Clinical Trials Records UK

Description of Business Function

The function within the NHS and research-based pharmaceutical companies, of managing processes for drug development and maintaining clinical trial documentation.

Basis of Retention and Disposition

The Medical Research Council and the Department of Health provide guidance in this area. Please see the links in the section below. Legally account must be taken of The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 and Data Protection.

Retention Rules Per Record Type

Research Records

The Medical Research Council’s Data and Tissues Tool Kit guidance on archiving provides retention guidance for both Basic research and Population health and clinical studies records. Please see http://www.dt-toolkit.ac.uk/researchscenarios/archiving.cfm

For the Department of Health’s Research involving the NHS: retention of records please see http://www.noclor.nhs.uk/sites/default/files/Retention%20of%20Records%20in%20NHS%20Research.pdf

Citations and References

Data Protection Act 1998, Sch. 1, Part I, 5th Principle, “Personal data processed for any purpose or purposes shall not be kept for longer than is necessary for that purpose or those purposes

The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006, particularly sections 18 and 28 http://www.legislation.gov.uk/uksi/2006/1928/made

Research Governance Framework for Health and Social Care https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-edition

Governance Arrangements for NHS Research Ethics Committees http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4005727

MRC Guidance on Personal Information in Medical Research http://www.mrc.ac.uk/consumption/Idcplg?IdcService=GET_FILE&dID=6233&dDocName=MRC002452&allowInterrupt=1

MHRA Guidance on the maintenance of regulatory compliance in laboratories that perform the analysis or evaluation of clinical trial samples http://www.mhra.gov.uk/home/groups/is-insp/documents/websiteresources/con051910.pdf

The Pharmaceutical Records and Information Management Organization (PRIMO) http://www.pharma-rim.org/

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