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Records Retention Schedule for files relating to research data.
Clinical trial records
Notwithstanding this schedule, clinical trial records must be kept for a longer period if required by the funder.
Research data is made up of the following headings:
- 3.1 Research data
Ref Record group Examples Trigger Retention Citation Notes 3.1.1 Records of interventional (IMPs, blood, devices, radiation beyond standard clinical practice, surgical intervention) and non-interventional clinical trials used in regulatory submissions except ATMPs. Trial master file;
Investigator site file;
Information referred to in SI 2005/50 reg 7(3)(a), 7(5) and 7(6);
Information specified in SI 2005/50 reg 8(1) and Schedule Part 6 Section B;
Serious adverse events;
Lab books.End of trial. 15 2003/63/EC Annex 1 Pt 1 5.2(c);
SI 2004/1031 reg 31A(7);
SI 2005/50 regs 7(1)(g), 7(4), 8(3)(b), 12A(1)(a);
CPMP 5.5.123.1.2 Records of interventional (IMPs, blood, devices, radiation beyond standard clinical practice, surgical intervention) and non-interventional clinical trials used in regulatory submissions except ATMPs: no marketing applications in the EU pending or contemplated. Trial master file;
Investigator site file;
Information referred to in SI 2005/50 reg 7(3)(a), 7(5) and 7(6);
Information specified in SI 2005/50 reg 8(1) and Schedule Part 6 Section B;
Serious adverse events;
Lab books.Last marketing authorisation. 2 2003/63/EC Annex 1 Pt 1 5.2(c);
SI 2004/1031 reg 31A(7);
SI 2005/50 regs 7(1)(g), 7(4), 8(3)(b), 12A(1)(a);
CPMP 4.9.5, 5.5.8, 5.5.113.1.3 Records of interventional (IMPs, blood, devices, radiation beyond standard clinical practice, surgical intervention) and non-interventional clinical trials not used in regulatory submissions except ATMPs. Trial master file;
Investigator site file;
Information referred to in SI 2005/50 reg 7(3)(a), 7(5) and 7(6);
Information specified in SI 2005/50 reg 8(1) and Schedule Part 6 Section B;
Serious adverse events;Lab books.End of trial. 5 SI 2004/1031 reg 31A(7);
SI 2005/50 regs 7(1)(g), 7(4), 8(3)(b), 12A(1)(a)3.1.4 Records of clinical trials of ATMPs, including viral vectors, whether or not used in regulatory submissions. Trial master file;
Investigator site file;
Traceability records;
Serious adverse events;
Lab books.Expiry of product. 30 SI 2012/1916 Sch 4 para 27;
ENTR 7.33.1.5 Records of population health or clinical studies funded by MRC. End of research. 20 MRC GRP B.3 3.1.6 Records of basic research funded by MRC. End of research. 10 MRC GRP B.3 3.1.7 Records of research funded by the European Regional Development Fund, operating under State Aid rules. Grant of last aid. 10 This is the minimum retention period. See ERDF website and individual project agreements with funding bodies. 3.1.8 Animal research. Project licences;
Personal licences;
ASPA inspectors' reports;
Information mentioned in 2010/63/EC art 30.1;
Records of regulated procedures;
Health records of animals;
Records of the source, use and disposal of protected animals used in procedures;
Lab books.End of research. 5 Animals (Scientific Procedures) Act 1986 c 14 ss 4(5), 5E(1), 18(2E), Sch 2C para 8(b);
HO3.1.9 Animal research. Records of AWERB advice provided under 2010/63/EC art 27.1;
Records specified in 1986 c 14 s 5G(2);
Individual history files of dogs, cats or NHPs which have died or have been set free or re-homed.End of research. 3 Animals (Scientific Procedures) Act 1986 c 14 Sch 2C paras 6(4), 9(1)(e);
1986 c 14 s 5G(1)3.1.10 Records documenting the conduct of all other research funded by all other organisations. Research data not covered by specific entry in this schedule, including lab books. Completion of project + 10 years (date of last funding payment + 10 years for projects funded by the European Union). 10;
REVIEW.JISC A shorter or longer retention period may be appropriate, depending on the discipline and the characteristics of the project, or may be required by a research sponsor. See UCL Research Data Policy. 3.1.11 Management of projects funded by the European Structural Funds. Financial and workforce records;
Project Management and implementation records;
Publicity.Date of last payment. 3 1083/2006 - 3.2 Administration and quality management
Ref Record group Examples Trigger Retention Citation Notes 3.2.2 Applications for ethical approval. High Risk studies. End of research. 6 UCL 3.2.3 Applications for ethical approval. Minimal-risk studies. End of research. 1 UCL 3.2.4 REF staff data. Discussions of staff selection strategies and decisions (SSRG and REFSG papers);
Staff eligible for REF and those selected;
Appeals against non-selection;
Individual staff circumstances;
Output data;
Research environment data and statements.REF submission. 6 UCL 3.2.5 REF staff data - original notes. Forms and notes relating to individual staff circumstances. REF submission. 1 UCL 3.2.6 Full REF submission. REF submission. 12 UCL 3.2.7 Full REF submission. REF impact case studies. PERMANENT PERMANENT UCL 3.2.8 Full REF submission. REF preparations report. PERMANENT PERMANENT UCL 3.2.9 External clinical quality assurance - pathology. Returns, Correspondence, ethical approval and consent;
Reference samples of material capable of long-term storage.AY 10 RCP 166 3.2.10 External clinical quality assurance - pathology. Samples of degradable pathology materials. Assessment 1M (if possible) RCP 166 3.2.11 Research misconduct. Case files on the investigation and resolution of allegations or research misconduct. Closure. 6 Limitation Act 1980 s.11 - List of citations
Acts of Parliament
- Limitation Act 1980.
- Animals (Scientific Procedures) Act 1986.
Statutory Instruments and EU Regulations
- 1083/2006: Regulation laying down general provisions on the European Regional Development Fund, the European Social Fund and the Cohesion Fund.
- 2003/63/EC: Directive amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
- 2004/1031: Medicines for Human Use (Clinical Trials) Regulations.
- 2005/50: Blood Safety and Quality Regulations.
- 2012/1916: Human Medicines Regulations.
UK and EU statutory guidance
- CPMP: CPMP/ICH/135/95: Note for guidance on good clinical practice 2002.
- JISC: Model records retention schedule 2019.
- MRC GRP: Good research practice 2012.
- RCP: The retention and storage of pathological records and specimens 5th ed 2016.