Research Study Close-down and Archiving Procedures

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1 Title: Outcome Statement: Research Study Close-down and Archiving Procedures To inform researchers of the process for closing down research studies, retaining and storing research materials in the Trust. Bonnie Teague, Research Manager Written By: Reviewed: In Consultation With: ICT Security and Governance Manager Approved By and V1.0 Research Governance Committee, 26 th September 2013 Date: With Reference To: EU ICH E2F, European Medicines Agency 2010 ICH Topic E 6 (R1): Guideline for Good Clinical Practice Department of Health: Research governance framework for health and social care: Second edition, 24 April 2005 Medicines for Human Use in Clinical Trial Regulations (2004) Associated Policies: Applicable To: For Use By: Trust IG-61 Network Structure, Configuration and Security IG2-6 Storing Information Electronically R&D005 Conducting Clinical Trials of Investigational Medicinal Products R&D008 Trial Management: Trial Master Files and Site-Specific Files R&D009 Research Auditing and Monitoring Processes R&D016 Research Adverse Event and Safety Reporting Procedures Trust staff working on research studies taking place in NSFT. Research Teams, Chief Investigators, Research and Development, Clinical Teams R&D013 Reference Number: Version: 1.0 Published Date: 27 th September 2013 Review Date: 1 st October 2014 Impact Assessment: Completed 19 th September Reason for Development/Review Implementation and Monitoring Regulations and guidance about research management state that each participating NHS Trust should have procedures and policies in place to support close-down of research and the archiving of research materials on site. To be implemented by the Research Office and detailed in Research training courses. Adherence to policy will be monitored on an annual basis using departmental database of archived studies. Page 1 of 17

2 1.0 Introduction According to the Clinical Trial Regulations 2006 and the Research Governance Framework for Health and Social Care 2005, essential documents related to the conduct of a research study are required to be retained for a minimum of 5 years after the completion of a trial. In practice, many Institutional sponsors require the retention of research documents and data for much longer periods of time. During the period of retention, research studies may be subject to auditing by sponsors or the Research and Development Office or Inspections by Regulatory Authorities. Each participating Trust in a research study requires a formal system in place for the long-term storage and security of research documentation. Clinical Trial Regulations and the Research Governance Framework also require processes and systems to be in place for the close-down or termination of research studies at an Institutional level. 2.0 Purpose The purpose of this Standard Operating Procedure (SOP) is to describe the measures and actions to be followed by researchers working on research studies within the NSFT when closing down or terminating a research study, and arranging for long-term storage for research data (archiving). This policy is relevant for studies being sponsored by the NSFT and for studies sponsored by external organisations. 3.0 Definitions and Abbreviations Case Report Forms (CRFs): A record of data collected for the specific purposes of clinical research, completed using source data. CRFs are used to collect data generated for a trial subject, in accordance with the protocol, during the course of their participation in a trial. They also ensure compliance with regulatory requirements. CRFs can be in paper, optical or electronic format, depending on the needs of the study protocol, but all should be dated and version controlled. Chief Investigator (CI): The lead researcher who has overall responsibility for the conduct of the research study across all sites in a country, including maintaining study documentation. Clinical Trial of an Investigational Medicinal Product (CTIMP): An investigational product or device is defined in the Medicines for Human Use (Clinical Trial) Regulations 2004 as any investigation in human subjects, other than a non interventional trial intended: To discover or verify the clinical, pharmacological or other pharmoco-dynamic effects of one or more medicinal products To identify one or more adverse effects of these medicinal products To study absorption, excretion or distribution of medicinal products with a view of ascertaining the safety or efficacy of such products. Since May 2004 when the Trial Regulations came into force, CTIMPs have been regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA) who needs to give explicit authorisation for a CTIMP to be conducted in addition to the standard approvals required for clinical studies. This is termed Clinical Trial Authorisation or CTA. The NSFT does not currently sponsor CTIMP studies. Essential Documents: Essential documents are those documents which individually or collectively permit the evaluation of the conduct of a trial and the quality of the data produced. (ICH GCP manual pg 21) and should be kept in a secure but accessible manner, they should be Page 2 of 17

3 legible, accurate and with a clear description as to it s purpose. Examples of essential documents include: Case report forms Serious adverse events/reactions (SAE s/sar s) Suspected Unexpected Serious Adverse Events (SUSAR s) Protocols Investigational Brochures Patient information leaflets Amendments to documents and protocols Communication Pharmocological documentation Interventional Clinical Trial: A comparative evaluation of two or more treatments or interventions undertaken in accordance with approved standard protocols in a health-care setting. Investigational Medicinal Product (IMP) A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form. [EU 2011/C 172/01] MHRA: Medicines and Healthcare Products Regulatory Authority. The MHRA is a UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe. Their main roles with research are to regulate clinical trials of medicines and medical devices and monitor and ensure compliance with statutory obligations relating to medicines and medical devices. The MHRA's Good Clinical Practice (GCP) Inspectorate is part of the Inspection, Standards and Enforcement Division of the MHRA. The function of the GCP Inspectorate is to assess the compliance of organisations with UK and EU legislation relating to the conduct of clinical trials in investigational medicinal products. This is achieved through carrying out inspections of sponsor organisations that hold clinical trial authorisations (CTA) or organisations that provide services to clinical trial sponsors (host organisations). Non-CTIMP Clinical Trial: Evaluation of an intervention/treatment that does not involve investigational medicinal products. Non-Interventional/Observational study: An observational research project that does not involve a change to treatment or interventions for research purposes. Delegation (of Duties) Log: A study-specific record of delegated roles and duties of the local study team involved in the conduct of the research. Each role identified in the log should be signed and dated by each named individual and counter-signed and dated by the PI. Participant Information leaflet/sheet: The document that is provided to all potential participants that informs them of all the relevant and necessary information that is needed to make a fully informed decision as to whether to participate in the research. Participant information leaflets should include what will be expected of them during the study, risks and benefits, duration of the study, support that is available Page 3 of 17

4 Principle investigator (PI): A person that has overall delegated duty for the conduct of the research study at each individual participating research site. Research Nurse (RN), Clinical Studies Officer (CSO)/Research Assistant (RA): A research practitioner employed by research team, Trust or research body with delegated duties to carry out specific allocated duties as identified in Trust approval documentation and supported by the delegation log. Research Ethics Committee (REC). NHS RECs safeguard the rights, safety, dignity and wellbeing of people participating in research in the National Health Service. A favourable opinion from REC to conduct a research project involving NHS patients or identifiable patient data must be obtained prior to the start of any research activity involving direct contact with participants. Research and Development Offices (R&D): Research and Development Offices review the local feasibility of conducting research studies in the relevant NHS premises. The research review is a risk-assessment based approach, evaluating the availability of support to conduct research studies and safeguarding current policies and practice. Approval from NSFT Research & Development must always be obtained prior to any research activity for all studies starting in the Trust. Source Data: Source data are all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the clinical trial. Source data are contained in source documents (original records or certified copies). Source documents are original documents and records where study data are first recorded e.g. hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists and pharmacy dispensing records. Source documents are considered "Essential Documents" that allow evaluation of the clinical trial and ensure the quality of the data and serve to certify Sponsor and CI compliance with GCP and regulatory requirements. The process referred to as Source Data Verification (SDV) is an evaluation of the data recorded in the data collection tool against the source documents. Sponsor: The organisation with overall responsibility for the conduct of the clinical trial within the UK. At the NSFT, the sponsor s representative for research is the Research Manager. Trial Master File (TMF): A master file kept by the study sponsor or CI. It contains all the essential documents and correspondence for the study. Whilst TMF guidelines are directed towards CTIMP trials, Non-CTIMP studies should also follow the standard outlined and is specified by the ICH GCP when it refers to a Trial Master File as being for all studies, not only clinical trials. 4.0 Duties and Responsibilities 4.2 Sponsor: The Institution with legal responsibility for the conduct of the research study across all participating sites. The sponsor is responsible for: Indemnity, financial and contractual arrangements for the whole study. The necessary approvals required to be in place by the start of the study. Study set-up and full trial documentation set-up with study training arranged to local research teams. Ensuring that appropriate emergency reporting procedures are in place at each site. the provision of study medication to be sent to local Pharmacy sites where required. Establishing comprehensive monitoring and audit functions throughout the study by arrangement with local teams. Informing regulatory and other approving authorities of study close-down or early termination. Page 4 of 17

5 Confirmation with local sites that the study has been archived in accordance with sponsor policy and/or study protocol. 4.3 Chief investigator (CI): The lead researcher with responsibility for the conduct of the clinical trial across all research sites, including but not limited to the following areas. Qualifications and agreements (Good Clinical Practice (GCP) Training, delegation of trial-related duties) Adequate Resources to conduct the overall study time, funding, demonstrate ability to recruit (via pilot etc) Medical care of trial subjects: A qualified clinician, who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical decisions On-going communication with research approving bodies throughout the trial (amendments, annual reports etc) Ensure full compliance with protocol and document deviations and submit amendments to Research approving bodies. Investigational Product (if applicable) - responsible for IMP accountability at site/s (can be assigned to appropriate pharmacist) Randomization Procedures and Unblinding responsible for following trial s randomization and blinding/unblinding procedures (if applicable) Informed consent responsible for following GCP guidelines on informed consent Records and Reports follow GCP guidelines on Case Report Forms and source documentation, maintenance of trial documentation, financial agreements and archiving Progress Reports provide written summaries to research approving bodies (annually or more frequently if requested) and sponsor regarding substantial changes to trial Serious Adverse Events (SAEs)- responsible for ensuring all SAEs reported to sponsor Premature Termination or Suspension of Trial Responsible for ensuring trial subjects, institution sponsor and research approving bodies are promptly informed if trial ends prematurely or is suspended Final Report ensure that final report is provided to research approving bodies and sponsor The CI will be responsible for the integrity of the study protocol and publications resulting from the study 4.4 Principal Investigator (PI); The lead researcher with delegated responsibility for the conduct of the clinical trial aligned with the responsibilities of the chief investigator (listed above) across the local site only. Duties will include: Set-up and maintenance of trial documentation, Participant identification and recruitment, Participant follow-up assessments Ensuring that the study is being conducted to study protocol, trust policy and GCP standards. Conducting the trial in accordance with the protocol, including: informed consent; reporting of adverse events / reactions (and urgent safety measures) as per protocol and sponsor policy; unblinding procedures; and IMP accountability at the trial site; and adequate trial documentation and archiving of trial documentation. Responsible for the set-up and conduct of the study at the local site and ensure that all trial documentation and appropriate training has been received and passed onto the study team. Inform Chief Investigator, Local Research Team and local Research Office about the close-down or early termination of the study. Nominate or delegate duties to a member of the local research team to undertake study shutdown and archiving processes as stated on the delegation log. Page 5 of 17

6 4.5 Local Research Team Clinical Studies Officer/Research Nurse/Research Assistant, if delegated by the PI and supervised appropriately, support the conduct of the research study at the local site, if recorded on the study delegation log: Duties could include: Set-up and maintenance of trial documentation. Participant identification and recruitment. Participant follow-up assessment. Arrangement and collection of prescribed study medication from Pharmacy. Ensuring that the study is being conducted to study protocol, trust policy and GCP standards. Arrange for local archiving of study documentation. 4.6 Trust Research and Development (R&D) office: The participating NHS organisation is required to have procedures in place for conducting the trial locally. These procedures include: Provision of adequate training for all site staff to conduct the study confidently and competently; Ensuring clarity of roles and responsibilities (e.g. contracts and agreement, delegation log) Appropriate knowledge of the trial and quality systems in all peripheral departments (e.g. laboratories, radiology, medical records); Ensure systems and facilities are fit for purpose (e.g. computer systems, equipment) Arrange for local study data to be archived on Trust premises in collaboration with study research teams. Advising local research teams about the conduct and management of the trial in accordance with the protocol, including: informed consent; reporting of adverse events / reactions as per protocol (and urgent safety measures); unblinding procedures; and IMP accountability at the trial site. Assist local study teams to perform study shut-down procedures and undertake local close-down or study termination monitoring and audit visits. Manage process for electronic archiving of data in collaboration with ICT. Compliance with GCP guidance, Clinical Trial Regulations and any other relevant frameworks as assessed through local approval procedures and audit/monitoring of the study as required. 5.0 Guidance to Good Practice 5.1 Study Close-down The proposed end date of a research study is determined by the study protocol. The protocol should also state the circumstances or events which may determine an early termination date. These events may include Safety Concerns Poor Participant reaction/tolerance to study intervention Poor recruitment Sponsor s decision Investigator s decision For NSFT-sponsored studies, it is the duty of the Chief Investigator to inform the NSFT Research Office as soon as possible that the study has, or shortly will be, terminated. The Chief Investigator Page 6 of 17

7 should also inform all Principal Investigators about the end of the study with a detailed written explanation of the termination or suspension. For non-nsft sponsored studies, the Principal Investigator will be informed by the Chief Investigator or the sponsor about the study closure. It is the duty of the Principal Investigator to inform the NSFT Research Office about the end of the study so that monitoring and archiving processes can be completed. For all studies, the Principal Investigator must submit a Study Close-down/Termination report to the NSFT Research Office (Appendix 1). NB For Clinical trials of investigational medicinal products (CTIMPs) or medical devices, it is the legal responsibility of the sponsor (or delegated to Chief Investigator) to notify the regulatory authority (MHRA) and approving Research Ethics Committees within 15 days that the study has terminated early at each site. This notification should be stored within study documents prior to archiving. If the trial is prematurely terminated or suspended for any reason, the local investigator, upon consultation with the Sponsor and Chief Investigator should promptly inform the trial subjects and assure appropriate therapy and follow-up for the subjects. Archiving procedures should not be undertaken until study close-down procedures have been completed. In some cases, this may require the sponsor to conduct a final monitoring visit to reconcile study files prior to storage Once study close-down/termination procedures have been completed, it is the duty of the principal investigator to inform the Chief investigator that the study has closed/terminated at the local site. 5.2 Auditing and Monitoring Outcomes All studies in the NSFT may be subject to a final close-down audit at the end of the study. This will be performed by the Sponsor, Regulatory Authority and/or NSFT Research office upon notification of the close of the study. The audit will be arranged within 28 days of initial notification. Each research team is encouraged to conduct an internal self-audit of the study prior to the final R&D audit. A self-audit toolkit is available from the Research and Development office and should be conducted and signed off by the trial coordinator, principal investigator or other named person delegated the duty for undertaking study file management at the local site. A signed copy of the toolkit should be placed in the front of the Trial Master file or Study File and a copy sent to R&D for their records. If there are any significant findings or actions required as a result of the self-audits or any outstanding findings from previous audits conducted by the Research Office, sponsor or regulatory authority, it is expected that the study will not be archived until the identified issues have been resolved. 5.3 Duration of required Archiving The duration to store study materials should be clearly written within the original approval application forms and the study protocol. For studies sponsored by the NSFT, the following durations are recommended: Page 7 of 17

8 Observational Studies i.e. not changing practice, conducting interviews/data collection only Interventional Studies i.e. delivering new therapies, support packages or changes to treatment. 5 years 10 years For studies not sponsored by the NSFT including all Clinical Trials of Investigational Medicinal Products, the storage duration for all research materials could range from 5-25 years as recorded by the protocol and sponsor policy. 5.4 Electronic Data Storage and Archiving Archiving of supplementary research materials on encrypted/secured electronic formats is allowable, although not recommended for long-term storage (i.e. over 5 years) due to advancements in technology. It is advisable that as many documents and spreadsheets as possible are printed out and filed with main documentation. Where research data must be stored electronically, the data is required to be placed onto a secure transferable electronic format i.e. encrypted memory stick, and sent to Research and Development at the same time as the paper files to be archived. The data will be stored on a secure NSFT server which can be accessed for auditing or safety purposes by nominated Research and Development staff members only. The NSFT electronic research study archive adheres to Trust policies and standards for physical and environmental security for long-term storage, including server back-up and disaster recovery operations Study Databases Where studies hold research information on electronic databases, the designated database manager should undertake database lock-down procedures to ensure that access to the final dataset is restricted for final analysis, prior to study archiving. Digital preservation issues should be agreed prior to archiving to ensure that access is maintained as required throughout the archiving period. 5.5 Procedure for archiving studies All research materials related to NSFT participants and studies should be archived within the Trust, through Research and Development. The study team should inform Research and Development of their intention to archive the study by completing the Archiving Request form in Appendix 2 and ed to Alternatively the information can be accepted in an . Archiving boxes can be ordered by the research team or obtained through Research and Development. Each Box is approx. 390mm long x 33mm wide x 260mm deep. The final weight of the box should be in line with Trust manual handling policies. R&D will provide the study team (and/or Archive requestor) with an archive reference number which should be written clearly on the archive box using the labels in Appendix 3. All trial-related documentation should be placed in an easily understandable and/or clearly labelled order within one or more archive boxes using the Archive check-list in Appendix 4. Trial-Related Documentation is classified as: Essential Documents Trial master file and/or local site file Delegation Log Page 8 of 17

9 Any other relevant documents related to the management of the study. A list of documentation to be archived is available in Appendix 5. Any participant identifiable information should be archived separately from anonymised/crf data by placing the information in either a separate archive box or a clearly marked sealed envelope. Any electronic information formally held on laptops or Trust desk-top computers should be saved in a clear order on an encrypted NHS/Trust memory stick or other secure electronic device, with a paper list of contents, and archived with the paper documentation in a sealed envelope. Researchers are advised, however, that any stored electronic data should be minimal due to longterm technology changes. The study team should complete 2 forms (Appendix 3) per box to be placed on the front and side of the boxes (not the top as this will be covered by stacking) by clearly stating: R&D approval/iras reference number i.e. 2011MHXX Name of Local Lead investigator i.e. Chief or Principal Investigator Name of the Study (short-title or acronym is sufficient) Date of archiving Duration of archiving, as written on the Ethics and R&D applications. Date of Destruction. Labels should be completed electronically or in permanent/indelible pen. NB The date of destruction should be calculated by the date of study closure plus the duration of archiving as stated in IRAS. Once complete and checked, the archive boxes should be sealed with parcel tape and transferred securely to R&D i.e. through a porter request. A separate copy of the completed and signed Check-list should also be sent to R&D. If study team members have left the Trust before archiving, or do not have the capacity to archive, R&D staff members may complete the archiving process, once study documents and the Archive request forms have been received in the office. Once confirmation has been received from Health records confirming that the boxes have been archived, an will be sent to the study PI/main co-ordinator (and/or original requestor of Archiving) informing them of the archiving record details. 5.6 Accessing Archived Studies In the case of the study team or auditors requiring access to archived study material, the study team must put in a request in writing to R&D at least 7 days in advance of the date required, with a clear justification as to why access is required. R&D will arrange for the box to be transferred back to the R&D office from Health Records, where it will be held securely until the study team can collect the box. After the study team or auditors have completed their tasks, the boxes will be archived using the same steps as above. Page 9 of 17

10 Appendix 1: Research Project Close-down/Termination Report Template 1. Investigators Details NSFT RESEARCH PROJECT CLOSE-DOWN/TERMINATION REPORT Research & Development The Knowledge Centre Hellesdon Hospital Drayton High Road Norwich NR6 5BE Tel: Fax: Chief Investigator Principal Investigator Name: Address: Telephone: 2. Details of study Full title of study: Name of main REC: REC reference number: R&D Number: Date NSFT R&D approval received: 3. Commencement and termination dates What was the actual start date? What was the actual completion date? Was the completion date as scheduled? If no, state the reason why (For studies which have terminated earlier than expected, please give a full explanation on a separate document if required) Page 10 of 17

11 4. Recruitment of participants Number of participants recruited: Number of participants completing trial: Number of withdrawals due to: (a) lack of efficacy (b) adverse events (c) self-withdrawal (d) non-compliance (e) other Total number of withdrawals: Were there been any serious difficulties in recruiting participants? If Yes, give details: Proposed in original application: Actual number recruited: Proposed in original application: Actual number completed: Yes / No Have there been any protocol violations? Yes/No If Yes, give details and any remedial action taken: Have there been any Serious Adverse Events for the study? Yes/No If Yes, please give details of how many at each participating site: 5. Reports Self-audit report(s) submitted: Previous annual reports are available and archived with study files: (Annual reports include: Trust R&D, Ethics and, where applicable, funding bodies) Yes / No Yes / No Page 11 of 17

12 6. Other Please list any give any other information that you feel relevant (e.g. any difficulties incurred etc). Next Steps: Please send this signed report to: (scanned, electronic format) or Research and Development, The Knowledge Centre, Hellesdon Hospital, Drayton High Road, Norwich, NR6 5BE (hard copy, wet-ink format) Prepare your study for full close-down and archiving in the NSFT. Inform REC and other approving bodies of Study close-down retain reports in study files. Complete Final self-audit report for submission with this report Confirm that all site PIs have been informed of study termination/close-down. Inform NSFT R&D of any future publications arising from the study. Inform study funders of any future publications arising from the study (usually 28 days notice). Final Study Audit: Please indicate here if you wish for the Research Office to conduct a final close-down audit (if not performed recently). 7. Declaration I declare that all information in this final report is correct to the best of my knowledge. I have delegated the study shut-down and archiving duties to the following named member of the research team:.. [NAME OF RESEARCH TEAM MEMBER]. Signature of Principal Investigator: Print name: Date: NB The formal date of study close-down/termination at the NSFT will be the date stated by the Principal Investigator above. Page 12 of 17

13 Appendix 2: Research Archiving Request Form PLEASE COMPLETED REQUEST FORM TO NSFT Research Archiving Request Form Short Title of Study: R&D #: Principal Investigator at Close of Study: Date of Closure of Study: Length of Archiving Period: Number of Boxes for Archiving: Please tick if you require Archiving Boxes to be provided by R&D (Boxes must be collected in person). Please tick if you require R&D to undertake entire archive process on behalf of the study team [If study team are not available]. Request Form Completed By: NAME: TELEPHONE: Page 13 of 17

14 Appendix 3 Archive Box Labels (2 per box, placed on the sides of the box not the top) R&D Archive # Name of Study R&D Study Ref Date Archived Name of Investigator Contents of Box Period of Retention Date to be Destroyed R&D Archive # Name of Study R&D Study Ref Date Archived Name of Investigator Contents of Box Period of Retention Date to be Destroyed Page 14 of 17

15 Appendix 4: Research Archiving Check-List NSFT Research Archiving Check-List Short Title of Study: R&D #: Principal Investigator at Close of Study: Date of Closure of Study: Length of Archiving Period: Number of Boxes for Archiving: Check-List: Please tick to confirm that these procedures have been undertaken: All study-related documentation has been placed in Archive boxes Participant Identifiable Data has been archived separately to Anonymised Data (Separate Box, or Sealed Envelope for small studies) All electronic data held on shared drives, laptops and any other electronic device has been archived (either through paper print-outs or accessible electronic method) and sent to Research and Development for Trust Electronic Archiving. The Archive boxes have been securely sealed with Parcel Tape. The Archiving Request Form has been sent to Research and Development and an Archive Reference Number has been generated. The Archive Labels have been completed and placed on the Front and side of each box Arrangements have been put in place to securely transfer the boxes to R&D, Hellesdon Hospital. Check-List Completed By: NAME: TELEPHONE: Page 15 of 17

16 Appendix 5: List of Research Documents to be archived after completion or termination of a research study. Non-Identifable or Participant Specific Documents Approved Protocol including amendments. Approved templates of Patient information sheets, letters of invitation and Consent forms. Clean templates of other participant information i.e. GP letters. Regulatory applications and approval documentation (including amendments). Sponsorship Acceptance Letter Ethics Committee composition/membership Delegation and Signature logs. CVs of Research Team Training Logs and relevant certificates of Research Team. Correspondence/newsletter/reports. Annual Reports and Safety reports. Financial and Contractual information plus Indemnity certificates. Investigator Brochure (plus revisions) Meeting Minutes and Agendas. Trial set-up, Audit and monitoring reports. Close-down and final reports (including End of Trial Notification). Details of data management and database systems including validation. Calibration Certificates (for equipment) Copies of Study-related reports and publications. Pharmacy-related Files (CTIMPs only): Instructions for handling and storing investigational medicinal products Sample of label for investigational products Shipping records for investigational products Decoding procedures for blinded studies Investigational Product Accountability Log Pharmacy Delegation Log Temperature logs Certificate of analysis of investigational products Patient specific or identifiable Documents Case report forms. Appointment logs. Permission to contact forms. Signed consent forms. Data Queries and File Notes. Patient notes. Participant correspondence. Search list for identifying eligible patients. Subject Screening and recruitment logs Communication logs with participants. Completed SAE/R & SUSAR Logs and Forms. Treatment Allocation/Randomisation List and Information Clinical Study reports Page 16 of 17

17 Monitoring Statement Aspects of the policy to be monitored Timeline and reporting procedure s to regulatory authorities Monitoring method Changes to EU regulations and REC reporting to be monitored by R&D in accordance with published guidance. Individual/Team responsible for monitoring Research Manager (Research and Development) Frequency Annually to be reviewed, changes monitored constantly in response to national publications. Findings: Group/Comm ittee that will receive the findings/moni toring report Research Governance Committee Action: Group/Committe e responsible for ensuring actions are completed Research Governance Committee Page 17 of 17

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