SOP08: Standard Operating Procedure for Archiving at Trial Closure

Transcription

1 SOP08: Standard Operating Procedure for Archiving at Trial Closure Authorship Team: Sarah Gaze, Mel Storey & Ian Russell for Joint SOP Group on Trial Administration (viz Angela Evans, Hayley Hutchings, Kathy Malinovsky, Anne Seagrove) Approved by WWORTH JMG (Ian Russell in chair) Signature Date 0 Version Record Version Number Effective Date Reason for Change 0 16 Jan 2009 Derived from SOP developed by NWORTH Apr 2009 Reviewed by JSOPG on 23 April Jun 2009 Amendments by SG Jul 2009 Amendments following review by SS Jul 2009 Further amendments following review by JSOPG 18 July Jul 2009 Final amendments following review by development group Jul 2010 Approved in principle at JMG May 2010 Minor formatting amendments Sept 2011 SOP prepared for JSOPG.MS. Examples in practice ENIGMA, PROBAT, STEPWICE Oct 2010 Revised following JSOPG meeting and discussion with ITR Dec 2010 Further revision following JSOPG review meeting Jan 2012 Further amendments SG/MS Feb 2012 Further amendments ITR Mar 2012 Further amendments MS Apr 2012 Authorised for use by JEG May 2013 Minor formatting amendments Feb 2014 Amendments to 6.4, minor formatting SG/MS Mar 2014 Amendments following JSOPG meeting, comments from ABMU and examples in practice (SAFER 2) Apr 2014 Further amendments following JSOPG review May 2014 Remove training log post JSOPG discussion, including JSOPG comments - MS & CS WWORTH-SOP08ArchivingV Page 1 of 16 Not guaranteed if printed

2 1 Table of Contents 0 Version Record Table of Contents Glossary Introduction Purpose Roles and Responsibilities Procedure General principles Procedure flow chart Duration of archive Storage arrangements Security At WWORTH Process for access Process for destruction Training Plan References Related SOPs Appendices Appendix 1: Site Archive Record of a Trial adopted by WWORTH Appendix 2: WWORTH Archive Record of a Clinical Trial Appendix 3: WWORTH Archive Retrieval Log Appendix 4: Label for boxes or files of material archived at WWORTH WWORTH-SOP08ArchivingV Page 2 of 16 Not guaranteed if printed

3 2 Glossary The full Glossary is in Swansea University H drive/documents/526- WWORTH/Development Group/Glossary. 3 Introduction Standard Operating Procedures (SOPs) are succinct formal documents designed to achieve consistency in specified trial functions by specifying standard practice in performing those functions (GCP 1.55 & EMeA, 2002). While SOPs should cite relevant legislation & regulations, and key references & evidence, they need not expound theory. WWORTH SOPs should accord with all relevant regulations, including the European Union Clinical Trial Directive, ICH Good Clinical Practice (GCP) and the current NHS Research Governance Framework. They will seek to distinguish between regulations for CTIMPs and for other research. This document forms part of the set of standard operating procedures of the West Wales Organisation for Rigorous Trials in Health - WWORTH. It identifies the roles, responsibilities and actions of the individuals involved in the process of archiving of trials, for both WWORTH and Abertawe Bro Morgannwg University Health Board (ABMU HB) It is a legal requirement for clinical trials of an IMP (CT IMPs) to adhere to the Medicines for Human Use (Clinical Trials) Regulations , which transpose the EU Clinical Trials Directive (2001/20/EC) 2 into UK law. As of August 2006, (following the implementation of the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006) 3, the regulations incorporate the European Commission Directive 2005/28/EC on Good Clinical Practice (GCP) 4 which includes detailed guidelines on archiving. Regulation 31A of the amended UK Regulations requires that sponsor and chief investigator shall ensure that the medical files of trial subjects and essential documents relating to that clinical trial are archived and retained for at least five years after the conclusion of the trial. As part of their clinical trial guidelines, the European Commission has issued detailed recommendations on archiving 5. For trials whose data may be required for a licensing application, it is recommended that these guidelines, together with those of Section 8 of the ICH GCP Guideline, are followed. The essential documents for a trial, as stored in the Trial Master File (TMF) at WWORTH (see WWORTH SOP03 Master Site File) or the Trial Site File (TSF) at trial sites, should be filed and archived in a way that facilitates management, monitoring, audit and inspection of the Trial. Archived hard copy and electronic WWORTH-SOP08ArchivingV Page 3 of 16 Not guaranteed if printed

4 documents should be readily retrievable and available for audit and inspection upon request. These documents individually and collectively a) enable both the conduct of the clinical trial and the quality of the data produced to be evaluated; and b) show whether the trial is, or has been, conducted in accordance with the applicable requirements of Clinical Trials Directive 2001/83/EC and the Commission Directive 2005/28/EC on GCP. 4 Purpose To define the process of archiving for trials managed by or adopted by WWORTH and ABMU HB. This SOP considers archives of source data documents and archiving of electronic data files at WWORTH, ABMU HB and their adopted trial sites. 5 Roles and Responsibilities The people responsible for using and implementing this SOP are as follows: The trial s Sponsor has overall responsibility for the integrity of a trial. If the Sponsor is Swansea University and WWORTH has adopted the trial, responsibility may be delegated to the Director of WWORTH. If the sponsor is the ABMU HB, the responsibility will rest with the R&D Department. The WWORTH Manager then has the doubly delegated responsibility of ensuring that archiving accords with the principles of GCP, notably Paragraphs & 12. He or she is responsible for managing the Archive Logs and access to, and integrity of, the archive storage area. He or she is also responsible for instructing PIs to destroy archives at the defined time and for keeping a record of destruction for five years. When ABMU HB is the Sponsor, the R&D Department named archivist will be responsible for arranging for storage and logs of archive documentation following the completion of a study. He or she will also arrange for the destruction of records, at the appropriate time, set by the Sponsor. It is the role of Trial Managers (TMs) (or Trial Co-ordinators (TCs)) in conjunction with Trial Data Managers (TDMs) to archive specific trials. TMs, if not personally responsible for the trial databases, are responsible for requesting copies of final raw and cleaned up databases from the TDM and the statistics files required for archive (Master sets and other syntax and analysis files, see WWORTH SOP28 Statistics) from the trial statistician for storage in the WWORTH or ABMU HB archive. They are also responsible for passing documents, information about computer archives and electronic or other storage media to the WWORTH Manager for storage in the WWORTH or ABMU HB archive. WWORTH-SOP08ArchivingV Page 4 of 16 Not guaranteed if printed

5 It is the TM s role to ensure that PIs are aware of the need for archiving and that resources are available for local archiving (see WWORTH SOP16 Site Setup). They are responsible both for liaising with PIs and local co-ordinators about archiving at WWORTH adopted trial sites and for collecting details of the location of those site archives. They will pass on all documents about site archives to the WWORTH Manager for storage in the WWORTH archive. It is the role of TDMs to check, correct, lock and compact the final databases (see WWORTH SOP22a Data Collection Management) and store them on appropriate electronic media. They are responsible for supplying data and electronic files to the TMs. If the trial has no TDM, then the TM will either perform this role or delegate technical tasks to appropriately qualified IT specialists. It is the role of CIs to sign off the completed trial archive at WWORTH and also to ensure access to the archive, usually by delegating this task to WWORTH. It is the role of PIs at trial sites to archive their site documents and electronic data, logging the location and the person to contact for retrieval in case of audit and for notifying the TM of these details and of any subsequent changes. PIs also have the role of signing off the site archive log. PIs who retire or relocate, and are therefore unable to fulfil this role, will notify the sponsor in writing about this and specify who is now responsible. The WWORTH Unit Manager will have oversight of archiving. ABMU HB will have oversight of the archiving requirements of ABMU HB sponsored studies. 6 Procedure 6.1 General principles Archiving should be carried out as soon as possible after the database closure date when outputs have been completed. (See WWORTH SOP22a Data Collection Management, WWORTH SOP22b Data Protection Confidentiality, Site Setup and Contract), taking into consideration access for publication. At the WWORTH archiving facility, the appropriate WWORTH documentation should be completed (Appendix 1, 2, and 3). Access to or movement of the material should be noted in the log-book. Any materials booked out of the archiving facility should be returned in one-month, or the booking reviewed by the WWORTH Unit Manager. Records should be kept for the time period agreed with sponsor and in accordance with specific trial requirements. At the end of the specified WWORTH-SOP08ArchivingV Page 5 of 16 Not guaranteed if printed

6 retention period, the material should be reviewed and/or disposed of in a safe and secure manner. 6.2 Procedure flow chart End of Trial (End of Trial Notification Form) Data Cleaning Data Analysis Site-level database closure Archive of hard copy files Archives of WWORTH or and electronic files at site (6.4, 6.5) ABMU HB hard files (6.4, 6.5,6.6) and electronic files Archive log at site WWORTH TRIAL Archive log at WWORTH or ABMU ARCHIVE LOG (6.6) HB 6.3 Duration of archive The site-level archive will be kept for 5 years depending on the requirements of the sponsor. The study-level archive will be kept for 5 years unless the sponsors and the ethics committee specify otherwise. Specific conditions or patient groups may have their own guidance relating to duration of archive. All types of records relating to children and young people will be retained until the patients 25 th birthday or 26 th if young person was 17 at conclusion of treatment, or 8 years after death. If the illness or death could have potential relevance to adult conditions or have genetic implications, the advice of clinicians should be sought as to whether to retain the records for a longer period (NHS Code of practice (Part 2 (2 nd Edition))). The responsibility for informing the archivist of when records relating to children and young people can be destroyed should be deferred back to the CI. WWORTH-SOP08ArchivingV Page 6 of 16 Not guaranteed if printed

7 TSFs, (see WWORTH SOP03 Master Site File) must be stored for the appropriate period defined in 6.2 (see Appendix 1). Patient notes should be flagged to identify that the participant is taking part in a clinical trial, and not destroyed prematurely by the HB. A detailed archive log should be prepared and stored ready for possible audit or inspection. A copy must be sent to the WWORTH Manager. All regulatory documents relating to a clinical trial and local site assessments and copies of local regulatory agreements should be stored, together with financial agreements between WWORTH and partners. These will be contained in the TMF (see WWORTH SOP03 Master Site File). All other hard copy documentation and electronic data files relating to a trial adopted by WWORTH will be kept for a minimum of five years after the end of the trial. (see WWORTH SOP07 Site Closure) unless the sponsor or regulatory authorities require longer. In the case of a CTIMP leading to a marketing application, the duration of archive will be until at least two years after the last approval of a marketing application in the EU. 6.4 Storage arrangements Paper documents for WWORTH-adopted studies should be stored in a sealed container in a dry environment to ensure that they are maintained in a legible condition.. Electronic data files should be stored on appropriate contemporaneous electronic media in a fire-proof box and on a backed-up host institution server. (See WWORTH- SOP22bDataprotectionconfidentiality). The WWORTH IT manager should be responsible for ensuring storage media is kept up-to-date. At WWORTH, both should be kept in a secure, locked environment with access limited to authorised people, notably TMs and their successors. The WWORTH Unit Manager and WWORTH Director will hold the keys to the archive room. Those needing access will their request, and be required to sign for the key. They must complete the log book with their name and signing in and out times on entering the archive room. Laminated summary sheets on both doors of the archive room will explain access arrangements, who the key-holders are and the specific type of data that may be stored in a step-by-step guide. Data that only exists in electronic form for trials based at Swansea University will be stored in a specially designated password protected archive folder on the H drive, unless it is already held within the SAIL WWORTH-SOP08ArchivingV Page 7 of 16 Not guaranteed if printed

8 gateway. The WWORTH Unit Manager and WWORTH Director will hold the password for this folder. The trial CI or their designate will hold passwords for individual trial folders within the archive folder. It will not be necessary to duplicate data as hard copy. Paper documents archived by ABMU HB are stored on site in locked cabinets within a secure unit, and off site archive documents are stored with a commercial archiver, used by the ABMU HB. The R&D Department archivist and Quality Assurance Officer have access to all storage areas, and access to off-site storage. With all archive storage arrangements, a data storage agreement should be in place. Archive storage areas should be inspected and a record of the visit and inspection kept in the TMF. 6.5 Security It should be ensured that data on paper or electronic media is stored in such a way that it cannot be altered without appropriate authorisation and creation of an audit trail and that the data stored on the server complies with the procedures outlined in WWORTH SOP22b Data Protection Confidentiality. The WWORTH Unit manager and WWORTH Director will hold the keys to the archive room, of which there will be five sets. Those wishing for access will their request, and be required to sign for the key. The keys for the locked storage cabinets in the archive room will be kept in a separate locked cabinet, to be accessed only by WWORTH Unit Manager or a delegate. Paper documents archived by the Health Board are stored on site in locked cabinets within a secure unit, and off site archive documents are store with a commercial archiver, used by ABMU HB. The R&D Department archivist and Quality Assurance Officer have access to all storage areas and access to off-site storage with an external commercial archiver company. 6.6 At WWORTH Paper documents and electronic files will be stored as described in 6.3, 6.4 and 6.5, within the WWORTH Archive Room at Swansea University, currently in the Grove Building. The location and access arrangements will be recorded in an Archive Log within the WWORTH office (see Appendix 2). Details of location and access arrangements at all local trial sites will also be recorded in this log. A signed content sheet will be kept in each container in the WWORTH Archive Log. Storage of archives can be transferred by the sponsor to a subcontractor WWORTH-SOP08ArchivingV Page 8 of 16 Not guaranteed if printed

9 (eg commercial archiver). The sponsor will record the transfer; and the new owner shall be responsible for data retention and archiving in accordance with the regulations. Paper documents archived by the Health Board are stored on site in locked cabinets within a secure unit, and off site archive documents are store with a commercial archiver, used by ABMU HB. The R&D Department archivist and Quality Assurance Officer have access to all storage areas, and access to off-site storage with an external commercial archiver company. Electronic files are stored on an All Wales database. Access to this database is only by password. 6.7 Process for access The archive log should be maintained at the WWORTH office and should include: Location of and access arrangements to paper documentation relating to trials Location of and access arrangements to paper or electronically stored data at trial sites A record of all essential documents (see WWORTH- SOP03Mastersitefile) that have been entered into the archive. An archive retrieval log to track and retrieve documents on loan from the archive. If a request is made to access archived material, an entry must be made on the archive retrieval log to ensure accurate recording of this process An Archive Retrieval Log should be completed to access archived documentation held by WWORTH (See Appendix 3). Internal audits may be carried out by WWORTH or ABMU staff with the authorisation of the WWORTH Director (see WWORTH SOP18a Quality Management). The sponsor or regulatory authorities may request retrieval in order to conduct an external inspection (see WWORTH SOP18b Preparing Audit Inspection). Regulatory authorities who wish to carry out an inspection of the site files for a particular trial shall be given details of access to local site archives that are listed in the WWORTH archive log. The archive log should be maintained at the R&D Department and should include: WWORTH-SOP08ArchivingV Page 9 of 16 Not guaranteed if printed

10 Location of and access to access arrangements to paper documentation relating to trials Location of and access arrangements to paper or electronically stored data at trial sites An archive retrieval log to track and retrieve documents on loan from the archive. If a request is made to access archived material, an entry must be made on the archive retrieval log to ensure accurate recording of this process. An Archive Retrieval Log should be completed to access archived documentation held by the R&D Department for the ABMU HB. Internal audits may be carried out by WWORTH or ABMU HB staff with the authorisation of the WWORTH Director (see WWORTH SOP18a Quality Management) or the ABMU HB R&D Director. The sponsor or regulatory authorities may request retrieval in order to conduct an external inspection (see WWORTH SOP18b Preparing Audit Inspection). Regulatory authorities who wish to carry out an inspection of the site files for a particular trial shall be given details of access to local site archives that are listed in the WWORTH or ABMU HB R&D archive log. 6.8 Process for destruction The reasons for destruction of essential documents should be documented and signed by a person with appropriate authority (Appendix 1 and 2). This record should be retained for a further five years (ref) from the date that the essential documents were destroyed. The Sponsor or person acting on behalf of the Sponsor should notify investigators in writing when their trial records can be destroyed. 7 Training Plan All WWORTH and ABMU HB staff involved with trials must undertake the appropriate generic and trial-specific training to ensure that they meet with the specific employers mandatory training requirements and the specific requirements of the trial. For example, for SU staff, all new employees must attend induction, fire and safety training (as well as role-specific training courses, e.g. laboratory safety). For new staff, additional training requirements should be identified alongside the specific role requirements and the WWORTH Unit Manager and the ABMU HB R&D Manager should make provision for the new staff member to attend the necessary courses as soon after appointment as is practicably possible. WWORTH-SOP08ArchivingV Page 10 of 16 Not guaranteed if printed

11 It is the responsibility of the WWORTH Unit Manager and the ABMU HB R&D Manager (alongside the CI or TM) to identify all the SOPs that are relevant to a specific trial and in which the new member of staff should be trained. The WWORTH Unit Manager, ABMU HB R&D Manager or the SOP author will provide group training for trial staff and/or one-to-one training, as required for new staff in relation to the specific SOPs identified. Training records should be filed both by the main employer and the staff member, in accordance with the specific employer requirements. Trial specific training should be filed in TMF or TSF as appropriate and every individual involved in a trial should have an individual training record (see WWORTH SOP02 Training). Where the tasks specified in the individual SOPs are delegated to WWORTH staff, CIs/PIs or TMs, these delegated staff must ensure that they have attended a training course on GCP and keep up-to-date through attending refresher courses. It is the responsibility of the CI/PI to ensure that all staff allocated duties on the study delegation log template of responsibilities are suitably trained in the activities linked to those duties (see WWORTH SOP16 Site Setup, Appendix 9 and Appendix 10). Each trial should maintain a central training log and ensure that WWORTH has access to that log, not least to integrate the logs of staff who work on more than one trial. Similarly trials should ensure that each site maintains a local training log, not least to integrate the logs of staff who work for more than one sponsor. Training will be in two stages. First training in the principles of that SOP will take place during monthly meetings of JSOPGs by the authors of the SOP. Second training in using that SOP in practice will be undertaken by a person experienced or responsible for the process of archiving. WWORTH core staff should be involved in this process. This person can be nominated by the WWORTH Manager. Both trainer and trainee will sign the log (see WWORTH SOP02 Training) to confirm that training is complete. 8 References 1. Medicines for Human Use (Clinical Trials) regulations 2004 (S.I. 2004/1031) EU Directive (2001/20/EC) The Clinical Trials Directive EN:PDF 2. WWORTH-SOP08ArchivingV Page 11 of 16 Not guaranteed if printed

12 lex/pri/en/oj/dat/2001/l_121/l_ en pdf 3. Medicines for Human Use (Clinical Trials) Amendment Regulations S.I. 2006/1928) 4. EU Directive (2005/28/EC) on Good Clinical Practice 13:0019:EN:pdf 5. ICH (1996) E6 - Guidance for Good Clinical Practice 9 Related SOPs WWORTH SOP01a on SOPs WWORTH SOP02 Training WWORTH SOP03 Master Site File WWORTH SOP07 Site Closure WWORTH SOP16Site Setup WWORTH SOP18a Quality Management WWORTH SOP18b Preparing Audit Inspection WWORTH SOP22a Data Collection Management WWORTH SOP22b Data Protection Confidentiality WWORTH SOP28 Statistics WWORTH SOP31 Sponsorship and Adoption WWORTH SOP32 Detecting and Managing Misconduct, Serious Breaches and Deviations from GCP/Protocol 10 Appendices Appendix 1 Site Archive Record of a Clinical Trial managed by WWORTH Appendix 2 WWORTH Archive Record of a Clinical Trial Appendix 3 WWORTH Archive Retrieval Log Appendix 4 Label for boxes or files of material archived at WWORTH WWORTH-SOP08ArchivingV Page 12 of 16 Not guaranteed if printed

13 Appendix 1: Site Archive Record of a Trial adopted by WWORTH When asked by the WWORTH Manager after the end of a trial, please complete this form and retain one copy in the archived Trial Site File, keep a copy in your Department and send one copy to the WWORTH Manager. When informed by the WWORTH Manager that documents and electronic media may be destroyed, please arrange for destruction, sign final column and send a copy to the WWORTH Manager. When consent forms have been destroyed, send the final copy of this form to the WWORTH Manager ISRCTN Local reference Title Sponsor Investigator Document Location Date archived TSF, incl R&D and ethics docs Patients consent forms CRFs (hard copy or CD) Other Planned destruction date Date destroyed Reason for destruction I confirm that the above documents have been archived in accordance with all applicable regulations. Signed (Investigator or R&D Manager) date.. I confirm that the above archive components have been destroyed in accordance with all applicable regulations. Signed.. (Investigator or R&D Manager) date When completed or amended, copies of this form should be sent as follows: the Trial Manger; the archive log; WWORTH and R and D where appropriate WWORTH-SOP08ArchivingV Page 13 of 16 Not guaranteed if printed

14 Appendix 2: WWORTH Archive Record of a Clinical Trial ISRCTN Sponsor Title Trial Manager Chief Investigator(s) Document Location Date archived TMF, incl R&D and ethics docs Minutes of TMG Minutes of DMEC and TSC CRFs (hard copy or CD) Details and location of Trial Site archives Pharmacy files Other Planned destruction date Date destroyed Reason for destruction I confirm that the above documents have been archived in accordance with all applicable regulations. Signed (Chief Investigator) date.. I confirm that the above archive components have been destroyed in accordance with all applicable regulations. Signed.. (Chief Investigator) date One copy of this form, and amended later forms, to be stored in the archive. One copy to be filed in the WWORTH Office. WWORTH-SOP08ArchivingV Page 14 of 16 Not guaranteed if printed

15 Appendix 3: WWORTH Archive Retrieval Log A copy of this form should be completed for each request to review an archive. Archive Retrieval Log Trial name: ISRCTN: Data archive material requested: Documentary material requested: Date retrieval requested: Box(es) to be retrieved: Date box(es) were retrieved: Name and signature of retriever: Temporary location of box(es): Date box(es) were returned: Name and signature of returner: Name and signature of individual who is responsible for archiving: WWORTH-SOP08ArchivingV Page 15 of 16 Not guaranteed if printed

16 Appendix 4: Label for boxes or files of material archived at WWORTH Name of Study Sponsor PI or TM Start Date End Date Main Outcome of Publication Destruction Date Contact Name WWORTH-SOP08ArchivingV Page 16 of 16 Not guaranteed if printed