This SOP may also be used by staff from other NHS areas, or organisations, with prior agreement.

Transcription

1 Standard Operating Procedure: SOP Number: SOP-QA-32 Version No: 1 Author: Date: (Gary Cooper, Named Sponsor Archivist, NHS Grampian and University of Aberdeen) Approved by: Date: (Professor Julie Brittenden, R&D Director, NHS Grampian) Approved by: Date: (Professor Steve Heys, Head of School, University of Aberdeen) Issue Date: Date Effective: Review Due Date: Document History: Version Description of Changes Date Effective 1 Change of number for Q-Pulse Clarification of files and responsibilities in 1.2 Addition of associated documentation at 3 Clarification of QA Manager responsibilities at Change of responsibilities to archiving team at 7.4 (Replaces UoA-NHSG-SOP-021 V2) This SOP will be reviewed at least every 3 years from initial and subsequent issue dates. Page 1 of 10

2 1. PURPOSE/INTRODUCTION 1.1 To describe the joint University of Aberdeen (UoA) and NHS Grampian (NHSG) procedure for the archiving of data from all interventional research projects involving human participants which are locally sponsored, and for hosted studies. Interventional research projects include: Clinical Trials of Investigational Medicinal Product (CTIMPs) falling under the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended and other Interventional Studies (e.g. surgical studies, device studies and non CTIMP drug studies and any other projects deemed to be interventional by the Sponsor). 1.2 Clinical research documents are those which are contained within the Sponsor TMF, Investigator TMF (held by the CI), site files (if appropriate, held by the PI) and pharmacy file (held by the Clinical Trial Pharmacist). All component parts of the TMF must be archived together, in their entirety, at the end of the trial (final publication) although individual teams may archive completed sections once that activity is complete. See SOP-QA-31 Research Study Closure including Project Suspension and Early Termination. Research project data may be generated in electronic and/or paper form. Source documents may be original documents, data, and records (e.g. hospital records, clinical and office charts, laboratory notes, memoranda, participant diaries or evaluation checklists, participant completed questionnaires, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and medico-technical departments involved in the clinical trial). 1.3 For CTIMPs, clinical trial regulations require that all clinical trial information shall be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification and that the confidentiality of records that could identify subjects shall be protected, respecting the privacy and confidentiality rules in accordance with the requirements of the Data Protection Act 1998 and the law relating to confidentiality. 2. SCOPE This document applies to all researchers and sponsor staff participating in interventional research projects sponsored and/or co-sponsored by UoA and NHSG and hosted studies. This SOP may also be used by staff from other NHS areas, or organisations, with prior agreement. 3. RELATED DOCUMENTATION Page 2 of 10

3 3.1 Appendix 1 (attached) Appendix 2 (attached) SOP-QA-24 SOP-QA-31 TMP-QA-34 TMP-QA-35 TMP-QA-36 TMP-QA-37 Contact details Archiving process summary Managing a change in CI of a CTIMP Research Project Closure including Project Suspension and Early Termination Archive Approval form (HSB and RSS) Archive Retrieval form (HSB and RSS) Archive Review Notice (HSB and RSS) Archive Destruction form (HSB and RSS) 4. REFERENCES 4.1 Scottish Executive Health Department Research Governance Framework for Health and Community Care 2nd Edition (2006) UK Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004 No. 1031) as amended. Health Research Authority website Medicine and Healthcare Products Regulatory Agency website (MHRA) Current versions of these documents can be accessed via the Clinical Research Governance and Quality Assurance Website: It is assumed that by referencing the principal regulations, all subsequent amendments made to the principle regulations are included in this citation. 4.2 ABBREVIATIONS CI CTIMP ISF MHRA NHSG REC TMF UoA Chief Investigator Clinical Trials of Investigational Medicinal Product Investigator Site File Medicine and Healthcare Products Regulatory Agency NHS Grampian Research Ethics Committee Trial Master File University of Aberdeen 5. RESPONSIBILITIES 5.1 UoA AND NHSG UoA and NHSG, as sponsors and/or co-sponsors of interventional research projects, are responsible for ensuring that there is appropriate oversight in place to ensure that staff comply with this procedure. Page 3 of 10

4 5.1.2 UoA and NHSG, as sponsor or co-sponsors of interventional research projects, are responsible for ensuring that there are appropriate and adequate archiving facilities in place, or contracted, to ensure that staff are able to comply with this procedure UoA and NHSG, as sponsors or co-sponsors of interventional research projects, are responsible for ensuring that there is a named lead archivist and named archive staff with documented responsibilities for overseeing the archive process. The QA Manager is responsible for ensuring that the Sponsor archives their files along with the Investigator TMF and Pharmacy file (if appropriate) at the end of the trial in their entirety. 5.2 CHIEF INVESTIGATOR Chief Investigator s (CI) who conduct interventional research projects sponsored and/or co-sponsored by UoA and NHSG are responsible for ensuring that interventional research projects data is archived in accordance with this SOP It is the responsibility of the CI to ensure that interventional research project data is not destroyed prior to the end of the agreed retention period; nor should they be kept for longer than stated in the application to the REC, which gave the trial a favourable opinion and the funder s obligations for retention. It must be ensured that sponsor requirements are complied with and this may require the CI to communicate any changes in the original application to the REC The CI is responsible for ensuring that research interventional research project data is made available for audit or inspection on request, during the agreed archive period. The named lead archivist and/or QA Manager (or delegate) is responsible for ensuring that clinical research data is retrieved from the archive (or contractor) in a timely manner and returned to the CI If a CI leaves their post and moves to another area, they are responsible for appointing a named local delegate with responsibility for ensuring that the clinical research data continues to be retained and is destroyed at the agreed time. The CI/PI must inform the sponsor of the change in responsibility. See SOP-QA-24 Managing a Change in CI of a CTIMP. 5.3 ARCHIVE STAFF The named lead archivist and archiving team are responsible for ensuring that that interventional research projects data is stored securely in approved archive facilities which have appropriate environmental conditions, vector control, controlled access and that records of data location are maintained The named lead archivist and archiving team are responsible for ensuring that removal, request for review, re-location and/or return of clinical research data held in the archive is appropriately authorised and adequately documented, and that any data removed Page 4 of 10

5 from the archive is returned to the archive in a timely manner The named lead archivist and archiving team are responsible for ensuring that destruction or disposal of clinical research data held in the archive is appropriately authorised and adequately documented. 6. PROCEDURE 6.1 ARCHIVING PLAN Retention periods should be documented in the application to the REC from which a favourable opinion of the trial is sought. All essential documents and data from CTIMPs must be retained for twenty-five years after the conclusion of the research project, unless subject to any other third party obligations e.g. funder s terms and conditions. All other studies should be archived for a minimum of ten years after completion of the research Archiving arrangements, including a retention schedule, shall be agreed and documented between the Sponsor(s) and CI at project set up. It is expected that retention periods defined within the archiving plan will usually be applied without a need to extend data retention periods It is essential that arrangements are made to ensure that patient medical records and the source data held within are retained throughout the archiving period. Within NHSG it is policy for the medical records of adults to be destroyed 6 years after the last hospital attendance of an individual or 3 years after death. In order for records to be retained, it is essential that the medical records of all patients involved in an interventional research project are marked by placing an adhesive sticker to the pink sheet of the patient medical record. The minimum information that these stickers should document are: Short trial title. Trial ID number (NHSG R&D, Ethics Reference and EudraCT number). Name of local investigator. Name of department and contact number. Retention date If essential documents and data are required to be kept for a longer period of time than originally stated, it is the responsibility of the CI to seek agreement from the appropriate body/authority (e.g. ethics committee, funder and/or sponsor) to extend the retention period of the archived material For multicentre interventional research projects, the CI must determine where the site file (ISF) and other associated essential interventional research data shall be archived. This may be at site or it may be returned to Sponsor for archiving with the TMF. This information should be documented in the TMF. Where the Site is responsible under the terms of any regulations, guidelines or Page 5 of 10

6 delegation under the Protocol for archiving medical records, primary data, information or data emanating or received by them during or after the course of the Study, the Site shall comply with all of its obligations. In the delegation schedule to the agreement the sponsor usually delegates responsibility for archiving of Site File and source documentation in a secure location, with oversight by the trial manager/ctu (if appropriate). 7. ARCHIVING PROCESS 7.1 At final publication the CI, or delegate, shall contact the archiving team in the first instance. (See Appendix 1). For hosted studies the sponsor remains responsible for archiving. The PI shall check the contract to establish if archiving has been delegated from the sponsor. 7.2 ARCHIVING ELECTRONIC DATA If retained on a computerised system, electronic data files shall be held on a UoA or NHSG secure networked server. Data files should be locked in a read only format, so that they cannot be altered or deleted, with access restricted to those authorised to view them. This should be documented in the TMF. Assistance may be required from the appropriate IT teams If copies of data are backed up onto an intermediate storage medium, these shall be placed in the main archive along with the other clinical trial documents. If an intermediate storage medium is being used, consideration should be given to the shelf life of the storage medium and its future accessibility and readability. 7.3 ACCESS TO ARCHIVED DATA For UoA sponsored or co-sponsored Interventional Research Projects; access to archived trial documents should be arranged through the archive team, Health Sciences Building, UoA. The Archive Retrieval Form (TMP-QA-34) should be completed For NHSG sponsored Interventional Research Projects; access to archived trial documents should be arranged through the QA Team. For access to hosted studies; access to archived trial documents should be arranged through the QA team. 7.4 DESTRUCTION OF ARCHIVE DATA Prior to the end of the allotted archiving period, the CI will be contacted by the archiving team, or QA Team to arrange for the review of documents. They will be asked to complete the Archive Review Notice (TMP-QA-36). The destruction or retention of documents should be discussed between Lead Archivist (or delegate) and CI. Page 6 of 10

7 7.4.2 Once agreed, the destruction of archived documents from CTIMPs sponsored and/or co-sponsored by UoA and archived within the HSB will be coordinated by the archiving team. Destruction of archived documents from CTIMPs sponsored by NHSG will be coordinated by the QA Team. Page 7 of 10

8 SOP-QA-32 - APPENDIX 1 - CONTACT DETAILS TYPE OF INTERVENTIONAL RESEARCH STUDY SPONSORED OR CO- SPONSORED HOSTED, COMMERCIAL AND NHSG SPONSORED NAMED GCP ARCHIVIST Gary Cooper QA Manager Rowett Institute of Nutrition and Health University of Aberdeen g.cooper@abdn.ac.uk ARCHIVE FACILITY Health Sciences Building (HSB) Removal Services Scotland (RSS) Off-Site LOCATION OF ARCHIVE FACILITY Foresterhill Aberdeen AB25 2ZD 6 Oakbank Park Place Oakbank Industrial Estate Livingston West Lothian EH53 0TN ARCHIVIST CONTACT DETAILS Technical Resource Manager Health Sciences Building University of Aberdeen clsmarchive@abdn.ac.uk Tel Quality Assurance NHS Grampian Research & Development grampian.randd@nhs.net Tel ARCHIVING FORMS AVAILABLE FROM: calresearchgovernance/ Quality Assurance NHS Grampian Research & Development grampian.randd@nhs.net Tel Page 8 of 10

9 SOP-QA-32 - APPENDIX 2 - ARCHIVING PROCESS SUMMARY REQUESTING INPUT INTO THE ARCHIVE Ensure that your data is ready to be archived. Check with your Head of Department (if appropriate) and Sponsor. Contact the archive team to obtain archive boxes, (contact details available Appendix 1). Download/request relevant Archive Approval Form (see Appendix 1). Enter details in all required fields with as much information as possible. Pack up contents in specified box(s) (removing plastic polypockets, ring binders etc). Place the large label on the smallest side of the box and the associated barcodes (for offsite archiving only) on the Archive Approval Form. Insert one copy of the form in each box, keep one copy for your own records and send one copy of each form to the archivist contact. Once the form has been completed liaise with the Archivist Contact (see Appendix 1) who shall issue archive identity labels. On receipt of completed forms the Archivist Contact shall contact the University Porters or RSS (as applicable) to arrange the uplift of the box(s). The Archivist Contact shall contact the department to inform them of the uplift day/date. Please note that the HSB Archive or RSS will not accept any items into their facility without prior authorisation from the archivist contact. ARCHIVE RETRIEVAL If an archived study or part thereof is required to be withdrawn from the archive for a period of time, the CI/PI/Named Contact Person MUST complete an Off-Site Archive Retrieval Form which can be obtained as per Appendix 1 The form should then be returned to the archivist contact who will arrange for the boxes to be returned to the CI/PI/Named Contact Person within 10 working days of receipt of the written request. Page 9 of 10

10 PLEASE NOTE For CTIMPs: Retrieved boxes can be kept for up to 4 WEEKS before they should be returned to the archive. If required for a longer period a request should be made to the Lead Archivist/archive contact. For Non-CTIMPS: Retrieved boxes can be kept for up to 3 MONTHS before they should be returned to the archive. If removed material or part thereof is not to be returned to the archive in the allocated timeframe then this MUST be reported to the archivist contact with details listed on the retrieval form. The contents list must be updated and signed; one copy in the box and one copy to archivist contact. RETENTION DATE REVIEW AND DISPOSAL When a project is due for review (i.e. the retention period specified at the time of initial archiving has elapsed) then the PI/Named Contact Person will be notified by the archiving team. The PI/Named Contact Person should decide whether to: (a) Archive the data for a further period of time or, (b) Securely dispose of the data The CI/Named Contact Person should complete and sign the Archive Review Form. In some cases an confirmation of the disposal of the boxes can be used as authorisation for the disposal of study material. The will be attached to the form. In exceptional circumstances, a CI/Named Contact Person may request that the data is returned to them. This represents a transfer of custody back to the individual CI/Named Contact Person. This shall be recorded on the Archive Retrieval Form (TMP-QA-35) and research governance shall be informed. Page 10 of 10