Clinical Trials in Molecular Imaging: The Importance of Following the Protocol

Trembath, LisaAnn; Opanowski, Adam

doi:10.2967/jnmt.110.083691

Cited by 4 publications

(4 citation statements)

References 1 publication

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“…We identified 31 articles related to GCP training and classified them into the following 5 categories: qualitative and survey, 8 – 17 investigator and site staff training, 18 – 24 research networks, 25 – 30 policy and guidance, 31 – 34 and online training modules. 35 – 38 GCP training programs referenced in the literature range from departmental-based training for researchers to centralized GCP training programs offered at the university or organizational level (eg, training offered by government agencies).…”

Section: Resultsmentioning

confidence: 99%

Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency

Arango

Chuck

Ellenberg

et al. 2016

Ther Innov Regul Sci

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Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. The goal of GCP is to ensure the protection of the rights, integrity, and confidentiality of clinical trial participants and to ensure the credibility and accuracy of data and reported results. In the United States, trial sponsors generally require investigators to complete GCP training prior to participating in each clinical trial to foster GCP and as a method to meet regulatory expectations (ie, sponsor’s responsibility to select qualified investigators per 21 CFR 312.50 and 312.53(a) for drugs and biologics and 21 CFR 812.40 and 812.43(a) for medical devices). This training requirement is often extended to investigative site staff, as deemed relevant by the sponsor, institution, or investigator. Those who participate in multiple clinical trials are often required by sponsors to complete repeated GCP training, which is unnecessarily burdensome. The Clinical Trials Transformation Initiative convened a multidisciplinary project team involving partners from academia, industry, other researchers and research staff, and government to develop recommendations for streamlining current GCP training practices. Recommendations drafted by the project team, including the minimum key training elements, frequency, format, and evidence of training completion, were presented to a broad group of experts to foster discussion of the current issues and to seek consensus on proposed solutions.

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Section: Resultsmentioning

confidence: 99%

Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency

Arango

Chuck

Ellenberg

et al. 2016

Ther Innov Regul Sci

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“…The CQIE program was not designed to be a prospective study of the impact of rigorous site quality assurance and quality control (QA/QC) on image metrics or study power, etc ., although a few studies have demonstrated reduction of bias and variability when site qualification and QA/QC procedures are implemented (9,10). However, we are aware of only one study showing the cost-effectiveness of the level (ie, rigor) of site qualification and QA/QC versus the impact on image metrics or study power (11).…”

Section: Discussionmentioning

confidence: 99%

Performance Observations of Scanner Qualification of NCI-Designated Cancer Centers: Results From the Centers of Quantitative Imaging Excellence (CQIE) Program

et al. 2017

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We present an overview of the Centers for Quantitative Imaging Excellence (CQIE) program, which was initiated in 2010 to establish a resource of clinical trial-ready sites within the National Cancer Institute (NCI)-designated Cancer Centers (NCI-CCs) network. The intent was to enable imaging centers in the NCI-CCs network capable of conducting treatment trials with advanced quantitative imaging end points. We describe the motivations for establishing the CQIE, the process used to initiate the network, the methods of site qualification for positron emission tomography, computed tomography, and magnetic resonance imaging, and the results of the evaluations over the subsequent 3 years.

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“…Additional information about protocol amendments, deviations, and variations; form FDA 1572; and practical advice on how to maximize compliance with the protocol can be found in a previous publication (29).…”

Section: Form Fda 1572mentioning

confidence: 99%

SNMMI Clinical Trial Network Research Series for Technologists: Application of Good Clinical Practice to Clinical Research in Medical Imaging

Trembath¹,

Frye

Scott

et al. 2022

J. Nucl. Med. Technol.

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CE credit: For CE credit, you can access the test for this article, as well as additional JNMT CE tests, online at https://www.snmmilearningcenter.org. Complete the test online no later than March 2026. Your online test will be scored immediately. You may make 3 attempts to pass the test and must answer 80% of the questions correctly to receive 1.0 CEH (Continuing Education Hour) credit. SNMMI members will have their CEH credit added to their VOICE transcript automatically; nonmembers will be able to print out a CE certificate upon successfully completing the test. The online test is free to SNMMI members; nonmembers must pay $15.00 by credit card when logging onto the website to take the test.This article is part of a series developed by the Clinical Trials Network of the Society of Nuclear Medicine and Molecular Imaging to offer training and information for molecular imaging technologists and researchers about various aspects of clinical research. This article covers the topic of good clinical practice and how that relates to those portions of the Code of Federal Regulations that govern clinical research in the United States, such as title 21, part 312, and the Common Rule. The purpose of this article is to inform technologists and researchers about standard roles, documents, guidance, and processes that are elemental to the conduct of clinical trials and to offer additional resources for learning about these processes.

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Clinical Trials in Molecular Imaging: The Importance of Following the Protocol

Cited by 4 publications

References 1 publication

Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency

Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency

Performance Observations of Scanner Qualification of NCI-Designated Cancer Centers: Results From the Centers of Quantitative Imaging Excellence (CQIE) Program

SNMMI Clinical Trial Network Research Series for Technologists: Application of Good Clinical Practice to Clinical Research in Medical Imaging

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