Presentation on theme: "Tips to a Successful Monitoring Visit"— Presentation transcript:
1 Tips to a Successful Monitoring Visit Ngoc Tran, CCRANT Research, Inc.
2 Person delegated by the Sponsor to oversee the conduct of a clinical trial by ensuring that study activities are in accordance to the protocol and regulatory requirements.Study Monitor
3 Roles and Responsibilities Act as a liaison between Site and SponsorAssure rights, safety and well-being of subjects are protectedReview trial data for accuracy, completeness and verifiableOversee study activities for protocol, GCP and regulatory complianceRoles and ResponsibilitiesVerifies that the investigator has adequate qualified personnel and resources.Verifies that the facilities, including lab and equipment are adequate to safely and properly conduct the trial.
8 Site VisitsEvaluation/Pre-StudyInitiationMonitoringClose-out
9 Evaluation/ Pre-Study Visit Purpose Assess Investigator’s interest and qualificationEvaluate Site’s capability to properly and safely conduct clinical trialRequest Investigator and Study Coordinator attendanceEvaluation/ Pre-Study Visit PurposeSetting the stage.
10 Evaluation/ Pre-Study Visit Expectations Obtain Signed Confidentiality AgreementProvide protocol synopsis for reviewEvaluate by phone or in personEvaluation/ Pre-Study Visit ExpectationsMeet & Greet
11 Preparing for an Evaluation/Pre-Study Visit Review protocol synopsisObtain copies of the Investigator’s CV and credentialsVerify that there is sufficient personnel, resources and necessary equipment to conduct the clinical trialAssess ability to meet enrollment goals and timelinesSchedule tour of facilities (i.e. pharmacy, lab, etc).
12 Initiation Visit Purpose Provide Protocol and Investigational Product/Device TrainingOutline expectations of Investigator and research personnelConfirm study supplies receivedInitiation Visit PurposeWhy Initiations are so critical for the Sponsor and the Site to engage in open dialogue.
13 Initiation Visit Purpose Collect remaining essential documentsOccurs prior to enrollment commencingAttendance expected of Investigator and Key Research PersonnelInitiation Visit PurposeWhy Initiations are so critical for the Sponsor and the Site to engage in open dialogue.
14 Sample of Initiation Agenda Detailed discussion of the protocol, including:Overall study design and objectiveStudy primary and secondary endpointsInclusion/Exclusion CriteriaStudy ProceduresDrug/Device Administration, Storage, and HandlingConsent and enrollment proceduresAdverse event reportingInvestigator and research personnel roles/responsibilitiesCase report forms (Electronic or Paper)Monitoring frequency & expectationsSponsor specific forms/logsIdentify potential problems and concerns
15 Preparing for Initiation Visit Review protocol and identify potential challenges and/or concerns for discussionBecome familiar with Sponsor provided documents/formsBegin maintenance of regulatory filesObtain remaining essential documentsConfirm and audit supplies received
16 Preparing for Initiation Visit Schedule tour of the site, pharmacy & labNotify appropriate research personnelArrange meeting room logisticsStart Delegation of Authority Log & Site Signature Log and Training LogCompare Sponsor forms and Institutional Forms for similarities/differences
17 Monitoring Visit Purpose Review progress of clinical trial and ensure protocol adherence and regulatory compliance while maintaining the rights, safety and well-being of subjectsFrequency is dictated by complexity of the study and Sponsor requirementsInvestigator and key research personnel should be available for questions
18 Monitoring Visit Preparation Reserve monitoring space which provides access to phone, internet, and copy/faxSchedule visits with the Investigator, Pharmacy, Laboratory and Regulatory office, if applicableRequest access to medical records/source documentsComplete CRFsPrepare regulatory filesAllot time to meet with Monitor to discuss visit findings
19 Preparing Source Documents Provide list of subjects with corresponding medical record numberOrient monitor to medical record layoutVerify all consented subjects have properly completed Informed Consent Forms and process is well documentedReview drug compliance records and reconcile discrepanciesAssure lab, diagnostic and radiology reports are available for reviewFlag sections of the chart to ease search of informationHave Investigator or designee document review of laboratory results especially if out-of-rangeEnsure deviations or missing information is well documented
20 Preparing CRFs Complete CRFs up to visit date Answer queries appropriatelyEnsure data is accurate and verifiable by making source documents availableReview Adverse Events(AE) being sure that grade, severity and attribution are assessed and documentedReview concomitant medications for start/stop dates and corresponding AE entry
21 Preparing Regulatory Files Make sure files are complete and currentRetain all versions of the protocol, Investigator Brochures, laboratory certification, lab normals, FDA Form 1572, CVs, licenses, financial disclosureFile IRB acknowledgement of receipt, if applicable, approval and correspondencesUpdate signature and enrollment logsRetain Sponsor correspondences
22 Close-Out Visit Purpose Occurs when study is complete and database is lockedFinal review of regulatory filesReconciliation of IP/DeviceReview record retention requirementsCollect IRB notification of study closureClose-Out Visit Purpose
23 Close-Out Visit Preparation Secure monitor space/roomProvide regulatory files and case booksEnsure Investigator and site staff are availableSchedule final pharmacy visit for drug returnGather unused supplies for return/destruction