Common issues identified during clinical trial applications

Name: Common issues identified during clinical trial applications
Creator: Medicines and Healthcare products Regulatory Agency
License: https://www.nationalarchives.gov.uk/doc/open-government-licence/version/2/
Keywords: applications,assessment,clinical-trials,declarations,guidances,templates

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Health And Social Care

Published

March 22, 2017

Last updated

November 6, 2023

Description

This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.

Organization

Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧

Country / Region

United Kingdom

License

Open Government Licence 2.0 (United Kingdom)

Feedback

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6 Main files

Common issues: Validation

Updated on November 6, 2023

html

URL: https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications/common-issues-validation
Permalink: https://data.openrid.co/en/datasets/r/43d866e1-756d-41c1-bcba-7ed588dedea5
MIME Type: text/html

Created on: March 22, 2017
Modified on: November 6, 2023

Common issues: Non-Clinical

Updated on November 6, 2023

html

URL: https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications/common-issues-non-clinical
Permalink: https://data.openrid.co/en/datasets/r/6b1510a6-0c2e-4408-a45d-4dec905b91ef
MIME Type: text/html

Created on: March 22, 2017
Modified on: November 6, 2023

Common issues: Clinical

Updated on November 6, 2023

html

URL: https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications/common-issues-clinical
Permalink: https://data.openrid.co/en/datasets/r/2d9775ac-adf3-499f-8b99-b27342e49eb6
MIME Type: text/html

Created on: March 22, 2017
Modified on: November 6, 2023

Common issues: Pharmaceutical

Updated on November 6, 2023

html

URL: https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications/common-issues-pharmaceutical
Permalink: https://data.openrid.co/en/datasets/r/11938cce-6f82-4659-9319-771b2554f333
MIME Type: text/html

Created on: March 22, 2017
Modified on: November 6, 2023

Useful Resources

Updated on November 6, 2023

html

URL: https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications/useful-resources
Permalink: https://data.openrid.co/en/datasets/r/59e6b5cc-1d2a-41ca-b998-3a5eedd20deb
MIME Type: text/html

Created on: March 22, 2017
Modified on: November 6, 2023

Qualified Person's Declaration Template

Updated on November 6, 2023

pdf

URL: https://assets.publishing.service.gov.uk/media/5ffedfc6d3bf7f65dc48ccf9/QP_Declaration_Template.pdf
Permalink: https://data.openrid.co/en/datasets/r/3fd26c57-8841-4081-9ced-e56eab86546d
MIME Type: application/pdf

Created on: March 22, 2017
Modified on: November 6, 2023

Common issues identified during clinical trial applications

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Regulated products

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