University Hospitals Birmingham NHS Foundation Trust CONTROLLED DOCUMENT RDS014 Research Related Archiving CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Version Number: 1 Controlled Document Sponsor: Controlled Document Lead: Approved By: Procedure Governance Insert brief summary of purpose of document RDS014 Head of R&D Governance Research Governance Facilitator R&D Committee On: Sept 2014 Review Date: Sept 2017 Distribution: Essential Reading for: Information for: Research Archivist, Study Archivist, Investigators and Key Researchers All staff involved in research conducted at the Trust
Version Control Log: The table below provides an overview of the summary of changes from previous version of an SOP. Where no previous version exists there will be no summary of changes on record. Version Summary of changes Review date number 1 N/A initial release Sept 2017 RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 2 of 21
Table of Contents Table of Contents... 3 Abbreviations & Definitions... 3 1. Purpose... 4 2. Scope... 4 3. Procedure... 6 3.1. Study Set Up... 8 3.2. Archive Plan... 9 3.3. During the Study... 10 3.4. Study Closure - When to Archive... 10 3.5. Ordering supplies... 10 3.6. Duration of Retention... 11 3.7. What to archive... 12 3.9. Preparing Documents and Electronic Data for Archive... 12 3.11. Archive Facilities... 17 3.13. Retrieval... 18 3.14. Destruction... 19 4. Quality Records... 20 5. Templates... 20 6. References... 20 Abbreviations & Definitions Term/ Abbreviation CI CRFs CTIMP ECG IMP MHRA PI R&D REC Research Archivist SOP Study Archivist TRUST Definition/ Description Chief Investigator Case Report Forms Clinical Trial of Medicinal Product Electrocardiogram Investigational Medicinal Product Medicines and Healthcare Products Regulatory Agency Principal Investigator Research and Development Research Ethics Committee Archive point of contact appointed within R&D Governance responsible for overseeing the implementation of study specific archive plans and acting as a point of contact between the off-site archive company and Study Archivist. Standard Operating Procedure Delegated archivist appointed within the research team responsible for preparing documents and data for archiving and ensuring archive plans are in place. University Hospital Birmingham RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 3 of 21
1. Purpose 1.1. The purpose of this SOP is to describe the process for on site and offsite archiving of documents relating to research studies that are conducted at the Trust. 1.2. This procedure will ensure; 1.2.1. Information is stored correctly 1.2.2. Information is accessed in line with Trust policies and procedures (see The Trusts Document Management Policies and Procedures) 1.2.3. Protection of sensitive data 1.2.4. Staff awareness of responsibilities and accountability 1.2.5. Information is accessible when required 1.2.6. A standardised approach to archiving 2. Scope 2.1. This procedure applies to all research studies. For the purposes of this archiving procedure research studies fall into one of the three categories and the procedure is applied differently according to the category of the study. The categories are: 2.1.1. All Trust-sponsored research studies 2.1.2. Externally-sponsored research studies where there is a contractual responsibility for the Trust to archive. In these circumstances the External Sponsors processes, if complete, regarding archiving must also be followed. This SOP will make it clear what process needs to be adhered to in these circumstances. 2.1.3. Externally-sponsored research studies where there is no contractual responsibility for the Trust to archive. 2.2. For the last category (see 2.1.3) where the Trust has no contractual responsibility for archiving, the Sponsor is responsible for the archiving arrangements and the study team should follow the Sponsor s processes. If the External Sponsor requires the research study to be archived by the Trust then on site archiving will be arranged according RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 4 of 21
to the Trust-wide Document Archiving Procedure (Controlled document number 587). 2.3. Any reference to Externally Sponsored research studies in the remainder of this SOP will be referring to those where there is a contractual responsibility for the Trust to archive. 2.4. Any reference to all research studies will mean those in categories 2.1.1 and 2.1.2. RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 5 of 21
3. Procedure RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 6 of 21
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3.1. Study Set Up 3.1.1. The Chief Investigator (CI) for Trust sponsored studies and the Principal Investigator (PI) for externally sponsored studies will have overall responsibility for the archived study documentation, data and materials. 3.1.2. When a research study is being setup it is the responsibility of the CI for Trust sponsored studies and the PI for externally sponsored studies to ensure that a named Study Archivist is appointed for the research study who will be responsible for archiving study documentation and data. This person must be named on the delegation of duties log and the archive plan and will be responsible for liaising with the R&D Governance Research Archivist when the study is ready to be archived and will make the necessary arrangements for the documents and data to be prepared for archive. 3.1.3. The CI (or PI for externally sponsored studies) should ensure an archive plan (see section 3.2) has been agreed by the Sponsor and documented at study set up/start up, these should cover the duration of the archive (see section 3.6). 3.1.4. For Trust sponsored studies the template RDT025 available from the R&D Governance Research Archivist outlines what should be included in an archive plan. Externally sponsored studies must follow their sponsors archiving plans. 3.1.5. For externally sponsored studies archiving responsibilities delegated to Trust by the Sponsor must be clearly defined and documented within the contractual agreements between the Sponsor and the Trust. Funding for archiving must be secured at this stage, this should cover the costs for archiving off-site and any supplies that may be required (e.g. boxes, paper wallets or sleeves, labels). RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 8 of 21
3.2. Archive Plan 3.2.1. The archive plan should cover the following: a) Which documents and data will be sent for archive, this should include any plans for archiving electronic records b) Timelines for the set up of archive and retention of the study data and associated documentation, bearing in mind the applicable regulations and The Data Protection Act 1998. c) The appointed Study Archivist to be responsible for archiving the study on completion/ termination and for the duration of the retention period. d) Instructions for preparation of the study files for archive, e.g. ordering of archive boxes, box labels and the preparation of inventory lists to ensure archived data can be retrieved for audit. e) Selected location for archive (see section 3.11) including details of any off-site archive companies, if applicable, that are secure with appropriate environmental controls and adequate protection from fire, flood and unauthorised access. f) Costs associated with archiving, in particular where archive companies are involved and who will be responsible for covering the costs. g) Dates of destruction of the archived documentation and data (see section 3.14). 3.2.2. For Trust sponsored studies the CI will ensure a copy of the archive plan is sent to R&D Governance Research Archivist and the R&D Governance Research Archivist will prompt for the archive plan and any updates to the plan, where required, at various stages of the study 3.2.3. For externally sponsored studies the archive plan should be provided by the sponsor. The PI is responsible for ensuring any procedures and plans provided by the sponsor are made available to the delegated Study Archivist and key members of the research team. RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 9 of 21
3.2.4. Where external sponsor has arranged archiving off-site their procedures must be followed. The PI is responsible for ensuring the Study Archivist has a copy of information provided by the Sponsor. 3.3. During the Study 3.3.1. Following start up for both Trust and externally sponsored studies the Research Team is responsible for communicating any changes to key members of the team responsible for archiving to R&D Governance (RDS004 and RDS013). 3.3.2. Contract addendums or amendments affecting archive arrangements may take place during the study and should be agreed by all parties responsible (RDS010 and RDS013). 3.4. Study Closure - When to Archive 3.4.1. The study may not be archived immediately at the time it is declared finished if data analysis requiring access to study files is ongoing. Archiving can take place some time after the end of study has been declared as long as the documentation is not required, except for audit or regulatory inspections. 3.4.2. The point at which such documentation and data are archived may be after any articles based on that piece of research have been published. 3.4.3. Once the CI (or PI for externally sponsored study) is ready to archive the study the Study Archivist should begin preparing the documents for archive as per sections 3.9 and inform the R&D Governance Research Archivist. 3.5. Ordering supplies 3.5.1. The Study Archivist is responsible for ensuring supplies are ordered for the study files to be prepared for archive long term. 3.5.2. Archive boxes may be ordered via the R&D Research Archivist. The Study Archivist must perform a review of the documents and RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 10 of 21
inform the R&D Research Archivist of the exact number of boxes required to avoid surplus boxes being ordered. 3.5.3. Individual sponsors will be invoiced for the archive materials and number of boxes archived for each study; therefore files relating to different studies may not be archived together in one box as the funding arrangements may differ. 3.5.4. Other supplies such as tags, archive labels, paper files and tamper proof tape may be ordered via stationary. 3.6. Duration of Retention 3.6.1. For all studies the Sponsor is responsible for determining the duration of archiving and retention of documentation and data, taking the following into account: a) The type of study (e.g. CTIMP for regulatory submission) b) Regulatory requirements at the time that a study is ready for archiving c) Statements included in the protocol or other submissions. NB: Where the Trust is Sponsor this responsibility has been delegated to the CI. 3.6.2. A minimum period should be allowed to ensure that all queries are answered and study related paperwork and data collected. 3.6.3. If CTIMPs are to be included in regulatory submissions then study specific essential documents and data should be retained until at least 2 years after the last approval of a marketing application to the EU (where appropriate). 3.6.4. Medical files of research subjects shall be archived for at least 5 years after the end of the trial in accordance with SI 1928/2006.The timeframes may be longer than the specified 5 yrs (or 15 yrs for CTIMPs) if requested by the Sponsor, funder or regulatory bodies. 3.6.5. During the retention period the documents and data must be readily available to a licensing authority on request and must be complete and legible. RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 11 of 21
3.7. What to archive 3.7.1. For CTIMPs sponsored by the Trust, the following should be archived: a) The Trial Master File, which includes: i) Essential documents relating to the conduct and management of the study from beginning to end ii) Local site files iii) CRFs iv) Pharmacy site file v) Sponsor file vi) R&D File vii) Any additional documents that may be required as part of an audit trail of a process in relation to the CTIMP viii) Any source data documents that are not part of a participants medical notes b) For Non-CTIMPs sponsored by the Trust: i) Local site files ii) Case Report Forms (CRFs) iii) Sponsor File iv) R&D File v) Any additional documents that may be required as part of an audit trail of a process in relation to the CTIMP vi) Any source data documents that are not part of a participants medical notes 3.8. For externally sponsored research studies the Sponsor will determine what it requires to be archived for both CTIMP and Non-CTIMP studies: 3.9. Preparing Documents and Electronic Data for Archive 3.9.1. The steps below provide guidance to the delegated Study Archivist on preparing documents for archive; a) All metal clips should be removed as metal rusts over time and may damage the record. RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 12 of 21
b) Documents must be removed from all plastic wallets to avoid the ink being rubbed off onto the plastic. c) Documents must be re-filed in paper files or wallets and then placed within the archive boxes; these may be ordered via the Research Archivist. 3.9.2. For details on inventory lists and labelling see section 3.10. 3.9.3. Handling Source Data a) All data queries must be fully resolved before the study is archived. b) Where applicable for electronic data a database lock may be required prior to data analysis (see section 3.9.5). c) Source Data that is part of current medical records: i) For all studies, Source Data (paper or electronic) that form part of current medical records (e.g. ECGs, lab test results) should remain with the medical records and a note detailing the location of these included with the archived documents. ii) ECG printed results should be photocopied and the copy retained in the patient notes (as original ECG results can fade quickly) or scanned into Clinical Portal for electronic medical records. d) Case Report Forms (CRFs): i) All CRFs should be removed from their binder, if applicable and filed with individual patient packs. ii) Documents relating to participant visits should be in chronological order, with the earliest visit at the top. iii) These can then be filed into the archive box in individually labelled envelopes or paper files. iv) One copy of the current blank CRF should be retained if possible. v) Duplicate copies of source data document should not be archived with study documents. RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 13 of 21
3.9.4. Pharmacy Documents and IMP a) For CTIMPs only original pharmacy prescriptions are to be included as part of the archived pharmacy file. b) Duplicate copies should not be archived with the site file essential documents and should be destroyed at the time of archiving. c) For further details on IMP handling and management refer to the Pharmacy IMP Management Procedure. 3.9.5. Electronic Data a) It is the responsibility of the CI (Trust Sponsored) /PI(externally sponsored) to notify the Study Archivist as soon as known that electronic study data will need to be archived. b) The Study Archivist must document within the Archive Plan any data that is to be archived electronically and where this will be held. c) Electronic data should be encrypted and copied onto a read-only media device for archiving with the study documents, a copy of this will also be held electronically backed up on Trust servers. d) Electronic data must be backed up onto secure servers. e) Any data transfers must be done via an encrypted source. f) Electronic media onto which data has been backed up must be access controlled (e.g. password controlled login) and stored securely, the selected media should be unlikely to become obsolete during the planned storage. g) Archived data should be transferred to a newer more appropriate media or incorporated into paper format if necessary. h) Portable storage devices such as memory sticks may not be used to hold electronically archived data due to the risk of them being lost or stolen. RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 14 of 21
i) Consideration must also be given to the software or hardware requirements in order to maintain readability of the data for the planned archive period. j) Study data held on computer servers should then be permanently deleted as soon as the study has been reported and the participants notified of the results, this is the responsibility of the CI/PI. k) For any electronic data that remains online, the CI is responsible for ensuring a procedure for data lock and prevention of unauthorised access is in place. l) Future access to such data should be controlled by the Study Archivist, who should maintain a log of access requests as with the paper archive. 3.9.6. Electronic Materials: a) Where the archive of electronic materials such as CDs, discs, tape and memory cards (as appropriate) is required the following considerations should be taken into account: i) There should be adequate resource available at the site to be able to access information held on the electronic media for the duration of archive (e.g. CD drives) ii) The media should be packed in a way to prevent damage or exposure to dampness, excessive heat or the elements. iii) Ideally they should be packed separately to the documents to avoid any situations where plastic could damage the paper. b) Where possible data held on such materials should be backed up and archived electronically with Sponsors approval. RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 15 of 21
3.10. Inventory Lists and Labelling 3.10.1. For each archived study the delegated Study Archivist will prepare a list detailing what has been included in the archived study documents (see template RDT026). 3.10.2. Due to the varying nature of each study; guidance on lists may be provided by the R&D Research Archivist on a study by study basis upon request. 3.10.3. A copy of these lists will be archived with the archive boxes and a copy retained on site with the R&D Research Archivist and Study Archivist to facilitate the retrieval process. 3.10.4. The Trust has a template for an `Archive Box Label available for on and off-site archiving which provided by the Research Archivist to the researchers responsible for preparing individual studies for archive. 3.10.5. The Study Archivist responsible will label each Archive Box with: a) The box number and how many boxes there are (e.g. 1 of 5, 2 of 5) b) Contact number of the Trust R&D Governance Office c) The study RRK reference d) Date of Archiving e) Expected end date of archiving 3.10.6. The study specific inventory list will document the content of each Archive Box. 3.10.7. Two identical labels must be prepared for each box, one for the outside of the box and one to be archived inside the box, as the outer label may fade over time. 3.10.8. Once final checks have been performed by the Study Archivist the boxes may be sealed using tamper proof tape. 3.10.9. Once the boxes are ready the R&D Research Archivist will arrange for them to be sent to the archive facility (see section 3.11) and will update the R&D database to log the following information: a) The archive box number RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 16 of 21
b) Where the documents have been archived c) The number of actual archive boxes per study d) The date of archive e) The timeframe of archive f) The expected end date of archive. 3.11. Archive Facilities 3.11.1. Where the documents are to be archived will depend on whether the study is a externally sponsored study, a trust sponsored CTIMP study ora Trust sponsored non-ctimp study. This section sets out what the archive facilities are for each type of study. 3.11.2. Trust sponsored Non-CTIMP study a) Non-CTIMP studies sponsored by Trust and study specific data that is to be archived on site will be archived as per the Trust wide on site Archiving Procedures (see section 3, figure 2). b) The delegated Study Archivist will provide an inventory and location of the archived study to the R&D Research Governance Archivist for Sponsor records. Where such documents are required for inspection the Study Archivist will inform the Research Archivist of when the documents have been retrieved and returned to their location. 3.12. Trust sponsored CTIMP studies and externally sponsored research studies: a) The Trust has a contract in place with a commercial offsite archiving facility for the archiving of study documents for Trust sponsored CTIMPs and externally sponsored studies. b) The Trust R&D Governance team will periodically audit the facility to ensure they meet all requirements of being secure, with appropriate environmental controls and adequate protection from fire, flood and unauthorised access. RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 17 of 21
c) This audit may take place once every 2 years (or as required) either by site visit or by confirmation from the company of accreditation via BSI or MHRA inspections. d) R&D Governance will retain copies of any applicable certificates of accreditation the company has. e) The commercial company Archivist shall be provided with details of named Investigators or Study Archivists who will have authorisation to access their study files and data, in order to ensure controlled access. f) The commercial company Archivist will inform R&D Governance Research Archivist when/if the files are accessed by the named Investigators and when they are returned to archive. R&D Governance will keep a record of all such requests. g) If an alternative facility has been agreed during the NHS Permission process this can be used. 3.13. Retrieval 3.13.1. For trust and externally sponsored studies any Investigator wishing to retrieve study documentation must submit this request through the R&D Research Archivist; the appointed Study Archivist may contact the R&D Research Archivist on behalf of the Investigator. 3.13.2. The Study Archivist will keep a log of who has requested access to the archive, for what purpose and what documents were included in or removed from the archive. 3.13.3. Process for retrieval from on-site facility: a) For Trust sponsored studies archived on site the Study Archivist should liaise with the Research Archivist. b) The Research Archivist will ensure that all R&D records relating to the document being retrieved are maintained and kept up to date to ensure the document is tracked while it is on site. RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 18 of 21
c) Once returned to archive the Research Archivist and Study Archivist will ensure all records are updated to reflect when the document was returned to archive and whether there have been any changes to the retention requirements. 3.13.4. Process for retrieval from off-site facility: a) Study Archivist or Investigator to submit the request to the R&D Research Archivist. b) Research Archivist will liaise with point of contact at the off-site facility to request retrieval providing relevant information from the inventory list. c) A chain of custody form will be completed to ensure the document retrieved is tracked. d) All records relating to the document or box while it is onsite will be updated to reflect its current location. e) Once the document or box is no longer required it will be returned to archive via the Research Archivist. f) The Study Archivist will ensure that checks are performed; the document is repacked as per section 3.9, and returned to the Research Archivist. g) The Research Archivist will contact the off-site archive facility point of contact and ensure that all records (including the chain of custody form) relating to the return of the document or box has been updated. 3.14. Destruction 3.14.1. Studies Archived off-site: a) On the defined destruction date the archive company will contact Trust s Research Archivist for confirmation that the box may be destroyed. b) The Trust s Research Archivist working alongside the Study Archivist will ensure that authorisation for destruction or if necessary an extension to the duration of archiving is RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 19 of 21
obtained from the external Sponsor or CI (for trust sponsored studies). c) Once confirmed that the box may be destroyed the Research Archivist will inform the archive company of this. d) The archive company will provide confirmation of destruction to the Research Archivist who will update the R&D archive inventory accordingly. 3.14.2. Studies Archived on-site: a) For studies archived on site the responsible Study Archivist should liaise with the Sponsor point of contact, usually the CI or the named sponsor representative as indicated on the IRAS form, for confirmation on whether the documents should be destroyed or whether an extension is required to the retention period. b) Once the Sponsor has authorised the destruction the files may be removed from storage and destroyed as per Trust procedures. 4. Quality Records 4.1. Study specific Archive Plans 4.2. Archive agreements 4.3. Archive lists 5. Templates 5.1. Archive Box label 5.2. Archive Inventory List 5.3. Chain of custody form 6. References 6.1. With special thanks to the Alliance Trust for allowing their SOP RDS011 to be referenced. 6.2. The Medicines for Human Use (Clinical Trials) Regulations: SI 2004/1031 as amended 6.3. The Data Protection Act 1998 RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 20 of 21
6.4. ICH GCP E6 Guideline for Clinical Practice RDS014: Research Related Archiving; SGS; 28 Apr 2014 Page 21 of 21