Subject Safety In Clinical Trials
We seek to minimize the potential risks associated with participating in clinical research by taking the steps outlined below:
Institutional Review Board:
An Institutional Review Board (IRB) evaluates each study to determine that it complies with regulatory guidelines to ensure participant safety and well-being. The IRB is an independent committee including medical and non-medical professionals.
Informed Consent Form:
The study specific Informed Consent Form (ICF) is a guide given to each participant that includes study information prior to participation. The ICF includes study specific information such as:
Investigational product information
Payment for participation
Confidentiality of records
A research team member will explain the study procedures and review the ICF with participants. It is encouraged at this time to ask any questions regarding study participation.
The Principal Investigator (PI) ensures that each study is conducted under medical supervision. Qualified medical professionals are available at all times during a study to assist the participant.
Prior to starting a study, participants are required to provide their medical and dental history also including prescription and non-prescription medicines and dietary supplements. This information’s is reviewed by a study professional to ensure that participants are safely qualified for the study.
Use the links provided to learn more about how clinical trials are conducted and what you can expect if you participate.