Frequently Asked Questions

ValidCare National CBD Clinical Study

 

Who is conducting the study?

ValidCare, the leader in CBD safety research studies, on behalf of many of the leading national CBD brands in the USA.


How do I know if I’ve been accepted into the study?

After enrolling for the ValidCare Study app and joining the study, you will be asked a number of questions to determine your eligibility for the study. If eligible, you will be notified immediately within the app.


How do I download and register for the app I’ll need to record my CBD experiences?

Click on the link included on your invitation email for either your iOS or Android device, or simply visit your app store and search for “ValidCare Study.”


When will I receive the product I’ll be using?

You will select your product after completing your medical history. Sponsor brands will ship your product within 24-48 hours. The app will ask you daily to confirm when you receive your product in order to kick off the study.


What kind of product will I be using? Will it be psychoactive?

All products will be consumed orally (Tincture, edible etc.) and have been selected by the participating brands. You will be prompted to select your one product from your sponsor brand after you have been approved for the study and completed the registration process. Hemp derived CBD contains <.03% THC and is not psychoactive. All products will have a Certificate of Analysis (CoA) available for review.


How often do I take the surveys in the app and for how long?

You will take surveys daily for approximately 5 weeks. Most days, there is only one question.


How do I know when and where to get a blood test?

You will be asked to schedule your blood test after 3 weeks of recording your product use. You will receive an email with a requisition for your blood draw, as well as a link to schedule your blood test. Instructions will also appear in the RESOURCES section of the app. You will be able to select a local lab and schedule a time at your convenience.


Who pays for the blood test?

ValidCare will provide you with a voucher for the blood test. There is no cost for you.


What exactly are you looking for in the blood sample?

Scientists will be looking at any effects of CBD on blood outcomes, particularly those that affect the liver and testosterone in males.


What if something negative is found in my blood sample?

If any irregularities are found, the doctor associated with your selected blood lab will review the results and follow up with you directly. The study Principal Investigator will be notified as well and will contact you directly if deemed necessary. You may be  asked to answer additional questions through the app and schedule and go to the laboratory to complete an additional blood draw.


What will happen to my blood test results?

All data and records generated during this study will be kept confidential in accordance with HIPAA privacy and the Investigator and other personnel will not use such data and records for any purpose other than conducting the study. Your results will be blinded and made available to the Principal Investigator conducting the study via a HIPAA compliant secure portal. Your name will not be associated with your final results in the study submission and write up. Your results will be combined with those of the 700+ other participants, shared with the FDA, and published in peer-reviewed national medical journals.


What if I am unable or unwilling to complete the study?

You may voluntarily terminate participation at any time during the study. The Principal Investigator may terminate your involvement as well after enrollment based on any reasonable criteria (including but not limited to the Investigator’s concern for your safety, truthfulness, etc).


How will I know that I have successfully completed the study and earned the $100?

You will have successfully completed the study so long as you have your use of oral CBD products for a minimum of 20 of the 30 days over the observational period AND provided a serum sample at a designated laboratory for testing of liver function within 3 days of completion of the thirty (30) day journaling period.

If you have to be contacted for more information after initial analysis you will be paid an additional $25 after the additional desired information is obtained via the app or by study personnel.

If you are asked to and in fact complete a second blood draw, you will be paid another $50.


What are the risks of taking CBD?

CBD may cause minor side effects including: drowsiness, headache, dry mouth, low blood pressure, and light-headedness.  Rarely, CBD may cause an allergic reaction.  High doses of CBD may interact with drugs taken for epilepsy or other drugs and cause elevations of liver function tests.


Why can’t I participate if I have to have my blood drawn in NY/NJ/RI?

The states of  NY, NJ or RI have different regulations for blood labs on their ability to accept orders for blood samples remotely. If you are a residents of these states, you will need to go to a neighboring state in order to participate.