Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-002: 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=5 | ||
| | |unit=5.4.3 | ||
| | |scope=HM | ||
| | |doc_part=Article 30 | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
|tags=TAG-00069-Imm-rhe ++ TAG-00017-Spo-die ++ TAG-00246-Inv-hte ++ TAG-00134-Eth-kom ++ TAG-00057-Com-deR | |||
|tags_display=[[Glossary:TAG-00069-Imm-rhe|Urgent safety measure]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00246-Inv-hte|Investigator responsibilities]], [[Glossary:TAG-00134-Eth-kom|Ethics committee]], [[Glossary:TAG-00057-Com-deR|Competent authority]] | |||
|comment=Repeated entry: 5.4.1 ++ 5.4.3 | |||
| | |||
Urgent safety measures: sponsor and investigator obligations (repeated) | Urgent safety measures: sponsor and investigator obligations (repeated) | ||
| | |content=Urgent safety measures | ||
= | |||
Urgent safety measures | |||
30.—(1) The sponsor and investigator may take appropriate urgent safety measures in order to protect the subjects of a clinical trial against any immediate hazard to their health or safety. | 30.—(1) The sponsor and investigator may take appropriate urgent safety measures in order to protect the subjects of a clinical trial against any immediate hazard to their health or safety. | ||
(2) If measures are taken pursuant to paragraph (1), the sponsor shall immediately, and in any event no later than 3 days from the date the measures are taken, give written notice to the licensing authority and the relevant ethics committee of the measures taken and the circumstances giving rise to those measures. | (2) If measures are taken pursuant to paragraph (1), the sponsor shall immediately, and in any event no later than 3 days from the date the measures are taken, give written notice to the licensing authority and the relevant ethics committee of the measures taken and the circumstances giving rise to those measures. | ||
}} | |||
Latest revision as of 13:50, 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 5 — Unit 5.4.3 |
| Scope | HM |
| Document part | Article 30 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Urgent safety measure, Sponsor, Investigator responsibilities, Ethics committee, Competent authority |
Content
Urgent safety measures 30.—(1) The sponsor and investigator may take appropriate urgent safety measures in order to protect the subjects of a clinical trial against any immediate hazard to their health or safety.
(2) If measures are taken pursuant to paragraph (1), the sponsor shall immediately, and in any event no later than 3 days from the date the measures are taken, give written notice to the licensing authority and the relevant ethics committee of the measures taken and the circumstances giving rise to those measures.
