The role of monitoring of research for compliance and detecting misconduct
Frank Wells, Michael Farthing in Fraud and Misconduct in Biomedical Research, 2019
The monitor (or clinical research associate (CRA), as he or she is often referred to in some regions) is one of the key persons involved in overseeing the conduct of studies and ensuring data quality. Monitoring itself is the process of overseeing a study to ensure patient safety, data quality, protocol compliance, and regulatory compliance. The monitor is also the ‘eyes and ears’ of the sponsor at the site. The clinical monitor is responsible for ensuring the completeness and accuracy of the subject’s medical records, and ensuring that the regulatory documents are complete and up-to-date and that all the essential information required by the study is recorded on the CRFs. The major role of a regulatory agency review is evaluation of the data submitted in support of the marketing application. The data must be correct, be validated, and reflect the results and conclusions of the study so that the regulatory agency review can draw proper conclusions about them.16
Clinical Research
Gary M. Matoren in The Clinical Research Process in the Pharmaceutical Industry, 2020
The clinical research associate usually is an inexperienced person with a B.S., pharmacy degree, R.N., or other special scientific medical training. The CRA is involved in the technical aspects of the design and execution of clinical studies and associated data analysis functions. He also assists in support of marketed products. The CRA usually assists, at different levels, in all general functions of drug development. The scope of activities includes initial drafting of protocols and medical reports, and monitoring of studies once they are in progress.
Retrospective analysis of predisposing factors for difficult lumbar punctures requiring image guidance in pediatric oncology patients
Published in Pediatric Hematology and Oncology, 2021
Michael J. Frett, Heidi Meeks, Kyle J. Morgan, Hasmukh Prajapati, Vinod Maller, Robert Gold, Doralina Anghelescu
The data collected included demographic and clinical data, factors expected to be associated with technical difficulties during LPs, and procedural details (Table 3). Classification as overweight (BMI ≥ 25) or obese (BMI ≥ 30) was in concordance with the current Centers for Disease Control and Prevention guidelines.13 The current recommendations for platelet counts of > 50 × 109 and international normalized ratio (INR) levels of < 1.5 for LP procedures were considered when evaluating the results.14 A single clinical research associate collected the data, and a second researcher (HM) verified the data accuracy in 20% of the dataset. Data were managed with the Research Electronic Data Capture (REDCap) web-based application hosted at St. Jude.15,16 REDCap is a secure platform designed to support data capture for research studies, providing an interface for data capture, audit trails, automated data export, and data integration.
Ethics and etiquette in an emergency vaccine trial. The orchestration of compliance
Published in Global Bioethics, 2020
Arsenii Alenichev
After graduating, while working as a clinical research associate, I learned that the compliance of people enrolled in clinical studies is of critical importance for researchers and sponsors for two main reasons. First, it is easier to run statistical analysis when participants follow all of the planned procedures without deviations. Second, research institutions that can run trials with high compliance rates are likely to attract other projects. Identifying a per-protocol population allows researchers to present high-quality data to sponsors, and potentially helps a trial advance from an experimental phase to a licensed product on the market. Thus, an ability to execute high-compliance trials is an important performance indicator amongst research units competing for projects.
Maine Cancer Genomics Initiative: A Model for Translational Outreach
Published in Oncology Issues, 2021
Jens Rueter, Jennifer Bourne, Patton Amanda
“One of the interesting things about the MCGI study,” said Bourne, “is that we have enabled practices in the state of Maine that have no research infrastructure to participate in a human subject protection program-compliant way in this study. What that means is we have a clinical research manager and clinical research associate in our offices who talk to the patients at rural practices who might want to participate in the MCGI study and enroll them on the study. In this way we provide support to enable the practice to be part of the research and ensure that interested participants are able to join the study.”
Related Knowledge Centers
- Adverse Drug Reaction
- Clinical Trial
- Medical Research
- Good Clinical Practice
- International Council For Harmonisation of Technical Requirements For Pharmaceuticals For Human Use
- Protocol
- Case Report Form
- Clinical Research Coordinator
- Eudralex