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Post-Trial Provisions
34. In advance of a clinical trial, post-trial provisions must be arranged by sponsors and researchers to be provided by themsel… +
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Prior authorisation
A clinical trial shall be subject to scientific and ethical review and shall be authorised in accordance with this Regulation.
T… +
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Procedures for general medical devices for clinical investigations
16.— […]
(11) The manufacturer, or their single authorised representative, shall—
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Procedures for general medical devices for clinical investigationsN.I.
16.—(1) Subject to paragraph (2), no person shall supply a relevant device (if … +
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Processing of special categories of personal data
1. Processing of personal data revealing racial or ethnic origin, political opinions, religious o… +
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Processing of special categories of personal data
1. Processing of personal data revealing racial or ethnic origin, political opinions, religious or p… +
Protection of clinical trial subjects
[…]
2. A clinical trial may be undertaken only if, in particular:
[…]
(f) provision has been made for insurance … +
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Protocol Amendment
A documented description of a change(s) to a protocol.… +
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Q1.2: How to apply risk-proportionate approaches to CCTs?
Proportionate risk-based approaches should be applied for complex clinical trials, with risk… +
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USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 Q15 +
Q15. I am a study monitor and am unable to conduct on-site monitoring visits due to the COVID-19 public health emergency. May I remotely perform the s… +
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Q5.2: How to integrate pre-screening and screening processes for biomarkers within the shared framework of CCTs?
[…]
There might also be situations wh… +
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Q: Muss jährlich eine Bestätigung von der Ethikkommission eingeholt werden, dass die klinische Prüfung fortgesetzt werden kann?
A: Dafür gibt es kein… +
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RECRUITMENT ARRANGEMENTS (INFORMATION PER MEMBER STATE CONCERNED)
59. Unless described in the protocol, a separate document shall describe in detail … +
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REMOVED MARCH/APRIL 2025
https://basg.gv.at/gesundheitsberufe/klinische-studien/gute-klinische-praxis-und-gcp-inspektion/faq-regulatorische-anforderun… +
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REPLACING OF INFORMATION
8. The particulars listed in sections A, B and C, other than those particulars listed in paragraph 9, may be omitted from th… +
Radiopharmaceuticals used as investigational medicinal products or as auxiliary medicinal products for a medical diagnosis
Articles 66 and 67 shall n… +
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Randomisation
The process of deliberately including an element of chance when assigning participants to groups that receive different treatments in or… +
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Record type: Advanced medical therapy research: master file
Category: Clinical Trials and Research
Retention period: 20 years
Disposal action: Review … +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 2 – 3 +
Recording and reporting of adverse events that occur during performance studies
2. The sponsor shall report without delay to all Member States in w… +
Recording and reporting of adverse events that occur during clinical investigations
1. The sponsor shall fully record all of the following:
(a) any… +
