If you are concerned that the clinicalRSVP database does not accurately reflect your participation in research studies, you may request that the research site provide you with an accuracy validation form. Once you have obtained this form, you can contact us to resolve the discrepancy.
Helpful Information about clinicalRSVP and the
rights and safety of Research Participants
If you are a volunteer looking to participate in a clinical trial at a site
using clinicalRSVP, it is important that you understand how the clinicalRSVP
database works to protect your rights, safety, and privacy, as well as the
health and safety of the general population. Below are some questions and
answers to help keep you informed. We thank you for the contributions you
make by volunteering to participate in clinical trials, and for working with us
to improve the overall quality of research. Please don’t hesitate to contact us
if you have additional questions.
What is the purpose of clinicalRSVP?
clinicalRSVP is a clearinghouse used by clinical research sites to make sure study
volunteers do not participate in more than one clinical research study at a time.
Doing more than one clinical trial without waiting the appropriate length of time
between studies can be dangerous and can also negatively impact the study data being
collected. Therefore, the clinical research industry uses clinicalRSVP to objectively
authenticate that study volunteers are in one study at a time.
Why is study data important and how does clinicalRSVP improve study data?
In order for the FDA to approve a new drug, it must look at clinical trial
study data to determine that the drug is safe and effective. Because of this,
it is important this study data is accurate and complies with the study protocol
inclusion/exclusion criteria. Part of this criterion stipulates that volunteers
wait a certain length of time between research studies. clinicalRSVP ensures
that study data is not impacted from a study participant doing more than one
clinical trial at the same time.
How does clinicalRSVP impact the value of my contribution to research?
By being checked in clinicalRSVP, a volunteer’s contribution to research is more
valuable because the study data it generates becomes more reliable and can be used
to help find cures more effectively.
How does clinicalRSVP improve volunteer safety?
clinicalRSVP allows a research site to get added assurance about a volunteer’s
eligibility in a research study according to inclusion/exclusion criteria.
However, it is important study participants still read the Informed Consent
Form (ICF) to understand safety risks and to discuss these risks with the
research site if there are questions.
How does clinicalRSVP protect a study participant’s privacy?
clinicalRSVP is designed so that study participants remain de-identified.
This means clinicalRSVP does not capture or store names in the database.
Your name and contact information stays safely at your doctor’s office or
research site in accordance with HIPAA and other privacy standards.
Are research volunteer names entered into clinicalRSVP?
No. clinicalRSVP does not collect or store study participant
names or contact information.
What is the purpose of the fingerprint scan?
clinicalRSVP utilizes a fingerprint scan in order to confirm participant
identity. This allows clinicalRSVP to house participant eligibility data
without collecting or storing the names of participants.
Are research participant’s fingerprints stored in the clinicalRSVP database?
No. clinicalRSVP does not store any fingerprint images.
Only a unique code generated from the fingerprint scan is stored.
Is participant study data stored in clinicalRSVP?
No. clinicalRSVP does not collect or maintain study data.
Study data is maintained by the research site at which you
are participating and remains at the site.
What information about volunteer participation is maintained by clinicalRSVP?
clinicalRSVP houses and stores a series of safety and eligibility dates which inform research sites about when a study volunteer is eligible to participate in a clinical trial.
Will my fingerprint image be stored in the clinicalRSVP database?
No, your fingerprint image will not be stored in the database.
Each fingerprint generates a unique code, and only those codes are stored.
When will a research clinic check my eligibility data in clinicalRSVP?
A research clinic will check your eligibility data when you are screened
and again when you arrive to begin the clinical research study.
The research clinic may also check this information at other times
leading up to and during the clinical research study.
What happens if a research clinic checks my participation in clinicalRSVP?
By checking this information, a research clinic may determine whether
or not you are eligible to participate in a clinical research study.
Again, this is for your safety and to make sure the study’s results are accurate.
It is also important that you know that checking clinicalRSVP is just one step
that a research clinic takes in deciding whether you may be eligible to participate
in a clinical research study. The research study that you want to participate in will
also likely have specific eligibility requirements.
Can study volunteers opt out of clinicalRSVP?
Research sites using clinicalRSVP require that study volunteers
undergo a clinicalRSVP check at screening before participating in a
clinical trial. Therefore, study volunteers cannot opt out of clinicalRSVP
if they wish to participate in the clinical trial. However, participants
may request that their information be removed from the clinicalRSVP database
after the clinical trial is completed and has cleared all outstanding safety
and eligibility dates. If you wish to be removed from the clinicalRSVP
database please contact:
clinicalRSVP
401 E. Las Olas Blvd. Suite 130-395
Fort Lauderdale, FL 33301
888-308-7787
contact@clinicalRSVP.com
Who will have access to my information once entered into the clinicalRSVP database?
Once your information is entered into the database, all research clinics, sites and
contract research administration and management organizations participating in the
clinicalRSVP database will have access to this information. In addition, the database
administrator (Independent Data Integrator, LLC) will have access to the data.
What do I do if I think that information in the clinicalRSVP database about my participation is not accurate?
If you are concerned about its accuracy, you can request that the research clinic provide you with a
clinicalRSVP accuracy validation form. The form includes the information contained in the database
including stored information about participation in a research study. You may request that the research
site provide you with an accuracy validation form by calling 1-888-308-7787.
For subjects participating in research in Canada,
what factors determine the clinicalRSVP lockout date?
The clinicalRSVP lockout date is determined based on a
study's Informed Consent Form (ICF). In determining the
proper lockout date before you may participate in another
clinical trial, clinical trial investigators consider several
factors including the final dose date, final visit date,
total blood volume withdrawn, drug washout period and other
safety periods.