Clinical Participants

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:
401 E. Las Olas Blvd. Suite 130-395
Fort Lauderdale, FL 33301

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.

Have Questions?
clinicalRSVP is dedicated to protecting the welfare, safety, and rights of research participants.