If you are involved in real estate investing, you’re bound to run into a bad tenant or two. Sometimes you think you rent out your property to the right people, but once they’ve moved in, it seems like you’re dealing with entirely new ones.

I have been living in Vietnam for four years and have moved to five different apartments since then. With this frequency of moving, I have learned a few things which I happily share with my friends and with you, if you are looking for a place to live in Ho Chi Minh City right now.

While breaking a lease is something to avoid, as with any binding contract, sometimes circumstances intervene and it becomes unavoidable. Here are a few pieces of advice to make the process a bit easier.

Renting an office space should be one of your top priorities at the onset of starting your business. However, it takes more than simply looking up available lots around town and choosing one at random. Here are some tips on the right way to rent out small business space.

Renting privately can be a great option. You have much more choice about the type and location of property you end up living in.

Costly rentals, hefty mortgage payments and the rising expenses on monthly bills are convincing more and more people to let their rooms in flatshares and find flatmates to foot the bill.

Many entrepreneurs become so excited about launching their new business venture that they fail to find the right location for it. This is one of the first steps that can be very critical to your success in future.

Home moving is surely a hassle. Luckily, a little preparation work can mean the difference between a minor headache and an all-out life takeover.

To take your first-time buyer from shopping to purchasing requires a lot of investment, a bit of armchair psychology, and a lot of research, and you absolutely must stay on your toes. We put together 10 tips to help you close the deal with first-time buyers.

With her aggressively successful tactics, mega broker Dolly Lenz has sold over $8.5 billion in premium properties to rich and famous customers. Here are some of her valuable secrets for those looking to sell properties.

As a home seller, everyone wants to sell their home quickly at the highest price. Five simple tips below can help you.

Finding a home that satisfies all your requirement has been a difficult task, but for many people, selling home is even more difficult. Lots of sellers have to sell their homes at a cheaper price than they expected before and accept a loss. To avoid being troubled with the sale and make it faster, follow guides in the Infographic below for the best preparation before selling your home.

Home buyers or sellers normally face many difficulties and obstacles that need time and effort to overcome. To save time, avoid risks and make the purchase faster and smoother, most people hire real estate agents for effective advice and assistance.

The last few years have been interesting for property, many investors have been implementing the lessons learned during the GFC and the following recovery. The downturn proved even the best investors can’t predict exact market timings, which is why they don’t try to ‘crystal ball’ the market. So follow their lead: learn from the past, get expert advice, check your finances and you will be on your way to investment success. Below are a few top tips for investing.

When it comes to building a retirement nest egg for the future, property is still regarded as one of the safest long-term investments.

With a population of about 90 million people, and one of the fastest growing economies in the world, Vietnam is proving to be an attractive place for foreign investors to do business. With a stable political environment and great economic potential, Vietnam is taking firm steps towards industrialization and modernization.

If you are currently searching for a perfect buy to let investment property anywhere in the world, the experts at British listed real estate and lettings agency Belvoir have revealed five things to consider before you put pen to paper and sign on the dotted line.

If you don’t have a big budget to invest in largest cities, think about buying properties in regional towns with many advantages. However, it’s important to look for the right location to pour your money.

Australian leading investment property expert Chris Gray provides simple but powerful tips to choose safe investments with good rental returns.

One of the best ways to invest your money and build wealth can be buying property. Many new investors often feel overwhelmed before entering property investment. Here are 4 helpful tips to protect your money poured in property.

मां-बाप अपने बच्चों की खुशियों के लिए कई तरह के छोटे बड़े त्याग करते रहते हैं। बच्चों की हर जिद्द पूरी करते हैं। ऐसे में बच्चे ज्यादा जिद्दी होते जाते हैं।

From a patchwork quilt to a crisp-packet necklace, learn new skills with the help of some top British designers

Creative director and star of Netflix’s Next in Fashion, Daniel W Fletcher has plenty to get on with while in social isolation, designing a collection for Fiorucci as well as one for his own brand. In his down time, he is taking up a DIY challenge to make a patchwork quilt based on a dress he made during the filming of Next in Fashion, using other designers’ leftover scraps. The design – inspired by concerns over the melting polar ice caps – is an arctic landscape.

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Touch is key to social relationships, and while coronavirus social distancing measures may limit physical interactions, there are still many ways to connect from afar, says evolutionary psychologist Robin Dunbar

Whether you are at home alone or juggling work and family, those working in mental health share their advice on how to cope with the covid-19 pandemic

The more people we encounter, the higher the risk of virus transmission. So, how do we keep safe when going to the shops?

Gary Neville took to Twitter to answer questions around Paul Pogba and Bruno Fernandes, and Manchester United's future transfer policy.

Find a hobby, for starters, and don't forget the mission, say scientists who have worked at remote research stations

Everybody loves a cool trick. No matter how well we know an app or program, there’s almost always some shortcut we never learned. The same goes for hardware: We may use gadgets every day without knowing their helpful quirks.

We shouldn't expect a normal level of learning right now and teachers are prepared to catch kids up this fall. Their message to parents: Leave it to us.

Three tips to use this time to get started on a routine

Part 6 of Tristan H. Cockcroft's nine-part expanded "Playbook" explains nine tips to use during the fantasy baseball season, from trade strategies to how to value rookies and closers.

Memories of beaches – in the UK or further afield – as well as village bars, sunrise views and days out with tea and cake are sustaining readers during lockdown

A day out in Whitby. Morning tea and fruit cake with Wensleydale at Bothams. Walk to the sea, and out onto the pier. Walk up the beach, climb up the cliff and then back to the town past the whale’s jaw. Fresh crab sandwiches for lunch, then climb the 199 steps to the Priory. Back down, just enough time for afternoon tea and cake before crossing back over the river for a fish supper at the Magpie. Drive back over the beautiful North Yorkshire moors; the end of a perfect day, in perfect weather every time.
Nigel Goddard

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What you need to know to keep connected.

No eqiupment, no problem

A string of other stars, like Emma's friends Octavia Spencer and Jonah Hill, have also contributed to the #WeThriveInside campaign

Hollywood pros share user-friendly video chatting tips to make your video conferencing look and sound its best.

Former Arsenal manager Arsene Wenger believes England could produce football's next superstar to take over from Lionel Messi and Cristiano Ronaldo - but Kylian Mbappe is the front-runner

The former Chief Digital Officer for New York City shares advice for how business leaders can best manage their personal media outlets.

Keep on reading: Top Social Media Tips for Execs

Your Zoom or Skype meetings don't have to look like hostage videos. Here's what some experts advise.

Sharing third-party AWS workflow options that can be integrated to increase your operation's effectiveness and productivity when working in the cloud. 

Keep on reading: Automating the Cloud: AWS Tools and Tips

Anx·i·ety (noun)
The state of uneasiness caused by apprehension of possible misfortune.

Yep.  That’s the word that comes to mind whenever anyone mentions FDA inspections.

But anxiety often stems from a lack of control, and in a regulatory inspection, you have more control than you might think.  There are many steps you can take -- before, during, and even after an inspection is over -- that can give you a fair degree of control over the outcome.   Here, Polaris auditors Lauren Kelley and Michele Commins share some of those steps with you.



Pre-inspection Preparation
For-cause inspections may be unannounced, but routine FDA inspections of submission data are scheduled in advance*.  That means most inspections are not pop quizzes; they’re final exams.
Remember how happy you were when a teacher gave you access to a prior year’s exam to study from?  You knew the type of questions that would be asked.  You knew how to prepare.

So this is the first tip we’d like to share.  FDA has, indeed, given you a copy of their exam in advance, in the form of its Compliance Program Guidance Manual, CPGM 7348.811.  This is the document all FDA field investigators use to conduct inspections at clinical sites.  It outlines in great detail what documents investigators will review, what dates they’re going to verify, what processes they’ll evaluate, what data they’ll collect, and what records they’re going to compare.  Despite its rather uninspired title, this is your copy of the final exam.

You know cramming is a risky strategy, so the earlier you get familiar with the CPGM the better.  Inspection readiness is a state of preparedness more than it is a laundry list of activities; it takes some time to get there.

When the Inspector’s in the House
According to the CPGM, one of the first pieces of information the FDA investigator will obtain is a list of all of the studies performed by the clinical investigator, including protocol number, sponsor, and study dates.  So even though FDA has scheduled its inspection with you, and has told you what study the investigator is coming to inspect, any study is fair game.  An FDA investigator can look at any document she wants, or talk to any staff member he chooses, whether related to the “assigned” study or not.

Most of your preparation will have been study-specific; questions about other studies will catch your staff off-guard, and a review of records for other studies may find them less than inspection-ready.  So here’s our second tip.   Avoid anything that might pique the investigator’s curiosity about a study that is not the original subject of the inspection.  Make sure the room you reserve as your investigator’s “home base” is free of any documents, reports, notes, phone lists, and post-its.  Make sure you tidy up offices, workspaces, and facilities site-wide, and keep extraneous chatter in check.

After the Visit
If your FDA inspection resulted in zero observations, then stop reading, thank your awesome staff members, and go celebrate.  If, however, you did receive a Form FDA 483, it’s probably not the end of the world, but you do have some work to do.  Our third tip is this:  remember that the sponsor/CRO is your ally here.  They have as much invested in FDA’s assessment of your study data as you do, and they have the regulatory, QA, even legal resources that you might not.   You’re not required to formally respond to 483s, but if you do, you’re likely to receive a more favorable Establishment Inspection Report (EIR) in the end.  Let your sponsor/CRO help you with your response.

Tips Do Not a Plan Make
Tips are helpful, but you’ll need more than that to ensure a successful FDA site inspection.  You need an inspection readiness plan -- a plan that you document and keep current.  All site staff members need to train on the inspection procedures and the individual roles they will play.  (Fourth tip: don’t forget to train your temporary employees; an office temp working at the receptionist desk could be the first person your FDA investigator speaks with.)

A Last Thought
Inspections are stress-inducing events, and nervous people make mistakes.  Investigators know this, and expertly exercise the “pregnant pause,” knowing how difficult it is for people to withstand an excruciating silence without volunteering unsolicited information.

So one last tip:  conduct a mock inspection before the FDA comes to visit.  It will stress test your procedures and identify improvements you need to implement.  A thorough mock inspection will give staff members an opportunity to rehearse their roles and interview techniques so they can execute your plan and speak to the FDA investigator with confidence.

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* For-cause inspections are also known as Investigator-oriented, and routine inspections are also known as study-oriented.

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

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.

Over the years, attendees of MAGI Clinical Research Conferences have collected a set of practical, actionable suggestions for improving clinical trials. More than eighty such tips appear in the July 2019 edition of Journal of Clinical Research Best Practices*.  In this post, Polaris auditors weigh in on some of their favorite MAGI suggestions. Surprising no one, they also were eager to share some of their own.

Our Favorites Tips from MAGI

So how does a clinical trial tip earn a spot on our exalted Faves List?  First, it must be something we don’t see too often, or not as much as we’d like.(If most organizations already do a useful thing, it doesn’t really qualify as a helpful tip; it’s really just a common practice.) Second, the effort to implement the tip can’t be too onerous. If a practice requires too much interdepartmental coordination, change management, training, money, or resources, it’s not a tip. It’s a full-blown initiative.

So here they are. Each tip from MAGI attendees is in bold font. Our accompanying commentary is in plain text:

• To help ensure quality study conduct, clinical sites should prepare protocol-specific quality checklists for each study. We’ve written about quality checklists from the auditing perspective before. They’re not a panacea, certainly, but that doesn’t mean they can’t be very useful.
  
  
• After study close-out, sponsors and CROs should consider holding conference calls with groups of sites to capture lessons learned. This in turn could be used to improve training, SOPs, SIVs, etc.
  
  
• As a recruitment aid, clinical sites should create pocket-sized, laminated study cards that list the inclusion/exclusion criteria for a study.  Site staff members can keep these cards in their lab coat pockets and quickly refer to them when treating a patient who could be a potential subject.
  
  
• CROs should share risk assessments and mitigation plans with Sponsors. We agree, but would also encourage CROs to keep the sites involved and aware of risks so they can anticipate them and proceed accordingly.
  
  
• Sponsors/CROs should ensure proper qualifications of vendors prior to executing contracts. It’s hard to argue with this logic, but we don’t see it as much as we should. Too often qualification audits come after the paperwork has been signed. Should the audit uncover noncompliance or quality risks at the vendor site, it’s much harder to get the vendor to make necessary changes after the contract is in place.
  
  
• CROs should align 3rd party contracts with the Sponsor/CRO contract and the Clinical Trial Agreement. Yep.

Additional Tips from Polaris QA/Compliance Auditors

The MAGI list of clinical trial tips brought others to mind that we wanted to share. We applied the same criteria to these suggestions as we did to the MAGI contributions: (1) not necessarily rare, but not as common as it could be, and (2) not overly complex or expensive to implement.

• When evaluating outsourcing partners and clinical sites, Sponsors and CROs should make sure to look at personnel turnover rates. Frequent turnovers may suggest underlying problems that could jeopardize study conduct and quality.
  
  
• Sponsors and CROs should make sure their Monitoring Report templates are consistent with the Clinical Monitoring Plan (CMP). For example:
  
  
• The CMP calls for a focus on a particular set of critical variables, but the report template only has a place for recording that 100% SDV was completed. This means that there’s no way to document that the monitor put special emphasis on anything.
• The CMP requires bi-direction review of study data – a confirmation that what is in the CRF can be verified in the source, and all pertinent data in the source can be found in the CRF – but the report template only allows for the former to be documented.
  
  
• Every member of the site team has valuable input. It’s important to include the study PI, CRC, pharmacist, and other key personnel in the discussions. In 2017, we wrote an article about the important, yet often overlooked, input that the pharmacist on site can provide.
  
  
• There are many reasons that trial participants leave a study, many of which can’t be remedied with improved site practices. But sites that demonstrate they value the participation of their study volunteers, and honor the time they’re spending and contribution they’re making, tend to have better retention results. To that end:
  
  
• To help participants schedule their time, sites can prepare calendars that include all study visit dates and indicate the activities and procedures they entail. (This, of course, needs to be approved by the IRB).
• When participants arrive, they shouldn’t have to sit in a waiting room or empty exam room; they should be seen immediately so they don’t feel their time is being wasted.
• Sites can provide beverages and light snacks to their study participants who especially appreciate them immediately after a fasting blood draw (protocol permitting, naturally). It’s a small courtesy, and not difficult to do. Whose day isn’t brightened by a proffered nosh?**

Uh oh. Now we got you all thinking about mini muffins and cheddar popcorn. Go ahead. Grab a treat. We'll talk later.

________________________________________________________________
 * Journal of Clinical Research Best Practices, July 2019

** Proffered Nosh™ would be a really great name for a restaurant. Or a fictional Scotland Yard Inspector -- legendary for his wit, brilliance, wine pairings, and fashion sense.

Bank Exams Preparation Tips 2020: Have a look at important Tips and Strategies for bank exam preparation to fetch recruitment in banks as PO/Clerk/SO. Know details of SBI Clerk 2020, IBPS RRB 2020, IBPS PO 2020, IBPS Clerk 2020, RBI Assistant 2020, LIC AAO/ADO 2020 and other bank exams. 

Dec 14, 2019

Chinese diplomats in Africa are robustly defending Beijing’s policies on Twitter as part of a new and sometimes aggressive public relations campaign which is playing out across the globe as the country’s envoys answer President Xi Jinping’s call to “tell China stories well”.south chi

Dec 14, 2019

Chinese diplomats in Africa are robustly defending Beijing’s policies on Twitter as part of a new and sometimes aggressive public relations campaign which is playing out across the globe as the country’s envoys answer President Xi Jinping’s call to “tell China stories well”.south chi

Dec 14, 2019

Chinese diplomats in Africa are robustly defending Beijing’s policies on Twitter as part of a new and sometimes aggressive public relations campaign which is playing out across the globe as the country’s envoys answer President Xi Jinping’s call to “tell China stories well”.south chi

Dec 14, 2019

Chinese diplomats in Africa are robustly defending Beijing’s policies on Twitter as part of a new and sometimes aggressive public relations campaign which is playing out across the globe as the country’s envoys answer President Xi Jinping’s call to “tell China stories well”.south chi

Dec 14, 2019

Chinese diplomats in Africa are robustly defending Beijing’s policies on Twitter as part of a new and sometimes aggressive public relations campaign which is playing out across the globe as the country’s envoys answer President Xi Jinping’s call to “tell China stories well”.south chi

Washing and drying clothes can take a toll on your wallet and the planet – these easy tips make it better.