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STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Com-203
SOP Title: Internet-Based Remote Monitoring of Non-EPIC Research Data
5. SPECIFIC PROCEDURES
5.1 The purpose of routine monitoring visits is to review the accuracy and completeness of the study. If the monitor requires to have access to the subjects PHI in EPIC, it can only be granted through a request of a temporary account with only the study subjects available for review. The temporary account will be available only for the specified time frame that the monitor will conduct the RMV. If the monitor does not require EPIC access, then all PHI should be printed out and placed in the subjects’ binder for review. The monitor will need access to the subjects’ binders in order that they can compare the data in the source documents with that provided to the sponsor in the case report forms and electronic database EDC. Documentation of the study procedures will also be reviewed. Additionally, they will compare the concordance of the essential documents stored in the site’s regulatory binder with that kept by the sponsor. A site activation letter will be sent confirming that the site is active and open for enrollment and will be sent to the site along with a monitor visit follow-up report outlining any other action items or observations that need to be addressed by the site. This letter and follow-up report will be filed in the appropriate section of the regulatory binder.
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Monitoring Visit Items
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Monitoring Visit Items
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Review of IP supply and comparison to documentation
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Review of informed consent documents for each subject
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Review of regulatory study document files (essential documents)
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Review of CRFs and comparison to source documentation (e.g., medical record)
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Review facilities and equipment
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Verification that only eligible subjects are enrolled
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Verification of investigator compliance with protocol and any amendments
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Verification that any therapy modifications are documented
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Verification that investigator and staff are adequately informed about the trial
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Verification of complete and accurate reporting of adverse and serious adverse events
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Verification that the investigator has accurately prepared and provided all required reports to the sponsor, IRB, and institution, and that each document is complete, accurate, dated, legible, and properly identifies the trial
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Verification that any missed visits, tests, or procedures are accurately documented on the subject’s CRF
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Notification of the investigator of any CRF discrepancy, entry error, omission, or illegibility
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Verification that all subject withdrawals or drop-outs are reported and explained
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Verification that the CRF corrections are made with dated, initialled documentation and explained, if required
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Verification that only authorized persons have written on the CRF
SOP No. 25, 10-16-2020