At Sanguine, our community is our top priority. We want you to feel comfortable and secure when participating in a study.
Sanguine Prioritizes Patient Data Privacy and Protection
Sanguine's procedures and systems are HIPAA compliant and we are committed to keeping your information confidential. When your health information and biospecimen are shared with a researcher, they are shared using an anonymized unique identification code. This code cannot be used by third parties to connect participants with their health information. All personal identifiers are removed from any information shared with researchers and all medical records are fully redacted.
Sanguine operates under an electronic informed consent process which executes 21 CFR part 11 compliant e-signatures, and Sanguine systems interacting with study participant information are HIPAA-compliant.
Sanguine utilizes two internationally-recognized IRBs (Advarra and WCG IRB) for review and approval of all study protocols, specific study documentation, and study participant facing information. Both Advarra and WCG IRB are organized and operates in compliance with: FDA, OHRP, and International Conference on Harmonization (ICH).
Participation in a research study with Sanguine involves Informed Consent. Informed Consent means that we have explained the study to you and you understand the potential risks and benefits of participation in the study. You are provided with resources, information, and time to make an informed decision about participation.
The type of information collected during a research study includes personal information like your name, contact information, and address; health information like medical diagnoses, medical history, and medications; and demographic information like your age, sex, and ethnicity. Your personal information is collected when you sign up online to be a part of our database, during an over the phone screening, and through your medical records. All of these data points are crucial to matching you to a specific research study cohort and for coordinating an appointment.