Monthly Archives : February 2017

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Hart Healthy Challenge continued: happy eating

Hart Healthy Challenge continued: happy eating

We are just about three-quarters of the way through our Hart Healthy Month and wanted to share some of our activities with you! 

Along with our physical activity goals, our team is engaging in nutritional goals as well. Here is a sampling of those goals:

  • Reducing food intake by 25%
  • Eating more veggies
  • Eating less junk food
  • Reducing sugars and caffeine
  • Drinking more water
  • Eating dinner earlier

Some additional tips for healthy eating come from the American Heart Association webpage for Happy, Healthy Eating for Kids, which applies to kids of ALL AGES!

Eat the Rainbow – try to get as many different colored vegetables and fruits as you can in each meal.  Make it fun for you and your family!

Choose fruits and vegetables instead of French fries in the cafeteria and at restaurants.

Stay hydrated with water so you aren’t tempted to eat to satisfy your thirst.

Our team is also putting together an e-book of our favorite healthy recipes.  Yummy options like this Green Soup with Yams and Sage  from EatingWell and others abound! Check out these links as well for tasty and healthy options:  allrecipes and foodnetwork

Stay tuned for the results of Hart Healthy Month early in March!  In the meantime, stay active and make incremental changes to improve your heart health!

Hart Clinical Consultants Contact page

Essential documents Deep Dive: Advertisements Hart’s Good Clinical Practice glossary series

Essential documents Deep Dive:  Advertisements

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  and clinical protocol/protocol amendments and informed consent tracking in this portion of our glossary series.

The Good Clinical Practice (GCP)  guideline states that an advertisement in a clinical trial is used for subject recruitment. These documents must be reviewed by the IRB/EC and filed in the Investigator’s portion of the trial master files.  Thorough review and documentation of these files is required “to document that recruitment measures are appropriate and not coercive.”

Another guidance from FDA regarding recruiting study subjects provides direction on direct media advertising of potential research participants as well as receptionist scripts. Direct advertising is any form of communication that is intended to be “seen or heard by prospective subjects” for soliciting their participation in a study. As long as these materials are accurate and are not coercive, this type of recruitment is not objectionable.  Advertisements include things like flyers, posters, and bulletin board postings, but also may include newspaper, radio, or television ads.  Recruitment materials for health professionals, like “dear doctor” letters or articles intended for the general public, like news stories, do not fall under the description of study recruitment “advertisements”. 

Any communication with a prospective study participant is required to be reviewed by an IRB in order to confirm that the wording does not unduly influence the individual. Undue influence can include leading the subject to believe they will be receiving a newly approved drug, by using words like “new treatment” instead of “investigational treatment” or by making promises of “free medical treatment”, when the actual scenario is that the subject won’t be charged to participate in the study. Another regulatory no-no is to make any claim about the investigative product, either implicitly or explicitly, that the treatment is safe or effective for the purposes used in the study or that it is the same or better than any other treatment.

Generally, an advertisement should contain the following types of information:

  • Name and address of the clinical investigator and of the research site
  • Purpose of the research
  • Study eligibility criteria
  • Benefits of participation
  • Commitment required of the subject
  • Location of the research
  • Who to contact

This guidance provides general information on internet advertisements, but we will address the use of social media in clinical trials in an upcoming post (stay tuned!). Until then, look here for some tips on social media in clinical studies.

Thank you for reading HCC’s glossary series! Next time we will continue to examine key essential documents by looking at insurance requirements for a trial in the US.

Hart Clinical Consultants Contact page

Essential documents Deep Dive: informed consent tracking Hart’s Good Clinical Practice glossary series

Essential documents Deep Dive: informed consent tracking 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 and clinical protocol/protocol amendments in this portion of our glossary series.

 

Image courtesy of fda.com

Informed consent is a broad subject and we will be covering the why, what, and how of the informed consent process in future posts of our medical ethics series (additional ethics topics here and here). Today’s glossary post is about managing the informed consent document as an essential document in the trial master file (TMF).

A full history of the life of a study informed consent should be available in the TMF.  This means at a minimum, for each IRB/EC approved informed consent, the TMF should contain:

  • The version that was submitted to the site coordinator, with his or her changes tracked,
  • The version submitted to the IRB, and all submission documentation,
  • Any versions that went back and forth with the IRB/EC, with tracked changes and all correspondence between the IRB/EC and site during that process,
  • IRB/EC approval documents with the stamped and approved version of the consent, and all correspondence related to that approval.

Every change to an informed consent version should have a unique identifying name and date of revision, whether it is a draft prior to submission to the IRB/EC or during their review, or if it is a stamped and approved versions that can be used to consent patients into a trial.

The more organized and better labeled your informed consent files are, the easier it will be to find pieces of documentation in the future when an auditor is asking for them! 

Thank you for reading HCC’s glossary series! Next time we will continue to examine key essential documents by looking at advertisements used during a trial.

Hart Clinical Consultants Contact page

Hart Healthy Challenge: A tradition of caring.

Hart Healthy Challenge: A tradition of caring.

Heart disease has been the leading cause of death in the US and worldwide for several decades. In the past few years, the burden has slightly decreased, but it remains a health problem that policy makers, providers, and patients are working to prevent.

Luckily, it is also one of the most preventable diseases.  To improve awareness and education about heart disease, February has traditionally been Heart Health Month, and 2017 is no exception.

Healthfinder.gov suggests a few things to help us all raise awareness about preventing heart disease. One of those ideas is to encourage family members to make small changes in their lives, like using spices to season their food instead of salt or parking at the far end of the grocery parking lot to get a little bit more walking in during your day.

To that end, here at HCC, we are kicking off HART Healthy Month for our staff.  Each year, in honor of our healthy hearts, we encourage our team members to make changes in their eating and activity behaviors by sponsoring friendly competition during February.  Via this competition, we take steps (both literally and figuratively!) to improve our own health and strive to improve the lives of others by donating to an organization in the community. See here, here, and here for information about what we did in 2016’s HART Healthy Month and here and here for how we gave back to our communities last year.

This year, 2017, we will be having a weighted lottery competition, where team members can get bonus tickets entered into the lottery by completing a variety of food and exercise related activities aimed at helping us make incremental changes to our lifestyles.  The month will culminate with two lottery winners receiving a $250 fitness toolkit customized to each winner,  commemorative HCC schwag in the form of a workout t-shirt, and a group donation of $1500 to a charity, which we will choose by voting during the month.

If you see our HCC staff this month, ask them about what they are doing for Hart Healthy Month and consider joining them for a quick jaunt outside and be heart healthy together!!

Hart Clinical Consultants Contact page