Page 500 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Com-202
SOP Title: External Review of Research Documents and Medical Records
1.0 PURPOSE
This procedure outlines the process for providing external reviewers (e.g. monitors, auditors, and state/federal reviewers) with access to research documents, participant medical records, and clinic space to observe study-related procedures performed at Children’s Health.
2.0 SCOPE
This procedure is applicable to all research studies done within CCBD that are subject to review by an external third-party 1) during normal conditions, and 2) during time of pandemic and HICS structure.
3.0 RESPONSIBILITY
The Research Administration team is responsible for coordinating access to the appropriate research documents and participant medical records to an external reviewer. They will work with the appropriate departments at Children’s Health so that records can be provided in a manner that is secure, confidential, and per institutional requirements.
All onsite sponsor visits are expected to follow the on-site sponsor guidance attached the back of the SOP. All sponsor representatives coming on site are expected to provide a vaccine attestation and obtain approval to come on site at least 10 business days prior to the day of the visit. Additional requirements extend to representatives that will go into the clinic spaces. Remote access to EPIC requires a Monitor Access Form to be completed 10 business days prior to the day the access is needed.
3.1 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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