J clin monit trial#
In-person interactions between trial sponsors, CROs, and study sites extend beyond monitoring and auditing. Specific comments from sponsors and auditors performing remote monitoring at our center included increased responsiveness of clinical research personnel, ease of following clinical documentation through use of the EMR, and more availability of study teams for exit interviews. This fortuitous transition helped to more efficiently manage these operational changes. With goals of improving oversight, limiting discrepancies, and avoiding redundancies, the office had completed converting most paper source documentation to electronic format before the COVID-19 pandemic.
J clin monit verification#
Sponsors and auditors signed institutional agreements for access to the electronic medical record (EMR), allowing remote source data verification between electronic data capture contents and information in the EMR-including recently implemented electronic research notes. 6 At our site, planned, routine audits and monitoring visits were immediately converted to remote format. According to an ASCO survey reported in JCO Oncology Practice in May 2020, this change was consistent among the majority of centers surveyed. In March 2020, following the announcement of the COVID-19 public health emergency, our center immediately suspended all onsite monitoring and auditing until further notice with only rare exceptions. Along with other adjustments such as remote consent, telehealth visits, off-site diagnostic studies, and shipping of oral study therapy directly to patients' homes, the FDA, the National Institutes of Health Central Institutional Review Board, and the National Cancer Institute have also encouraged remote monitoring. Travel restrictions, quarantines, and safety concerns have prevented on-site monitoring activities at most sites. The COVID-19 pandemic appears to have provided the impetus to revisit the feasibility and utility of remote monitoring. Considering the need for travel, lodging, and orientation to a site's documentation, on-site monitoring may be costly and inefficient, often requiring continuous attendance by study staff who would otherwise be engaged in clinical trial conduct. Depending on a center's enrollment activity, these visits may last days and may recur every few weeks. Potentially driven by a perceived need to verify all source data, study sponsors have continued to send monitors to enrolling sites on a regular basis. For many clinical trials, any remote evaluation is limited to automated, system-generated queries driven by missing, incomplete, or inconsistent data. 3ĭespite these advances and recommendations, clinical trial monitoring and auditing have remained largely on-site activities. Instead, the FDA recommended a risk-based approach focusing on critical study parameters. In 2013, the US Food and Drug Administration (FDA) released guidance to industry, indicating that 100% source data verification was not an economical use of resources. 2 At the same time, regulatory authorities have encouraged a more streamlined approach to clinical trial oversight. Most medical institutions have migrated medical records into electronic platforms. Many clinical trial case report forms-the documents detailing patient characteristics, medications, laboratory and radiology results, and adverse events-are now fully digitized. Recent years have seen a remarkable technological shift. The only way that representatives of study sponsors, contract research organizations (CROs), and regulatory authorities could review such data was by traveling to study sites and manually combing through these records. Medical records were documented on paper. Information on study participants and events were recorded on paper case report forms. For decades, the landscape and model for clinical trials necessitated on-site, in-person monitoring and auditing. 1 At the same time, technological advances have supported tremendous shifts in non–patient-facing activities, including clinical research oversight. Through virtual clinic visits, telehealth has allowed clinicians to evaluate and treat patients while minimizing exposure risk. Technology has enabled clinical medicine to adapt remarkably during the COVID-19 pandemic.
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