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10. 7 Medical care of subjects
The principal investigator shall
[…]… +
10.2 Qualification of the principal investigator
[…]… +
10.3 Qualification of investigation site
The principal investigator shall be able to demonstrate that the proposed investigation site […]… +
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10.3 Responsibilities of the investigator
The investigator is responsible for ensuring:
· Proper and safe handling of the investigational and, when ap… +
10.4 Responsibilities of the sponsor and monitor (see also Sections 5 and 6)
The sponsor is responsible for:
· Supplying the investigational and, when… +
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10.6 Compliance with the CIP
The principal investigator shall
[…]… +
10.8 Safety reporting
The principal investigator shall
[…]… +
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11. In this Part—
“amendment to the clinical trial authorisation” means an amendment to—
(a)the terms of the request for authorisation to conduct… +
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11. ROLE OF THE DRUG REGULATORY AUTHORITY
The role of governments is to provide the legal framework for clinical trials. The aim should be twofold:
(… +
11.2 On-site inspections
As permitted by national regulations, the drug regulatory authority may carry out on-site inspections of the clinical trial s… +
13. CONSIDERATIONS FOR MULTICENTRE TRIALS
[…]
For example, a committee or an individual could be responsible for overseeing the initiation overall per… +
17. All medical research involving human participants must be preceded by careful assessment of predictable risks and burdens to the individuals and g… +
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19. With regard to the notification of adverse events, the protocol shall identify the categories of:
(a) adverse events or laboratory anomalies that… +
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2 Protection of personal data
(1) The [F4UK GDPR] and this Act protect individuals with regard to the processing ofpersonal data, in particular by—
(a… +
2. Clinical investigations
2.1. Objectives
The objectives of clinical investigation are:
— to verify that, under normal conditions of use, the per… +
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2. Following an intervention pursuant to paragraph 1, informed consent in accordance with Article 29 shall be sought to continue the participation o… +
2. Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the… +
2. Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 2 +
2. Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the… +
2. Methods
2.1. Clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific … +
