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1 Subject: ROUTINE MONITORING VISITS Standard Operating Procedure Prepared By: Beaumont Research Coordinating Center, Research Institute PURPOSE Prior Issue Date 8/15/2011 No. 706 Issue Date 4/21/2014 Page 1 of 5 Routine monitoring visits occur one or more times during the period after the Initiation Visit but before the Study Closeout Visit. Guidelines for scheduling monitoring visits shall be determined according to the stage of development, complexity of the study, the rate of subject accrual and other factors. These visits are conducted for routine monitoring only and are intended to ensure the protocol and applicable regulatory requirements are being followed, subjects rights and safety are protected, and to confirm data integrity and quality. The objectives of routine monitoring visits are to: Document and report on clinical study progress. Document the protocol and associated forms are current. Update the site team of any changes in study conduct/documentation. Ensure BRCC requirements and investigator obligations are met. Ensure continued acceptability of the investigator, his/her team and facility. Obtain and review current clinical data, reports and source documents. Ensure adequate investigational product inventory and accountability. SCOPE RESPONSIBILITY PROCEDURE These policies and procedures apply to the BRCC and its employees. They specifically apply to those who oversee and monitor the conduct of clinical trials involving human subjects. The BRCC Administrative Manager is responsible for designating a trained and qualified member of the research team to serve as study monitor. The monitor is responsible for preparing for, conducting and documenting all monitoring visits. A. Scheduling/Frequency of Visits 1. Estimate the number of anticipated monitoring visits based on study design complexity, phase of development, investigator s experience, previous site compliance, rate of subject enrollment and any other unique attributes of the study and the site. 2. Outline the planned monitoring schedule in the clinical protocol. Monitoring high-risk or critical studies warrants scheduling the first visit after the enrollment of the first subject, with multiple monitoring visits occurring thereafter. 3. Conduct a minimum of one monitoring visit at each study site when appropriate. Research Institute Administration Disclaimer: User must ensure that any printed copies of this policy/procedure are current by checking the policy and procedure web page before use.

2 Subject: ROUTINE MONITORING VISITS Standard Operating Procedure Prepared By: Beaumont Research Coordinating Center, Research Institute Prior Issue Date 8/15/2011 No. 706 Issue Date 4/21/2014 Page 2 of 5 4. Conduct unscheduled monitoring visits as needed. Unscheduled visits may be based on reports or evidence of potential noncompliance with any sponsor/regulatory requirements (noted during a prior scheduled visit or received from any other source, including employees of the investigator), significant increases in subject enrollment rates, or changes in protocol/personnel and training activities. 5. Contact the investigator or designee regarding scheduling and conducting monitoring visits. 6. Confirm date and logistics of the monitoring visit in writing and provide the investigator with list of source documents and records (e.g., hospital charts, laboratory records, etc.) to be reviewed. B. Preparation for a Monitoring Visit 1. Review the relevant contents of the project and site files in the RMF prior to the monitoring visit. 2. Review the current clinical protocol and informed consent form prior to the monitoring visit. 3. Review CRFs for any data received to date that generated a query to the investigator for clarification or correction. 4. Review previous monitoring reports for any outstanding items that must be addressed prior to or during the next scheduled visit. 5. Prepare a list of questions and issues to be checked against source documents or other documents at the site. 6. Determine the site s inventory of investigational products, forms, or other relevant materials and arrange to provide additional items as necessary. C. Conducting a Monitoring Visit 1) Overall Study Status 1. Verify the site s study files contain all required documents and records and that they are accurate, complete and current. 2. Confirm the investigator routinely files and forwards essential and required information to other required parties appropriately (IRB/HIC). 3. Assess subject enrollment rates and examine unexpectedly high or low recruitment. 4. Obtain information on subjects who failed to meet inclusion criteria, d give informed consent, or withdrew from the study for any reason. 5. Confirm eligibility of enrolled subjects. 6. Confirm that all subjects have signed the informed consent form. 7. Evaluate status of follow-up plans and visits for subjects (assess all a sample of subject records) and identify problems. Research Institute Administration Disclaimer: User must ensure that any printed copies of this policy/procedure are current by checking the policy and procedure web page before use.

3 Subject: ROUTINE MONITORING VISITS Standard Operating Procedure Prepared By: Beaumont Research Coordinating Center, Research Institute Prior Issue Date 8/15/2011 No. 706 Issue Date 4/21/2014 Page 3 of 5 8. Confirm that safety and efficacy assessments are conducted per protocol. 9. Verify that all specimens for protocol-specific laboratory studies are being stored and forwarded properly and that specimen preparation documentation is maintained. 10. Meet with investigator and key staff to discuss any scientific or administrative problems and possible solutions. 2) CRF Review 1. Verify that CRFs are being completed in a timely manner and per protocol requirements. 2. Review all CRFs (or a sample) to ensure they are complete, legible, and consistent with protocol specifications and signed by the investigator. 3. Evaluate allocation of investigational products and verify that the randomization procedures were carried out per protocol, if a randomized controlled study. 4. Check data in CRF against source documents to assess accuracy and completeness of the information. 5. Review and address omissions and queries and ensure corrections are properly made prior to departure. 6. Tabulate changes and corrections for updating the study database. 7. Assess whether all AEs have been documented and reported as specified in the protocol and other relevant regulatory procedures. 3) Investigational Products and Other Clinical Supplies 1. Verify storage of investigational products and other clinical supplies. 2. Assess investigational product dispensing and accountability records. 3. Examine storage freezers and other storage equipment to confirm they are appropriate for the clinical protocol s requirements and that calibration and temperature logs are maintained in the site study files. 4) Staff and Facilities 1. Confirm the investigator s control of the study and assess his/her ongoing participation and any responsibility delegations not previously reported. 2. Assess the ongoing suitability of facilities and staff for conducting the study. 3. Note and record any changes in staff or the facility not previously reported. 4. Discuss scheduling additional study training for new staff.. Research Institute Administration Disclaimer: User must ensure that any printed copies of this policy/procedure are current by checking the policy and procedure web page before use.

4 Subject: ROUTINE MONITORING VISITS Standard Operating Procedure Prepared By: Beaumont Research Coordinating Center, Research Institute Prior Issue Date 8/15/2011 No. 706 Issue Date 4/21/2014 Page 4 of 5 5) Communications Records 1. Confirm that copies of all mail (electronic, paper) and facsimile correspondence and notes of telephone conversations are maintained o at the site. 6) Protocol Violations 1. Note if the records show any evidence that protocol violations have occurred and record the nature of those violations. 2. Review any study conduct issues or other incidents of noncompliance with the investigator and other key study personnel and document the issues on the monitoring report. D. Documenting Results of Monitoring Visits and Follow up Actions 1. Document all visits by monitors and other authorized parties on the Site Visit Log. 2. Document the outcome of all scheduled and unscheduled monitoring visits. 3. Provide BRCC management with the completed monitoring visit chec for review. 4. Provide BRCC the monitoring report within twelve business days of monitoring visit for review. 5. Forward to site the summary and monitor report within fifteen business days of monitoring visit. 6. Forward to the PI a copy of the summary monitor report. 7. Forward to sponsor the detailed monitor report. 8. File the completed forms, summary and monitoring report in the appropriate site RMF binder. ASSOCIATED POLICIES APPLICABLE REGULATIONS AND GUIDELINES 702 Documentation and Records Retention 705 Initiation Visit and Site Training 707 Study Close-out Visit 21 CFR Selecting Investigators and Monitors 21 CFR Review of Ongoing Investigations ICH E6, 4.1 Investigator s Qualifications and Agreement ICH E6, 5.5 Trial Management, Data Handling and Record Keeping ICH E6, 5.18 Monitoring FDA Guidelines for the Monitoring of Clinical Investigations (January 988) Original Revision Research Institute Administration Disclaimer: User must ensure that any printed copies of this policy/procedure are current by checking the policy and procedure web page before use.

5 Subject: ROUTINE MONITORING VISITS Standard Operating Procedure Prepared By: Beaumont Research Coordinating Center, Research Institute Prior Issue Date 8/15/2011 No. 706 Issue Date 4/21/2014 Page 5 of 5 Research Institute Compliance Committee Review Date: Corporate Administration Approval: Date: V.P. Research or Chief Medical Officer Research Institute Board Approval: Date: Research Administration Approval: Administrative Director Date: Research Institute Administration Disclaimer: User must ensure that any printed copies of this policy/procedure are current by checking the policy and procedure web page before use.

6 Attachment to SOP 706: Routine Monitoring Visits MONITORING VISIT CHECKLIST AND REPORT Note: Monitoring Report must be reviewed by the project manager within days of visit if the monitor states that action is required. The project manager must take action on the recommendations within days of review. Investigator Site Name Protocol # Title STUDY PERSONNEL PRESENT DURING VISIT Name Title Name Title Name Title Monitor Visit dates: from TYPE OF VISIT Scheduled Periodic visit Unscheduled Explain Technical Explain Other Specify SUBJECT INFORMATION Total # Subjects Enrolled Total # Subjects Planned # Subjects Screened Total # Subjects Completed # Subjects Active # Subjects Prematurely Withdrawn # Unanticipated AEs # CRF Collected: To Date # Protocol Deviations This Visit Page 1 of 5

7 1. Verification of Documents and Records A Documents Revision# Date N/A Current/approved protocol/amendment(s) Current/approved investigator brochure/other Current/approved informed consent form B Records Yes No NA Telephone logs current Site visit logs current Written files current Clinical study contract Curricula Vitae of relevant site personnel IRB approval letter Required progress reports Lab certification & normal ranges Subject logs Investigational product shipping and accountability records Action Item/Issue Reviewed on Monitor 2. Facility/Workload Status Yes No NA Has investigator accepted new studies since last visit? Is investigator properly supervising other personnel? Is investigator devoting enough time for the study? Any changes in site key personnel since last visit? Has facility/work area changed since last visit? Are treatment facilities adequate? Page 2 of 5

8 Action Item/Issue Reviewed on Monitor 3. Investigational Product Accountability Yes No NA Are product storage facilities adequate, secure? Has location of product storage changed since last visit? Product forms complete and up-to-date? Was product inventory checked and counted? Accountability Form complete and up-to-date? Action Item/Issue Reviewed on Monitor 4. Subject Verification and CRF Review If all subjects cannot be reviewed, select a statistically valid number of subjects for complete review. List selected CRFs by subject s identification code below. List inconsistencies in table and discuss in comment section. Page 3 of 5

9 4. Subject Verification and CFR Review cont. from previous section Yes No NA Is subject enrollment adequate? Is subject enrollment log up-to-date? Do subjects meet eligibility requirements? Have subjects signed informed consent form? Are CRF completed properly and on a timely basis? Are CRF legible, accurate and complete? Are other worksheets legible, accurate and complete? Were source documents checked for CRF reviewed? Were the data collected verifiable? Were there any inconsistencies noted in reviews? Did subjects have required lab work, etc.? Is follow-up current and properly recorded? Are dropouts/withdrawn subjects documented? Have adverse events been adequately documented? Have there been any protocol violations since last visit? Do site records match up with sponsor records? Action Item/Issue Reviewed on Monitor 5. Investigator/Monitor Meeting Yes No NA Reviewed all significant findings? Discussed all action items? Reviewed regulatory issues specific to visit? Reviewed corrected items from previous visit? Action Item/Issue Reviewed on Monitor Page 4 of 5

10 . 6. Overall Review of Study Status Yes No NA Is maintenance of records complete? Is site in compliance with protocol and IRB? Are subjects accruing within timelines? Is additional clinical/technical training required? Action Item/Issue Reviewed on Monitor 7. Recommendations of Monitor No action needed study conduct is compliant with regulations, protocol and IRB requirements. No action required, but visit site again in weeks to ensure corrections have been made. Action required: Investigator is noncompliant, schedule review meeting. Action required: Terminate study at site. Signature of monitor Date 8. Recommendations of Project Manager I agree with the recommendations of the monitor. I do not agree with the recommendations of the monitor. Reason: Page 5 of 5

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