SOP-QA-32 V2. Document History Version Description of update Date Effective 1 Change of number for Q-Pulse

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1 Title: Effective Date: Review Date: Author: Gary Cooper, Named Archivist QA Approval: Richard Cowie, QA Manager Approver: Prof Maggie Cruickshank, R&D Director Approved by QA: N/A Document History Version Description of update Date Effective 1 Change of number for Q-Pulse Clarification of files and responsibilities of QA Manager at 1.2, Change to responsibilities of archiving team at 7.4 Addition of associated documentation at 3 2 Reformatted Revised labelling requirements at to match SOP-QA-36 Clarification of archiving plan at 3.4 Clarification of data storage on intermediate storage medium at 3.12 Maximum weight of archive boxes for RSS at Appendix Scope 1.1 This document applies to all researchers, archive and Sponsor staff participating in interventional research projects sponsored or co-sponsored by University of Aberdeen (UoA) and/or NHS Grampian (NHSG) and any hosted studies. It may also be used for archiving of any research data. 1.2 This SOP may also be used by staff from other NHS areas, or organisations, with prior agreement. 2. Responsibilities Archive team Chief Investigator (CI) Sponsor QA Manager Ensure data is stored securely, retrieved and destroyed appropriately. Ensure research data is archived and not destroyed before the agreed date nor retained longer than stated in the REC application & funder s obligation. Ensure research data is available for audit and inspection as appropriate. Inform Sponsor if there is to be a change in CI. Ensure sufficient archiving facilities are available and a suitable named archivist is identified. Ensure Sponsor archives their files appropriately with the TMF 3. Procedure Introduction 3.1 Clinical research documents are those which are contained within the Sponsor TMF, Investigator TMF (held by the CI), site files, (if appropriate and held by the PI) and pharmacy file (held by the Clinical Trial Pharmacist). All component parts of the TMF must be archived by the end of the trial (after final publication) although individual teams may archive completed sections once that activity is complete (see SOP-QA-31 Research project closure). Page 1 of 5

2 3.2 Research project data may be generated in electronic and/or paper form. Source documents may be original documents, data, and records (eg hospital records, clinical and office charts, laboratory notes, memos, participant diaries, 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, the laboratories and medico-technical departments involved in the clinical trial). 3.3 For Clinical Trials of Investigational Medicinal Products (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. 3.4 Retention periods shall be documented in the application to the Research Ethics Committee (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 eg funder s terms and conditions. All other studies should be archived as stated in the protocol, or for a minimum of ten years after completion of the research. 3.5 arrangements, including a retention schedule, shall be agreed and documented between the Sponsor and CI at project set up. It is expected that retention periods defined within the archiving plan shall usually be applied without a need to extend data retention periods. 3.6 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. These stickers shall document the following: Patient name CHI number Research study Do not destroy until Contact Signature 3.7 If essential documents and data are required to be kept for a longer period than originally stated, it is the responsibility of the CI to seek agreement from the appropriate body/authority (eg REC, funder and/or Sponsor) to extend the retention period of the archived material. 3.8 For multicentre interventional research projects, the CI must determine where the site file 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 shall be documented in the TMF. Where the site is responsible under the terms of any regulations, guidelines or delegation in the protocol for archiving medical records, primary data or information or data emanating or received Page 2 of 5

3 by them during or after the course of the study, the site shall comply with all of its obligations. 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). process 3.9 The named archivist and the archive team are responsible for ensuring that the integrity of all archived data in their custody is protected. The archive team shall ensure there is controlled access, pest control and that appropriate authorised records are maintained of all removals, requests for review, relocation and/or return 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. electronic data 3.11 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 stored on 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. Access to archive data 3.13 For UoA sponsored or co-sponsored Interventional Research Projects; access to archived trial documents shall be arranged through the archive team, Health Sciences Building, UoA. The Archive Retrieval Form (TMP-QA-35) must 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 shall be arranged through the QA team. Destruction of archive data 3.15 Prior to the end of the allotted archiving period, the CI (or delegate if no longer available) shall be contacted by the archiving team, or QA Team, to arrange for the review of documents. They shall be asked to complete the Archive Review Notice (TMP-QA-36). The destruction or retention of documents shall be discussed between the named archivist, or delegate, and CI, and if appropriate the Archive Destruction form (TMP-QA-37) completed Secure destruction of archived documents from studies sponsored and/or co-sponsored by UoA, and archived within the HSB, shall be co-ordinated by the archiving team. Destruction of archived documents from studies sponsored by NHSG shall be co-ordinated by the QA Team (see TMP-QA-37 - Archive Destruction form). 4. Abbreviations and definitions CHI number Community Health Index (a unique ten digit identifier for NHS patients) Page 3 of 5

4 5. Related documentation and references SOP-QA-32 Appendix 1 SOP-QA-24 SOP-QA-31 TMP-QA-34 TMP-QA-35 TMP-QA-36 TMP-QA-37 process summary Managing a change in CI of a CTIMP Research project closure Archive approval form (HSB and RSS) Archive retrieval form (HSB and RSS) Archive review notice (HSB and RSS) Archive destruction form (HSB and RSS) 6. Archive contact details University of Aberdeen Sponsored and co-sponsored studies are archived on-site: Health Sciences Building, Foresterhill, Aberdeen. Contact: Named Archivist: clsmarchive@abdn.ac.uk NHS Grampian Sponsored, Hosted* and commercial studies* are archived off-site: The Box Vault, Removal Services Scotland (RSS) Contact: Quality Assurance Team, Research & Development, Foresterhill House Annexe, Aberdeen. grampian.randd@nhs.net or * Hosted and commercial study Sponsor may request studies are returned to them for archive or may arrange for off-site archiving. Consult with the study Sponsor as appropriate. Page 4 of 5

5 SOP-QA-32 Appendix 1 process summary Requesting input into the archive Check with your Head of Department (if appropriate) and Sponsor that data is ready for archive. Contact the archive team or QA team to obtain archive boxes (see 6). Download/request Archive approval form (TMP-QA-34). Enter details in all required fields with as much information as possible. Once the form has been completed liaise with the appropriate contact (see 6) who shall issue archive identity labels. Pack contents into specified box(s). For RSS the weight for each box must not exceed 16 Kg. Place the large label on the smallest side of the box and the associated barcodes (for off-site 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. Seal the archive box with appropriate tamper evident security tape (available from Sponsor). On receipt of completed forms the contact shall direct the University Porters or RSS (as applicable) to arrange uplift and confirm with the researcher the date and time agreed. Archives will not accept items without prior authorisation from the archivist contact. Archive retrieval If an archived study (or part) is required to be withdrawn from the archive for a period of time, the CI/PI/Named Contact Person shall complete an Archive retrieval form (TMP-QA-35). The form should then be returned to the archivist contact who will arrange for the box(s) to be returned to the CI/PI/Named Contact Person within 10 working days of receipt of the request. CTIMPs: Retrieved boxes can be kept for up to four weeks before they should be returned to the archive. If required for longer a request should be made to the named archivist/archive contact. Non-CTIMPS: Retrieved boxes can be kept for up to three months before being returned to archive. If removed material, or part thereof, is not to be returned to the archive in the allocated time frame then this shall be reported to the archivist contact with details listed on the retrieval form. The contents list must be updated and signed; one copy placed in the box and one copy sent to archive contact. Retention date review and disposal When a project is due for review (ie the retention period specified at the time of initial archiving has elapsed) the PI/Named Contact Person shall be notified by the archiving team. The PI/Named Contact Person shall confirm disposal or archive of the data for a further period. The CI/Named Contact Person shall complete and sign the Archive Review Notice (TMP-QA-36). confirmation of the disposal can be used as authorisation for the disposal of study material. The shall be printed and attached to the notice. 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 5 of 5