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5. 7 Vulnerable populations
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5. AUTRES OBLIGATIONS DE NOTIFICATION DE DONNEES DE SECURITE POUR LES PROMOTEURS CONDUISANT DES ESSAIS CHEZ LES VOLONTAIRES SAINS EN FRANCE
5.1. Disp… +
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5. DESIGN ELEMENTS AND DATA SOURCES FOR CLINICAL STUDIES
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Master protocol studies allow for the investigation of multiple drugs or multiple conditi… +
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5. RESPONSIBILITIES OF THE SPONSOR… +
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EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 5 +
5. Results
5.1. Overview of GCP inspections requested by the CHMP and carried out between 2000-2012
Between 2000-2012, a total of 398 site inspectio… +
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5. „Hauptprüfer“ den verantwortlichen Leiter einer Gruppe von Prüfern, die in einer Prüfstelle eine klinische Prüfung oder Leistungsstudie durchführen… +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.1 +
5.1 Pre-existing Conditions (formerly referred to as Baseline AEs)
A pre-existing medical condition identified on baseline assessment is not considere… +
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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 5.1 - 5.2-001 +
5.1. Certified copies
A certified copy is a paper or electronic copy of the original document that has been verified (e.g. by a dated signature) or ha… +
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 5.1 - 5.2-002 +
5.1. Certified copies
A certified copy is a paper or electronic copy of the original document that has been verified (e.g. by a dated signature) or ha… +
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 5.1 +
5.1. What needs to be reported?
Any breach of:
• The Regulation (EU) No 536/2014.
or
• The clinical trial protocol version applicable at the time of … +
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5.12 Study reports
The sponsor is responsible for ensuring the preparation and appropriate approval(s) of a comprehensive final clinical study report … +
5.13 Handling of adverse events
The sponsor should provide special forms for reporting any adverse event that occur during the clinical trial. The spo… +
5.14 Termination of trial
If the sponsor elects or is required to terminate the clinical trial prematurely, then the investigator(s), ethics committee… +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.2 +
5.2 Pre-Treatment AEs
A pre-treatment adverse event is an adverse event that occurs after a participant has signed an informed consent, but before int… +
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.1 +
5.3.1 Persistent AE
A persistent AE (e.g., chronic) is one that extends continuously, without resolution between treatment cycles/courses.
Instructio… +
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.2 +
5.3.2 Recurrent AEs
A recurrent AE is one that occurs and resolves during a cycle/course of therapy and then reoccurs in a later cycle/course.
Instru… +
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5.6 Investigational product
The sponsor is responsible for supplying the investigational pharmaceutical product(s) and, if applicable, comparator prod… +
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5.6 Statistical Analysis
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For double-blind studies, the statistical analysis should be finalised before treatment assignments are revealed. Therefo… +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.6.6.1 +
5.6.6.1 Pregnancy
• Although not an AE in and of itself, pregnancy as well as its outcome must be documented via CTEP-AERS. CTEP agrees to soliciting… +
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5.8.2 Process of obtaining informed consent
The principal investigator or his/her authorized designee shall comply with […]… +
