The Private Facility Has Installed A Pair Of Result6 Compact Nearfield Monitors To Complement Its Existing Range Of Recording And Mixing Equipment.

Frank Reich has worked hard to find ways to teach the Colts virtually, including bringing in an NBA legend to inspire the team.

Frank Reich has worked hard to find ways to teach the Colts virtually, including bringing in an NBA legend to inspire the team.

Shwetha K. Shetty
Apr 1, 2020; 61:546-559
Methods

The hydrolysis of triglycerides in triglyceride-rich lipoproteins by LPL is critical for the delivery of triglyceride-derived fatty acids to tissues, including heart, skeletal muscle, and adipose tissues. Physiologically active LPL is normally bound to the endothelial cell protein glycosylphosphatidylinositol-anchored high-density lipoprotein binding protein 1 (GPIHBP1), which transports LPL across endothelial cells, anchors LPL to the vascular wall, and stabilizes LPL activity. Disruption of LPL-GPIHBP1 binding significantly alters triglyceride metabolism and lipid partitioning. In this study, we modified the NanoLuc® Binary Technology split-luciferase system to develop a novel assay that monitors the binding of LPL to GPIHBP1 on endothelial cells in real time. We validated the specificity and sensitivity of the assay using endothelial lipase and a mutant version of LPL and found that this assay reliably and specifically detected the interaction between LPL and GPIHBP1. We then interrogated various endogenous and exogenous inhibitors of LPL-mediated lipolysis for their ability to disrupt the binding of LPL to GPIHBP1. We found that angiopoietin-like (ANGPTL)4 and ANGPTL3-ANGPTL8 complexes disrupted the interactions of LPL and GPIHBP1, whereas the exogenous LPL blockers we tested (tyloxapol, poloxamer-407, and tetrahydrolipstatin) did not. We also found that chylomicrons could dissociate LPL from GPIHBP1 and found evidence that this dissociation was mediated in part by the fatty acids produced by lipolysis. These results demonstrate the ability of this assay to monitor LPL-GPIHBP1 binding and to probe how various agents influence this important complex.

Joseph Tran
Oct 1, 2012; 30:173-178
Practical Pointers

David C. Klonoff
Aug 1, 2018; 41:1681-1688
Emerging Technologies: Data Systems and Devices

Amazon is offering up to 34 percent off Samsung monitors and tablets today. Plus, you can save on the Dell XPS 15 and pre-order Nintendo Switch Animal Crossing: New Horizons Edition.

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We may call them “site inspections”, but it’s not the site that’s being inspected when a regulator visits; it’s the Principal Investigator. Though a PI typically delegates study tasks to other staff members, he or she remains solely responsible for the conduct of the study. In fact, the ICH E6(R2) addendum adds two new sections to the international guidance that emphasize PI supervision.

That’s what makes the Delegation of Authority (DoA) log so important and why regulatory inspectors care about it so much. A DoA log serves as evidence that a PI has assigned study tasks only to those staff members with the education, training, and experience to carry them out. If delegates are unqualified to perform their tasks, subject safety could be at risk and it’s highly likely that the study data would be unusable.



Monitors – you can really make a big contribution here. At the outset of the study, you can verify that your PI has made appropriate delegations and the DoA log is complete. You can cross-match the log with training records, CVs, licenses, and source documents and correct any problems as early in the study as possible. Then, throughout the study, you can verify that the DoA log is being maintained.

Coverage
Without referencing any other site document, monitors can spot two types of DoA log omissions.

(1) Missing Assignments. Are there study tasks to which no one has been delegated? The tasks in a DoA log are often represented by a short code to conserve space. A legend at the end of the log translates the code into its corresponding task. Monitors can compare the legend to the DoA log entries to see if any tasks are omitted.


(2) Gap in Assignments. Due to staff turnover, reassignment, leaves of absence, etc., delegation for a task frequently does not last the duration of the entire study. A column in the DoA log indicates the delegation start and stop date.  Monitors can check to make sure that when the delegation for a task ends for one staff member, it is picked up by another.

Qualifications
Once you’re satisfied the DoA log completely covers all tasks for the duration of the study, you can check to make sure delegates have the necessary qualifications. You’ll want to compare the log with training records, CVs, and medical licenses from the regulatory binder.

• Has the staffer charged with recording vital signs during a subject visit been formally trained to take blood pressure? Is it documented?
• Did an incoming pharmacist receive protocol training prior to the start date of his study assignments?
• Does state law allow a registered nurse to dispense investigational product, or is a nurse practitioner or physician’s assistant required? Does the protocol require only an M.D. conduct certain procedures? Does the DoA log show the requirement is being followed?

Study Procedures
Even after the focus of the monitoring visit moves past the DoA log itself, you should revisit the log during source document review.

• Have any study tasks been conducted by staff members who have not received official delegation to do so?
• Perhaps the protocol requires a blinded IP dispenser. If so, has the delegated dispenser conducted any other study procedure?

PI Oversight
The PI is responsible for ensuring subject safety, compliance with the regs and the protocol, and control of the investigational product. That obligation cannot be delegated away. PI oversight is critical to a successful study, and the DoA log is where PI oversight starts.

Procedures that are performed by unqualified or ineligible personnel put both study participants and study data at risk. These are the very things regulatory inspectors work to guard against. Good monitors know it and make verifying the DoA log a priority.

__________________
A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

The tech helps owners take care of their dogs the way the dogs take care of them.

Masimo CEO Joe Kiani discussed how the medical device maker's telehealth systems can be useful in the fight against coronavirus.

Nonvalidated BP devices that dominate the online marketplace are a significant barrier to accurate home BP monitoring and cardiovascular risk management.

Novel device, which is in the size of a wristwatch, can monitor an individual's body chemistry to help improve athletic performance and identify potential health problems.

Imports - Television Receivers, Incl Video Monitors in Mexico increased to 182382 USD THO in March from 149240 USD THO in February of 2020. Imports - Television Receivers, Incl Video Monitor in Mexico averaged 244579.31 USD THO from 2014 until 2020, reaching an all time high of 465923 USD THO in October of 2015 and a record low of 149240 USD THO in February of 2020. This page includes a chart with historical data for Mexico Imports of Television Receivers, Incl Video Monit.

Thousands of pieces of medical equipment have been delivered to hospitals in Ireland as a result of Conor McGregor's €1million donation to the fight against coronavirus.

British doctors want the matchbox-sized gadgets, known as pulse oximeters, to be given to those in most urgent need for free.

A blog post describes project Tidal, which is a part of Alphabet's 'X' division that develops 'moonshot' projects. Tidal is creating a computer vision system that uses AI to monitor fish health.

WeChat is monitoring messages sent by international users to help identify content that might need to be preemptively censored in China and maintain a database of blacklisted content.

Roy Hodgson was not surprised to see the pitchside monitor used during their 1-0 defeat to Derby in the FA Cup but is unsure if he wants it to become a regular occurrence.

China’s cyber laws are rather broadly defined. Incidentally, Tencent’s privacy policy documents for China and the rest of the world, does not indicate that non-China accounts will be under surveillance.

One main feature of Hubstaff is an activity monitor that gives managers a snapshot of what an employee is doing. Broken down in 10-minute increments, the system tallies what percentage of time the worker has been typing or moving the computer mouse. That percentage acts as a productivity score.

The app on your phone tells you the weather for the next 10 days—that’s the furthest forecasters have ever been able to predict. In fact, every decade for the past hundred years, a day has been added to the total forecast length. But we may be approaching a limit—thanks to chaos inherent in the atmosphere. Staff writer Paul Voosen joins host Sarah Crespi to talk about how researchers have determined that we will only be adding about 5 more days to our weather prediction apps. Also this week, host Meagan Cantwell interviews Trygve Fossum from the Norwegian University of Science and Technology in Trondheim about his article in Science Robotics on an underwater autonomous vehicle designed to sample phytoplankton off the coast of Norway. The device will help researchers form a better picture of the base of many food webs and with continued monitoring, researchers hope to better understand key processes in the ocean such as nutrient, carbon, and energy cycling. This week’s episode was edited by Podigy. Download the transcript (PDF) Listen to previous podcasts About the Science Podcast [Image: Joshua Stevens/NASA Earth Observatory; Music: Jeffrey Cook]