Whitepaper that shows how easy you can build a fuzzer for the MQTT protocol by using the Polymorph framework.

This python script is a fuzzer for the ISO-8385 financial protocol. It is compatible with sulley and bofuzz and is now part of the official bofuzz release.

A git clone action can leak cached / stored credentials for github.com to example.com due to insecure handling of newlines in the credential helper protocol.

The Pre–Action Protocol for Possession Claims (the Protocol) has been in operation for three months. In 2009, we are beginning to get an idea of how the courts are interpreting its use. However, before going further, it's worth remembering wha...

Evidencing compliance The introduction of the pre-action protocol for possession claims in November 2008 represented one of the most significant changes for lenders in recent years. Few would argue with the principle behind the protocol - to encou...

The coronavirus outbreak and various responses by authorities across the globe have prompted several amendments to government Intellectual Property Offices (“IPOs”), courts, and in some cases filing deadline extensions. These specia...

In these extraordinary times a number of insurers and “claimant” law firms have agreed a protocol that should avoid unnecessary procedural problems. The full and commendably concise text can be found here. In summary, signatories t...

News & Events 9th May 2020 Protocol will help businesses and workers to return to work safely following COVID-19 closures The Health and Safety Authority (HSA) have been charged with oversight and enforcement The Minister for Business, Enterprise and Innovation, Heather Humphreys TD, today Saturday, 9 May 2020 published the National 'Return to Work Safely Protocol'. The Protocol clearly and comprehensively sets out the steps and processes that businesses must take to mitigate the spread of COVID-19 in the workplace. The Protocol was developed and agreed in consultation with the members of the Labour Employer Economic Forum, which is the forum for high-level dialogue between government, and...

The US President appeared puzzled that the aide, Katie Miller, press secretary for Vice-President Mike Pence, had contracted the virus "out of the blue". ......

mXT2113TD-AT_2v0_Protocol_Guide_A.zip

mXT2912TD-AT_1v0_Protocol_Guide_A.zip

mXT2912TD-AT_2v0_Protocol_Guide_A.zip

mXT144U_1v0vAB_Protocol_Guide_A.zip

Purpose of review

Diverse adverse events have been associated with administration of glatiramer acetate (GA), mainly local reactions at the injection site. Other, less frequent generalized reactions include isolated postinjection reactions and anaphylaxis, which may lead to discontinuation of GA.

Recent findings

Close collaboration between the allergy and neurology departments is needed to study adverse reactions to GA. The allergy study should include a detailed history and skin prick and intradermal tests with GA and, if possible, determination of specific IgE levels. Furthermore, the implication of other drugs should be ruled out.

Summary

An accurate diagnosis of reactions to GA is essential if we are to confirm or rule out allergy to GA. When an allergy diagnosis is confirmed or firmly suspected based on clinical evidence, desensitization protocols are increasingly seen as safe methods for reintroduction of GA.

Key Points

Method for highly sensitive detection of phosphorylation in B cell subpopulations.

B cell subpopulations show different phosphorylation levels upon BCR stimulation.

While NBA teams are slowly gearing up to return to training facilities this week, the league has reportedly issued a memo prohibiting those with elevated temperatures from participating.  

• Goodell’s memo outlines protocols for reopening team facilities
• NFL set to release full regular-season schedule on Thursday

The NFL has set protocols for reopening team facilities and has told the 32 teams to have them in place by 15 May.

In a memo sent by league commissioner Roger Goodell and obtained Wednesday night by the Associated Press, several phases of the protocols were laid out. The first phase to deal with the coronavirus pandemic would involve a limited number of non-player personnel, initially 50% of the non-player employees (up to a total of 75) on any single day, being approved to be at the facility. But state or local regulations could require a lower number.

Related: Why is it always the white NFL players who get a second chance?

Related: Eli Manning predicts 'tough' start for Tom Brady with Buccaneers

Local and state government officials must consent to reopening

The team must implement all operational guidelines set by the league to minimize the risk of virus transmission among employees

Each club must acquire adequate amounts of needed supplies as prescribed by the league

An Infection Response Team with a written plan for newly diagnosed coronavirus cases

An Infection Control Officer to oversee all aspects of the implementation of the listed guidelines

Each employee who returns to work at the club facility must receive Covid-19 safety and hygiene training prior to using the facility, and agree to report health information to the ICO

The response team must consist of a local physician with expertise in common infectious disease principles; the team physician can fill that role. Also on the response team will be the infection control officer, the team’s head athletic trainer; the team physician, if he or she is not serving as the local physician; the human resources director; the team’s chief of security; its mental health clinician or someone with equivalent clinical expertise; and a member of the club’s operations staff such as the facility manager

Continue reading...

LaLiga has agreed with the Spanish Football Federation (RFEF) and the National Sports Council that Spanish clubs can return to training, subject to health recommendations.

NFL Commissioner Roger Goodell sends memo to 32 clubs discouraging public comment by officials on 2020 season, and lays out protocols for reopening of facilities.

The Adelaide Crows and the AFL investigate a possible breach of the code's training protocols by a group of players at a Barossa Valley resort being used as a quarantine hub.

Attorney General Eric Holder today announced a revised version of the National Protocol for Sexual Assault Medical Forensic Examinations (SAFE Protocol, 2d.) The SAFE Protocol is a voluntary best practices guide to conducting sexual assault medical forensic examinations protocols.

Year in and year out, protocol deviations are the most common FDA Site Inspection finding. Why does this keep happening?

If you’ve seen FDA’s Inspectional Observation Summaries, you know that in 2015 the most frequently cited violation in clinical research by far was “failure to conduct research in accordance with the investigational plan.”  Do you know this finding also topped the list the year before that?  And the year before that?  In fact, deviating from the protocol has been the most common observation every year for the last decade.

Why does this keep happening?



The Nature of Protocols
This will come as a surprise to no one: not all protocols are well written.  Important procedures can be hidden in the most obscure places.  Charts depicting Time and Events Schedules are famous for carrying dozens of footnotes that appear nowhere else in the protocol, yet convey important study procedures.   For instance, a pre-dosing column may include a footnote that provides a timeframe for performing a physical exam; a post-dosing footnote might specify the interval at which vitals must be taken.   Failing to follow study procedures compromises subject safety and data integrity; FDA won’t care whether the procedures were in big bold italics or 7-point font.

This, too, may come as no surprise, but not all protocols are error-free.   Information in charts may not match the narrative.  Procedures in Section A may conflict with procedures in Section B.  When the FDA investigator spots an inconsistency, you’ll be asked which of the two conflicting procedures you followed and why.  If you performed procedure A only because you didn’t even notice there was a B, it will be clear you didn’t read the protocol as thoroughly as you needed to.  The FDA investigator may become concerned that your study execution differed from the sponsor’s intention.  This is not a concern you want to trigger.

For these reasons, it’s imperative that study staff read and understand the protocol.  Study team members need to ask questions about anything they’re unsure of, seek clarification on protocol inconsistencies, and get responses that satisfy before starting the study.   A PowerPoint overview is not sufficient training.

One more irksome attribute of protocols that can make them difficult to follow -- they change.  While most study sites allocate time and resources for initial protocol training, many lack a plan for training staff on protocol amendments.   A disproportionate number of protocol deviations occur in amended procedures, and it’s often because staff members have been insufficiently trained on them.  (And when you do train on protocol amendments, don’t forget to document it.)

Deviation Temptation
A protocol is not a suggestion; PIs cannot substitute their own judgment for prescribed procedures, no matter how well-intentioned the departure.  The protocol for a psoriasis study might call for the PI to perform a series of punch biopsies, very invasive procedures.  After the first biopsy, an empathetic PI might be tempted to skip a second if he observes the plaque is clearing up; the drug is working.  But this would be a protocol deviation.  The protocol for another study might preclude the use of a particular drug, even though the drug is routinely used throughout the practice to treat a symptom that a study participant is exhibiting.  But the study protocol trumps standard of care; prescribing the drug would be a protocol deviation.

A PI who feels she must deviate from the protocol for some reason must obtain prior approval, since failure to follow the protocol can jeopardize the reliability of the study data, if not subject rights and safety.



Deviations Happen
So you’ve thoroughly read the protocol, you’ve asked your questions and received the necessary clarifications, you’ve trained your staff on the protocol and its amendments, and you do your best to follow them.

Despite all your preparation and vigilance, protocol deviations happen.  They just do.  And when they do, here are two don'ts.

(1) Don’t panic.

(2) Don’t let an FDA investigator find them first.
Take the time to fully document any protocol deviations.  Be sure to record why they happened, how they were corrected, and what was submitted to the IRB.

[Note: IRBs have different requirements about what types of protocol deviations should be communicated.  Out-of-window visits are common and are frequently considered too minor to report.  But nothing’s black and white.  If the missed visit resulted in missed doses, that would probably change the calculus. The PI needs to determine whether to notify the IRB, and if no submission is thought necessary, it’s a good idea to document why not.]

_______________________________________________________________

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

Protocol trumps practice. This principle seems clear enough, but complying with it is not always as straight-forward as it sounds. Years of practicing medicine has reinforced the way a physician responds to medical situations. But do these responses run counter to the investigational plan? Can a site’s commitment to standard of care affect its ability to meet enrollment targets?


There’s a lot to consider.



What’s Your Standard of Care?
When deciding whether or not to conduct a particular study, a PI needs to verify that the protocol is aligned with practice norms. For example, an early phase trial might exclude a medication that is part of a practice’s routine therapy. Is the study placebo-controlled? Does it feature a specific comparator drug? Will it include a washout period? Any of these elements could present enrollment challenges or preclude a site from accepting a study at all. Responsible sites want to make thoughtful decisions about study suitability; they want to provide realistic enrollment estimates. Sponsors want this too, and can help sites do both these things by providing them a sufficient level of detail about protocol procedures as early as possible.


The Road to Deviations is Often Paved with Good Intentions
Therapeutic misconception – a well-documented phenomenon in clinical research – occurs when a study participant “fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment.”* Study participants are not alone in this. Researchers blur the distinction themselves when they conduct procedures that are consistent with clinical care but deviate from the protocol. This may be particularly true for PIs who recruit participants from their own practices. An endocrinologist might ordinarily reduce dosage for a particularly diminutive patient. A pulmonologist would often skip a scheduled chest x-ray she felt wasn’t needed to avoid exposing her patient to unnecessary radiation. An orthopedic surgeon may decide his patient needs more recovery time than usual before attempting her first walk. In a clinical care setting, these decisions are sound, made in an individual patient’s best interest. In a clinical trial, if they differ from the investigational plan and haven’t been approved by the Sponsor, they’re protocol deviations.**

It May be Par for the Course, But It's Still an AE
Specialists who have experience treating particular conditions are also familiar with the complications that ordinarily accompany them. A nephrologist, for instance, knows that a patient with end-stage renal disease frequently experiences bloat from a buildup of fluid between dialysis sessions. Though useful for a doctor treating patients, this knowledge can actually work against a doctor running a trial. How? A PI may fail to report a stomach ache as an AE because it’s so typical, so expected. “Bloat is common for renal patients. If I recorded every GI incident, I’d be recording AEs all day.” At its surface, this PI’s argument sounds reasonable, but what if the study drug itself is contributing to the participant’s discomfort? In order to assess the drug’s gastrointestinal effect, the PI must document the frequency and severity of all GI events.

Lab values that are either above or below normal range are also prime candidates for AE underreporting. “Of course the participant’s liver enzyme is high – we’re testing a cholesterol drug.”

The Importance of Study Oversight
Any GCP course worth its registration fee will discuss the distinction between standard of care and the study protocol. In practice, the distinction is not always as obvious as training sessions might suggest. This is where well-trained CRAs come in. As site monitors, CRAs are in a position to catch deviations that result from lapses into standard of care. Reading through progress notes, a monitor can ensure that any untoward medical event has been reported as an Adverse Event. They can verify that procedures conducted by the PI and site staff are compliant with the protocol. Then, by reviewing which types of data must be collected and emphasizing the importance of following certain protocol procedures, monitors can take the opportunity to re-educate study personnel and help them avoid these common pitfalls.

_______________________________________________________________________
* Lidz CW, Appelbaum PS (2002) The therapeutic misconception: problems and solutions. Med Care 40: V55-V63.

**Andrew Snyder of the HealthEast Care System wrote a thoughtful piece describing the compatibilities that do exist between clinical care and clinical research. His arguments provide a useful counterpoint to the issues we’re raising here. https://firstclinical.com/journal/2017/1707_Research_vs_Care.pdf

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

Hopefully someday we can say the same thing about an effective effort to combat greenhouse gas emissions.

After evidence that China violated the treaty intended to protect the earth's ozone layer, the country has leapt into action.

eeeeeewaaaakkksssshhhhh

The Swiss Government on September 20, 2019, announced that it has exchanged instruments of ratification with the United States to bring into force a Protocol to their double tax agreement.

The United States Senate could soon approve ratification of four long-pending double tax avoidance treaty protocols.

Columbus, OH - As the country gradually re-opens for travel as restrictions ease, Red Roof®, the leader in upscale economy lodging, has launched Red Roof RediClean™, as it welcomes guests back. Red Roof RediClean includes rigorous enhanced cleaning ...

ORLANDO, Fla. - Wyndham Destinations (NYSE:WYND), the world's largest vacation ownership and exchange company, today shared updated cleaning protocols and preventative measures for its 230 vacation club resorts and sales centers. The company's Vacat...

It was only the other week that Andreesen Horowitz announced their second blockchain-focused fund of $515 million. In the announcement, they said: “We are still early in this Web 3 build-out. High-performance programmable blockchains will make decentralized network development much more accessible. After years of R&D, we are excited that a number of next-gen programmable […]

It was only the other week that Andreesen Horowitz announced their second blockchain-focused fund of $515 million. In the announcement, they said: “We are still early in this Web 3 build-out. High-performance programmable blockchains will make decentralized network development much more accessible. After years of R&D, we are excited that a number of next-gen programmable […]

It was only the other week that Andreesen Horowitz announced their second blockchain-focused fund of $515 million. In the announcement, they said: “We are still early in this Web 3 build-out. High-performance programmable blockchains will make decentralized network development much more accessible. After years of R&D, we are excited that a number of next-gen programmable […]

Finn Russell was dropped from Scotland's Six Nations opener after refusing to stop drinking at the team's hotel bar and then skipping training the following morning.

Stanford professor Scott Hubbard said in an interview that NASA must adopt 'planetary protection' to keep alien viruses from returning from the human Mars mission and contaminating Earth.

Various health and hygiene measures 'that could be in place for up to a year' will also be discussed by Premier League clubs next week as Project Restart plans are outlined

Firefighters followed a 230-year-old protocol when battling last night's blaze at Notre Dame in Paris, according to a Twitter user, citing a lecture at Versailles on long term city planning.

Chief of Protocol Sean Lawler has left his post, following reports of a possible internal probe of allegations of intimidation and harassment.

Top-flight clubs were provided with a seven-page document last week outlining hygiene guidelines aimed at protecting players and staff from Covid-19.

EXCLUSIVE: Premier League players must keep their cars spotless as part of coronavirus hygiene measures. Clubs will implement a raft of protocols designed to protect from the virus.

Stanford professor Scott Hubbard said in an interview that NASA must adopt 'planetary protection' to keep alien viruses from returning from the human Mars mission and contaminating Earth.