- Foreword
- Preface
- Acknowledgements
- Contributors
- Symbols and abbreviations
- Chapter 1 Research: why and how?
- Chapter 2 Navigating research methods: basic concepts in biostatistics and epidemiology
- Chapter 3 Navigating research methods: quantitative and clinical/epidemiological methods
- Chapter 4 Navigating research methods: qualitative methods
- Chapter 5 Navigating research methods: evidence-based medicine (EBM)
- Chapter 6 Navigating research methods: critical appraisal
- Chapter 7 Navigating research methods: clinical audit
- Chapter 8 Setting the scene and ICH GCP in clinical and healthcare research
- Chapter 9 Informed consent in a research setting
- Chapter 10 Ethics of clinical and healthcare research: general considerations, Mental Capacity Act, Human Tissue Act
- Chapter 11 Role and responsibilities: investigator and research team
- Chapter 12 Role and responsibilities of the sponsor
- Chapter 13 Monitoring
- Chapter 14 Clinical trial design
- Chapter 15 Clinical trial protocols: study protocol
- Chapter 16 Data capture tools: case report form (CRF)
- Chapter 17 Clinical trial supplies: investigational medicinal products (IMPs)
- Chapter 18 IMP accountability
- Chapter 19 Safety reporting
- Chapter 20 Data management
- Chapter 21 Research project management
- Chapter 22 Essential documents
- Chapter 23 Archiving
- Chapter 24 Audits and inspections
- Chapter 25 Fraud and misconduct
- Chapter 26 Authorship
- Chapter 27 Publication process
- Chapter 28 Start-up toolkit: from funding an idea, through implementation, to achieving an impact
- Index
(p. 453) Archiving
- Chapter:
- (p. 453) Archiving
- DOI:
- 10.1093/med/9780199608478.003.0023
This chapter discusses the importance of archiving the data. As well as regulatory advice the requirements of the most useful reference guide, ISO11799, is reviewed. Practical advice on issues such as location, storage, security, and environmental controls is given. The management of the archive from preparation to transfer of data is described. Methods of indexing and cataloguing together with tracking are detailed and systems for retrieval of data are explored. The role of the archivist in audits and inspections is discussed as the content of the TMF will be assessed during audit to ensure a clear audit trail is maintained. Retention times for essential documents are reviewed in the EU the regulation stipulates that data has to be kept for 25 years. As more and more information has to be archived the use of off-site or commercial archives is becoming more common and the additional requirements for a third party service provider are described. The introduction of eArchiving and the associated problems with long term storage of electronic data are discussed along with the various methods that may be used. The FDA issued guidance for electronic data and compliance with this guidance, CFR21 part 11, is vital. CFR 21 part 11 is widely followed within Europe and the standard is frequently referred to by the regulatory inspectors.
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- Foreword
- Preface
- Acknowledgements
- Contributors
- Symbols and abbreviations
- Chapter 1 Research: why and how?
- Chapter 2 Navigating research methods: basic concepts in biostatistics and epidemiology
- Chapter 3 Navigating research methods: quantitative and clinical/epidemiological methods
- Chapter 4 Navigating research methods: qualitative methods
- Chapter 5 Navigating research methods: evidence-based medicine (EBM)
- Chapter 6 Navigating research methods: critical appraisal
- Chapter 7 Navigating research methods: clinical audit
- Chapter 8 Setting the scene and ICH GCP in clinical and healthcare research
- Chapter 9 Informed consent in a research setting
- Chapter 10 Ethics of clinical and healthcare research: general considerations, Mental Capacity Act, Human Tissue Act
- Chapter 11 Role and responsibilities: investigator and research team
- Chapter 12 Role and responsibilities of the sponsor
- Chapter 13 Monitoring
- Chapter 14 Clinical trial design
- Chapter 15 Clinical trial protocols: study protocol
- Chapter 16 Data capture tools: case report form (CRF)
- Chapter 17 Clinical trial supplies: investigational medicinal products (IMPs)
- Chapter 18 IMP accountability
- Chapter 19 Safety reporting
- Chapter 20 Data management
- Chapter 21 Research project management
- Chapter 22 Essential documents
- Chapter 23 Archiving
- Chapter 24 Audits and inspections
- Chapter 25 Fraud and misconduct
- Chapter 26 Authorship
- Chapter 27 Publication process
- Chapter 28 Start-up toolkit: from funding an idea, through implementation, to achieving an impact
- Index