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EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Section 4 +
OTHER OBLIGATIONS OF THE SPONSOR
4. The Sponsor shall appoint a monitor that is independent from the investigational site to ensure that the invest… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 4 +
OTHER OBLIGATIONS OF THE SPONSOR
4. The sponsor shall appoint a monitor that is independent of the investigation site to ensure that the clinical per… +
OTHER OBLIGATIONS OF THE SPONSOR
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2. The Sponsor shall have an agreement in place to ensure that any serious adverse events or any other event… +
OTHER OBLIGATIONS OF THE SPONSOR
1. The sponsor shall undertake to keep available for the competent national authorities any documentation necessary… +
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Observational study
A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or heal… +
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Other reporting obligations relevant for subject safety
1. The sponsor shall notify the Member States concerned through the EU portal of all unexpe… +
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PART 3
AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE OPINION
Interpretation of Part 3
11. In this Part—
“amendment to the clinical trial au… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-002 +
PART 3
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 ha… +
PART 4
GOOD CLINICAL PRACTICE AND THE CONDUCT OF CLINICAL TRIALS
Good clinical practice and protection of clinical trial subjects
28.—(1) No person sh… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. ; 3. +
PARTICULARS AND DOCUMENTS THAT MUST ACCOMPANY AN APPLICATION FOR AN ETHICS COMMITTEE OPINION, A REQUEST FOR AUTHORISATION, A NOTICE OF AMENDMENT AND A… +
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CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 19 +
PREGNANT AND BREASTFEEDING WOMEN AS RESEARCH PARTICIPANTS… +
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PROCEDURAL PROVISIONS RELATING TO THE REFUSAL OR AMENDMENT OF, OR IMPOSITION OF CONDITIONS RELATING TO, CLINICAL TRIAL AUTHORISATION AND THE SUSPENSIO… +
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PROTOCOL
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17. The protocol shall at least include:
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(m) a description of the measures taken to minimise bias, including, if applicable, rand… +
PROTOCOL
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17.The protocol shall at least include:
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(ah) a statement from the sponsor (either in the protocol or in a separate document) conf… +
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 7 Part 2 2. +
PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE MANUFACTURE OR ASSEMBLY OF INVESTIGATIONAL MEDICINAL PRODUCTS
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2. The h… +
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055
Date of Entry 12/21/2020
FR Recognition Number 2-282
Standard
ISO 1… +
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Performance studies regarding devices bearing the CE marking
1. Where a performance study is to be conducted to further assess, within the scope of… +
Persons assessing the application
1. Member States shall ensure that the persons validating and assessing the application do not have conflicts of … +
Persons assessing the application for a substantial modification
Article 9 applies to assessments made under this Chapter.… +
Platform trial Broad -
term for a number of clinical trial (CT) designs characterised by a shared framework that allows for the investigation of mult… +
