1. Sponsor and investigator trial master file
The TMF is usually composed of a sponsor TMF, held by the … +
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 a) +
3.1.2. Categorisation of findings
a) General overview
A total of 470 deficiencies, comprising 17 critical (3.6%), 260 major (55.3%) and 193 minor (41.… +
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3.10.1.6 Risk Reporting
The sponsor should summarise and report important quality issues (including instances in which acceptable ranges are exceeded,… +
3.11 Quality Assurance and Quality Control
[...]
3.11.4 Monitoring
The aim of monitoring is to ensure the participants’ rights, safety and well-being … +
3.11 Quality Assurance and Quality Control
[...]
3.11.2 Audit
When performed, audits should be conducted in a manner that is proportionate to the risk… +
3.11.4 Monitoring
[...]
Monitoring activities may include site monitoring (performed on-site or remotely) and centralised monitoring, depending on the… +
3.11.4.5.2 Investigator Site Selection, Initiation, Management and Close-out
[...]
(j) Confirming the arrangement for the retention of the essential r… +
3.11.4.5.3 Monitoring of Investigational Product Management
(a) Confirming, for the investigational product(s):
(i) That storage conditions are acc… +
