As a clinical trial volunteer at CRCF patients receive close personal attention by our team of expert doctors, nurses, technicians, and support staff. They have access to innovative drugs and treatments. Patients receive all treatments and medical care related to the trial at no cost. In most cases patients are also compensated for time and travel expenses. Most of all, our patients are helping doctors and researchers to learn more about their conditions. Therefore, providing the knowledge needed to advance medicines and better treatments.
Participant Rights
Clinical Research of Central Florida is committed to protecting your rights.
Participant’s rights are very important and written into every protocol for a clinical study. Some of these rights include the right of the participant: to be completely informed, have their safety be the most important goal of the research doctor and staff, to have privacy and confidentiality, to receive medical treatment for the study purposes at no charge, and to withdraw from the study at any time for any reason.
Before any treatment or testing related to determining eligibility for a trial can be started each participant must read, understand and sign an Informed Consent Form (ICF). The ICF helps to ensure the participant is completely informed. It will explain the purpose of the trial and must be clear so that the participant understands any potential risks and benefits of the trial and the goals of the research. Participation is totally voluntary and the participant has the right to quit at any time.
Participant Safety
Clinical Research of Central Florida is committed to your safety.
Safety of participants is our research doctor’s and staff’s highest priority. Strictly following the protocol and closely monitoring the participants are some of the ways to help ensure safety. The Food and Drug Administration (FDA) along with the Institutional Review Board (IRB), do periodic reviews of clinical trials to ensure Good Clinical Practices (GCP) standards are being followed, participants are being properly consented, and clinical trial protocols are strictly followed.
GCP is a worldwide standard that is provided by International Conference on Harmonisation (ICH) to provide assurance of the safety and efficacy of the newly developed compounds. One standard of GCP in place to protect participants is the informed consent process. It ensures participants have reliable information as they decide whether to join a study.
Another important safety procedure comes directly from the clinical trial’s protocol called the inclusion/exclusion criteria. It outlines strict guidelines about who should be selected to join. This criteria is used to identify appropriate participants and help keep them safe.
We here at CRCF have processes in place that ensure high quality assurance standards and procedures. We pay close attention when obtaining medical histories and medications so that the information is complete and accurate. We take extra time to explain the study information to the potential participant so they have complete understanding of the study and make sure it agrees with their expectations before joining.
Participant Privacy
Clinical Research of Central Florida is committed to protecting your privacy.
CRCF follows Florida medical regulations as well as federal guidelines for clinical research concerning your medical record and study records. Patients can trust that CRCF will keep their personal health information private. The policies and procedures implemented are in full compliance with those of the Health Insurance Portability and Accountability Act (HIPAA) that was passed in August 1996 and became effective in April 2003.
No reports are made to employers, schools or to insurance companies. Information obtained during the course of the study is kept in confidential files and who has access to that data will be explained to you before the study starts in an informed consent process.