Development of the Clinical Specimen Information Management System for Multicenter Clinical Studies.

Some multicenter clinical studies require the acquisition of clinical specimens from patients, and the centralized management and analysis of clinical specimens at a research institution. In such cases, it is necessary to manage clinical specimens with anonymized patient information. In addition, clinical specimens need to be managed in connection with clinical information in clinical studies. In this study, we have developed a clinical specimen information management system that works with electronic data capture system for efficient specimen information management and the system workflow has verified at Osaka University Hospital. In addition, by combining this system with medical image collection system that we have developed previously, the integrated management of clinical information, medical image, and clinical specimen information will become possible. This specimen information management system may be expected to provide the platform for integrated analysis utilizing clinical information, medical image, and data from clinical specimens in multicenter clinical studies.

Common problems and suggestions of biological sample management in drug clinical trials / 中国药房

OBJECTIVE To provide a reference for improving the relevant standard operating procedures （SOP） and biological sample management in drug clinical trials. METHODS According to Good Clinical Practice， Data On-site Verification Points of Drugs Clinical Trials， Human Genetic Resources Management Regulations Implementation Rules， Qualification Examination Rules of Drug Clinical Trials Institution， based on the experience of managing clinical trials programs， the irregularities in biological samples management were analyzed by using statistical quality control tables and protocol deviation （PD） reported by sponsors， in the context of the quality control of drug clinical trials projects managed by the author from July 2016 to May 2023. The precautions in various aspects of sample management were put forward. RESULTS & CONCLUSIONS A total of 101 biospecimen- related irregularities were found in the 60 drug clinical trials projects. Biological sample collection， preservation， and handling were the aspects with the highest incidence of irregular operations in biological sample management， accounting for 37.62%， 25.74%， and 21.78%， respectively. Regulating the management of biospecimens requires multiple efforts. The institutional office and the ethics committee carefully reviewed the consistency of the protocols， informed consent， and genetic office application involving biospecimen collection and handling when the project was initiated. Institutional office quality controllers should pay attention to the attendance and training of authorized personnel at project initiation. The principal investigator， research nurse， collector， handler， transporter， relevant personnel of the central laboratory， and institutional office quality controller have their roles during the project implementation phase. On this basis， all parties involved in the management of biological samples should do a good job of effective communication， find problems and report them in time， and conduct special studies on key aspects.

UPO Biobank: The Challenge of Integrating Biobanking into the Academic Environment to Support Translational Research.

Biobanks are driving motors of precision and personalized medicine by providing high-quality biological material/data through the standardization and harmonization of their collection, preservation, and distribution. UPO Biobank was established in 2020 as an institutional, disease, and population biobank within the University of Piemonte Orientale (UPO) for the promotion and support of high-quality, multidisciplinary studies. UPO Biobank collaborates with UPO researchers, sustaining academic translational research, and supports the Novara Cohort Study, a longitudinal cohort study involving the population in the Novara area that will collect data and biological specimens that will be available for epidemiological, public health, and biological studies on aging. UPO Biobank has been developed by implementing the quality standards for the field and the ethical and legal issues and normative about privacy protection, data collection, and sharing. As a member of the "Biobanking and Biomolecular Resources Research Infrastructure" (BBMRI) network, UPO Biobank aims to expand its activity worldwide and launch cooperation with new national and international partners and researchers. The objective of this manuscript is to report an institutional and operational experience through the description of the technical and procedural solutions and ethical and scientific implications associated with the establishment of this university research biobank.

COVID-19 sample management: experiences of Harare City, 2021.

COVID-19 sample management is pivotal in controlling the pandemic. Results of 28/45 (62.2%) cases identified at a high school COVID-19 outbreak in Harare's Northern district were not reported within the recommended 24 hours of notification. This leads to delayed patient management. We evaluated the sample management system for COVID-19 in Harare City. A descriptive cross-sectional study was conducted in Harare City. Health care workers involved in COVID-19 sample management at a high school outbreak in the Northern district namely clinicians, laboratory, environmental and administrative personnel were purposively sampled. Interviewer-administered questionnaires were used to collect data. Quantitative data were analyzed using Epi info version 7. Medians and proportions were generated. A 3-point Likert Scale was used to measure knowledge levels of health care workers on COVID-19 sample management. Thirty health care workers were interviewed and females were 20/30 (66%). Participants had not been trained in sample management. Overall knowledge level was good for 7/30 (23%) of the participants. Of the samples collected, 156/451 (34.6%) were wrongly sent to the national microbiology laboratory and 53/156 (34.0%) of the results were received. Sample management of COVID-19 samples in Harare City was found to affect patient management because of poor knowledge of healthcare workers, lack of transportation and communication means. The need for training cadres involved in the management process and availing adequate resources can improve turnaround time of results hence patient management.

HEnRY: a DZIF LIMS tool for the collection and documentation of biomaterials in multicentre studies.

BACKGROUND: Well-characterized biomaterials of high quality have great potential for acceleration and quality improvement in translational biomedical research. To improve accessibility of local sample collections, efforts have been made to create central biomaterial banks and catalogues. Available technical solutions for creating professional local sample catalogues and connecting them to central systems are cost intensive and/or technically complex to implement. Therefore, the Translational Thematic Unit HIV of the German Center for Infection Research (DZIF) developed a Laboratory Information and Management System (LIMS) called HIV Engaged Research Technology (HEnRY) for implementation into the Translational Platform HIV (TP-HIV) at the DZIF and other research networks. RESULTS: HEnRY is developed at the University Hospital of Cologne. It is an advanced LIMS to manage processing and storage of samples and aliquots of different sample types. Features include: monitoring of stored samples and associated information data selection via query tools or Structured Query Language (SQL) preparation of summary documents, including scannable search lists centralized management of the practical laboratory part of multicentre studies (e.g. import of drawing schemes and sample processing steps), preparation of aliquot shipments, including associated documents to be added to shipments unique and secure identification of aliquots through use of customizable Quick Response (QR) code labels directly from HEnRY support of aliquot data transmission to central registries. In summary, HEnRY offers all features necessary for a LIMS software. In addition, the structure of HEnRY provides sufficient flexibility to allow the implementation in other research areas. CONCLUSION: HEnRY is a free biobanking tool published under the MIT license. While it was developed to support HIV research in Germany, the feature set and language options, allow much broader applications and make this a powerful free research tool.

Establishing and Maintaining a Robust Sample Management System.

This paper has been written by the SLAS Sample Management Special Interest Group to serve as a guide to the best practices and methods in establishing and maintaining a high-quality sample management system. The topics covered are applicable to sample types ranging from small molecules to biologics to tissue samples. It has been put together using the collective experience of the authors in start-up companies, small pharma, agricultural research, IT, academia, biorepositories, and large pharma companies. Our hope is that sharing our experience will streamline the process of setting up a new sample management system and help others avoid some of the problems that we have encountered.

Samasy: an automated system for sample selection and robotic transfer.

Sample automation and management is increasingly important as the number and size of population-scale and high-throughput projects grow. This is particularly the case in large-scale population studies where sample size is far outpacing the commonly used 96-well plate format. To facilitate management and transfer of samples in this format, we present Samasy, a web-based application for the construction of a sample database, intuitive display of sample and batch information, and facilitation of automated sample transfer or subset. Samasy is designed with ease-of-use in mind, can be quickly set up, and runs in any web browser.

MetaLIMS, a simple open-source laboratory information management system for small metagenomic labs.

Background: As the cost of sequencing continues to fall, smaller groups increasingly initiate and manage larger sequencing projects and take on the complexity of data storage for high volumes of samples. This has created a need for low-cost laboratory information management systems (LIMS) that contain flexible fields to accommodate the unique nature of individual labs. Many labs do not have a dedicated information technology position, so LIMS must also be easy to setup and maintain with minimal technical proficiency. MetaLIMS is a free and open-source web-based application available via GitHub. The focus of MetaLIMS is to store sample metadata prior to sequencing and analysis pipelines. Initially designed for environmental metagenomics labs, in addition to storing generic sample collection information and DNA/RNA processing information, the user can also add fields specific to the user's lab. MetaLIMS can also produce a basic sequencing submission form compatible with the proprietary Clarity LIMS system used by some sequencing facilities. To help ease the technical burden associated with web deployment, MetaLIMS options the use of commercial web hosting combined with MetaLIMS bash scripts for ease of setup. MetaLIMS overcomes key challenges common in LIMS by giving labs access to a low-cost and open-source tool that also has the flexibility to meet individual lab needs and an option for easy deployment. By making the web application open source and hosting it on GitHub, we hope to encourage the community to build upon MetaLIMS, making it more robust and tailored to the needs of more researchers.

Novel bone metabolism-associated hormones: the importance of the pre-analytical phase for understanding their physiological roles.

The endocrine function of bone is now a recognized feature of this tissue. Bone-derived hormones that modulate whole-body homeostasis, are being discovered as for the effects on bone of novel and classic hormones produced by other tissues become known. Often, however, the data regarding these last generation bone-derived or bone-targeting hormones do not give about a clear picture of their physiological roles or concentration ranges. A certain degree of uncertainty could stem from differences in the pre-analytical management of biological samples. The pre-analytical phase comprises a series of decisions and actions (i.e., choice of sample matrix, methods of collection, transportation, treatment and storage) preceding analysis. Errors arising in this phase will inevitably be carried over to the analytical phase where they can reduce the measurement accuracy, ultimately, leading discrepant results. While the pre-analytical phase is all important, in routine laboratory medicine, it is often not given due consideration in research and clinical trials. This is particularly true for novel molecules, such as the hormones regulating the endocrine function of bone. In this review we discuss the importance of the pre-analytical variables affecting the measurement of last generation bone-associated hormones and describe their, often debated and rarely clear physiological roles.

Diagnosis and management of Ebola samples in the laboratory.

The magnitude of the 2014-2016 West African Ebola virus outbreak has highlighted the importance of immediate and rapid deployment of control measures in affected areas. While many prophylactic and therapeutic options entered clinical trials in the past two years, larger use to impact on Ebola spread will not be possible until at least one product meets final approval by regulatory agencies. Control of the West African outbreak was achieved almost entirely by breaking chain of transmissions through case identification and specialized treatment, communication, safe burials and other proven methods. To achieve this in a timely manner, epidemiologists and medical teams are working in concert with laboratories to identify infected individuals and provide care within Ebola treatment units. Herein, we review an outbreak response workflow from the point of view of mobile laboratories and summarize methods that have been used by them during the West African Ebola virus outbreak of 2014-2016.

Sample Management: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team.

The importance of appropriate sample management in regulated bioanalysis is undeniable for clinical and non-clinical study support due to the fact that if the samples are compromised at any stage prior to analysis, the study results may be affected. Health authority regulations do not contain specific guidance on sample management; therefore, as part of the Global Bioanalysis Consortium (GBC), the A5 team was established to discuss sample management requirements and to put forward recommendations. The recommendations from the team concern the entire life span of the sample and include the following: 1. Sampling procedures should be described in the protocol or within the laboratory manual. This information should include the volume of the sample to be collected, the required anticoagulant, light sensitivity, collection and storage containers, and labeling with a unique identifier. 2. The correct procedures for processing and then storing the samples after collection at the clinical/non-clinical testing site and during shipment are also very important to ensure the analyte(s) stability and should be documented. 3. Chain of custody for the samples must be maintained throughout the complete life span of each sample. This is typically maintained via paper and electronic data systems, including Laboratory Information Management Systems (LIMS) where available. 4. Pre- and post-analysis storage location and conditions must also be clearly defined at the analytical laboratory. The storage temperature of the samples must be traceable and controlled by monitoring and warning alerts. The team suggests moving away from using temperatures and to adopt standard terminology of "room temperature," "refrigerator," "freezer," and "ultra-freezer" that have defined and industry-wide accepted temperature ranges. 5. At the end of the study, documentation of the samples' disposal is required.

Delivering an Automated and Integrated Approach to Combination Screening Using Acoustic-Droplet Technology.

Drug combination testing in the pharmaceutical industry has typically been driven by late-stage opportunistic strategies rather than by early testing to identify drug combinations for clinical investigation that may deliver improved efficacy. A rationale for combinations exists across a number of diseases in which pathway redundancy or resistance to therapeutics are evident. However, early assays are complicated by the absence of both assay formats representative of disease biology and robust infrastructure to screen drug combinations in a medium-throughput capacity. When applying drug combination testing studies, it may be difficult to translate a study design into the required well contents for assay plates because of the number of compounds and concentrations involved. Dispensing these plates increases in difficulty as the number of compounds and concentration points increase and compounds are subsequently rolled onto additional labware. We describe the development of a software tool, in conjunction with the use of acoustic droplet technology, as part of a compound management platform, which allows the design of an assay incorporating combinations of compounds. These enhancements to infrastructure facilitate the design and ordering of assay-ready compound combination plates and the processing of combinations data from high-content organotypic assays.

Ethical Considerations on the Reuse of Clinical Laboratory Blood Samples in Research / 中国医学伦理学

By referring to the domestic and foreign relevant regulatory guidelines, this paper analyzed and sum-marized the ethical point in the design phase in the perspective of relevant regulations of clinical waste sample man-agement and biological sample management. It also analyzed the focus problems including the difference in sample library and clinical laboratory remaining sample as well as the ownership of the sample, to provide theoretical basis for ethics committee to review this kind of protocols.

Compound precipitation in high-concentration DMSO solutions.

Screening compounds precipitate out of high-concentration DMSO solutions and cause issues in the liquid-handling equipment used to process the samples as well as false-positives and false-negatives in the biological data. This report examines the extent of the precipitation issue, correlation with physico-chemical properties of compounds, and measured concentrations. Possible ways to allow recovery of the precipitated solids are also described. This study also investigated whether particulates were present from the time of initial solubilization in DMSO or whether precipitation occurs during freeze-thaw cycling.