Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-001: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 | ||
| | |module=3 | ||
| | |unit=3.1.1 | ||
|scope=HM | |||
|doc_part=Schedule 1 | |||
Part 3 | Part 3 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
| | |tags=TAG-00029-Inf-rte ++ TAG-00027-Inc-son ++ TAG-00025-Sub-mer | ||
|tags_display=[[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00027-Inc-son|Incapacitated subject]], [[Glossary:TAG-00025-Sub-mer|Trial participant]] | |||
|comment=Repeated entry: 3.1.1 ++ 3.1.4 | |||
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|- | |||
| | |||
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Conditions for adults able to consent or who consented before incapacity | Conditions for adults able to consent or who consented before incapacity | ||
| | |content=CONDITIONS WHICH APPLY IN RELATION TO AN ADULT ABLE TO CONSENT OR WHO HAS GIVEN CONSENT PRIOR TO THE ONSET OF INCAPACITY | ||
= | |||
CONDITIONS WHICH APPLY IN RELATION TO AN ADULT ABLE TO CONSENT OR WHO HAS GIVEN CONSENT PRIOR TO THE ONSET OF INCAPACITY | |||
1. The subject has had an interview with the investigator, or another member of the investigating team, in which he has been given the opportunity to understand the objectives, risks and inconveniences of the trial and the conditions under which it is to be conducted. | 1. The subject has had an interview with the investigator, or another member of the investigating team, in which he has been given the opportunity to understand the objectives, risks and inconveniences of the trial and the conditions under which it is to be conducted. | ||
| Line 58: | Line 24: | ||
5. The subject has been provided with a contact point where he may obtain further information about the trial. | 5. The subject has been provided with a contact point where he may obtain further information about the trial. | ||
}} | |||
Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| Reference | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| Validity area | GBR |
| Scope(s) | HM |
| Document name | The Medicines for Human Use (Clinical Trials) Regulations 2004 |
| Version / Revision | 01-May-2004 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | The Medicines for Human Use (Clinical Trials) Regulations 2004 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.1.1 |
| Scope | HM |
| Document part | Schedule 1
Part 3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Informed consent, Incapacitated subject, Trial participant |
Content
CONDITIONS WHICH APPLY IN RELATION TO AN ADULT ABLE TO CONSENT OR WHO HAS GIVEN CONSENT PRIOR TO THE ONSET OF INCAPACITY 1. The subject has had an interview with the investigator, or another member of the investigating team, in which he has been given the opportunity to understand the objectives, risks and inconveniences of the trial and the conditions under which it is to be conducted.
2. The subject has been informed of his right to withdraw from the trial at any time.
3. The subject has given his informed consent to taking part in the trial.
4. The subject may, without being subject to any resulting detriment, withdraw from the clinical trial at any time by revoking his informed consent.
5. The subject has been provided with a contact point where he may obtain further information about the trial.
