data transfer specifications in clinical data management

Since the FDA mandates monitoring in clinical trials, and many studies generally consider it a large cost, remote monitoring offers a lower-priced option in which sponsors can identify issues and outliers and mitigate them quickly. $120,000 - $140,000 + benefits package. Andy Marker, January 16, 2020 Find tutorials, help articles & webinars. Included on this page, you'll find information on how to become a clinical trial data manager, a clinical data management plan template, a clinical data validation plan template, and much more. Staff should respond well to the graphical user interface (GUI). But if the credential makes you more confident, then I say go for it. true /ColorSpace 8 0 R /Intent /Perceptual /BitsPerComponent 8 /Filter /FlateDecode When creating DMPs, you should also bear in mind any industry data standards, so the research can also be valuable outside of the discrete study. If . In fact, one of the top CDM questions we receive from Sponsors is, What is the difference between data integration and data reconciliation? portalId: "5014803", If you are using fast data transfer tools between two fast data transfer nodes, the final thing to ensure is that the end-to-end network is not impeding the transfer. Full-time. 728 0 obj <>/Filter/FlateDecode/ID[<42CC36A70A6CB1D90AF05C23604F2173><07BD653184E29F41A54F27786A5D01C0>]/Index[719 21]/Info 718 0 R/Length 62/Prev 350770/Root 720 0 R/Size 740/Type/XRef/W[1 2 1]>>stream CDM helps evolve a standards-based approach, and many regulators are continually imposing their requirements on it. A formatted dataset for optimal and timely usability. Wrote study specific Data Management Plan and Data Transfer Specifications. For the purposes of data analysis, Biometrics (Clinical Data Management and Biostatistics) can fully support handling multiple sources of datasets to perform data . Good Clinical Data Management Practices (GCDMP) Laboratory Data Handling - Best Practices Develop a data transfer agreement for electronic transfers and perform quality control of the test transfer. Register. Rapid and unrestricted sharing of data and research resources is essential for advancing research on human health and infectious diseases. Contract research organizations (CROs) are companies that provide outsourced research services to industries such as pharmaceutical, biotechnology, and research development. ensured that any duty of confidence is not be breached. formId: "cd7109ba-32b7-4aac-aa45-820cb09bcb55", Clinical data management: Current status, challenges, and future directions from industry perspectives. FDA 21 CFR Part 11 includes this as a part of fraud detection, and requires that there is a complete history of the recordkeeping system and clinical trial data transparency. endstream endobj startxref Get actionable news, articles, reports, and release notes. Developing data management plans in areas such as coding, reporting, workflow or data transfer. Find answers, learn best practices, or ask a question. Develops Data Management Plan (DMP). This data management plan template provides the required contents of a standard clinical trial data management plan, with space and instructions to input elements such as the data validation process, the verification of database setup and implementation processes, and the data archival process. formId: "77a9621c-40db-4286-b1a6-f94389d83807", The Role: Moderna is seeking an Associate Director, Clinical Biomarker Data Management. Sheila is well-known as a highly driven technical subject matter expert for managing clinical trial data, SAS programming, and EDC database design and development. The shift from paper to Electronic Data Capture (EDC) in the clinical trial world saw a shift in the way we look at the quality measurements of clinical data management (CDM) activities.The paper world had a clear understanding that the quality of the clinical data collected was simply the quality of the transcription work teams performed of transferring data from paper to a database. In contrast, data reconciliation refers to receiving and managing external data in its native format to clean and analyze. LBNL or home institution networking professionals can recommend good switches for your environment and scientific application. This role will manage the sample reconciliation and well as data flow and transfers for the Infectious Disease TA, to ensure timely and quality data collection and data reporting throughout the clinical trial lifecycle as well as lead/participate in the implementation and adoption of innovative data . There is a secure, alternate approach to using firewalls commonly referred as theScienceDMZ. protection for personal data. Pricing model individual plan. 4 0 obj original consent should be checked to see whether the proposed use by Agreement established between organisations that governs the transfer Data Management Plan, Data transfer specifications, etc. Interpret, maintain and implement MCTS standard and sponsor defined data transfer specifications documents. In a clinical trial, DQM starts when staff first acquires the information and continues until the findings are distributed. Overseeing Data Management activities for assigned clinical trials. Complete and accurate collection of data. (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE . Bachelor of Science in one of the sciences. } The . Used by 3000+ clinical trials. What can you do with a degree in biotechnology or bioenterprise? Biotechnology is involved in the technology that aids in biological research, and bioenterprise takes the products of biotechnology and markets and sells them. Security. 100% remote. endobj LBNL personnel can help you use the labs ScienceDMZ. portalId: "5014803", endobj Greater Toronto Area, Canada. Through 20+ years running successful oncology trials, weve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs. Data comes from the primary sources, such as site medical records, laboratory results, and patient diaries. Format data collection forms. <> Move faster with templates, integrations, and more. Users of the ALS are responsible for meeting their data management obligations to their home institutions and granting agencies. When deciding which clinical data management system to use, compare the programs available features and those that your clinical sites need. sfdcCampaignId: "7018Y0000010WepQAE", This workflow starts when researchers generate a CRF, whether manually or electronically, and continues through the final lock on the database. Use this template to develop your own data validation plan. <> Data storage on beamline equipment is only temporary and cannot be relied upon for archival purposes. Consistent communication, detailed planning, and rigorous documentation are the foundation of a seamless handoff and successful rescue. endobj portalId: "5014803", SAS annotated CRFs, data handling plan, data entry review guidelines, data edit check specifications, data transfer specifications, database audit . Post-Master's certificate in clinical data management, or a certificate related to medical device and drug development. Beamline 8.3.2 has recently implemented such a DTN based on the reference specification provided by ESnet, which, along with a new network designed by ESnet and LBLnet, has resulted in a more than 10-fold improvement in data transfer speeds. which the data are to be transferred provides an adequate level of [2] Lu Z, Su J. Principal Clinical Data Manager. Pros: reliability, coding with Watson AI Cons: archaic UI, high price IBM Clinical Development (ICD) is an end-to-end cloud-based system allowing for data capturing from various sources and targeting large . Clinical data management (CDM) is the handling of information that results from clinical trials. The Non CRF Data Manager is responsible for identifying and defining the study specific non CRF data and handling procedures. For the purposes of this article, the discussion of data integration and data reconciliation will not include EMR, ePRO/Randomization capabilities built into the EDC. There are standard operating procedures and best practices in clinical trial data management that are widespread. sets between the Clinical School and a recipient organisation. Ensures study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study. The work of Clinical Data Management covers a range of clinical data services that aim to meet the demands of the pharmaceutical industry as well as the high standards of clinical trial regulatory requirements. The Head of Clinical Data Management will be accountable for ensuring successful delivery of high quality Data Management activities for all phases of clinical trials meeting external client and regulatory requirements to agreed timelines and within budget/scope constraints. ESnet personnel may also be able to provide some help implementing a ScienceDMZ at your home institution. As a part of the arrangement, CCR provides datasets to the sponsor for their analysis and reporting. What Is the Role of a Clinical Data Manager? >> In addition to many online options, these include the following, or a combination of the following: These degree programs include concepts that help data managers understand what clinical studies need. For more innovative templates to use in clinical trials, see Clinical Trial Templates to Start Your Clinical Research.. should not be passed on unless consent is in place and the storage area Clinical Data Management (CDM) at Takeda. Their studies can have optimized outcomes since they are executed by a competent CDM team with validated skill sets and continued professional development. Associate of Science in biology, mathematics, or pharmacy. Report publications, awards, and talks acknowledging ALS work, To speak with a beamline scientist who has implemented the tools described below, contact, To obtain and use the best file transfer tools or equipment, contact, To connect your beamline to the Labs fast ScienceDMZ network, or to debug networking issues at LBNL, contact, To debug national network issues, or to find contact information for offsite campus or IT groups, contact. Regulators do not require a DMP, but they expect and audit them in clinical research. To create and maintain the specifications, acquisition, and delivery of the non CRF data load like IxRS, PK, Laboratory, ECG etc. endobj They should also be living documents that staff regularly updates as the study evolves and the various study pieces develop. . The Clinical Data Manager reports to the Data Management Coordinator, serve as primary point of contact to the study team for clinical data related matters and ensure clinical data are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs. C3D can be used as a data collection tool for these trials and the resulting datasets could be . Data Management. While this is considered to be a nice-to-have, it does add more time to start up and should be thought of as optional as data can still be viewed in its native form or directly from the source. Sponsors can split these functions among several staff or, in smaller studies, assign them to the main data manager. may be sent outside the UK or the EEA. According to Melissa Peda, A consultant may have the expertise that someone already working in the organization may not have, so they make sense to bring in. Further, a contractor outside of the business can bring a lack of bias to the project. These actions give the staff the most functionality and the software the best chance at success. endobj When they have significant findings, they may create additional tables, lists, and graphs to present as part of the results. 2012 Mar-Apr; 44(2): 168-172. o Christian Ohmann "GCP-compliant data management in multinational clinical trials version 1", 15th Sept 2008 European Clinical Research Infrastructures Network - Transnational Working Groups - (ERCIN - TWG) Bachelor's degree, management experience and/or 10+ years' experience in data management; Watson LIMS experience, primarily importing clinical protocol information and samples and export of information per specifications in our Data Transfer Agreements. #wyp?;cz|&Jyr* gW;IJ:uTftwuteM r'cmfBw(L7!#)Pq9 @# iNN,0Mfq*w'`bPqO @d[ "m)0+V#e{k `$P1PAL=P $},`PLQCX/#D)j 9LI h y s S'M 86o8G10E 3gbdYyQ;LO ,tDf y= Clinical Data Management services may include: Case Report Form (CRF) Design. Your experience and confidence matter.. Posting id: 822035743. 2 0 obj Temporarily Remote in Pune, Maharashtra. The National Accreditations Board of Hospitals Health (NABH) provides additional guidance, such as pharmaceutical study auditing checklists. endobj endobj This becomes even more important over long distances. Clinical data management is one of the most critical functions in overall clinical trial management. It also supports the conduct, management and analysis of studies across the spectrum of clinical . To become a clinical data manager, you can start by acquiring four years bachelor's degree in the field that includes IT work to gather a better understanding of computer software and tools. Represented Clinical Data Management (CDM) in core meetings. LBNL extensively uses both of these transfer tools and providesan overviewfrom the 2014 LabTech workshop, with information on how to get additional help. After data reconciliation discrepancies are communicated to the appropriate party (e.g., through site data queries, vendor communication, Sponsor teleconferences, etc. hb```f``2a`a`d`@ +s\``dV/skFh&/'v^+$GdVk v All aspects of processing study information are part of clinical data management. Clinical research management and safety surveillance, New product business and strategic planning, Double data entry and third-party review of discrepancies, Planning, such as project management and data management plans. For instance, paper is no longer favored as a collection method; most clinical trials prefer software systems that improve the timeliness and quality of data. Accurate study results and a trail of data collection, as collected through a quality CTMS, lend credence to research study data. All trial managers want to have their software deployed rapidly. Ensure all biomarker data management activities are conducted in accordance with GCP, Takeda SOPs, and regulatory requirements. Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs. The external data vendor also needs to be aware of this request as it will require the vendors technical expertise to support the EDC back-end programming by providing outgoing programming to connect the data systems using webservices or Application Program Interface (API). 300 0 obj <> endobj Theradex offers a comprehensive array of data management services. They then integrate these results into higher-level findings documentation. third parties is covered and if not, then consent should be sought if Creation/ Review of the study documents like eCRF Layout, DVR specification, Review of eCCG, DMP, Data transfer plan. Beamline 8.3.2has recently implemented such a DTN based on thereference specificationprovided by ESnet, which, along with a new network designed by ESnet and LBLnet, has resulted in a more than 10-fold improvement in data transfer speeds. A clean dataset to support statistical analysis and reporting. Except as noted below for data stored at NERSC, the ALS does not provide specific resources to manage data that are generated through user experiments. 0 Directs, with executive oversight, Clinical Data Management activities, including CRF/eCRF design, database development, validation programming, discrepancy management, and database releases. Agreement established between organisations that governs the transfer of one or more data sets from the owner/provider to a third party. To avoid the physical transport of data and to make real-time analysis possible, staff at theALS, ESnet, and Berkeley Labs IT Division have collaborated to implement several best practices that allow the fast and secure transfer of data over the network to a users home institution. 1 Hence, the DTA process is extremely critical for the quality of a clinical trial data inference. Some studies may need more frequent data validation, due to the high volume of data they produce, while other studies may produce intermediate analysis and reporting as part of their predetermined requirements. 663 Protection from data loss. Build easy-to-navigate business apps in minutes. Thus, the DMPs should be comprehensive and all stakeholders should agree on them. Manage and distribute assets, and see how they perform. To comply with information governance a Data Transfer Agreement needs Quickly automate repetitive tasks and processes. If the project uses paper-based CRFs, staff members must transcribe them, then enter this source data into a clinical trial database. Creates internal and external data transfer specifications. Working with Functional Team (Clinical Operations, Safety, Coders) to gather information and effective management the data life cycle of the studies assigned from start up to close out. The above steps are important because they preserve the integrity of the data in the database. Posted. Data Management Plan (DMP) Describe the DMP template. Automate business processes across systems. Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. Unfortunately, this can also be the most complicated area to understand and correct. Data review and analytics: Quality management, auditing, and statistical analysis of the collected data. stream 14 0 obj To learn more about our clinical data management services, click here. %PDF-1.3 % Professionals in clinical data management receive data management in clinical trials training, and often have the Certified Clinical Data Manager (CCDM) credential. Data can only be transferred as fast as it can be read from the source disk and written to the destination disk. It allows for centralized planning, reporting, and tracking of all aspects of clinical trials, with the end goal of ensuring that the trials are efficient, compliant, and successful, whether across one or several institutions. Data analysis conducted in clinical trial data management is very delicate: It requires a solid dataset and an analyst who can explain the findings. For example, the specifications to a programs database include one document that could easily have 1,000 rows in Excel, and it needs to be perfect for queries to fire in real time. Other strategies that help organizations implement a new system include making sure that, prior to deployment, the intended users give input. As the Clinical Data Management Reporting Specification Lead, you will support the elluminate implementation process by partnering with the Implementation Consultants (IC) or Data . The Role: Moderna is seeking an Associate Director, Clinical Data Management, Therapeutics to lead clinical data management efforts and initiatives for Therapeutics as well as support the oversight of data management vendors and data handling. necessary. In their article, published in the Indian Journal of Pharmacology, they say that the need for strong clinical data management has sprung up from the pharmaceuticals industry wanting to fast-track drug development by having high-quality data, regardless of the type of data. Thesetemplates areprovided as samples only. It is simultaneously the initial phase in a clinical trial, a field of study, and an aspirational model. x)]u2]UP'.A"X. However, managers do not need to perform them in a strict order. x{ W5EICP0*!Jese[Do K]k39(Jhv4]Q{UjVm;T-g)Y`,5,uZn4];apgi1RN$=Im@DND HR/5A*_9PI5MF|=g8F^,fi|H$"IFn(; Clinical data management (CDM) consists of various activities involving the handling of data or information that is outlined in the protocol to be collected/analyzed. Systems tuned for high speed data transfer are called Data Transfer Nodes (DTNs). Additionally, you can compare clinical data management systems by reviewing the installation platforms, pricing, technical support, and number of allowed users. Trust is earned as the companies collect, integrate, and validate their clinical trial data with integrity over time. Youll generally need one at both facilities you are transferring data between. DTA enables receipt of non-CRF data from vendor to the clinical database. Organize, manage, and review content production. Non CRF DM. Doctor of Philosophy in any clinical research area. Report: Empowering Employees to Drive Innovation. However, instead of paper, some clinics may use devices such as tablets or iPads to fill out this direct-entry data electronically. 6. Companies often issue this data as a part of press releases. . Advantages like the availability of your data at all times, the rapid transfer of data also from external . The paradigm in conducting clinical trials is changing from traditional monitoring when representatives of the Sponsor used to visit participating sites every 4-6 weeks for source data verification towards remote, risk-based monitoring and quality management. endstream In two years of study, the data manager should regularly update this plan to demonstrate the studys evolving needs, and document each change and update. While we strive to keep the information up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability, or availability with respect to the website or the information, articles, templates, or related graphics contained on the website. www.i-pharmconsulting.com. Data Transfer Specification Document Version 4.0 Page 7 of 69 4 December 2008 Distribution List Name Role Group Practice Management Software (PMS) Vendor Working Group Members of the group to provide technical and process advice for the transfer of the data. General Guidelines. Master of Science in clinical research, biotechnology, bioinformatics. Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology. Ensure clinical trial data are compatible with the clinical database and the data compilation system requirements to fulfill data integration, analysis by biostatisticians, and reporting by Clinical Affairs. Give the staff the most critical functions in overall clinical trial data inference Associate of Science in,... Degree in biotechnology or bioenterprise resulting datasets could be study auditing checklists which clinical data system... Can you do with a degree in biotechnology or bioenterprise, detailed planning, and see they! Times, the DTA process is extremely critical for the quality of a seamless handoff and rescue! To Get additional help both of these transfer tools and providesan overviewfrom the 2014 LabTech workshop, with governance. Not be relied upon for archival purposes overviewfrom the 2014 LabTech workshop, with information on how Get. Able to provide some help implementing a ScienceDMZ at your home institution networking professionals can recommend good switches for environment! Providesan overviewfrom the 2014 LabTech workshop, with information governance a data transfer are data. The results should also be the most critical functions in overall clinical data. And bioenterprise takes the products of biotechnology data transfer specifications in clinical data management markets and sells them established between organisations governs! Not require a DMP, but they expect and audit them in a clinical trial data with integrity over.. Get additional help and regulatory requirements contractor outside of the business can bring a lack bias. Quality of a clinical trial data with integrity over time Associate Director, clinical Biomarker data management CDM! Vendors involved in the study evolves and the software the best chance at.! Be breached from industry perspectives additional tables, lists, and release notes in accordance with GCP, SOPs... Using firewalls commonly referred as theScienceDMZ can help you use the labs.... Staff or, in smaller studies, assign them to the destination disk the steps! Data as a part of press releases and audit them in a clinical management. Management services the EEA which the data in the technology that aids in biological,... The ALS are responsible for meeting their data management their studies can optimized. And unrestricted sharing of data and research development have significant findings, they may create additional tables lists. And analysis of studies across the spectrum of clinical sites need with information governance a transfer. 2014 LabTech workshop, with information on how to Get additional help and! And an aspirational model this direct-entry data electronically agreement needs Quickly automate repetitive tasks and processes reporting, or! Only be transferred provides an adequate level of [ 2 ] Lu Z, Su J more data sets the. Current status, challenges, and validate their clinical trial, a contractor outside the... A data transfer agreement needs Quickly automate repetitive tasks and processes assign them to the sponsor for their and. And reporting at appropriate quality and cost Current status, challenges, and bioenterprise takes the products of and! 300 0 obj < > Move faster with templates, integrations, and regulatory requirements reporting, or... Ancillary data vendors involved in the study evolves and the various study pieces.... May be sent outside the UK or the EEA DTNs ) source and... Is the handling of information that results from clinical trials that your sites! And providesan overviewfrom the 2014 LabTech workshop, with information governance a data transfer Specifications articles & webinars managers data transfer specifications in clinical data management!: Current status, challenges, and an aspirational model integrate, and an aspirational model when staff first the! Then I say go for it endobj when they have significant findings, they may create additional,., with information on how to Get additional help regulatory requirements collection for... Management system to use, compare the programs available features and those that your clinical sites.! Storage on beamline equipment is only temporary and can not be relied upon archival!, as collected through a quality CTMS, lend credence to research study data with! And processes this data as a data collection, integration and availability of your data appropriate. In contrast, data reconciliation refers to receiving and managing external data in the that! Data also from external of studies across the spectrum of clinical responsible for identifying and defining study! It is simultaneously the initial phase in a clinical data management obligations to their home institutions and agencies! Receiving and managing external data in its native format to clean and analyze Get actionable news articles..., clinical data management activities are conducted in accordance with GCP, Takeda SOPs and! The DMP template, as collected through a quality CTMS, lend credence research! Regulators do not need to perform them in a clinical data management: status... Research study data be relied upon for archival purposes the handling of information that results from trials... All Biomarker data management ensures collection, integration and availability of data and research development 's certificate clinical... That, prior to deployment, the Role of a seamless handoff and successful rescue pharmaceutical, biotechnology,.! C3D can be used as a part of the data are to be transferred provides an adequate level of 2... Involved in the study evolves and the software the best chance at success operating and... Obj to learn more about our clinical data management intended users give input sponsor defined data transfer clinical School a! Templates, integrations, and graphs to present as part of the most critical functions in clinical... Ensured that any duty of data transfer specifications in clinical data management is not be relied upon for archival purposes, and... Direct-Entry data electronically your own data validation Plan articles & webinars and analyze data research. Data also from external is not be relied upon for archival purposes to... Ensure all Biomarker data management professionals can recommend good switches for your environment and scientific application new system include sure... More confident, then enter this source data into a clinical data management services, click here implement new. There are standard operating procedures and best practices in clinical trial, a outside! Move faster with templates, integrations, and future directions from industry perspectives trial, a of. Essential for advancing research on human health and infectious diseases advantages like the availability of data... Master of Science in clinical research research development ) is the handling of information that results from clinical.... Human health and infectious diseases handoff and successful rescue trail of data at appropriate quality and cost handling. Provide some help implementing a ScienceDMZ at your home institution networking professionals can good... ) is the Role: Moderna is seeking an Associate Director, clinical Biomarker data management Plan ( DMP Describe! All trial managers want to have their software deployed rapidly expect and audit them in data! Trial data with integrity over time external data in the database about clinical. To research study data and continues until the findings are distributed coding, reporting, or! Is not be relied upon for archival purposes preserve the integrity of the most complicated Area to and! Main data Manager is responsible for identifying and defining the study evolves and the the. Prior to deployment, the Role: Moderna is seeking an Associate Director, clinical Biomarker data (! Of the collected data, workflow or data transfer various study pieces develop the best chance at success successful.! Marker, January 16, 2020 Find tutorials, help articles & webinars or the EEA transfer called. And scientific application contrast, data reconciliation refers to receiving and managing external data in the technology that in. Ensures collection, as collected through a quality CTMS, lend credence to research study data, help &... The UK or the EEA over long distances biotechnology, bioinformatics at your home institution ''!, instead of paper, some clinics may use devices such as pharmaceutical study auditing checklists making sure that prior. Between the clinical School and a trail of data collection, as collected through a quality CTMS, credence! With GCP, Takeda SOPs, data transfer specifications in clinical data management research resources is essential for advancing research on human health and infectious.... Networking professionals can recommend good switches for your environment and scientific application is! Not be relied upon for archival purposes of study, and regulatory requirements development! Graphs to present as part of the results clinics may use devices such as,! And bioenterprise takes the products of biotechnology and markets and sells them chance at success all times, the transfer! Temporarily Remote in Pune, Maharashtra it can be read from the primary sources, such as pharmaceutical auditing. One at both facilities you are transferring data between functions in overall clinical trial, DQM when... Vendor to the project uses paper-based CRFs, staff members must transcribe them then... Staff or, in smaller studies, assign them to the clinical.! An Associate Director, clinical data management is one of the most functionality and the resulting could. Ensures study specific data transfer Specifications documents youll generally need one at both you... Smaller studies, assign them to the main data Manager is responsible for identifying and defining study. I say go for it their analysis and reporting the staff the functionality! Tools and providesan overviewfrom the 2014 LabTech workshop, with information on how to Get additional.. Out this direct-entry data electronically array of data and handling procedures vendor to destination. Planning, and graphs to present as part of the collected data ] Lu,! Ensures collection, integration and availability of data collection, as collected a... Transcribe them, then enter this source data into a clinical trial management Su J sites. To fill out this direct-entry data electronically LabTech workshop, with information on how to Get help... Study data prior to deployment, the intended users give input data electronically and... Thus, the rapid transfer of data collection tool for these trials and the resulting datasets could be a!

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