INTERIM SITE MONITORING PROCEDURE

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1 INTERIM SITE MONITORING PROCEDURE 1. PURPOSE The purpose of this SOP is to describe the interim monitoring procedures conducted at Institution, according to GCP and other applicable local regulations. 2. SCOPE This procedure applies to the routine monitoring activities conducted by Institution personnel at all investigational sites where clinical trials are ongoing. 3. INTRODUCTION Monitoring is defined by The International Conference on Harmonisation of Good Clinical practice (ICH GCP) guidelines as: The act of overseeing the progress of a clinical trial, and of ensuring thet it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP and applicable regulatory requirement(s) ICH GCP section 1.38 Section 5.18 of ICH GCP states in detail the minimum requirements for monitoring of clinical trials: The purpose of monitoring is: Verify the reported trial data is accurate, complete and verifiable from source documents Verify that the conduct of the trial is in compliance with the approved protocol/amendment(s), with GCP, and with the relevant regulatory requirements Verify the rights and well-being of the human subjects are protected. Monitoring is an integral part of the Quality Control (QC) processes of a clinical trial and is designed to verify the quality of the study conduct and data. 4. DEFINITIONS Monitor: Any individual assigned by Institution who has responsibility for ensuring the proper conduct of the study at the site level. Monitoring Visits: The monitoring visits are those that commence after the initiation visit and continue until the study close-out visit. Study Team (ST): The individuals from Institution who are assigned to the Trial. The membership of the team is determined by the scope of the Trial. Sponsor: The individual, institution or organization financing the clinical study. Created by ICRIN (QM subgroup). Version XX. Date: Page 1 of 5

2 5. RESPONSIBILITIES The Clinical Operations department is responsible for conducting all monitoring visits according to the sponsor and/or Institution requirements and applicable regulations and guidelines (e.g., International Conference on Harmonization (ICH), Good Clinical Practices (GCP)). 6. PROCEDURE Monitoring visits will be made as agreed with the sponsor and/or as deemed necessary due to the size and complexity of the study, frequency of subject visits, occurrence of unexpected adverse events, previous experience with the site, the status of the study and the rate of enrolment. The first visit to a site should take place early in the trial, usually after the first patients have been enrolled at the site. The Code of Federal Regulations and ICH guidelines will be implemented as applicable in addition to sponsor and/or Institution Standard Operating Procedures (SOPs) MONITOR S RESPONSIBILITIES BEFORE THE MONITORING VISIT: 1. Schedule the visit with the site allowing enough time to cover the items listed in 6.2., as applicable. 2. Re-confirm the appointment in writing with site personnel and request that source data, case report forms (CRFs), and regulatory/essential documents be available as needed. Confirm time needed with the relevant study personnel. 3. Review past Monitoring Visit Report and/or Initiation Visit Reports to determine any outstanding issues. 4. Review any outstanding queries 5. Review Central Files (CF) documents. 6. Prepare the necessary documents to take to the site MONITOR S RESPONSIBILITIES DURING THE MONITORING VISIT 1. Document visit by signing the Visitor Log. 2. Review the source documentation as agreed upon with sponsor and verify that the data in the CRFs are complete, accurate, consistent and credible as recorded in the source documents 3. Verify adherence to protocol procedures including subject eligibility and observance of inclusion and exclusion criteria. 4. Review enrolment progress. If enrolment is slower than anticipated establish the reasons and endeavour to find ways to rectify the situation. If enrolment is faster than anticipated, establish the reasons, ensuring that subjects are truly eligible and that trial supplies are still adequate. Ensure that an updated Subject Identification Code List is in the investigational site file. 5. If applicable, verify that the randomisation procedure is being conducted Created by ICRIN (QM subgroup). Version XX. Date: Page 2 of 5

3 correctly - in the event of deviations notify the (Trial Team) TT immediately. 6. Assess if the Principal Investigator is adequately supervising the study and that all tasks performed by the delegated staff members are correctly performed and documented. 7. Verify that the informed consent procedure is administered using the most recent approved version for that site in accordance with the protocol and/or regulations. 8. Verify that the site has appropriately consented the subjects prior to the performance of any procedures required by the protocol. 9. Verify that any modifications to or deviations from the protocol are approved prior to entry into the study. All protocol deviations should be documented at the site. 10. Review adverse events and serious adverse events and confirm proper reporting of these per regulatory and Institutions procedures 11. Verify reconciliation and documentation of queries generated at the current visit and at previous visits. 12. Confirm corrected query forms have been signed. 13. Retrieve CRFs and supporting documents, if appropriate, ensure ecrf is current and that no backlog of data entry exists (e.g., ECGs, X-ray reports, laboratory reports) for transmittal per Institutions procedures 14. Verify that the Investigational Medicinal Product (IMP) is correctly stored, dispensed, and accounted for as indicated in the protocol. 15. Verify expiry dates of the Investigational Medicine. 16. Verify that the site s regulatory/essential documents are complete, accurate and current and match the Central Files documents for the site. 17. Check for adequacy of study-related supplies (e.g., CRFs, investigational products). 18. Verify that physiological samples (e.g., laboratory, biopsies) are being collected, stored, and shipped according to the study guidelines, if applicable and that an inventory of all specimens is maintained. 19. Follow-up on any issues outstanding from previous monitoring visit. 20. Provide site personnel with any relevant new information pertaining to the study. 21. Advise the site of study logistics (e.g. recruitment, retention, advertising). 22. Record any changes to staff involved in the study, ensure relevant Delegation of Responsibility forms are completed and signed by the Principal Investigator, and, where appropriate, collect up-to-date signed and dated CVs. Ensure that new staff has been adequately trained in the relevant study procedures MONITOR S RESPONSIBILITIES AFTER THE MONITORING VISIT: 1. Complete a Monitoring Visit Report (see Appendix 1 for minimum requirements) and submit to the designated Trial team member for review, approval and filing in the Central Files. Created by ICRIN (QM subgroup). Version XX. Date: Page 3 of 5

4 2. Submit any regulatory/essential documents collected at the site for filing in Central File using the appropriate document transmittal form. 3. Transmit retrieved CRF pages and supporting documentation to sponsor and/or Institution as appropriate 4. Generate and send to the site a monitoring visit follow-up letter documenting any significant findings and all outstanding issues. 5. Maintain telephone contact with the site until the next monitoring visit and document any significant discussions in a telephone contact report 7. INDEX OF ABBREVIATIONS CF CRF GCP IEC IMP IRB PI TT Central Files Case Report Form Good Clinical Practice Independent Ethics Committee Investigational Medicinal Product Institutional Review Board Principal Investigator Trial Team 8. APPENDICES Appendix 1: Minimum Requirements for Monitoring Visit Report 1. Date of visit 2. Protocol number 3. Trial identification 4. Principal investigator name 5. Location of site 6. Centre number 7. Name of monitor visiting the site 8. Type of monitoring visit, i.e. site selection, initiation, interim or close out 8. Names and roles of staff with whom the monitor interacted at the site 9. Subject status update (e.g., number of subjects screened, screened and failed, randomized, ongoing, completed, withdrawn) 10. Information indicating review of informed consent forms 11. Information on case report forms reviewed and retrieved 12. List of report of serious adverse events 13. Protocol violations and/or deviations found Created by ICRIN (QM subgroup). Version XX. Date: Page 4 of 5

5 14. IMP storage conditions 15. IMP accountability information (e.g., identification of subjects reviewed) 16. Regulatory/essential document issues 17. Items for follow-up 18. Signature of monitor completing report and team member approving 19. Date of signature Created by ICRIN (QM subgroup). Version XX. Date: Page 5 of 5

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