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G
Clinical Investigation
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6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a c… +
Clinical Investigation
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6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a c… +
I
Clinical Trial
Any interventional investigation in human participants intended to discover or verify the clinical, pharmacological and/or other pharm… +
Clinical Trial/Study Report (CSR)
A documented description of a trial of any investigational product conducted in human participants, in which the cl… +
Clinical development stages
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1.4 Type of clinical investigation design
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1.4.2 Exploratory clinical investigation
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1.4.3 Confirmatory c… +
G
Clinical investigation
1. In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established … +
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Clinical investigation audits… +
U
Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the pu… +
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Clinical investigation plan (CIP)… +
Clinical investigation report
D.1 General
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E
Clinical investigations in emergency situations
1. By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article 64(1) a… +
Clinical investigations on incapacitated subjects
1. In the case of incapacitated subjects who have not given, or have not refused to give, informe… +
Clinical investigations on minors
A clinical investigation on minors may be conducted only where, in addition to the conditions set out in Article 62… +
Clinical investigations on pregnant or breastfeeding women
A clinical investigation on pregnant or breastfeeding women may be conducted only where, i… +
Clinical investigations regarding devices bearing the CE marking
1. Where a clinical investigation is to be conducted to further assess, within the… +
Clinical trial master file
The sponsor and the investigator shall keep a clinical trial master file. The clinical trial master file shall at all time… +
G
Clinical trials conducted in third countries
34. If a clinical trial is being conducted at a trial site in a third country in addition to sites in th… +
E
Clinical trials in emergency situations
1. By way of derogation from points (b) and (c) of Article 28(1), from points (a) and (b) of Article 31(1) … +
Clinical trials on incapacitated subjects
1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consen… +
Clinical trials on minors
1. A clinical trial on minors may be conducted only where, in addition to the conditions set out in Article 28, all of th… +
