Tool Summary Sheet
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Clinical Monitoring
<Teleconference/Visit><Protocol Number>: <Protocol Title>
CROMS
Clinical Research Operations and Management SupportRho, Inc., Federal Division
v2.0 - 2017-10-31
Clinical Monitoring
NIDCR via OCTOM has a contract with Rho called CROMS (Clinical Research Operations and Management Support)This study has been selected for clinical monitoring as part of the clinical terms of award process.Acceptance of the terms and conditions of grant award includes agreement to be in compliance with NIDCR monitoring expectations.CROMS Clinical Research Associates (CRAs) provide independent clinical monitoring on behalf of NIDCR.Does not preclude study teams from conducting their own monitoring visits that report to other institutions
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Clinical Monitoring
CROMS and NIDCR collaborate to establish the Clinical Monitoring Plan (CMP) for each studyTiming and frequency of visits are based on several factors, including level of risk and enrollmentCMP Part A– General description of monitoring activities conducted on all CROMS studiesCMP Part B– Study-specific details:Frequency of visitsPercentage of consent and chart reviewCMP Part B may be finalized after site initiation
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Clinical Monitoring
The CRA will review study documents and may observe study processes to confirm adherence to:Good Clinical Practice (GCP)Data integrityInformed consent process and documentationStudy protocolAll other applicable regulations
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On-Site Visits
3 types of visits may be conducted by the CRA:Interim monitoring visit (IMV)For-cause visit (FCV)Close-out Visit (COV)CRA attends Site Initiation Visit (SIV)
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Visit Scheduling
Rho CRA schedules the visit with the study teamVisits are generally scheduled approximately a month ahead of timeBrief teleconference ahead of first IMV, as desiredConfirmation letter and tentative agenda sent to the team approximately 2 weeks before visit
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Visit Requirements
During on-site visits, the CRA will need access to the following:Work spaceInvestigator site file (including access to ISF documents maintained electronically, if applicable)Research records (paper and electronic)All signed consent forms
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Interim Monitoring Visit Activities
Consent form reviewConsent documentsDocumentation of consent process in chartChart review/source verificationRead-only database accessNumber of charts, selected data elements and percentage of data in each chart to be reviewed is addressed in the CMPInvestigator site file reviewElectronic filePaper file/binder
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Interim Monitoring Visit Activities
Serious Adverse Events (SAEs), Unanticipated Problems (UPs)Initial reportFollow-up informationProtocol Deviations ReviewResearch Specimen ReviewInvestigational Product Accountability
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Consent Form Review
Obtained prior to initiation of study proceduresProcess documented in sourceDate and timeVersion reviewedStudy personnel conducting the discussion(s)Topics discussed with participantAdequate time for review of consent and questionsParticipant received copy of consent documentValid signatures and datesCorrect version signed, including updates
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Source Documentation and Data Collection Form to Database Review
The CRA will review and verify:Accurate, complete, and current source documentation is being maintainedParticipant eligibilityCompletion of protocol-specified proceduresProper documentation and reporting of UPs/SAEs in the source and data collection forms/databaseAccuracy of data recorded on data collection formsItems entered directly in the database
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Investigator Site File Review
Verify and review all required essential documentsVerify all documents are current and expired documents are replaced, with maintenance of previous versionsReview Delegation of Responsibilities Log to ensure it is current and includes all site staff with signatures and appropriate study responsibilitiesReview Training LogsSign Monitoring Visit Log for each day of the visit
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Unanticipated Problems/Serious Adverse Events
The CRA will:Follow-up on previously reported UPs/SAEsVerify all newly reported events against source documentationIdentify unreported events recorded in source documentationConfirm events reported to IRB and as outlined in the protocol
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Investigational Product (IP) Accountability
The CRA will:Confirm shipping, storage, dispensing, and return of IP are occurring according to the protocol and MOP/SOPsPerform IP counts for stock and returned supply against dispensing logsConfirm proper disposition of used/unused IP
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Protocol Deviations
The CRA will:Identify potential deviations for discussion with study teamVerify that deviations are documented in sourceVerify deviations were reported to the IRB per their guidelinesAddress deviations with site personnel and establish plans to prevent future occurrence
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Quality Management (QM) Review
The CRA will:Review site-level QM reports against the QM Plan, for studies with on-site clinical monitoring where QM reports are not sent to NIDCRNote resolution of items noted in QM reportsNote any suggested items for follow-up or action based on QM findings
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For-Cause Visit Activities
May include:Activities generally conducted during an IMVDiscussion and review of site operations and study managementTraining/re-training, as appropriateExamples:Training for new study team memberVisit new pharmacy locationReport of findings suggests on-site follow-up
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Close-Out Visit Activities
Will include:Final consent form review, if neededVerification of required essential documentsCompletion of data review and source verificationConfirmation that UPs/SAEs have been documented in data collection forms and reported appropriatelyConfirmation that all lab samples have been shipped, as applicable, and appropriately storedConfirmation of change in study status with IRBConfirmation of study record storage location and that PI is aware of applicable record retention policies and possibility of audits by a regulatory agency or other group in future
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Monitoring Visit Follow-Up Activities
The CRA will:Review visit findings and help develop an action plan if neededAnswer questionsDiscuss significant findings with CROMS LCRA, Project Manager (PM), and NIDCRProgram and OCTOM staffPrepare a visit report, follow-up letter, and action items trackerDocuments are reviewed and approved by NIDCR OCTOMWork with the study team to schedule a teleconference approximately 4 weeks after receipt of the monitoring visit documents to follow-up on outstanding action items
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Contact Information
Lauren McGurk, Principal Clinical Research AssociateCROMS Lead CRAPh: 919-595-6858Email:[email protected]
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