Author: Dana Fletcher

Dana Fletcher serves as Medical and Technical Writer for Hart Clinical Consultants (HCC), providing technical content for HCC’s online presence. With more than 20 years’ experience in medical research in corporate and academic environments, and extensive experience with medical devices in cardiology, vascular surgery, infectious disease, and transfusion medicine, as well as experience with therapeutic integrative medicine modalities, Ms. Fletcher brings exceptional expertise and valuable insight to her writing for HCC.

In the past, Ms. Fletcher was Clinical Affairs Manager for Terumo BCT, where she managed all aspects of US clinical trial operations for new technologies in pathogen reduction of transfusion products. Before Terumo BCT, Ms. Fletcher worked for Abbott Vascular as Senior Clinical Research Associate for the Vessel Closure program, and led a team as Clinical Project Manager for the Carotid Stent and Embolic Protection program.

Before joining Abbott Vascular, Ms. Fletcher held several positions with Ischemia Technologies in Arvada, Colorado, including Manager of Clinical Development, Technical Services Specialist, and Clinical Affairs Associate. Early in her career, she was a Patent Investigator and Laboratory Research Associate with Biostar, Inc., in Boulder, Colorado, which specialized in point of care in vitro diagnostics for infectious disease testing. Ms. Fletcher is the owner of Evida Clinical Consulting, an independent consulting firm primarily engaged in medical and regulatory writing, data analysis, and project management.

Ms. Fletcher holds a Master of Arts degree in Biology (Cell Immunology focus) from the University of Colorado at Denver and a Bachelor of Science degree in Biology from The Pennsylvania State University. She is currently working on her Doctorate degree in Health Services Research in the Colorado School of Public Health at the Anschutz Medical Campus in Denver, Colorado, with an expected graduation date in 2018.

Dana Fletcher's Contributions



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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.

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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STAFF SPOTLIGHT – PATTI LAWRENCE IS PROMOTED TO SENIOR CRA

STAFF SPOTLIGHT 

PATTI LAWRENCE IS PROMOTED TO SENIOR CRA

Four years ago, a voice from Patti Lawrence’s past called her cellphone. Jim Hart, Chief Executive Officer of Hart Clinical Consultants, needed someone with clinical experience working in a cardiac cath lab. From that one phone call, Patti began a new phase in her professional career as a Clinical Research Associate, initially filling device proctoring roles, but diligently training as a clinical monitor. For the difference between the two roles, click here.

Since those days in 2013, Patti has worked on nine medical device trials with HCC, as both proctor and monitor. When she first joined HCC, she had very little monitoring experience, so she read everything she could about it while she was mentored by Jim and Stan Reaves, HCC’s Chief Operating Officer. Certification as a Clinical Research Professional (CRP) requires a minimum of two years’ experience in the field. In October of this year, Patti took and passed the SOCRA CRP certification exam.

Please help us congratulate Patti on her earning the CCRP certification and on her recent promotion to Senior Clinical Research Associate. 

Patti’s continued commitment and contributions to HCC, shine through her with her obvious love for her work. According to Stan Reaves, among her many accolades is a vast knowledge of cardiac and vascular anatomy and physiology. This knowledge and many years in the cath lab translates to client appreciation for her ability to teach difficult topics with simplicity, great analogies, and examples that lead to a thorough understanding by the learner. Stan provided this story that exemplifies Patti’s contribution to HCC, “Patti saw a need for education of team members for a stroke intervention trial and put together a presentation to teach the folks working on the project. She has also recently taken on the lead role for a seminal peripheral vascular device study, for which she has developed a strategy for training 40 study sites as part of her responsibility for coordinating site coverage.” A can-do attitude, perseverance, and an aptitude for adapting to most personality profiles enables Patti to develop strong working relationships with even the most demanding individuals for the long game.

Medical Device Executive Eric Knuteson had this to say about working with Patti to support clinical trials at Osprey Medical (Minnetonka, MN), “She exemplifies professionalism beyond reproach and is a calm pro who is able to navigate any customer situation with intuitive approaches to details and challenging requirements. She sacrifices her personal schedule to meet any clinical last-minute need, like booking last-minute travel on a Sunday afternoon.”

Patti says she could not be happier than she is right now working for HCC. “I truly enjoy working with and meeting new people” she says of the job, and enjoys the travel associated with it.  She is planning to use some of the travel perks she’s been collecting to go experience the Aurora Borealis up close by standing underneath, listening to the hissing and crackling of this natural phenomenon.

We are blessed to have Patti as part of our HCC family. Thank you, Patti, for being a key player and for your continued commitment to excellence in all you do!

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HART HEALTHY TIPS: THE GREAT AMERICAN SMOKEOUT

HART HEALTHY TIPS:

THE GREAT AMERICAN SMOKEOUT

Save the date Thursday, November 16th! The American Cancer Society holds a very important event that day, which can be the first day towards quitting smoking for many people.

It’s The Great American Smokeout!

According to the Centers for Disease Control and Prevention, approximately 36.5 million Americans (15.1% of all adults) smoke cigarettes. Smoking causes several life-threatening diseases such as cancer, stroke, lung and heart diseases, diabetes, emphysema, and chronic bronchitis. Over 16 million Americans have diseases caused by smoking. In the United States alone, cigarette smoking causes more than 480,000 deaths per year. The financial costs of smoking are significant with a $300 billion price tag in the United States, and direct medical costs of over $170 billion. Despite these costs, quitting can be difficult.

Many smokers want to quit, but don’t know where to start. According to a government study nearly 70% of adult smokers want to quit, but only 6 % could stop smoking. Withdrawal symptoms such as irritability, anxiety, having trouble focusing, feeling angry, cravings for tobacco products, and weight gain can make it hard to stick to a plan.  If a smoker can make it through these symptoms, the health implications are significant.

                                                                                                   *2015 Centers For Disease Control and Prevention

Health benefits begin within 20 minutes of quitting by lowering heart rate and blood pressure. After 1 year the risk of coronary heart disease is cut in half and after 5 years the risk of stroke is reduced to that of a nonsmoker. The risk of coronary heart disease returns to that of a nonsmoker 15 years after quitting. The sooner a person quits the better, too. Quitting at age 30 can add approximately 10 years of life expectancy compared to waiting until age 60 to quit, which only adds 3 years. A good plan can help reach goals of quitting.

The Great American Smokeout event is dedicated to increasing awareness of the importance of quitting and urges smokers to not only to quit for the day, but to make a plan to quit for good.  

Steps to a good plan for quitting:

  • Make the decision to quit
  • Pick a quit date and mark it on the calendar
  • Inform friends and family for support
  • Purge all cigarettes
  • Practice saying, “No thank you, I don’t smoke.”
  • Review support options such as nicotine replacement therapy, prescription drugs, support programs, acupuncture, herbal supplements, and mind-body practices

On your quit day, be sure to not smoke at all. Staying busy will help keep urges away. Be sure to drink plenty of water, start any nicotine replacement therapy chosen, and avoid situations where smoking is prevalent. If the urge to smoke arises, use the 4 D’s to help fight the urge: delay, deep breathe, drink water, and do something else.

So, take the challenge to invite a smoker in your life to the save the date, Thursday, November 16th, the first day to life without smoking.           

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HCC NEWS: THE VERMONT CARDIAC NETWORK CONFERENCE

HCC NEWS: THE VERMONT CARDIAC NETWORK CONFERENCE

On September 28, 2017, HCC staff members Cheryl Calhoun and Stan Reaves attended the Vermont Cardiac Network (VCN) Conference held in picturesque Woodstock, Vermont. VCN was established in 1984 to assure cardiac health status of Vermonters and other nearby residents. It is a group of physicians and nurses committed to providing quality educational programs in cardiac care and networking for the healthcare communities within Vermont and western New Hampshire.  More information can be found about the organization here.  VCN holds three conferences each year and this year approximately 100 people attended this Fall conference.

Stan Reaves presented “Late-Breaking Cardiac Clinical Trials Update” to the group. Stan presented introductory materials on the evolution of clinical trials, emphasizing the key elements of patient safety, informed consent, and ethics.  By illustrating mistakes made in the past, he drove home the message of safety and ethics; capitalizing on the importance of patient advocacy in all that we do.  Stan also reviewed recent drug and device clinical trials relative to cardiac care with the premise of using clinical trials to “build a better pump, better pipes, or better valves”.

Stan’s presentation was well-received by the group, garnering positive comments on the evaluation form, such as:

As a result of this presentation, …

  • I will look into nursing research as a career; better understanding of symptom control, and when to make referrals.
  • I will be more careful to spend extra time with patients describing procedures to ensure they make informed decisions, i.e., consents. 
  • I will better walk patients through explanation of the informed consent process.

Other presentations included:

“Sleep Disorders and the Impact on the Heart” by David Alsobrook, MD (North Country Hospital, Newport VT), which addressed the normal sleep cycle, where in the cycle certain sleep disorders interfere, and the structural changes that occur in the heart and circulatory system as a result of prolonged periods of increased intrathoracic pressures and hypoxia.

“The Structural Heart Journey-Learning to walk, to running the Marathon” by Faye Straight RN, BSN CRCC (University of Vermont Medical Center, Burlington VT), which presented the evolution of the Structural Heart Program at UVMC, from their start with the Medtronic CoreValve Evolut R trial for high risk (high STS scores) aortic stenosis subjects to their current program on target to treat 200 patients with severe aortic stenosis by Transcatheter Aortic Valve replacement (TAVR) this year.

Hats off to VCN for their fabulous work for the people of Vermont and New Hampshire!  Check them out here.

Many thanks to Chery, who has served on VCN’s Board of Directors since 2012, and who provided excellent feedback on the conference for this post, and to Stan Reaves who gave an engaging and informative talk at this year’s Fall VCN Conference.

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Vulnerable Populations: who are they?

Vulnerable Populations: who are they?

This is the fourth in a series of articles about medical ethics.  Our previous posts in this series included the basics of medical ethics, the difference between utilitarianism and deontology, and the Belmont Report.

Today we will review vulnerable populations.  The idea of vulnerable populations falls under the ethical construct of respect for persons.  Remember that this principle is about autonomy, where an autonomous individual is capable of making decisions about their personal goals and beliefs. In research, this means that participants of research voluntarily agree to participate and have enough information provided to them for them to make that decision reasonably. Individuals who lack this capacity, either fully or partially, are considered vulnerable because they may not have the maturity or capacity to make an informed decision.

 

Vulnerable groups include children, the poor, elderly people, homeless, the mentally ill, and racial or ethnic minorities. It can also include the uninsured or uneducated. In the case of prisoners, soldiers, or other institutionalized individuals, they may be under the influence of subtle coercion or undue influence.  Vulnerabilities may be classified as physical, psychological, or social according to the American Journal of Managed Care.

The FDA regulates clinical research in certain vulnerable groups specifically.  Children, prisoners, pregnant women, mentally or physically handicapped or disabled persons, and economically or educationally disadvantaged persons are specifically addressed in the US Code of Federal Regulations Title 21, Part 56.111, Criteria for IRB approval of research, and under Health and Human Services regulations, Title 45, Part 46.201, Subpart B—Protections for pregnant women, human fetuses, and neonates involved in research, Subpart C—Protections pertaining to biomedical and behavioral research involving prisoners, and Subpart D—Protections for children involved in research.

With approximately 1% of US residents incarcerated as of 2013, the issue of research ethics in this population is an important one. A 2002 report indicated that despite the requirements of  45 CFR 46, Subpart C that curtails most research on prisoners, the majority of this type of research occurs outside the purview of federal regulations and without review or approval by an IRB. Little research is conducted in prisons as medical clinical trials or biomedical studies, however, most studies were social, behavioral, program evaluations, or record review in nature.

Using prisoners as an example, we’d like to remind you that the number of vulnerable individuals is growing in the US. The issues surrounding medical care, and specifically research in these populations continue to challenge bioethicists and clinical researchers. So, continue to ask questions during protocol and informed consent development, while consenting potential participants, and while reviewing medical records to be aware of patients who may fit a vulnerable description.

Thank you for tuning into HCC’s ethics series.

Essential documents Deep Dive: Agreements

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,  and the use of advertisements.  Today we will be reviewing financial documents and insurance required prior to beginning a clinical trial.

The Good Clinical Practice (GCP)  guideline, ICH E6 R2, doesn’t go into great detail regarding how financial agreement should be arranged, but it does state that it should be addressed.  The guideline states that financial aspects of a trial should be documented in an agreement between the sponsor and the investigator or institution (page 19), and defines a contract as a “written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters” (page 3).

Many research institutions have checklists for what should be included in a contract between a study sponsor and the institution.  Things that may be required to address in your agreements yet may be overlooked include:

  • Agreement that procedures will be used to protect research participants
  • Dissemination of findings—roles that investigators and sponsors will play in publications, presentations, or other disclosure of results to the medical community, regulatory bodies, and patients
  • Responsibility for medical care for research-related injuries
  • Agreements for sponsor reporting of safety issues to the institution
  • Handling of intellectual property
  • Indemnification or insurance

If required by the applicable regulatory requirements, the sponsor should provide insurance or should indemnify the investigator or institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence (page25). In years past, it was virtually unheard of for sponsors in the United States to be required to purchase this type of insurance for U.S. -located studies. However, in recent years, the trend is growing for large institutions to require such a policy.

Generally, it is good business practice to have written agreements for each area that could be of value to the parties, such as intellectual property, for each area of potential liability, such as payments for research-related injuries, and for potential areas of disagreement, like dissemination of information.  It is no different for a clinical trial and the ICH E6 R2 GCP guidelines speak to the importance of having these documents in place without dictating exactly how they should be implemented.

Thank you for reading HCC’s glossary series!

Hart Health Hints for September 2017: Atrial Fibrillation

This installment of Hart Health Hints celebrates a year of this blog series that aims to inform our viewers about some important health tips. We especially love finding out about events in our communities that help bring awareness to health problems that our friends, our families, or ourselves may have. 

In our industry, we are experts in technical details of the disease processes and cutting-edge treatment solutions, but sometimes we are not as involved in community health, and know much less about the opportunities available to educate ourselves and our loved ones about various conditions.

This month we are highlighting National Atrial Fibrillation Awareness Month, sponsored by the American Foundation for Women’s Health.

Many people in our communities may ask, “What is A-FIB?”  Atrial fibrillation, or A-fib, is a condition where the heart beats irregularly. This condition is very common, but often little is known about it.  If left untreated, it can lead to dementia, heart failure, stroke, and death.  StopAfib.org is an advocacy organization dedicated to raising awareness around A-fib, and describes the condition in detail, provides links for A-fib resources and treatment information, and fosters communication among the A-fib community.

So, even if you don’t know anyone with atrial fibrillation, we encourage you to take a few moments this September to learn more about the resources available in your community for people wanting to learn about this interesting, and often ignored condition.  Try looking here and here for more information.

                                                                                                                       Pic courtesy of knowthrombosisday.org

Have a great September, and keep learning!