Academic-industry partnership advancing cannabis science: The Complementary Care Practice-Based Research Network

In this 2022 paper published in the journal Complementary Therapies in Medicine, Ennis et al. discuss the development of a practice-based research network in order to improve the state of understanding of Cannabis science in the state of Florida, as well as promote future clinical research related to the plant. The authors developed this research network after noting a dearth of such medical marijuana-focused research networks in the state. After providing an introduction, they walk through the steps that led to their Complementary Care Practice-Based Research Network (CC-PBRN), including the methods used in producing usable, de-identified data for research. The authors then summarize the results and address three major challenges in negotiating the "differing foci of academic and business organizations" in developing the network. After noting the strengths and limitations of their network, they conclude that "[t]he data generated by the CC-PBRN can be used to inform and guide patient-centered care, clinical decision-making, and health policy decisions" for medical marijuana patients in Florida.

Identifying risk management challenges in laboratories

In this 2023 paper published in the journal Accreditation and Quality Assurance, Tziakou et al. examine the state of risk management as it applies to the modern laboratory environment, tapping into numerous International Organization for Standardization (ISO) standards and a review of the literature on the subject. After a brief introduction, the authors discuss the risk management process and risk assessment techniques for organizations of all types. They then take a deep dive into how those techniques apply to the laboratory environment at every step of the lab's workflow, from sample and reagent management to reporting and digitalization of results. They conclude that given the major sources of risk they identified in the lab, "the laboratory can reduce the risks to a tolerable level when clear procedures, continuous supervision, inspections, timely training and continuous education of its staff, and upgrades of its equipment with systems automation are maintained." They add that "the implementation of risk-based thinking can positively affect the outcome of regular assessments in order to explore opportunities for increasing the effectiveness of the [quality management system] and preventing further negative effects."

An overview of data warehouse and data lake in modern enterprise data management

Noting only one known work comparing data warehouses (DWs) with data lakes (DLs), with that article failing to fully address "a comprehensive analysis of both data management schemes by addressing various aspects" in detail, Nambiar and Mundra take to that task in this 2022 article published in Big Data and Cognitive Computing. After an introduction to the state of DWs and DLs, the authors then discuss the finer points of both data management schemes, while also conducting a literature review on the topic. They then discuss the specifics of architecture regarding DWs and DLs, as well as the data management aspects and useful tools that enhance them. After discussing various challenges and opportunities for the two schemes, the authors conclude that "[d]espite being used interchangeably, they are two distinct storage forms with unique characteristics that serve different purposes."

A critical literature review of historic scientific analog data: Uses, successes, and challenges

While the management of digitally created data and information is largely in the scope of regulators, standards organizations, and company management these days, the non-trivial surplus of analog data and information (e.g., printed tables, field notebooks, photographs, drawings, maps, etc.) and what to do with it still weighs upon on the research community. Older data has long had uses in retrospective and current research, yet few large-scale solutions for making this analog data and information more FAIR (findable, accessible, interoperable, and reusable) have been developed. Kelly et al. emphasize this in their 2022 research published in the Data Science Journal and address what they consider should be a set of best practices to managing historic analog data and information. After proving background history on the concerns surrounding older analog data, the authors discuss ways that older analog data is currently and can be used, and they highlight the challenges that come with attempting to reuse such data. They then provide some possible paths forward with a best practice approach, before concluding that "[b]est practices (including selection of metadata schema, developing a data dictionary, describing data collection methods) and policies developed to govern the preservation and dissemination of digital data could serve as an example for developments concerning analog data."

Data management of microscale reaction calorimeter using a modular open-source IoT platform

In this 2023 article published in the journal Processes, Frede et al. of TU Dortmund University work with analytical consultancy d-fine GmbH to demonstrate experimental workflows of a microscale reaction calorimeter over d-fine's open-source internet of things (IoT) software platform. Their goal: provide an example of how data collection and capture methods can and should be standardized across an automated laboratory. After a brief introduction, the authors present their materials and methods, along with a case study of hydrolysis of acetic anhydride. After presenting the results of their case study, they conclude that "[t]he modular data platform complements the reaction calorimeter very well with additional functionalities," and by adding even more instruments, "[t]his approach will further harmonize data management within our laboratory while better applying FAIR Guiding Principles."

Beyond cannabinoids: Application of NMR-based metabolomics for the assessment of Cannabis sativa L. crop health

In this 2023 paper published in the journal Frontiers in Plant Science, Fernández et al. propose that Cannabis should be characterized "according to its chemical composition (i.e., its metabolome) and not only its botanical traits," while conducting a series of experiments to back their claim. After an introduction to cannabis and its chemical characterization, the authors describe the materials, methods, and results of their experimentation using metabolomics on high-THCA and high-CBDA C. sativa chemovars with medicinal potential. They conclude that many "differences between the two varieties beyond their cannabinoid composition" could be found through this experimentation, and that these differences could be "instrumental to breeders in the development of plant varieties agronomically adapted to specific environmental conditions." They also noted that fungal infections changed the metabolome of tested plants, which can better aid in the "classification of healthy and diseased plants."

Integrative diagnostics: The time is now—a report from the International Society for Strategic Studies in Radiology

In this 2022 paper published in Insights into Imaging, Beauchamp et al. focus in on the promise of "integrative diagnostics" as a means towards aggregating diagnostic data for more meaningful interpretation and contextualization, by extension translating to directly relatable clinical action. Looking specifically at radiology and pathology workflows, the authors describe what integrative diagnostics looks like, how the process should work, and what promise it holds for in vivo and in vitro radiology and pathology workflows. The authors turn to 24 different sources in highlighting the clinical potential of integrative diagnostics for a wide variety of diseases, highlighting the added clinical value and improved discovery possible with integrative diagnostics' application. After examining the current state of the art, the authors conclude by making several recommendations towards implementing integrative diagnostics, while also noting that "[c]reating financial models that demonstrate the economic value proposition of [integrative diagnostics] will be a necessary catalyst for change" for the overall health care system.

Ten simple rules for maximizing the recommendations of the NIH data management and sharing plan

In January 2023, the National Institutes of Health's (NIH's) Policy for Data Management and Sharing came into effect, requiring guidance on elements "for the submission of a data management and sharing plan (DMSP)" for NIH-funded projects. While the NIH created supplementary guidance to developing a DMSP, some ambiguity arguably remained. In this 2022 article published in PLOS Computational Biology, Gonzales et al. provide additional insight into the process. After a brief introduction, the authors present 10 helpful tips towards getting the most of a DMSP in complying with the NIH and its requirements. They conclude by examining the various stakeholders involved with the DMSP process and finding that "[g]ood DMSP practices can support better engagement with and accountability to the public who benefit from research."

Understanding cybersecurity frameworks and information security standards: A review and comprehensive overview

In this 2022 journal article published in Electronics, University Canada West's Hamed Taherdoost presents a narrative literature review of a variety of cybersecurity standards and frameworks as a means to "help organizations select the cybersecurity standard or framework that best fits their cybersecurity requirements." After providing a brief introduction, Taherdoost speaks generally about cybersecurity standards and frameworks, and what they help organizations of all types achieve with their own cybersecurity. The author then goes into greater detail of those standards and frameworks, as well as their supporting documentation. Taherdoost then presents the methodology for his literature review, followed by a discussion of the results of that review. The author concludes that the presented standards and frameworks help organizations "ensure the security of data against cyber threats," though one standard or framework "may not fulfill all the demands of an organization, and it may be necessary to employ a combination of standards in order to ensure security against cyber threats and data loss."

Bridging data management platforms and visualization tools to enable ad-hoc and smart analytics in life sciences

In this 2022 journal article published in Journal of Integrative Bioinformatics, Panse et al. discuss the state of research-based core facilities that share research resources across institutions or organizations, in particular in regards to data and information management. The authors note that the "interdisciplinary nature of such scientific projects requires a powerful and flexible platform for data annotation, communication, and exploration," and the authors—associated with the Functional Genomics Center Zurich (FGCZ)—present B-Fabric, their solution to data and information management in such settings. After providing a brief background, the authors discuss the development and application of B-Fabric at FGCZ, along with lessons learned. They conclude that with systems like B-Fabric, "ad-hoc visualizations and analytics can be realized on top of an integrative platform that captures and processes any kind of data and scientific processes." The platform is also able "to decouple metadata management from data processing and visualization components" while also optimizing specific software software environments for different research areas.

High-throughput methods to identify male Cannabis sativa using various genotyping methods

Genotyping of Cannabis sativa is a useful component of not only gender identification of plants for cultivators but also other types of laboratory testing and research of Cannabis. Performing such tests in a reliable, cost-effective, and high-performance way has significant value for Cannabis testing laboratories. In this 2022 journal article, Torres et al. compare a number of different genotyping techniques, ultimately demonstrating some of that value. After providing background information and their methodology, the authors discuss the results of gender testing using a wide array of genotyping techniques. They conclude that "the multiple methodologies presented here allow for accurate, quick, and cost-effective screening that will enable future development of germplasm and the industry." They add that their "real-time assays can be performed by cannabis testing laboratories performing diagnostic testing, as well as in the field with minimal molecular biology equipment and expertise."

Digitalization of calibration data management in the pharmaceutical industry using a multitenant platform

In this 2022 journal article published in Applied Sciences, Mustapää et al. turn to the calibration process of the pharmaceutical industry—as well as their regulatory- and standards-based requirements—as inspiration for building a proof-of-concept software platform that better ensures "the preservation of traceability and data integrity" of calibration data. After a lengthy and thorough background to the topic of laboratory calibrations and calibration data management, the authors present their proof of concept software platform, designed "to harmonize the data exchange between the parties of a calibration chain to enable automation of the data management processes in the receiving end." They then discuss the results of their efforts, challenges in advancing such metrology infrastructure, and topics that require further research. They conclude that the real use cases tested on their proof of concept "proved that the multitenant platform is an efficient means of organizing the exchange of [digital calibration certificates]," and that "the system would suit the requirements of other industries as well, providing cost-efficiency through economies of scale."

Introductory evidence on data management and practice systems of forensic autopsies in sudden and unnatural deaths: A scoping review

In this 2022 paper published in the Egyptian Journal of Forensic Sciences, Prahladh and van Wyk provide a first-of-its-kind comprehensive scoping review of "articles involving unnatural deaths, focused on data practice or data management systems, relating to forensic medicine, all study designs, and published in English," with the goal of being able to draw conclusions about the current academic view of forensic data management. After examining more than 23,000 articles, the authors were only able to find 16 that met their criteria, according to their stated methodology. After a thorough review of those 16 articles, the duo concludes that "the literature shows that electronic data reporting systems are relevant and were developed from the recognition of coronial data as not only a part of the death investigation but as a contributor to preventable death research and public health initiatives." However, there are few lower- and middle-income countries (LMICs) represented in the study, and the authors believe that given how "forensic medicine departments can utilize simple and available tools that can advance standardization of data collection, storage, and reporting," it would behoove more LMICs to consider pilot systems such as "the Nigerian pilot program [that] still managed to contribute to statistically relevant data for impactful research" while using low-cost and readily available data management tools.

From months to minutes: Creating Hyperion, a novel data management system expediting data insights for oncology research and patient care

From disparate pools of data and information to inefficiencies in using that disparate data and information, the academic cancer center wishing to operate more effectively while improving patient outcomes and enabling more impactful research must turn to well-implemented data management systems and integrations. The University of Rochester Medical Center's James P. Wilmot Cancer Institute (WCI) was no exception to this greater need, turning to developing a custom data management platform called Hyperion to meet their needs. In this 2022 paper published in PLOS Digital Health, key stakeholders of Hyperion at WCI present the background on cancer center data management, as well as their methods in developing and results in using Hyperion. They follow this with discussion of their results, concluding that "Hyperion has surmounted large challenges in working with healthcare data to merge, organize, validate, and package data for use in multiple applications" at WCI, while also "lowering the skill floor for interaction with and maintenance of the software, reducing costs, and encouraging user autonomy." They add that a similar such system, from their viewpoint, could provide similar benefits in other academic cancer centers.

Effects of the storage conditions on the stability of natural and synthetic cannabis in biological matrices for forensic toxicology analysis: An update from the literature

In this 2022 journal article published in Metabolites, Djilali et al. present the results of a literature review "of studies performed on the effects of different storage conditions on the stability of cannabis compounds present in various biological matrices." Noting a growing need for accurate testing for the presence of cannabis compounds in humans, the authors first review the state of analysis among conventional biological matrices (i.e., blood, plasma, urine, and oral fluids) before looking at alternative matrices (i.e., breath, bile fluid, hair, sweat, cerumen, and dried blood spots). From their literature analysis, the authors made several conclusions about the various matrices, their collection methods, and their testing. Depending on the matrix, the authors recommended specific sample containers and storage temperatures among the conventional matrices, while noting that more research is required concerning laboratory testing of alternative matrices.

Health data privacy through homomorphic encryption and distributed ledger computing: An ethical-legal qualitative expert assessment study

In this 2022 article published in the journal BMC Medical Ethics, Scheibner et al. present an assessment of Swiss hospital and medical research experts' views on using advanced technical solutions towards "sharing patient data in a privacy-preserving manner." In particular, the authors examine homomorphic encryption (HE) and distributed ledger technology (DLT) in the scope of European and Swiss regulatory frameworks. After an in-depth introduction on the topic, the authors present their methodology (an interview study) and their results, which touch upon five different information request scenarios. They then discuss the legal, ethical, and compatibility issues associated with using HE and DLT towards the problem of privacy-preserving patient data. They conclude that "a holistic approach needs to be taken to introducing HE and DLT as a mechanism for patient data management," one that tends "to recognize that social license and public trust from patients and physicians is as important as legal compliance."

Avoidance of operational sampling errors in drinking water analysis

This 2022 journal article published in AQUA - Water infrastructure, Ecosystems and Society sees Fernandes et al. presenting a computerized "system for reporting and learning from adverse events" in water sampling and analysis laboratories. The work was prompted by "a high frequency of adverse events in connection with sampling" at the Water Laboratory of Santiago do Cacém Municipality in Portugal. After introducing the topic of water quality testing and work related to using artificial intelligence (AI) in that testing, the authors describe their method of using a Eindhoven Classification Model (ECM) within the scope of ISO/IEC 17025 requirements. They then discuss the results of their software-based approach and conclude that their modular adverse event reporting and learning system has many strengths, particularly in that it "allows knowledge extraction, i.e., the identification of the main failure causes, possible trends, areas requiring improvement plans, or changes in procedures."

ISO/IEC 17025: History and introduction of concepts

In this 2021 paper publisher in the journal Química Nova, Miguel et al. present the ISO/IEC 17025 standard in a historical context, while also providing some additional details about the concepts the standard proposes. As a quality management standard that also addresses competence, impartiality, and consistent operations in the laboratory, the standard emphasizes the importance of well-planned quality assurance towards reliable and traceable laboratory results. After an introduction to the standard, the authors take an in-depth look at ISO/IEC 17025's history and what drove changes to the standard over time. The article then examines what the standard asks of laboratories, as well as what value it adds to those labs. "By enacting ISO/IEC 17025," the authors conclude, "testing and calibration laboratories demonstrate they are responsible with their activities and their impacts, and put quality management and metrological traceability at the forefront of their operations."

Differentiating cannabis products: Drugs, food, and supplements

Hemp? Cannabis? Marijuana? Industrial hemp? Salehi et al. note that terms like these and others are "a significant source of confusion for many," not just in the public but also within industry, marketing, and other groups. This not only causes issues with communicating research clearly but also employing that research to best effect. As such, the authors of this paper, published in the journal Frontiers in Pharmacology, pose the important question, "What is essential for defining Cannabis as a food, supplement, or drug?" Salehi et al. answer this question by reviewing a wide swath of current study on the Cannabis plant and its derivatives, highlighting critical definitions, composition, production practices, and pharmacological effects as part of defining the essentials of Cannabis. The authors also go into its use in foods, drugs, and supplements, as well as regulatory status and testing methodologies. They conclude that "despite all of the recent advances, several cannabis topics remain to be addressed," and addressing those topics will require more consistent terminology, greater understanding of the human endocannabinoid system, and a more consistent "platform for developing research about cannabis and related industries" within a number of countries.

Practical considerations for laboratories: Implementing a holistic quality management system

The quality management system (QMS) is increasingly a constant in laboratories of all types, lending support for better products and services coming out those labs. However, as technologies change and new challenges arise in research, medical, analytical, and R&D labs, the need for a more robust QMS becomes more obvious. In this 2022 article published in the journal Frontiers in Bioengineering and Biotechnology, Pillai et al. explore the varying frameworks of the QMS, which frameworks are best in which labs, and what implementation considerations should be made. After an informative introduction, the authors define the various laboratory types and match those types to the various QMS frameworks. They then provide a set of three critical recommendations for their implementation and use, concluding that while many frameworks are robust, the modern laboratory may need to incorporate more than one framework in order to fully achieve their quality goals. They add that "a holistic QMS framework complemented with guidance from multiple quality documents can benefit many laboratories that aim to address" the 12 quality system essentials (QSEs) of the Clinical and Laboratory Standards Institute (CLSI).
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