Marie-Claire Rickard, GCP & Governance Manager Rachel Fay, GCP & Governance Manager Elizabeth Clough, R&D Operations Manager

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1 Standard Operating Procedures (SOP) for: Monitoring SOP 28 Version 7.0 Number: Number: Effective Date: 29 th November 2015 Review Date: 6 th January 2017 Author: Reviewer: Reviewer: Authorisation: Name / Position Signature Marie-Claire Rickard, GCP & Governance Manager Rachel Fay, GCP & Governance Manager Elizabeth Clough, R&D Operations Manager Sally Burtles, Director of Research Services & Business Development Date 16th November 2016 Purpose and Objective: To outline the monitoring process of Barts Health NHS Trust [BH] and Queen Mary University of London [QMUL] Sponsored studies including, CTIMP, ATMP and Clinical Investigations of non-ce marked device studies. Monitoring is defined as the act of overseeing the progress of a clinical trial and of ensuring that it is conducted, recorded and reported in accordance with the protocols, standard operational procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirement(s): The purpose of monitoring is to verify that: The rights and well-being of human subjects are protected. The reported trial data are accurate, complete and verifiable from source documents. The conduct of the trial is in compliance with the currently approved protocol/amendment(s), Good Clinical Practice (GCP) and the applicable regulatory requirements. Monitoring has an integral role in the Quality Control (QC) of a clinical trial and is designed to verify the ongoing quality of the study. This SOP does not cover audits which are designed to assess and assure the reliability and integrity of a trial s quality control systems and are a way of measuring against recognised standards (Quality Assurance of QC). Please See SOP 22 - Audits for details. Note: For current active projects (trials issued with final JRMO approval prior to this SOP s effective date) the study will be monitored as per protocol and agreed monitoring plans (if applicable). Scope: This SOP is applicable to all CTIMP, ATMP and Clinical Investigations Clinical Investigations of non-ce marked device studies Sponsored by Queen Mary University of London and Barts Health NHS Trust. This SOP is for JRMO staff performing or overseeing monitoring. This SOP also applies to external parties performing monitoring activity on the Sponsor s behalf, during which oversight will be retained by the JRMO. For example: Clinical Trial Groups within BH/QMUL Clinical Trial Groups/organisations external to BH/QMUL, e.g. externally based Clinical Trials Units (CTUs) Monitoring of hosted trials, i.e. those which are Sponsored by external organisations, remains the MONITORING SOP 28 V7.0 Page 1 of 12

2 responsibility of the Sponsor and will be conducted in accordance with the Sponsor s SOPs and monitoring tools (see the associated documents to this SOP). Any delegated monitoring contractual arrangements between another external organisation the Sponsor and BH/QMUL will be assessed on a case by case basis. The scope of monitoring carried out under this SOP is to assess compliance with the requirements of the Research Governance Framework for Health and Social Sciences 2005, the Data Protection Act 1998, Statutory Instrument 2004/ the Medicines for Human Use (Clinical Trials) Regulations 2004 and all subsequent amendments, Good Clinical Practice (GCP) guidelines, and Barts Health and Queen Mary University of London research SOPs and Policies. Definitions : On site monitoring: Monitoring activities are primarily undertaken during a physical visit to the investigator site by one or more monitoring personnel Central or/and statistical monitoring: Monitoring activities that are undertaken by monitoring personnel at a location remote from the research site, for example a data centre Related SOPs: SOP 11A - Barts Health/ QMUL Sponsorship of CTIMPs for Researchers SOP 11B - Barts Health/ QMUL Sponsorship of CTIMPs for JRMO staff SOP 18a - Project closure: guidance for research staff of sponsored studies SOP 19 - Project closure: guidance for JRMO staff SOP 22 - JRMO Audits SOP 34 - JRMO staff training records SOP 35 - JRMO training SOP 36 - JRMO staff induction SOP 37 - Reporting serious breaches of GCP or trial protocol SOP 46 - Site Selection, Site initiation and Site activation SOP Text Responsibility Activity 1. JRMO Selection and training of monitors All monitors must be appropriately trained, and should have the scientific and/or clinical knowledge required to monitor the trial adequately. They are expected to acquire an appropriate level of knowledge of the assigned study, IMP(s), protocol, patient information sheet and consent/assent form/s, as well as the JRMO SOPs and policies, GCP and other applicable regulatory requirements. Training records (including study specific training) which include relevant qualifications and certificates will be kept and maintained by the monitor(s). JRMO study monitors (SMs) will be trained by the GCP Managers as per the JRMO training matrix (SOP 34 - JRMO staff training records, SOP 35 - JRMO training & SOP 36 - JRMO staff induction). This will include shadowed visits with an experienced monitor or supervisor where necessary. Non JRMO monitors will be asked to provide evidence of their training that complies with the JRMO training matrix (outlined above) to the GCP manager. This will be filed in the project file(s). New monitors should not undertake monitoring duties until agreed by the JRMO s GCP team. From herein, the term monitor will be used to indicate all JRMO delegated MONITORING SOP 28 V7.0 Page 2 of 12

3 monitors. The term supervisor indicates the monitor s line manager and /or monitoring report authoriser. When there is a monitoring supervisor this will be indicated in the monitoring plan. The monitor s responsibilities must be detailed in project monitoring plans. 2. JRMO Extent of Monitoring & Monitoring Plan The frequency and type of monitoring should consider, but is not limited to: the trial objective, scope, design, phase of the study, number of sites, complexity, blinding, randomisation, trial endpoints i.e. what source data should be verified to meet the end points, IMP (including IMP storage and shipment), vulnerability of the participants and the type of consent, experience and previous compliance of the Chief Investigator (CI), the experience and the extent of trial management support available to the CI, organisational reputational risks of the trial, And the trial interventional risks. It is the GCP manager s responsibility to determine the appropriate level and nature of the monitoring required for the trial which will be risk assessed in line with the JRMO SOP 23 - Risk assessment. The GCP manager will take each trial s risk assessment into account when reviewing the monitoring plan. Each trial s monitoring plan will be assessed on a case by case basis. However all trials under the scope of this SOP will undergo onsite monitoring. The type and combination of monitoring can be adapted and tailored to suit a particular trial. Central or/and statistical monitoring can be used to assess aspects such as site outliers, data patterns and trends across the trial, early safety signal detection and early identification of sites not completing or submitting CRFs or other forms, but is of limited use for aspects such as training, site motivation, source data verification, Non case report form deviations/ violations etc. The monitoring design will be detailed in the final monitoring plan (SOP 28, associated documents 1) and signed by the CI and the GCP manager. A copy of the plan should be kept in the TMF and Sponsor oversight file(s). The JRMO does not allow self-monitoring of CTIMPs by the CI/PI or research teams. Central monitoring, where data checks are performed by the co-ordinating centre, may be used but in conjunction with on-site monitoring as part of risk adaptive monitoring plan. MONITORING SOP 28 V7.0 Page 3 of 12

4 3. JRMO based Monitor Update the Sponsor s database and track the monitoring Following the GCP manager giving the greenlight to activate sites (see SOP 11 - Barts Health/ QMUL Sponsorship of CTIMPs), the monitor will update the monitoring schedule (database) and where applicable the Sponsor s database (ReDA) with site approvals and first monitoring visit due date (for BH and QMUL Sponsored projects). 4. Monitor Monitors Responsibilities are detailed in appendix A 5. CI The CI should notify the JRMO of all site and regulatory approvals It is the CI s responsibility to notify the JRMO (the relevant GCP manager) of all site and regulatory approvals, including international regulatory approvals (where applicable). 6. CI The CI should notify the JRMO of the first patients For CTIMPs, the CI must notify the GCP team once the first patient has been consented onto the trial at each site. 7. Monitor Schedule a monitoring visit The monitor should schedule the monitoring visit in line with the monitoring plan. Monitoring visits should be scheduled (where possible) at least two weeks in advance. Monitors should ask for appropriate staff to be present at the monitoring visit. This should include a short meeting with the PI for all site visits, but as a minimum must occur at every other visit. The purpose of this meeting with the PI is to discuss monitoring findings (so that they can be resolved immediately if possible), progress of the study, and any on-going site issues (so that the monitor can report this back to the Sponsor). Monitors should provide the site staff with a list of the documentation and members of staff that they require to see during their visit (e.g. the Investigator Site file [ISF], the medical notes/login to medical notes, or translator). The pharmacy should be visited at every onsite visit (unless it has been documented in writing from the GCP Manager to have risk adapted approach and this has been documented in the monitoring plan). The pharmacy visit must include checks that the pharmacy logs match the case report forms (CRFs)/screening logs, so that the documents are not seen in isolation. Where appropriate, other departments (e.g. imaging) should be contacted and arrangements should be made to visit them during the monitoring visit. 8. Monitor Preparing for a visit The monitor should review the relevant study documentation prior to the visit. This documentation includes, but is not limited to: Previous monitoring and/or audit report(s) (to ensure that previous findings have been closed) Monitoring plan (to assess compliance) Recent correspondence Latest version of the protocol CRFs (if available) Status of site (e.g. recruiting, in follow-up) MONITORING SOP 28 V7.0 Page 4 of 12

5 Recruitment at the site (if available, i.e. from the Sponsor s database, previous monitoring reports) 9. Monitor Conduct the monitoring visit The monitor should carry out the following activities using the JRMO approved monitoring forms, checklist and reports. The objectives of the visit are: To provide the Sponsor and the CI with an assessment of the site s overall compliance and performance. To check the compliance with all data entry criteria as specified in the protocol. To verify the adherence to the procedures schedule as documented in the protocol. To verify the accuracy and completion of the data recorded in the CRFs by comparing with the original data source, as outlined in the monitoring plan. To review all adverse events and SAEs to ensure they are appropriately assessed by the PI or delegated medic, reported within the time periods required by GCP, the protocol, the REC, JRMO SOPs, and to the applicable regulatory requirement(s). To conduct an IMP assessment which should include the accountability check of the IMP returns, dosing compliance, and IMP storage conditions that will include checking the temperature control log (if applicable). All monitoring visits should be logged on the site monitoring log. 10. Monitor Verify the study s data collection In respect to the case report forms (CRFs), and where required by the monitoring plan, the monitor will verify that: The data required by the protocol is reported accurately in the CRFs and that the data is consistent with the source documents. The source data verification (SDV) should be in accordance to the monitoring plan. The data is entered in a timely fashion and signed off by the PI or delegate in the study database and CRFs. Any dose and/or therapy modifications are within the protocol guidelines and well documented for each of the trial subjects. Concomitant medications and concurrent illnesses are reported in accordance with the protocol and in the CRFs and source data. If any subjects have failed to attend any visits, or if tests or examinations have not been conducted according to the protocol, they are clearly reported in the CRFs and deviation log. Withdrawn patients are followed-up and reported in the enrolment log and CRFs. Any reports of trial participants or partners pregnancy has been reported and followed-up in the CRFs, and reported to the Sponsor in accordance to SOP 26a - Phamacovigilance reporting for CTIMPs. Study specific equipment, devices, and software have been validated/calibrated and maintained. 11. Monitor Monitoring of central facilities and labs The Sponsor has risk assessed that NHS Trust laboratories where the trial laboratory work falls under the Trust s CPS accreditation, will not be routinely monitored unless acting as a central laboratory Central laboratories must be monitored on a regular basis as per the MONITORING SOP 28 V7.0 Page 5 of 12

6 monitoring plan, using associated document 2e JRMO Laboratory checklist On Site. Other central facilities (e.g. Imaging facilities) should be monitored in accordance to the monitoring plan, using associated document 2g JRMO Central Monitoring Data Collection Tool. 12. Monitor Classify the monitoring report findings Findings will be classed as: Minor: No significant concerns. Moderate: Significant (but not immediate) concerns regarding the safety and well-being of trial participants or project/data integrity. Major: Critical and immediate concerns regarding the safety and well-being of trial participants or project/data integrity. Monitoring report findings will be categorised into: 1. Essential documents a. Study b. Approvals 2. Vendors / contracts / subcontractor/ finance 3. Informed consent procedures 4. Inclusion and exclusion criteria 5. IMP and non-imp 6. Training & staffing 7. Deviation Study procedures 8. Pharmacovigilance 9. Randomisation and cohort allocation/un-blinding 10. Data Management (source data & CRF) 11. Trial equipment 12. Computer Systems 13. Deviations to GCP/regulations Multiple major findings and potential serious breaches should be notified to the CI and GCP manager immediately. Depending on the seriousness of the monitoring findings, the GCP manager will be notified and will, if necessary, escalate as per the JRMO Escalation Policy, via the R&D Governance Operations Manager, Director of Research Services & Business Development, Sponsorship Oversight Committee, and CAG/Institute as appropriate. The JRMO centralised log/database of monitoring visits, findings, reports is to be kept up to date by the JRMO Monitors. This will be discussed at regular intervals with the JRMO monitors, RG&GCP manager. Where the monitor has concerns about compliance this will be escalated to the GCP Manager, and where appropriate escalated to the Sponsor Oversight Group. The JRMO monitors and external monitors will provide quarterly (or as agreed) monitoring reports (see associated document 6) that summarise the trial s ongoing performance and monitoring compliance to the Sponsors Oversight Group. MONITORING SOP 28 V7.0 Page 6 of 12

7 13. Monitors Monitoring the Trial Database Studies monitored by JRMO monitor: All Study databases should be reviewed at least once a year. It is acknowledged that the monitor will not be an IT expert but they should assess and document whether the database: Is in the format and on the network described and agreed in greenlight meeting. Data is entered in a timely manner. Studies NOT monitored by JRMO based monitor: All quarterly monitoring summaries to the JRMO should include confirmation that the database: The database is in the format and on the network described and agreed in greenlight meeting. Case Report Forms (CRFs) have been received and reviewed as planned. Data has been entered in a timely manner from all sites. 14. Monitor Monitoring Report Urgent findings, i.e. which may affect participant safety and data integrity, that were not resolved during the visit must be dealt with/escalated immediately to the PI, CI, GCP manager, and supervisor before finalising the monitoring report. Draft the monitoring report and submit to the GCP manager/supervisor (as per the monitoring plan) within 10-working days of the visit (annual leave permitting). It is advised that monitors complete draft reports prior to conducting their next onsite visit (for this or another study). Reports should accurately describe which documents and source data were reviewed at the site and what was discussed with the study team. The report should record significant findings and list what was agreed with the research team at the site and the actions taken during the visit. A copy of the monitoring report should be issued within 15-working days of the visit. If the site cannot meet the monitoring visit reporting timelines this should be documented by the monitor (by or file note in an appropriate manner-) A copy of the report should be filed in the investigator/ pharmacy/ lab site file(s), along with the summary of findings, and answers from the team once resolved, in the trial master file (TMF), and for JRMO monitors the Sponsor file. The CI will be circulated copies of all monitoring reports, including those of central facilities and sites.). The Principle Investigator will be sent copies of all site, lab, pharmacy, and support departments. Actions should be followed up to resolution. If site/study teams fail to respond or complete actions within given time frames this should be escalated to GCP manager or supervisor within 1-week of the report deadline. Document any other pertinent communication with the study site. Document any deviations from the protocol or other issues and file these in the Investigator Site File (ISF) and/or the Trial Master File (TMF) with copies submitted to the GCP manager. MONITORING SOP 28 V7.0 Page 7 of 12

8 15. JRMO based monitors Document and log monitoring visits and reports Ensure all individual and quarterly monitoring reports are logged and documented and are saved appropriately (See associated document for details of how quarterly reports are logged). These will be logged in the current schedule/database, saved in ReDA, and saved in main electronic and paper Sponsor files. 16. CTUs/Clinical Trials Groups, performing monitoring on the Sponsors behalf Trial specific monitoring summaries will be logged in the same manner. External monitors must use JRMO approved monitoring tools and templates Delegated monitors should, where possible, use the JRMO templates and tools, and must implement the JRMO categorisation and findings classification. These can be adapted to individual studies, but should then be approved by the GCP managers with a waiver issued in writing. The CI is responsible for ensuring that the GCP team is provided with regular updates (as a minimum quarterly) on the monitoring findings (timelines for informing the JRMO will be defined in the monitoring plan & monitoring summaries). The report must take the form of the JRMO summary report (see associated Document 7) 17. All staff Triggered monitoring, audits, and suspending recruitment Any concerns that are raised about a trial by a monitor or by a monitoring report may trigger a JRMO audit visit, and/or the JRMO may revise the trial s monitoring plans/schedules. On rare occasions where there are serious concerns that have arisen from monitoring, the Sponsor may request the suspension of recruitment at a site, and will work with the CI to assess whether there is a requirement to temporarily suspend the trial for safety or other urgent reasons. On such rare occasions, the JRMO (Director of Research Services) may escalate monitoring concerns in accordance with the JRMO escalation policy to BH CAGs/QMUL Institutes. Please see MHRA website for guidance on suspending and halting trial and SOP 18a - Project closure: guidance for research staff of sponsored studies; or SOP 19 - Project closure: guidance for JRMO staff. MONITORING SOP 28 V7.0 Page 8 of 12

9 JRMO Responsibilities Flow Chart Selection of monitor based on training/knowledge Determine the extent of monitoring/monitoring plan Reserve the right to trigger/halt monitoring Investigators Responsibilities Flow Chart Notify the JRMO of all site & regulatory approvals Invite new monitors to the Site initiation visit Ensure monitors receive trial specific training Notify the JRMO of all site & regulatory approvals Notify the JRMO of first participants Meet the monitor during the monitoring visits Action findings in the monitoring report Monitor Responsibilities Flow Chart MONITORING SOP 28 V7.0 Page 9 of 12

10 Track & update monitoring activity on the sponsor s database Understand their responsibilities and the trial Schedule a monitoring visit Prepare for monitoring visit Conduct monitoring visit Verify study s data collection Monitoring central facilities/labs Classify report findings Review study database regularly Write Monitoring report and send to sites Log monitoring visits Follow-up monitoring findings to resolution Escalate unresolved findings to JRMO MONITORING SOP 28 V7.0 Page 10 of 12

11 Change Control This section outlines changes from version 6.0 to version 7.0 of this SOP. Summary and description of change: 1. Administrative corrections 2. Full document review that includes: Expansion of Purpose and Objective; expansion of Scope Addition of the section Related SOPs Addition of summaries for each section Section 1 specifics requirements for the training of monitors Section 2 specifics of what should be considered in the monitoring plan, and the inclusion of GCP risk assessment in the review of monitoring plans. Statement that JRMO does not allow self-monitoring of CTIMPs. Section 4 new section added titled monitor s responsibilities. Section 5 new section added titled The CI should notify the JRMO of all site and regulatory approvals. Section 6 new section added titled The CI should notify the JRMO of the first patients Section 7 new section added titled Schedule a monitoring visit Section 8 new section added titled Preparing for a monitoring visit Section 9 new section added titled Conducting the monitoring visit Section 10 new section added titled Verify the study s data collection Section 11 new section added titled Monitoring of central facilities and labs Section 12 new title Classify the monitoring report findings (previously titled findings review ). Section 13 new section added titled Study Database Section 14 new section added titled Monitoring Report Section 15 new section added titled Document and log monitoring visits Section 16 new section added titled External monitors are to use the JRMO approved monitoring tools and templates Section 17 titled Triggered monitoring, audits and halting trials expanded and includes specifics of the Sponsor Oversight Group, and halting studies. Associated Documents 1. Template monitoring plan (CTIMP) 2. Monitoring forms a. ISF Monitoring Form b. TMF Monitoring Form c. Single Site (Combined ISF-TMF) Monitoring Form d. Pharmacy Monitoring Form e. Lab Monitoring Form f. SDV Monitoring Form g. Central Facility Monitoring Form 3. Concise Close out forms a. Site Concise Close Out Visit b. Pharmacy Concise Close Out Visit c. Lab Concise Close Out Visit 4. Site Visit Log 5. Monitoring guidelines MRC 6. Quarterly Monitoring report template 7. Quarterly report JRMO crib sheet ( Not a public documents) MONITORING SOP 28 V7.0 Page 11 of 12

12 Appendix 1 Monitors Responsibilities Monitoring should be a designated task on the study delegation log. If working on the trial during set-up, the monitor should attend the site initiation visit (SIV) as part of their study training and familiarisation see SOP 46 - Site Selection, Site initiation and Site activation The monitor (and GCP manager) will be the main line of communication between the JRMO, on behalf of the Sponsor, to the Investigator(s) and site team(s). The monitor is responsible for conducting monitoring visits as per the monitoring plan, using the JRMO agreed monitoring tools. The monitor is responsible for writing the monitoring report and gaining their supervisor s approval of the report. The monitor will ensure that reports are disseminated to the correct people (see section 14). The monitor will ensure that central facility reports, i.e. central or labs or imaging, are circulated to the CI (who must have oversight of the whole study). The monitor is responsible for following-up with the PI/site/central facility team(s) to ensure that report findings are actioned within the report deadlines. The monitor is responsible for escalating findings to the GCP manager or supervisor, and to the CI if findings are unresolved or serious. The GCP manager will ensure that corrective and preventative action (CAPA) is put in place to prevent recurrence of the deviation. In the event that monitoring findings are not rectified, or meetings/visits are not held in a timely manner, the monitor and the GCP manager will escalate unresolved findings or concerns, in accordance with the JRMO escalation policy. The monitor will immediately notify the GCP manager in the event of any suspicion of scientific misconduct, fraud, or breach of GCP. This will be dealt with in accordance with the appropriate organisational policy and/or in accordance to SOP 37 - Reporting serious breaches of GCP or trial protocol. Should any of the following come to the monitors attention, it is their responsibility to escalate the event(s) to the GCP manager and their supervisor: o The monitor s report findings are not actioned or closed in a timely manner. o The trial team does not adequately respond to the monitor s written requests. o The monitor suspects non-compliance with the regulations or GCP. o There is a breakdown in the communication between the study team or in the management of a trial. o Requests for monitoring visits are obstructed or repeatedly postponed by the site team. o The monitoring visits are not compliant with the monitoring plan. o The monitor suspects that the CI or PI or other member of the research team is not fulfilling their Sponsor delegated duties. MONITORING SOP 28 V7.0 Page 12 of 12

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