Risk-Adapted Approach to clinical trials and Risk Assessments

Name: Risk-Adapted Approach to clinical trials and Risk Assessments
Creator: Medicines and Healthcare products Regulatory Agency
License: https://www.nationalarchives.gov.uk/doc/open-government-licence/version/2/
Keywords: assessment,clinical-trials,examples,guidances,mhra,risk-assessment,risks,strategy,uk

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Health And Social Care

Published

January 28, 2022

Last updated

January 28, 2022

Description

The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.

Organization

Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧

Country / Region

United Kingdom

License

Open Government Licence 2.0 (United Kingdom)

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7 Main files

Risk-Adapted Approach to clinical trials and Risk Assessments

Updated on January 28, 2022

html

URL: https://www.gov.uk/government/publications/risk-adapted-approach-to-clinical-trials-and-risk-assessments/risk-adapted-approach-to-clinical-trials-and-risk-assessments
Permalink: https://data.openrid.co/en/datasets/r/a77406dc-47d8-44aa-a0b7-d26098a1e2e8
MIME Type: text/html

Created on: January 28, 2022
Modified on: January 28, 2022

Example 1: Type A Protocol Synopsis

Updated on January 28, 2022

pdf

URL: https://assets.publishing.service.gov.uk/media/6221d69b8fa8f54912675250/Example_1_Type_A_Protocol_Synopsis__1_.pdf
Permalink: https://data.openrid.co/en/datasets/r/3eb486e5-9811-4f1d-88ed-fef1d056c3b8
MIME Type: application/pdf

Created on: January 28, 2022
Modified on: January 28, 2022

Example 1: Type A Risk Assessment

Updated on January 28, 2022

pdf

URL: https://assets.publishing.service.gov.uk/media/6221d6b18fa8f5490d52ef53/Example_1_Type_A_Risk_Assessment__1_.pdf
Permalink: https://data.openrid.co/en/datasets/r/8eae229e-f8c2-4cc1-a260-2646b0b1bb76
MIME Type: application/pdf

Created on: January 28, 2022
Modified on: January 28, 2022

Example 2: Type A Protocol Synopsis

Updated on January 28, 2022

pdf

URL: https://assets.publishing.service.gov.uk/media/6221d6c3e90e0710ae791059/Example_2_Type_A_Protocol_Synopsis__1_.pdf
Permalink: https://data.openrid.co/en/datasets/r/bec98959-2e0c-4a9c-97a3-fd66709748e7
MIME Type: application/pdf

Created on: January 28, 2022
Modified on: January 28, 2022

Example 2: Type A Risk Assessment

Updated on January 28, 2022

pdf

URL: https://assets.publishing.service.gov.uk/media/6221d7f08fa8f54915f438bd/Example_2_Type_A_Risk_Assessment.pdf
Permalink: https://data.openrid.co/en/datasets/r/1562fa8b-8f01-4b00-bc96-a6ecdcb8f866
MIME Type: application/pdf

Created on: January 28, 2022
Modified on: January 28, 2022

Example 3: Type A Protocol Synopsis

Updated on January 28, 2022

pdf

URL: https://assets.publishing.service.gov.uk/media/6221d722e90e0710ae79105b/Example_3_Type_B_Protocol_Synopsis.pdf
Permalink: https://data.openrid.co/en/datasets/r/e9f44bc3-b8a5-4068-ac65-f436979bec45
MIME Type: application/pdf

Created on: January 28, 2022
Modified on: January 28, 2022

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Risk-Adapted Approach to clinical trials and Risk Assessments

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