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Delays in research protocol development may be a single factor that hinders the career progression of academic faculty. Structured educational guidance during this phase proves crucial in mitigating setbacks in Institutional Review Board (IRB) approval and expediting trial implementation. To address this, the Protocol-in-a-Day (PIAD) workshop, a comprehensive 1-day event involving members from six critical facets of RO clinical trial implementation, was established, offering significant input to individual protocols. Efficacy and satisfaction of the PIAD workshop were assessed through a 5-question survey and the average time from submission to IRB initial approval. The normality of the data was analyzed using the Shapiro-Wilk Test. Nonparametric data was analyzed using a Mann-Whitney U test for significance. A total of 18 protocols that went through the PIAD workshop were activated. The mean time to IRB approval for protocols that went through PIAD was 39.8 days compared to 58.4 days for those that did not go through the PIAD workshop. Based on survey results, 100% of PIAD participants said the PIAD workshop was useful and 94% of participants stated that the PIAD workshop improved the overall quality of their protocol. Participant surveys further highlighted substantial improvements in trial quality, language, and statistical design and revealed that all participants found the workshop helpful. Therefore, both junior and senior faculty benefitted from this educational program during protocol development, as both groups demonstrated shorter times to IRB approval than non-participants. This acceleration not only fosters efficient trial implementation but also supports academic faculty in their career development.

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CT protocol management is an arduous task that requires expertise from a variety of radiology professionals, including technologists, radiologists, radiology IT professionals, and medical physicists. Each CT vendor has unique, proprietary protocol file structures, some of which may vary by scanner model, making it difficult to develop a universal framework for distilling technical parameters to a human-readable file format. An ideal solution for CT protocol management is to minimize the work required for parameter extraction by introducing a data format into the workflow that is universal to all CT scanners. In this paper, we report a framework for CT protocol management that converts raw protocol files to an intermediary format before outputting them in a human-readable format for a variety of practical clinical applications, including routine protocol review, protocol version tracking, and cross-protocol comparisons. The framework was developed in Python 3. Technical parameters of interest were determined via collaborative effort between medical physicists and lead technologists. Protocol files were extracted and analyzed from a variety of scanners across our hospital-wide CT fleet, including various systems from Siemens and GE. Protocols were subcategorized based on relevant technical parameters into regular, dual-energy, and cardiac CT protocols. Backend code for technical parameter extraction from raw protocol files to a JavaScript Object Notation (JSON) format was performed on a per-system basis. Conversion from JSON to a readable output format (MS Excel) was performed identically for all scanners using the universal framework developed and presented in this work. Example results for Siemens and GE scanners are shown, including side-by-side comparisons for protocols with similar clinical indications. In conclusion, our CT protocol management framework may be deployed on any CT system to improve clinical efficiency in protocol review and upkeep.

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BACKGROUND: Artificial intelligence (AI) techniques and methodologies for problem solving are emerging as formal tools essential to assist in nursing care. Given their potential to improve workflows and to guide decision making, several studies have been developed; however, little is known about their impact, particularly on decision making. OBJECTIVE: The aim of this study was to map the existing research on the use of AI in decision making in nursing. With this review protocol, we aimed to map the existing research on the use of AI in nursing decision making. METHODS: A scoping review was conducted following the framework proposed by the Joanna Briggs Institute (JBI). The search strategy was tailored to each database/repository to identify relevant studies. The contained articles were the targets of the data extraction, which was conducted by two independent researchers. In the event of discrepancies, a third researcher was consulted. RESULTS: This review included quantitative, qualitative and mixed method studies. Primary studies, systematic reviews, dissertations, opinion texts and gray literature were considered according to the three steps that the JBI has defined for scoping reviews. CONCLUSIONS: This scoping review synthesized knowledge that could help advance new scientific developments and find significant and valuable outcomes for patients, caregivers and leaders in decision making. This review was also intended to encourage the development of research lines that may be useful for the development of AI tools for decision making.

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Korean Institutional Animal Care and Use Committee (IACUC) is currently facing some operational pressing issues. 1) Review of the animal protocol containing controversial technology. 2) Review of the multi-institution animal protocol. 3) Review of veterinary clinical trials for client-owned animals. 4) Delay the review process in large institutions with a single IACUC. Here, the following three solutions are proposed to address the above issues. 1) Establishment of public IACUC. 2) Establishment of the Veterinary Clinical Study Committee as an advisory body to the IACUC. 3) Operating multiple committees rather than increasing the number of committee members on a single committee.

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On 1/20/2020 when the first case of a novel coronavirus (COVID-19) was confirmed in Washington state, its major impact was unknown. Memorial Sloan Kettering Cancer Center's (MSK) Hospital Incident Command System (HICS) was activated on 2/5, with our first COVID-19 case identified in early March. By 3/17, our Protocol Activation and Human Research Protection Program was fully remote and on 3/23, MSK leadership requested the creation of the COVID-19 Research Committee. Given the race to identify safe and effective treatments for COVID-19, modifications to workflows and review processes were needed. The goal was to provide quick access to COVID-19 treatments to our patients by creating a COVID-19 Committee as a "one-stop" committee, providing comprehensive review of clinical research related to COVID-19 including scientific review mandated by the Cancer Center Support Grant (CCSG) guidelines, prior to IRB review and protocol activation. Protocols that were reviewed by the COVID-19 Committee opened to accrual in an unprecedented 44 days from submission to the committee to open to accrual. Patients were accrued on most of the therapeutic protocols within 1 day of opening. These statistics have prompted our institution to explore how more protocols can benefit from this "one-stop" committee structure.

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Clinical trials are essential for evaluating advanced technologies and treatment approaches involving radiation therapy to improve outcomes for cancer patients. Clinical trials at cancer centers with designation from the National Cancer Institute must undergo scientific review in additional to Institutional Review Board approval. Given the highly specialized nature and rapidly advancing technologies of radiation therapy, and the small number of radiation oncology investigators at some centers, a lack of radiation oncology expertise among reviewers may present challenges at some cancer centers. This commentary aims to provide an overview of radiation therapy and special considerations for radiation oncology research that will serve as a helpful resource in the scientific review of clinical trials involving cancer patients.

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BACKGROUND: The rise of investigative and commercially available cell therapy products adds a new dynamic to academic medical centers; that is, the management of patient-specific cell products. The scope of cell therapy has rapidly expanded beyond in-house collection and infusion of cell products such as bone marrow and peripheral blood transplant. The complexities and volumes of cell therapies are likely to continue to become more demanding. As patient-specific "living drugs," cell therapy products typically require material collection, product provenance, transportation and maintenance of critical quality attributes, including temperature and expiration dates. These requirements are complicated by variations in product-specific attributes, reporting requirements and interactions with industry not required of typical pharmaceuticals. METHODS: To manage these requirements, the authors set out to establish a framework within the Immune, Progenitor and Cell Therapeutics Lab, the Current Good Manufacturing Practice facility responsible for cell manufacturing at Mayo Clinic Rochester housed within the Division of Transfusion Medicine. The authors created a work unit (biopharmaceutical unit) dedicated to addressing the specialized procedures required to properly handle these living drugs from collection to delivery and housing the necessary processes to more easily integrate externally manufactured cell therapies into clinical practice. RESULTS: The result is a clear set of expectations defined for each step of the process, with logical documentation of critical steps that are concise and easy to follow. CONCLUSIONS: The authors believe this system is scalable for addressing the promised growth of cell therapy products well into the future. Here the authors describe this system and provide a framework that could be used by other centers to manage these important new therapies.

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Introduction  Coronavirus disease 2019 (COVID-19) resulted in postponing non-emergency elective surgeries beginning in April 2020. Our hospital successfully restarted elective orthopaedic surgery during the pandemic to help improve the quality of life of patients with chronic disabilities.  This study describes the development of local protocols and pathways to allow for a safe restart of elective orthopaedic surgery in a COVID-19-free 'green' site. It includes the morbidity and mortality outcomes of those patients who underwent non-emergency orthopaedic operations during this time.  Methods  This is a prospective cohort study over an eight-week period evaluating 104 patients undergoing non-emergency orthopaedic procedures through a COVID-19-free surgical pathway. The primary outcome measure was 14-day postoperative mortality. The main secondary outcome measures were the development of a COVID-19 infection in the hospital and 14 days postoperatively as well as the need for intensive care unit admissions.  Results  No patients developed a COVID-19 infection. There were no intensive care unit admissions or postoperative deaths during our study time frame. There was no statistical difference seen for age (< 70 or > 70), gender, body mass index, or American Society of Anesthesiologists (ASA) grades in the development of postoperative complications.  Conclusions  This study describes a roadmap to setting up a protocolised elective operating service for orthopaedic surgery. It has shown that standardised protocols in a COVID-19-free 'green' site, preoperative COVID-19 testing, and adherence to national guidelines on self-isolation can help prevent developing COVID-19 infection postoperatively and reduce the risk of postoperative mortality.

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The Institutional Animal Care and Use Committee (IACUC) of Seoul National University (SNU) plays a key role in monitoring and managing the humane use of animals in scientific research. Here, as one of the pioneers of the IACUC in Korea, we reported SNU-IACUC operations and activities including committee establishment and legal formulation, protocol review, and post-approval monitoring of protocols, which the IACUC has undertaken in the last decade. In addition, legal regulations and improvements were also discussed, and encompassed the limited number of committee members and the single IACUC policy in Korea. As of December, 2020, amendments are on the table at the National Assembly. We also emphasized the independent nature of the IACUC in protecting activities, including approval and monitoring animal experiments, and its public role in narrowing the knowledge gap between society and scientists. Thus, the aim of this report is to help society and scientists understand the operations of the SNU-IACUC and its role in animal welfare.

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The COVID-19 pandemic changed the clinical research landscape in America. The most urgent challenge has been to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. International Review Board (IRB) offices developed plans to rapidly review protocols related to the COVID-19 pandemic. An online survey was conducted with the IRB Directors at Clinical and Translational Science Awards (CTSA) institutions as well as two focus groups. Across the CTSA institutions, 66% reviewed COVID-19 protocols across all their IRB committees, 22% assigned protocols to just one committee, and 10% created a new committee for COVID-19 protocols. Fifty-two percent reported COVID-19 protocols were reviewed much faster, 41% somewhat faster, and 7% at the same speed as other protocols. Three percent reported that the COVID-19 protocols were reviewed with much better quality, 32% reported slightly better quality, and 65% reported the reviews were of the same quality as similar protocols before the COVID-19 pandemic. IRBs were able to respond to the emergent demand for reviewing COVID-19 protocols. Most of the increased review capacity was due to extra effort by IRB staff and members and not changes that will be easily implemented across all research going forward.

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PURPOSE: Quantification of the frequency, understanding the motivation, and documentation of the changes made by CT technologists at scan time are important components of monitoring a quality CT workflow. METHODS: CT scan acquisition data were collected from one CT scanner for a period of 1 year. The data included all relevant acquisition parameters needed to define the technical side of a CT protocol. An algorithm was created to sort these data in groups of irradiation events with the same combinations of scan acquisition parameters. For scans modified at scan time, it was hypothesized that these examinations would show up only once in the organized data. A classification scheme was developed to place each "one-off" examination into a category related to what motivated the scan-time change. RESULTS: A total of 132,707 irradiation events were organized into 434 groups of unique scan acquisition parameters. One hundred forty-four irradiation events had acquisition parameters that showed up only once in the data. These "one-offs" were classified as follows: 25% represented rarely used protocols, 17% were due to service scans, 16% were changed for unknown and therefore undesired reasons, 15% were changed by technologists trying to adapt protocol to patient size, 12% were allowable scan-time changes, 8% of scans had tube current maxed out, and 6% of scans were changed to a higher dose mode as requested by radiologists. CONCLUSIONS: The outcome of this study suggests many areas of needed technologist training and chances for optimizing this institution's CT protocols.

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To sustain compliance with accreditation requirements of the ACR, Joint Commission, and state-specific statutes and regulatory requirements, a CT protocol review committee requires a structure for systematic analysis of protocols. Safe and reproducible practice of CT in a complex environment requires that physician supervision processes and protocols be precisely and clearly presented. This article discusses necessary components for data structure, and a description of an IT-based approach for protocol review based on experiences at 2 academic centers, 3 community hospitals, 1 cancer center, and 2 outpatient clinics.

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PURPOSE: Protocol review plays a critical role in CT quality assurance, but large numbers of protocols and inconsistent protocol names on scanners and in exam records make thorough protocol review formidable. In this investigation, we report on a data-driven cataloging process that can be used to assist in the reviewing and management of CT protocols. METHODS: We collected lists of scanner protocols, as well as 18 months of recent exam records, for 10 clinical scanners. We developed computer algorithms to automatically deconstruct the protocol names on the scanner and in the exam records into core names and descriptive components. Based on the core names, we were able to group the scanner protocols into a much smaller set of "core protocols," and to easily link exam records with the scanner protocols. We calculated the percentage of usage for each core protocol, from which the most heavily used protocols were identified. RESULTS: From the percentage-of-usage data, we found that, on average, 18, 33, and 49 core protocols per scanner covered 80%, 90%, and 95%, respectively, of all exams. These numbers are one order of magnitude smaller than the typical numbers of protocols that are loaded on a scanner (200-300, as reported in the literature). Duplicated, outdated, and rarely used protocols on the scanners were easily pinpointed in the cataloging process. CONCLUSIONS: The data-driven cataloging process can facilitate the task of protocol review.

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In 2008, the National Heart, Lung, and Blood Institute announced its intent to support a new asthma network known as AsthmaNet. This clinical trials consortium, now in its fifth year, has been charged with developing and executing clinical trials to address the most important asthma management questions and identify new treatment approaches in pediatric and adult patients. This review will discuss the organization of AsthmaNet and the scientific context in which the network was developed and began its work, report the results of an internal priority-setting exercise designed to guide the network's scientific strategy, and highlight the portfolio of clinical trials, proof-of-concept studies, and mechanistic studies planned for the 7-year period of the network to update the global asthma community regarding the progress and processes of the network.

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