STANDARD OPERATING PROCEDURE

Transcription

1 STANDARD OPERATING PROCEDURE Title Reference Number Archiving and the Destruction of Records SOP-RES-028 Version Number 2 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review Date 22 nd January 2018 Author(s) Reviewer(s) Melanie Boulter, QA Auditor Teresa O Leary, Head of Regulatory Compliance (Interim) Authorisation (Original signatures are retained by Research & Innovation) Dr Brian Thomson Director of Research & Innovation Dr Stephen Fowlie Medical Director 24 th Nov th Dec 2015 USERS OF THIS STANDARD OPERATING PROCEDURE MUST REFER TO TO ENSURE THE MOST CURRENT VERSION IS BEING USED

2 Page 2 of Document History Version Issue Date Reason for Change Number 1 7 th May 2014 Original SOP. Replaces SOP th Dec 2015 Internal review of Archiving processes

3 Page 3 of Introduction Archiving in the context of clinical research relates to the collection of essential documents for long term storage. Essential documents are defined as those that individually and collectively permit the evaluation of the conduct of a study and the quality of the data produced according to International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) E6. Archiving also forms part of the Trusts record management process. It is a legal requirement of the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004:1031 as amended) that all clinical trial information, including the Trial Master File (TMF), Investigator Site File (ISF) and the Pharmacy Site File (PSF) shall be recorded, handled and stored in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records of trial subjects remains protected. For all types of studies, the Data Protection Act 1998 applies. 3. Purpose and Scope The purpose of this standard operating procedure (SOP) is to describe the procedure for the archiving of study documents. It defines the responsibilities of both the Investigator and Nottingham University Hospitals NHS Trust (NUH) where acting as either a Sponsor and/or hosted site. This SOP applies to all types of studies. 4. Responsibilities 4.1 NUH Sponsored studies Sponsor Where NUH is the Sponsor, responsibilities for ensuring appropriate arrangements and funding are in place for archiving study data are fulfilled by the Research and Innovation (R&I) department. This responsibility may be delegated to a third party (such as an NHS Trust hosting the research) however this must be clearly defined in an agreement and costs outlined in the initial phases. Principle Investigator (PI)/Chief Investigator (CI) The Chief Investigator signs the NUH sponsor agreement which provides details of the arranged archiving for the study data generated at NUH and the sponsor TMF. The CI/PI is also responsible for contacting R&I when the study data is ready to be archived, and if, for any reason, there is a request to retrieve the study data from archive.

4 Page 4 of 11 The CI/PI (or delegate) must complete and sign the Archiving Request form (TAFR02801) to ensure a complete chain of custody is maintained. NUH Research and Innovation (R&I) A named Archivist is appointed as the delegated individual responsible for archiving on behalf of NUH. The Archivist will facilitate the archiving and subsequent destruction of study data. Archiving duties may be delegated to appropriate individuals should the archivist deem this necessary. The Archivist will also review and maintain the Archive Log (TAFR02802) to ensure study documents are archived appropriately and retained for the minimum retention period. For multi-centre research NUH will normally delegate the responsibility of archiving study data generated at the site to the organisation hosting the study (such as an NHS Trust). This will be fully documented in an agreement. In this instance sites should follow their local archiving procedure. 4.2 NUH Hosted studies Sponsor For studies which are not sponsored by NUH, the responsibilities for defining the requirements of archiving arrangements lie with the sponsor. Archiving can still be arranged on behalf of the sponsor and the inclusion of costs for this archiving service will be outlined at the original costing of the study and fully documented in an agreement. Ultimate responsibility for the quality, integrity, confidentiality and retrieval of the documents resides with the sponsor and the investigator. NUH Research and Innovation (R&I) The NUH R&I Archivist will facilitate the archiving of study data on written request from the Sponsor. Archiving duties may be delegated to appropriate individuals should the archivist deem this necessary. Where the Sponsors archiving procedures conflict with the procedures set out in the SOP, Sponsor procedures should always take precedence, It is essential that provisions for archiving are appropriately financed by the sponsor if this responsibility is delegated to NUH in an agreement.

5 Page 5 of Definitions Archive Archivist ATIMP CI CMD CRF CRO CTIMP Documas GCP GMP HRA ICH IMP Indemnity IP ISF MA NHS NRES NUH PI PSF QC R&I R&I Approval RCM REC RPM SAE SOP SSREC TMF UKCRC A collection of historical documents or records Named individual with specific responsibilities for reviewing and maintaining the archiving procedures and archive contents Advance Therapy Investigational Medicinal Product Chief Investigator Clinical Investigation of a Medical Device Case Report Form Contract Research Organisation Clinical Trial of Investigational Medicinal Product A document management system to assist with the management, control and governance of the research and ethics processes covering research and development projects Good Clinical Practice Good Manufacturing Practice Health Research Authority International Conference on Harmonisation Investigational Medicinal Product The guarantee to be responsible for someone else s loss Intellectual Property Investigator Site File Marketing Authorisation National Health Service National Research Ethics Service Nottingham University Hospitals NHS Trust Principal Investigator Pharmacy Site File Quality Check Research and Innovation Approval issued by NUH R&I for the study to go ahead on NUH premises Research Contracts Manager Research Ethics Committee Research Project Manager Serious Adverse Event Standard Operating Procedure Site Specific Research Ethics Committees Trial Master File UK Clinical Research Collaboration

6 Page 6 of Procedure 6.1 Record retention during study conduct Filing space should be available for the storage of ISFs during the conduct of the study, normally located in an Investigator s office or local secure filing area. Access to the files should be controlled, and available only to those who require it. PSFs will usually be stored within a secure area in the clinical trials pharmacy department. The minimum requirement is for documentation to be stored in conditions that minimise the risk of damage or loss of information. The risk of damage from water should be reduced by storing documentation above floor level and away from overhead water pipes. Documentation should be located in areas with minimal variation in temperature and humidity if stored for long periods of time, and be in an area with strict fire controls. A sponsor representative may conduct monitoring visits of the study site. As part of the routine monitoring visit the monitor will assess where the ISF is located and note whether storage arrangements are satisfactory and in line with the arrangements detailed by the investigator prior to authorisation. If the interim storage of the ISF is found not to be in accordance with regulations the investigator will have to take action to ensure that the ISF is stored appropriately (this includes the PSF). 6.2 Record retention following completion of a study Retention period All essential and any other relevant documents allowing the reconstruction of a study must be archived in accordance with this SOP. Minimum retention periods are as follows: i. Until at least 5 years after the conclusion of the study; or ii. Until at least 15 years after the completion of a clinical study or until at least 2 years after the last approval of a marketing application in a region where the ICH guidelines applies (whichever occurs first); and iii. Until there are no pending or contemplating marketing applications in a region where the ICH guidelines applies or as defined in the study protocol. iv. For ATIMPs, a minimum of 30 years after the expiry date of the product, or longer if required by terms of the clinical trial authorisation.

7 Page 7 of 11 Additionally, the sponsor or other owner of the data must retain all other documentation pertaining to the study as long as the product is authorised. Appendix 1 gives guidelines outlining the duration for which the NUH R&I would expect the retention of essential documentation generated during the course of a study to be Request to Archive Data Once a study is complete, the study data must remain at site for at least 6 months following the submission of the end of study report. Prior to archiving of study data the PI/CI (or delegate) and R&I staff will be required to inspect all documentation for archiving and give special attention to any elements that may be subject to rapid deterioration or media forms that may become obsolete over the archive period. This includes but is not limited to: i. Plastic wallets liable to remove print from documents; ii. Thermochromic paper print-outs (which fade and become illegible over time); iii. Electronic media; iv. Electromagnetic tapes; v. Photographs and films; vi. Dummy IMP/medical device samples/packaging; vii. Contaminated paper documents that may cause deterioration (from fungal or insect infestation for example). The PI/CI and R&I must ensure that any documentation held electronically are printed or placed onto an appropriate electronic media storage device (and checked it will be readable for the retention period) prior to archive. This includes a copy of the study database for NUH sponsored studies, for example. The PI/CI must also liaise with any support departments involved in the study (e.g. Pharmacy, Radiology, Laboratories etc.) to ensure all documentation is collated. Archive boxes are available for collection from R&I, NHSP, C-Floor, South Block, QMC. It is the PI/CIs responsibility to obtain the appropriate number of boxes for their data and pack up their data. On request, a transfer of boxes can be made from R&I to the PI/CI, particularly if they are based at a location different to R&I. Following 6 months of the publication of the end of study report (for NUH sponsored studies) or on request of the sponsor (for non-nuh sponsored studies) the PI/CI (or delegate) must make arrangements to transfer their study data to R&I as per the address above with a completed Archive Request form (TAFR02801). Completed forms should be ed to R&IEnquiries@nuh.nhs.uk.

8 Page 8 of 11 If it is impractical for archive boxes to be transferred to R&I (i.e. due to a large volume of data) the PI/CI should request that R&I visit their location to check the study data has been packed up correctly, and make arrangements for collection for transfer to the archive facility Transfer of Study Data to Archive On receipt of the completed Archive Request form, the R&I Archivist, or delegate, will check: i. The Archive Request form has been completed correctly; ii. The box contents is as per listed on the Archive Request form; iii. The data of one study only is contained in each box (i.e. ISF data from different studies must not be archived together); iv. The volume of data to archive does not exceed the contractual obligations of NUH (if set out in the original agreement); v. The date of destruction complies with the study protocol and minimum retention period as per the regulations; vi. The archive request is valid (i.e. on agreement from the sponsor as verified by the PI/CI). R&I will direct any queries to the PI/CI to resolve. R&I may prepare the department files for the study (R&I Files or Sponsor TMF) to be archived with the study data following a final QC of the files. R&I will assign an archive barcoding label to each box for archive (labels are provided by the archive service provider. This will be logged on the Archive Log (TAFR02802). R&I will make arrangements for collection of the data by the archive service provider. Data must be transferred from R&I to archive within 30 days of a completed archive request form. The date of collection of data to archive will be documented in the Archive Log Recall of Study data from Archive Study data may be temporarily recalled from archive by the Archivist or delegate on request from the PI/CI or sponsor, often for the purposes of audit or inspection. Requests, giving the reason for recall, must be sent to R&IEnquiries@nuh.nhs.uk giving 30 days notice where possible; however recalls can be made within 3 working days if an urgent request is made.

9 Page 9 of 11 Study data recalled from archive must be handled with the same level of access control and confidentiality measures as if the study were active. All archive recalls and returns will be documented in the R&I Archive Log by the Archivist, or delegate. 6.3 Destruction of Records The Archivist, or delegate, will review the Archive Log on a regular basis to check for studies approaching or those having reached the end of the minimum retention period. The Archivist, or delegate, will endeavour to contact the sponsor to confirm the study data may be destroyed, or if further retention is required. The Destruction of Records form (TAFR02805) should be completed by the Sponsor and returned to R&Ienquiries@nuh.nhs.uk in this instance. If further retention is required NUH may request an amendment to the original agreement and revision of costs to be negotiated prior to the extension. Any extension will be documented in the Archive Log. If no response is obtained from the sponsor, or the sponsor organisation no longer exists, the Archivist, or delegate, will contact the PI/CI to confirm the study data may be destroyed (the Destruction of Records form should be completed by the CI/PI and returned to R&Ienquiries@nuh.nhs.uk in this instance). If no confirmation is received from the sponsor or the PI/CI within 30 days of initial request, the Archivist, or delegate, will proceed to request the destruction of study data. All study data will be destroyed confidentially by the archive service provider. Written confirmation of destruction will be retained in the R&I files and a copy will be provided to the sponsor and PI/CI (if contactable). Evidence of destruction must be retained for a further 5 years after the date of destruction. The Archive Log will also be updated with destruction information. 7. References and Associated Documents The Medicines for Human Use (Clinical Trials) Regulations 2004, Regulation 31A (1) of SI 2004/1031 Directive 2003/63/EC Data Protection Act 1998 TAFR02801 TAFR02803 TAFR02805 Archiving Request Form Archive Log Destruction of Records Form

10 Page 10 of 11 Appendix 2. Recommended Period of Archiving of Essential Documentation The following matrix outlines the minimum duration for which NUH R&I would retain the essential documentation generated during the course of a research study. For those studies involving investigational devices or surgical intervention, the same principles will be followed as for studies of IMPs to reflect the risk associated with these types of study. For studies that do not involve regulatory submissions i.e. non interventional research that does not involve the use of an IMP or a device, the minimum period for archiving should be at least 5 years after completion of the study in line with MHRA recommendations. # Category of Study Recommended period of retention for investigator site file Location of investigator site file Point at which files can be destroyed 1 IMP study, NUH sponsored 15 years In a suitable location on NUH premises approved by R&I or at an agreed offsite facility. 15 years after the declaration by PI of the end of the study. 2 IMP Study Non- At least 5 years Investigator should The sponsor will commercially (longer if sponsor negotiate with the sponsor notify the PI of Sponsored requires) for the off-site storage of when documents documents. If this is not can be destroyed. possible then a location on NUH approved by the R&I can be used. 3 IMP Study At least 5 years Investigator should The sponsor will Commercially (longer if sponsor negotiate with the sponsor notify the PI of Sponsored requires) for the off-site storage of when documents documents. If this is not can be destroyed. possible then a location on NUH approved by R&I can be used. 4 ATIMP study, NUH sponsored 5 ATIMP study, externally sponsored 30 years studies (#1). 30 years after the declaration by PI of the end of the 30 years studies (#2). The sponsor will notify the PI of

11 Page 11 of 11 when documents can be destroyed 6 Investigational studies (#1). 15 years after the Device Study NUH studies (#1) declaration by PI Sponsored of the end of the study. 7 Investigational Studies (#2 or Device Study Studies (#2 or #3) #3). Studies (#2 or externally #3). Sponsored 8 Surgical Intervention Studies (#1). 15 years after the Study NUH Studies (#1) declaration by PI sponsored of the end of the study. 9 Surgical Intervention Studies (#2 or Study externally Studies (#2 or #3) #3). Studies (#2 or sponsored #3). 10 Non-interventional Study 5 years In a suitable location on NUH premises approved by R&I or at an agreed offsite facility. 5 years after declaration by PI of the end of study.