Safety Guidelines
St. Vincent Cardiovascular Research Institute oversees many different types of CVD research studies. Our first priority is the safety and well-being of every participant. Every clinical trial has a protocol to determine how a study is conducted, what type of patients are enrolled, and how to keep the study and its participants safe. The sponsor of the study (the pharmaceutical or device company) creates an independent, external committee to monitor safety known as the data safety monitoring board (DSMB). They meet on a routine basis to review all of the study information and to evaluate adverse results. The DSMB sees information that the site investigators are not allowed to see and with this exclusive perspective can help make the study safer. For example, if the DSMB feels the new treatment or therapy offers overwhelming benefit, they may stop the trial earlier than planned to report the results and to encourage faster acceptance or approval of that new therapy. Likewise, if the DSMB perceives a negative impact from the investigated treatment (more harm than good), the DSMB can stop the trial.
St. Vincent Cardiovascular Research Institute team members follow principles of good clinical practice:
- Trials are conducted ethically, as defined by the International Conference on Harmonization.
- Benefits outweigh risks for each patient.
- Rights, safety and well-being of patients prevail over science.
- All available non-clinical and clinical information on any investigational agent can support the trial as designed.
- All trials are scientifically sound and clearly described.
- All clinical trials have Institutional Review Board (IRB) approval.
- Medical decisions and care are the responsibility of qualified healthcare professionals, specifically physicians and, if applicable, dentists.
- Everyone involved in the clinical trial is qualified by training, education and experience.
- Informed consent is given freely by every participant.
- All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification.
- Confidentiality of subjects is respected and protected.
- Investigational products maintain Good Manufacturing Practices (GMP) for the manufacturing, storage and handling of the medication or medical device.
- Systems are in place to ensure quality measures are implemented during all aspects of the trial.