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Back to School, Back to Health Tips for a Healthy School Year

Back to School, Back to Health Tips for a Healthy School Year

By Jodi Fletcher

Summer is almost over and that means kids will be going back to school. Healthy kids are happy kids. There are some ways to ensure kids go back to school healthy and happy.

Yearly physical

Other than the occasional cold or flu, children don’t visit the doctor’s office often. A yearly physical examination enables the doctor to assess a child’s overall health. Back to school time is a perfect time to schedule these important screenings. The doctor will address important developmental concerns. They will also check the child’s heart and lungs. They may suggest nutritional and physical activity plans, as well as offering advice for children entering adolescence.

Nutrition

Since kids spend six to eight hours at school, what they are eating is important. According to the American Academy of Pediatrics (AAP), children consume 35% to 40% of their daily calories during the school day. Starting the day with a nutritious breakfast that includes protein can help a child focus better on their school activities. Some schools do provide breakfast for students. Not every child likes everything the school’s cafeteria offers. Luckily most schools provide parents with daily menus, so if a child does not like what is offered on a given day, a packed lunch can be planned. Lunches should consist of heart-healthy foods such as fruits and vegetables and lean protein. Foods high in sodium should be avoided. Soft drinks should also be avoided due to the high level of sugar and calories, which increase the risk of obesity, type 2 diabetes, and heart disease. Water, juice, or low-fat dairy products offer a healthier alternative. Schools offer different payment options for lunches, including free lunches to those who qualify. Every child should get enough to eat during their time at school.

Physical activity

Kids do plenty of sitting during the school day. That is why it is important to incorporate some physical activities into their day. According to the Centers for Disease Control and Prevention (CDC), children should participate in a minimum of 60 minutes of physical activity every day. This physical activity decreases the risk of obesity, type 2 diabetes, and heart disease.  Physical activity improves mental health, reducing stress and anxiety. The CDC breaks this recommendation down into three categories.

  • Moderate to vigorous intensity aerobic activity should make up most of the 60 minutes every day, with vigorous intensity activities 3 days per week.
    • On a scale of 0-10, moderate intensity activities are 5-6 and cause the heart to beat faster than normal. Vigorous intensity activities are 7-8 and cause the heart to beat even faster.
  • Muscle strengthening, such as gymnastics or push-ups, at least 3 days per week.
  • Bone strengthening, such as running, at least 3 days per week.

During the school day, children can participate in physical education, recess, and other classroom activities. After school, they can join athletic groups, playgroups, or participate in their favorite physical activity.

Sleep

 For many kids, summer is a time for staying up late and sleeping in. The days are longer and there is so much to do. However, as back to school approaches, kids need to get back into a better sleep schedule. Children who do not get enough sleep have a more difficult time concentrating and learning. Younger children need 10-12 hours of sleep, and getting up on time for school means getting to bed earlier than during the summer. According to the National Sleep Foundation and the Harvard Health Publishing, adolescents who don’t get enough sleep have an increased risk for higher cholesterol levels, higher body mass index, higher blood pressure, and hypertension. Limiting evening activities will help a child shift to use that time to do homework and study. A shift towards a consistent bedtime and wake time should begin at least a week before the start of school. This shift should also include limiting screen time. The AAP recommends that all devices should be removed from a child’s room at night and stop screen time at least one hour before bedtime.

Starting the new school year happy and healthy improves children’s ability to focus and learn. For more information about how to help with a child’s first day back to school go here.

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A Look at the Functional Service Provider

A Look at the Functional Service Provider

By Jodi Fletcher

What are functional service providers—FSPs–and how can they help you have a successful clinical trial?    

With so much data to analyze and process, documents to keep track of and regulations to follow in a clinical trial, outsourcing some of the work offers a cost effective and efficient approach.   Contract Research Organizations (CROs) have long been used by trial sponsors to achieve completion and compliance in clinical trials.  According to the Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice, the definition of a Contract Research Organization (CRO) is: “A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial related duties and functions.” 

Large, global companies have customarily outsourced responsibilities to full service CROs that perform multiple duties related to the trial, while smaller companies have often used “specialty CROs” designed to offer specialized services, such as source document monitoring, data management, or device training, where needed. However, in recent years, there has been a shift in how companies have been utilizing these organizations.  The increasing demand for complex clinical trials and the high overhead of building comprehensive, in-house, specialized clinical operations departments is driving the need for more outsourcing of services such as data management and analysis. Specialty CROs have filled this role in the past, but recently a re-branding of these organizations has more accurately labeled them as FSPs.  This model is becoming a more popular choice in both large and small sponsor companies.

The name of FSP for organizations providing high-level expertise in one or two areas of clinical operations has been gaining popularity because it more accurately delineates a full-service CRO from an organization which specializes. An FSP provides more flexibility and efficiency than traditional full-service providers. These organizations offer individual, focused services where the sponsor has the option to “pick and choose” which provider fits the area of the trial best. FSPs offer the option of expertise in the area of service or methodology. Companies may offer FSP services for clinical operations, data management, statistics, or medical writing. A sponsor may choose to use one or more FSPs for the trial, but it may also have several companies under contract per function to provide the most agile and complete coverage for individual studies.

FSPs, which can be generically referred to as functional outsourcing options, have become popular through the growing desire for a relationship driven approach rather than a project focused one.  Long term, flexible partnerships can be developed with targeted specialists, where several smaller vendors can be better than a single large one. Partnership development is crucial for the trial’s success. Partnerships in large CROs may take too long to develop because of the infrastructure necessary for a large vendor to operate and this may hinder startup or closure of certain trials.

Benefits of using an FSP:

  • Focused expertise
  • Competitive benefit
  • Risk mitigation
  • More efficient
  • Lower cost
  • Invested development in focused areas
  • Higher degree of control

Trust in the experience of the vendor is critical for a relationship to develop. This and cost are areas of concern in the process of service provider selection in clinical trials. (For more information go here and here) There are many ways that an FSP addresses these concerns. Often in an FSP arrangement, the technology and systems needed are provided by the sponsor, reducing the cost to invest in additional systems. This enables the sponsor to use existing personnel to focus on the management of the vendors and to oversee clinical operations.  In an FSP relationship, the vendor manages its staff, although the sponsor provides study-specific training and access to policies and procedures. This arrangement creates teams that are essentially an extension of the sponsors’ team. The result is increased transparency in the relationships that is easier to oversee and assess. An FSP relationship provides “senior-level governance, structure, and attention” throughout the process with this model aiming for efficient delivery while maintaining high quality and consistent service.

What to look for in an FSP:

  • Cultural and company values and strategies
    • Customer service approach, level of communication, conflict resolution, oversight
  • Experience and best practices
    • Does the company have plans in place based on what has worked previously?
  • Consistency
    • Turnover rates, human resource management
  • Flexibility to adapt
    • Strategic and proactive planning
  • Scalability to demand
    • Ability to tailor team relative to study size and complexity

The ability of the FSP to “fit” with the sponsor’s needs is imperative to the selection and the relationship that will be developed. Flexibility, integrity, trust, and experience are key factors in the success of the relationship.

Sometimes, a “one-size-fits-all” approach can be the right choice for a research service organization. However, in this era of specialization, an FSP may offer the most expertise and flexibility for the best results in your clinical trial.

WHAT SHOULD MONEY BUY? THE ETHICS OF ORGANS FOR SALE.

By Jodi Fletcher

How is value calculated? Webster Dictionary defines value as “the monetary worth of something” or “a fair return or equivalent in goods, services, or money for something exchanged” Should everything have a monetary worth? When it comes to how much a living organ is worth, there are factors that need to be considered. Is the organ worth more to the recipient, or to the donor? This is an ethical question that is hard to answer, but is a question in debate. 

There are multiple ethical facets to organ donation:

  1. First, do no harm:
    1. The donor has no medical need for surgery.
    2. There is a risk/benefit balance that needs to be considered. The organ recipient reaps disproportionate benefits compared to the donor.
  2. Informed consent: (for more information on informed consent go here)
    1. The donor must be competent and capable of understanding the risks involved.
    2. Must do so without any form of coercion.
  3. Regarding the question of financial compensation, vulnerable populations must be considered where a donor may lack the capacity to make an autonomous, voluntary decision to agree to donate an organ.

There is a shortage of organs for patients in need of transplants. According to U.S. Department of Health & Human Services there is a continuing decline in available donors. There is a question on how to obtain more organ donations. Proponents for selling organs are suggesting suspending or revoking the prohibitions of the National Organ Transplant Act of 1984 (NOTA). National Organ Transplant Act prohibits the sale of organs based on the idea of valuable consideration. According to the NOTA “The term “valuable consideration” does not include the reasonable payments associated with the removal, transplantation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of human organ in connection with the donation of the organ”. Current arguments for and against the selling of organs consider and evaluate several ethical questions.

Current arguments in favor of financial compensation for organs:

  1. Because demand for organs outpaces supply, it is believed that donation rates would increase if financial incentives were permitted.
  2. Organ donors are the only participants that receive no tangible benefits.
  3. Polls indicate societal support of compensation.
  4. Legal compensation of semen, hair, and plasma suggests the right of a person to use body parts as they wish.

Current arguments against compensation for organs:

  1. Potential abuse of vulnerable populations, such as those in a lower socioeconomic bracket.
  2. Reduction of altruistic donors who feel that compensation weakens their donations.
  3. Reduced donor disclosure due to motives based on compensation rather than altruism.
  4. Financial neutrality is a more ethical alternative.

For living organ donations such as kidney and liver transplants, the costs can add up for the donor. Travel, housing, and lost wages are all expenses that a living donor can incur. According to Warren, et. al.,  donors can incur an average of $6,000 in additional expenses. The goal of financial neutrality or at least the removal of “disincentives” is considered a more ethical approach to obtaining more donors.  

Proponents of financial neutrality suggest the coverage of:

  • Direct medical expenses: all pre and post donation costs related to the procedure
  • Direct nonmedical expenses: travel, housing, food, etc.
  • Indirect expenses: recovery time, lost wages

The recipient’s insurance may cover these expenses; however if it does not, there are organizations available to help. The National Living Donor Assistance Center (NLDAC) works to lessen the financial burden on donors through federal government grant funding.

            Although some countries allow the selling of organs, the theory of supply and demand may not be the best or most ethical motive. There are many other factors to consider.

Let us know your thoughts about the ethics of organ donation in the comments section. We’d love to hear from you!

Thanks for tuning in to the Hart Clinical Consultants Ethics Series!

JUNE IS MEN’S HEALTH MONTH – WEAR BLUE!

By Jodi Fletcher

Summer is a great time to ramp up those New Year’s health goals. The good weather and longer days don’t leave any room for excuses not to get healthy. The month of June has not only Father’s Day in it, but is dedicated as Men’s Health Month. That means time for men of all ages to take a closer look at their health. According to Menshealthmonth.org, the purpose of this month is “to heighten the awareness of preventable health problems and encourage early detection and treatment of disease among men and boys.” Federal, state, and local governments have declared the month of June as Men’s Health Month: to see your state’s proclamation go here. Awareness programs, activities, social media attention, and Men’s Health Week are just a few of the methods designed to encourage men to seek out information about their health. Family involvement is also an important factor in ensuring the men in our lives get the help they need towards longer, healthier lives.        

            Men’s health facts:

  • On average, men live 5 years less than women
  • 1 in 2 will develop cancer
  • Men have a higher death rate than women for most leading causes
  • Approximately 30,000 men in the U.S die yearly from prostate cancer
  • Men see the doctor half as much as women for preventative care
  • More men are uninsured than women

Common men’s health issues are managing chronic diseases such as diabetes, obesity, hypertension, heart disease, and high cholesterol. Other issues that affect health and quality of life are low testosterone and depression. Low testosterone affects sexual health, mood, memory, and energy. Low testosterone increases the risk of other chronic conditions as well. Prostate health problems are common in men, especially over the age of 50, although younger men can experience problems too. 

Prostate health issues:

  • BHP: benign prostatic hyperplasia is an enlarged prostate
    • Not cancerous
    • Most common in men over 50
    • Half of men age 50-60 and 90% by age 80
    • Causes discomfort and frequent, difficult urination
  • Prostate cancer
    • Most common
    • 2nd leading cancer resulting in death
    • No known prevention
  • Prostatitis
    • Inflammation possibly caused by infection
    • Most common in men under age 50

The American Cancer Society recommends that men with average risk factors for prostate cancer get regular screening at age 50. Risk factors include age, race/ethnicity, geography, family history and genetic mutations. Early detection is crucial for treatment. There are two main screening tests used for early detection. One is a blood test that determines the prostate-specific antigen (PSA) levels. The other test is a digital rectal exam (DRE) that checks the prostate.

Steps to improve health and stay healthy:

  • Eat healthy, include fruits and vegetables, and limit salt, sugar, and alcohol.
  • Participate in at least 2.5 hours of physical activity every week.
  • Quit smoking, for more information go here.
  • Reduce stress, try meditation or yoga.
  • Get regular checkups and preventative tests and screenings.
  • Know the signs and get help:
    • Heart attack: chest pain, weakness, pain in the arm/shoulder or neck/back, shortness of breath
    • Depression: sadness, grumpiness, hopelessness, fatigue, thoughts of suicide

Friday June, 15th is “Wear Blue Day” as a reminder of the importance of men’s health, but any day can be designated for group awareness building activities. Wear something blue to show your support, plan events, or create a fundraiser.   

Although the month of June is dedicated to men’s health, its message is important for the whole year. Join us in learning more about men’s health this month by going here  for more information.

Thanks for tuning in to Hart’s Healthy Tips!

May is Global Employee Health and Fitness Month

Whether you punch a time clock or work from home, your health is important to your workplace productivity and happiness. May is Global Employee Health and Fitness Awareness Month (GEHFM).  According to the GEHFM and Health.gov, the goal of this month’s awareness program is to “to promote the benefits of a healthy lifestyle to employers and their employees through worksite health promotion activities and environments”.  Throughout this month there are programs designed to help employers and employees improve their health.

The success of these programs depends on the support and dedication that comes from the employers and executive leaders. According to Health.gov, when executive leadership creates a culture of physical activity, employees are more likely to participate in wellness programs, and become more active. The National Coalition for Promoting Physical Activity (NCPPA) has developed a CEO pledge for executive leaders to utilize as an effort to establish a culture of health and wellness.

Benefits of the CEO Pledge are:

  • Employees will be healthier
  • Employees will be happier and more engaged
  • The organization will increase productivity
  • The organization will be better positioned to recruit and retain top talent
  • The organization will be publicly recognized as a forward-thinking employer and thought leader

The pledge calls for CEOs to implement at least six strategies that fall within three categories. These categories consist of policies that address behavioral, educational, and environmental/policy support.

  • Behavioral Support
    • “Healthy meetings” which involve walking, stretching, or other physical activity during the meeting
    • Inspirational programs such as recognition/rewards and individual or team competitions
    • Buddy systems
    • Sponsored walk/run events
  • Educational Support
    • Provide information
    • Invite speakers
    • Promote benefits of getting up and moving often
  • Environmental/Policy Support
    • Provide fitness classes onsite
    • Offer reimbursement/incentives for exercise expenses
    • Bike share discounts
    • Longer break time
    • Provide areas that support physical activity, such as showers, bike racks, clean and safe stairways, onsite fitness areas, walking paths, and “active office” furniture.
    • Allow work out friendly attire
    • Brief activity breaks

Once an organization’s health and wellness goals are established, there are great desk and office stretching exercises and activities that can help promote a healthy workplace.  Standing desks are becoming more popular in the workplace. This desk allows either sitting or standing to work at a computer or flat surface. Sitting for long periods of time without standing, stretching, or moving is unhealthy and contributes to a sedentary lifestyle.

Long hours of sitting are linked with a higher risk of:

  • Obesity
  • Diabetes
  • Cardiovascular disease
  • Cancer
  • Premature death

There are many benefits to a standing desk:

  • Comfort: standing can alleviate pressure on back, neck, and legs
  • Improved focus
  • Collaboration: it is easier for two people to view the computer
  • Versatility: divide time between standing and sitting

Whether you are an employer or an employee, it is important to have a happy, healthy work environment. Encourage executives and co-workers to implement and utilize physical activity and wellness programs in your workplace. May is the time to start during Global Employee Health and Fitness Month.  

CLINICAL QUALITY ANNOUNCEMENT: DAN BECK IS PROMOTED TO DIRECTOR OF CLINICAL QUALITY

HCC Staff update

We are very excited to announce the creation of the Director of Clinical Quality Assurance (CQA) position here at HCC and the promotion of Mr. Dan Beck into that role.  Jim Hart, President and CEO of HCC, says this of the expansion,” I am very excited to have Dan lead HCC’s Clinical Quality team.   Dan has an impressive resume of study monitoring and auditing that supports his understanding of industry regulations and compliance.   Along with this expertise, he possesses exceptional interpersonal and communication skills, which are critical to implementation and execution of quality methods and operations.”

Dan joined HCC in 2016 after serving in clinical director roles for three different medical device companies, including Advanced Stent Technologies, Inc. Thoratec Corporation, and KeraVision, Inc. Early in his career Dan worked as a CVT technician in the cardiovascular lab at St. John’s Regional Health Center in Springfield, MO.  In addition to his clinical and clinical research background, Dan brings experience from multi-functional areas of regulatory, manufacturing, R & D, and quality assurance.

This newly created position will encompass oversight of HCC’s clinical quality management system and will bring added resources to the already effective HCC Clinical Quality team.  The Director will work hand-in-hand with HCC colleagues to support clinical quality across all service areas. Per ICH-GCP E6(R2), clinical quality assurance must be an integral part of any clinical project; the Director of CQA position aligns with the current landscape to ensure that quality assurance and control provisions are paramount for HCC clients’ clinical projects.

Mr. Beck said this about the expansion of clinical quality at HCC, “I am personally excited about this role because it provides me with an opportunity to enhance the quality services of an already high-quality team, where I can apply nearly three decades of clinical research experience to a growing, dynamic company. As part of the wider HCC team, it is rewarding to contribute to the delivery of clinical quality assurance to our clients”.

 HCC’s goal is to provide the highest level of service to our clients – based on HCC people – supported by HCC systems. We at HCC strive to sustain peace-of-mind for our customers in their decision to join with Hart Clinical Consultants. Peace-of-mind knowing they can consistently expect, and receive, high-level performance with high quality assurance…

…across all pillars of service.

We are blessed to have Dan as part of our HCC family. Please help us congratulate him on his new role as Director of CQA.

STAFF SPOTLIGHT: BEN DOWN UNDER

Staff Spotlight:  Ben Down Under

By Ben Blaylock

All photos copyrighted Ben Blaylock, © 2017 Ben Blaylock.

On December 9, 2017, I left San Antonio, Texas, for a work trip to New Zealand.  Once the work was done, I tagged an additional 10 days on to my trip, rented a car, and set out on an adventure. Over those 10 days, I drove 3088 km, or 1918 miles exploring the North and South islands. That’s 200 miles further than San Antonio to San Francisco!!  This country has some of the most breathtaking scenery in the world… it was a truly memorable experience I won’t soon forget.

New Zealand

My formal destination was Tauranga, NZ, where I was set to monitor data for one of the trials we are working on at HCC. 

It took two days to get there–all in all close to 30 hours of travel time.  After a one-night layover in Brisbane, AU on December 10th, I arrived in Auckland, NZ on the afternoon of Monday, Dec 11th. It was then another 2.5hr drive from Auckland to Tauranga.

I worked from Tuesday through Thursday, Dec 12-14th, and had from Dec 15 – 24th of personal time to get out and explore.  Most of the trip was spent in NZ (10 days, Dec 11 – 21).   Our winter is their summer, so long daylight hours meant I could get out and explore after work until about 9 pm or so when the sun went down, so even though I had to work the first 3 days, there was plenty to explore in and around Tauranga until I was officially done with work on the afternoon of Thursday, Dec 14th.

I did a sea kayaking trip to Cathedral Cove, NZ.  They say it’s the most photographed spot in New Zealand and is the shooting location of the Prince Caspian Narnia movie.

Visited the Hobbiton movie set in Waikato NZ, filming location for the Lord of the Rings film trilogy and The Hobbit film series.  The Shire was truly spectacular. It’s like walking into Middle Earth… they have over 14 acres dedicated to the movie set alone, with 40 hobbit houses, each unique, meticulously decorated, and designed to reflect life and personality of the hobbit that lives there. So much detail…… just like out of the movies.

Went spelunking in the Waitomo caves in Waitomo, NZ, which is about 2 hours southwest of Tauranga,

One of my travel days was 17 hours long, which surprisingly, was one of the highlights of the trip.  On this particular day, I woke up at 4 am in Wellington, NZ and took a 3-hour car ferry across the Cook Strait from the North to the South Island to Picton, NZ.  From there I drove 10 hours southwest to Mount Cook, the tallest point in New Zealand. On the way, I saw beautiful flora. These are Lupine beside a creek near Mount Cook, NZ.

Mount Cook and Tasman Lake, nestled in the Southern Alps

Mount Cook is an international dark-sky reserve and has some of the darkest skies on the planet… and I had an observatory tour and time with the telescope booked that night.  Before making the drive, I learned they had canceled the night sky tour the last 5 nights in a row because of cloudy weather. They couldn’t make any promises that the tour would happen that night, but I had to try… Turns out it was a beautiful, clear night, the tour was on, and the sky was spectacular!!  Even with a few clouds, you could see the stars right through them, the sky is so dark there. Here’s some of what I saw through the telescope:

  • Seven Sisters (Pleiades) open star cluster
  • Five diamonds – star cluster. Had a couple of Red giants! 
  • Orion Nebula – beautiful! No clouds over Orion, very clear and sharp
  • 47 Tucanae – oldest star system – 11 billion years old – through a telescope just a  cluster. So beautiful!!
  • Small Magellanic cloud- 200 million light years away
  • Large Magellanic Cloud – 160 million light years. 3rd closest galaxy to the Milky Way. It contains tarantula nebula, we looked at it through the telescope 
  • and of course: the Geminid meteor shower!! It was mostly over, but because it was so dark there, I saw a good dozen or so shooting stars over Gemini… so bright!! No telescope needed.

Such a rare treat to see a part of the sky we just don’t see on this side of the world…. The southern cross wasn’t visible through the telescope, but I stayed up late until it crested just above the mountains about 1 am… and with the sky so bright, it was a sight to see.  

Australia

It’s not often I’m on this side of the planet, so the last three days of my trip I took the opportunity to visit Cairns, Australia and check off a bucket list item: dive the Great Barrier Reef.  It was my first dive ever, and I’m sure I’ve spoiled diving forever.  The water was crystal blue, the coral was alive and vibrant, and the sea creatures bigger than life.  Well worth the trip!

Found Nemo

School of Bumphead Parrotfish.  Each of these massive fish was about the size of a small human

I ended my trip in Sydney, Australia for one last look at the Southern sky 

Sunset from the Sydney Observatory

One of the biggest challenges driving in New Zealand was roundabouts! Just when I got comfortable driving on the left side of the road, I’d come to one, and usually got the horn from other drivers, or have to jam on my brakes to avoid a catastrophe. That definitely kept me alert and on my toes!  

The odd thing about driving on the left side of the road, though, was that for the first few days, I had to keep telling myself over and over, “Keep left, keep left, keep left.” There was even a big sticker on the dash that said those words in big bold red letters, which helped.  But after a week or so, driving on the left started to really make sense… we read from left to right, right?  When we’re scanning the horizon, our eyes naturally start on the left… so driving on the left started to really make sense.  So much so that when I got home, driving on the right felt weird, unnatural even. Thankfully, I quickly adapted back to driving on the right, but I still think about that sometimes and how we may be the ones who are driving on the “wrong” side of the road….

Tips for travelers

CRA work provides an amazing opportunity to get out and see the world. Even when I take trips in the US, I always try to make time to leave the hotel room and see what’s around.  Sometimes that means arriving earlier in the day or staying an extra day to see some sights.  

Tip #1: Stay at hostels when extending a work trip or traveling for fun. They’re usually situated right in the action, within walking distance to major sights and activity, bus/rail lines, etc.  Many hostels are in older historic buildings as well, with a great history.  Hostels are also much better than hotels for getting the low-down on walking tours in your area, sights to see, talking to fellow travelers, etc.  In addition to shared rooms for really cheap, most hostels have private rooms available as well, for much cheaper than a hotel.

Tip #2: For extended trips, mail your souvenirs or gifts home, rather than lugging them around your entire trip.  It’s a great way to lighten your load–and make room for more stuff!

I’m so excited and grateful for the chance to explore Australia and New Zealand and that my role with HCC provides diverse opportunities around the world. 

As always, thanks for tuning into the HCC blog!! 

 

ESSENTIAL DOCUMENTS DEEP DIVE: MONITORING REPORTS

Essential documents Deep Dive:  Monitoring Reports

Hart’s Good Clinical Practice glossary series

Welcome back to the Hart GCP knowledge series. We have been reviewing essential documents that are typically generated before the clinical phase of the trial begins. We have looked specifically at the Investigator brochure,  clinical protocol/protocol amendments, informed consent tracking,  advertisements, and agreements.  Now we will look at some key documents required once a clinical trial begins. Our first installment in this phase will be on monitoring reports.

To learn more about the monitoring process go here.  The Good Clinical Practice (GCP)  guideline, ICH E6 R2, defines a monitoring report as “A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs”.

The monitoring report should document a study’s progress and compliance with GCP guidelines, and should record any problems at the site, including both minor and major items.  Minor findings may be documents with errors or that need to be filed in the study trial file, while major findings could include findings related to safety or informed consent. In either case, the report documents the initial finding and tracks resolution of each finding.

The written monitoring report should be submitted to the sponsor after each trial site visit and should include, at a minimum:

  • Date of visit
  • Name of monitor
  • Name of the site and investigator or other personnel
  • A summary of what was reviewed, including statements regarding:
    • significant findings/facts
    • deviations/deficiencies
    • conclusions
    • actions taken or recommended to be taken

A sponsor representative should review and follow-up with any outstanding actions documented in the report, and reports should be signed by the sponsor as final once complete.

GCP indicates that “results of monitoring activities should be documented in sufficient detail to allow verification of compliance with the monitoring plan”, which is a plan for how monitoring will be conducted and who is responsible for given monitoring tasks.  

Sufficient detail means that not only should negative findings be reported with enough detail for follow-up and resolution to occur, but also that positive compliance should be detailed. For example, patients for whom the informed consent process was completed satisfactorily should be documented as such, not left blank. Omission of such detail is not an indication of compliance, but is rather a lack of detail that should be included to adequately document compliance.

Monitoring reports are a key tool used in conducting a clinical trial. Sponsors and CROs usually have operating procedures for how monitoring should be conducted and how the reports are to be written.  Some additional sources for monitoring and reports can be found here, here, and here.

Thank you for reading HCC’s glossary series and happy monitoring to you!

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HART’S HEALTHY NEW YEAR TIPS

HART’S HEALTHY NEW YEAR TIPS

By Dana Fletcher and guest author, Jodi Fletcher

Whether you make ‘resolutions’ or not, you can still start the New Year right with a few heart-healthy lifestyle changes.  There is no better time to start making healthy lifestyle choices than right now.

Sometimes, we can feel overwhelmed by the many things we could or should do to improve our health.  To combat that, try picking just ONE thing to change and stick to it. Kirsti Dyer from Columbia College suggests that making simple, reasonable goals is one way to successfully achieve them. 

We challenge you to pick one small thing from the lists below and try to stick to it.

The National Heart, Lung, and Blood Institute suggest heart-healthy lifestyle goals should include heart-healthy eating, physical activity, stress management techniques, healthy weight goals, and quitting smoking.

Many people know they should eat better, exercise more, quit smoking, and take time to relax. But how do we start?   Let’s break it down into simple steps that are achievable by anyone.

Heart-healthy eating:

  • Eat vegetables, fruits, whole grains, low-fat dairy, lean meats, poultry, eggs, nuts, seeds, legumes, soy products. This could mean that if you eat one piece of fruit per week, try to increase that to two or switch from full-fat milk to 2% fat. Keep it simple.
  • Learn what your calorie intake should be based on your sex, age, and activity level (for more information go here).
  • Limit sodium, saturated and trans fats, added sugars, and alcohol. Try drinking a glass of water in between alcoholic beverages to limit intake and the effects of alcohol and to stay hydrated.

Physical activity:

  • Helps with lowering health risks, weight loss and stress management.
  • Consult your doctor. This is one of the first things to do if you haven’t been active previously to know if you have any limitations on your activity levels.
  • A good goal is to shoot for at least 30 minutes per day, 5 days a week. If you haven’t been doing that, start slow. Start with 2 or 3 days a week for 5 minutes and slowly build up your time and days over a period of months.  Take the stairs instead of the elevator or park farther away from the grocery store door.  Take it slow and don’t try to increase too much too soon.  Just try to be a little bit more active each week and it will make an impact.
  • Break up sitting time. If you work at a desk, set an alarm so you get up at least every 30 minutes, get up and walk around, refill your water cup, or even just stretch at your desk.  Experts say you should try to break up sitting with more active tasks.

Stress management techniques:

  • There are many classes, videos and audio meditations readily available. One easy way to start is just to sit for 1-5 minutes and focus on breathing deeply and slowly. You don’t have to sit for an hour in deep contemplation to get benefits from meditation.

  • Physical activity. Activity, especially outside is a great way to de-stress.
  • Relaxation therapy. This could include yoga, creative imagery, breathwork, massage, or many other modalities to help you relax and release stress.
  • Talk it out. Find a friend, family member, counselor, or group to talk through stressful situations.
  • Seek professional help if you can’t reduce your stress on your own.
  • For more information go here

Healthy weight goals:

  • A loss of just 3-5% of current body weight lowers triglycerides and glucose levels.
  • Consult your doctor on any weight loss plan to make sure it is safe and appropriate for you.
  • A good place to start is to review the Body Mass Index (BMI) to find out whether you need to lose weight, but remember, you can have a BMI in the normal range and still be unhealthy if you aren’t active and eating healthy.
  • Healthy eating habits, physical activity, and managing stress are key components of any healthy weight loss plan. Focus on improving those areas of your life, and achieving your weight goals will be much easier.

And of course, quit smoking. 

Most of us know that smoking increases the risk of heart disease. The AHA recommends that people seeking to stop smoking should find professional help in the form of their doctors, support groups, or other counseling services. Quitting is tough, but the first step is finding the support you need to make it happen. They also recommend:

  • Set a quit date
  • Choose your quit method
  • Decide if you will need medicine to help you quit
  • Plan your quit day
  • Do not smoke starting on your quit day
  • For more information go here and here

So, take our challenge and pick one thing to do in January to start down the path to a healthier heart!  Let us know in the comments section what you do!

Happy New Year and have a heart-healthy 2018, and beyond!

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MESSAGE FROM THE PRESIDENT: LOOKING BACK TO LOOK FORWARD

MESSAGE FROM THE PRESIDENT: LOOKING BACK TO LOOK FORWARD

Last year at this time, alongside the visions of sugarplums dancing in my head were thoughts of gratitude. As 2017 has progressed and now comes to a close, I am struck by what those visions have meant for me this year.  Marcus Lemonis, CEO of Camping World, and host of the television show, The Profit, is famous for saying that products and processes can be improved, but that:

“People are the most important thing.”

This is what I’d like to share with you today. In our business, it is truly the people that make all the difference and I am grateful for the people I work with and the relationships HCC has cultivated around the world. Our theme this year was indeed about people and relationships.

In 2017, we added staff to allow for growth of our infrastructure and improvement of our processes. Our team has infused new, fresh ideas to our business and for this, I am so very thankful.  In 2018, we hope to continue to grow and build our capabilities by relying on the talents and skills of the HCC team. By building on our strengths, we will be adding new functionalities to the services we offer.

I often see companies like ours grow at rates that are unsustainable, where growth outpaces the companies’ ability to provide high-quality services. It is our goal for 2018 to continue to grow HCC, but to grow at a deliberate pace such that we can continue to provide the highest quality service, where we continue to strive to do the right things and to do right by our team.  Or, as Ivan Chouinard, CEO of Patagonia, author of Let My People go Surfing: The Education of a Reluctant Businessman and famed climber has said, 

How you climb a mountain is more important than reaching the top.”

 

Wishing you and yours a blessed holiday season, with joy, love, and success in the coming new year

From all of us at HCC

Jim Hart