12. Resources
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Medicines and Healthcare Products Regulatory Agency (MHRA)
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
Health Research Authority (HRA)
Medicines and Medical Devices Act 2021
https://www.legislation.gov.uk/ukpga/2021/3/enacted
Research Ethics Committees
Research Ethics Service and Research Ethics Committees
https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/
HRA- Gene Therapy Advisory Committee
https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/gene-therapy/
The Medicines for Human Use (Clinical Trials) Regulations 2004
https://www.legislation.gov.uk/uksi/2004/1031/contents
The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006
https://www.legislation.gov.uk/uksi/2006/1928/pdfs/uksi_20061928_en.pdf
Medicines and Medical Devices Act 2021
https://www.legislation.gov.uk/ukpga/2021/3
HRA- Decentralized trial methods position statement
Integrated Research Application System (IRAS)
https://www.myresearchproject.org.uk/
HRA- Step by Step guide to using the IRAS for combined review
Document Management for combined review applications
UK- Policies, Standards & Legislation
https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/
UK- Human Tissue Act 2004
https://www.legislation.gov.uk/ukpga/2004/30/pdfs/ukpga_20040030_en.pdf
HTA- Code of Practice and Standards of Research (Code E)
https://content.hta.gov.uk/sites/default/files/2023-06/Code%20E%20-%20Research.pdf
The Genetically Modified Organism (Contained Use) Regulation 2014
https://www.hse.gov.uk/pUbns/priced/l29.pdf
The Genetically Modified Organism (Deliberate Release) Regulation 2002
https://www.legislation.gov.uk/uksi/2002/2443
Gene Therapy Advisory Committee
https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/gene-therapy/
Guidance on the use of genetically modified microorganisms in a clinical setting
https://www.hse.gov.uk/biosafety/assets/docs/part6.pdf
HRA- Progress Reports
https://www.hra.nhs.uk/approvals-amendments/managing-your-approval/progress-reports/
ABPI- Clinical Trial Compensation Guideline
https://www.abpi.org.uk/publications/clinical-trial-compensation-guidelines/
MHRA- Current Fees
https://www.gov.uk/government/publications/mhra-fees/current-mhra-fees
UK- GDPR
https://www.legislation.gov.uk/eur/2016/679/contents
UK- Data Protection Act 2018
https://www.legislation.gov.uk/ukpga/2018/12/contents
MHRA- GxP Data Integrity Guidance_March 2018
https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity
MHRA Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice
Annex 13
https://www.gmp-compliance.org/files/guidemgr/2009_06_annex13.pdf
The Electronic Identification and Trust Services for Electronic Transactions Regulations 2016- UK Statutory Instrument 2016 No.696
https://www.legislation.gov.uk/uksi/2016/696/made
MHRA- Guidance “Access to Electronic Health Records by Sponsors representatives in clinical trials”
A guide to good practice for digital and data-driven health technologies
Data Ethics Framework
https://www.gov.uk/government/publications/data-ethics-framework
Nuffield- Council on Bioethics- The Collection, linking and use of data in biomedical research and health care: ethical issues
https://www.nuffieldbioethics.org/publications/biological-and-health-data
Information Commissioner’s Office (ICO)- Digital Services Providers
https://ico.org.uk/for-organisations/the-guide-to-nis/digital-service-providers/
Information Commissioner’s Office (ICO)- Network and Information Systems (NIS)
https://ico.org.uk/for-organisations/the-guide-to-nis/what-is-nis/
Information Commissioner’s Office (ICO)- Guidance on the use of cloud computing
Information Commissioner’s Office (ICO)- The Research Provisions
https://ico.org.uk/for-organisations/uk-gdpr-guidance-and-resources/the-research-provisions/
UK- Research and Innovation- Research with potentially vulnerable people
Care Act 2014
https://www.legislation.gov.uk/ukpga/2014/23/part/3/chapter/2/enacted
HRA- Our role protecting research participants
https://www.hra.nhs.uk/about-us/what-we-do/our-role-protecting-research-participants/
HRA- Consent and Participant Information Guidance
https://www.hra-decisiontools.org.uk/consent/
HRA and MHRA- Joint Statement on seeking and documenting consent using electronic methods (eConsent)
MHRA- Procedures for UK Paediatric Investigation Plan (PIPs)
https://www.gov.uk/guidance/procedures-for-uk-paediatric-investigation-plan-pips#section-six
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