Clinical Trial Monitoring: Documentation and Closure
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Price: $195.00 USD  |
Download Showcase your commitment to quality, compliance, safety, and professional excellence by earning a recognized certification of training.Training Program: Clinical Trial Monitoring: Documentation and ClosureTraining Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced eLearning. Immediate access to training materials upon enrollment. Description:  From start to finish, proper monitoring ensures trial success. This course teaches how to protect subject welfare, ensure data accuracy, and comply with GCP and regulatory requirements - all the way through trial closeout.
Take the next step in your professional growth and earn an industry-recognized certification from Biopharma Institute -designed for professionals who want to excel in ensuring the safety and effectiveness of medicinal products. These programs not only give you up-to-date regulatory and compliance insights but also deliver practical skills that employers value. Whether you're enhancing your current role or preparing for a new opportunity, Biopharma Institute certifications are designed to set you apart in the competitive and highly regulated pharmaceutical industry. |
Outline:Module overview Sets out the module's scope, objectives and notes on terminology. Site monitoring visits Regular visiting of investigational sites by a CRA is the front line of clinical trial monitoring. The visits allow face-to-face interaction with study site personnel and direct access to source records and site resources, providing the best opportunity for the CRA both to assess and to influence the progress and quality of a trial. In this session, we discuss monitoring tasks, the frequency and duration of visits, preparation for a visit, the kinds of deficiencies that may be found at the site, interaction with study staff, assessment of protocol compliance in a variety of areas, investigational product and subject recruitment issues, review of findings, and report and follow-up. Data checking Review and verification of data in CRFs and source documents is considered by many to be the CRA's principal task. It takes up most of his or her time on a monitoring visit and constitutes the primary measure taken on behalf of the sponsor to assure the quality of the data provided by the investigator. In this session, we describe how to carry out CRF review and source document verification (SDV). We discuss the extent of SDV required, outline differences between paper and electronic CRFs, identify aspects of trial conduct for which CRFs and source records should be checked, discuss on-site corrections and resolution of discrepancies, and outline data retrieval and data query procedures. Close-out visit Almost all clinical trials require an on-site visit to close the study at a site, irrespective of whether routine monitoring visits have been made. In addition to completing tasks typically carried out at a routine visit, the CRA will be required to perform some actions specific to the end of the trial, such as retrieving or authorizing the destruction of unused supplies, retrieving some essential documents, and reminding the investigator of continuing responsibilities. In this session we describe the close-out of a trial at an investigational site. Risk-based monitoring Monitoring of clinical research by traditional methods, particularly as regards data checking, is time consuming and laborious. In recent years, regulatory authorities have focused attention on ways of making quality management in general, and monitoring in particular, more efficient through a risk-based approach. Implications of this approach include: increased emphasis on centralized monitoring rather than site visits; and a move away from 100% source document verification toward risk-based and statistically directed sampling of data. In this session we provide a brief introduction to principles of risk-based monitoring. Fraud and scientific misconduct The great majority of healthcare professionals undertaking clinical research act with honesty and integrity. However, cases of scientific misconduct and downright fraud do occur. Besides damaging the reputations of those who commit them, such actions have potentially serious consequences for the research and might even affect public health. In this session we distinguish error, misconduct and fraud, discuss the CRA's role in detecting them, and describe their consequences. Assessment Multiple-choice mastery assessment. | Objectives:Who will benefit from this module? The module is intended for those involved in clinical research and development, in particular the monitoring of clinical trials, and those who require an understanding of what this entails. It and its companion module CT06 provide a comprehensive introduction to monitoring for new CRAs, or additional training and professional development for those already working in the field. It will also be of value to a clinical research coordinator (CRC), clinical investigator and other healthcare professionals involved in clinical studies. Learning objectives
This course has been updated to reflect the ICH E6(R3) Good Clinical Practice (GCP) Guidelines update. | |
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