How is research non-compliance addressed?
• Clinical trial suspension until all areas of noncompliance are addressed • Data generated by the clinical trial may be determined ineligible for use • Clinical trial termination • Referral to the Scientific Misconduct Committee • Food and Drug Administration (FDA) notification • Notification of the VHA • DHHS Office for Human Research Protections (OHRP) notification • The site will be required to develop study-specific Standard Operating Procedures, and site-specific Standard Operating Procedures. • Studies being conducted at the site will be audited again for future compliance and to help identify and correct any other problems. • The site staff will be required to complete additional clinical research training and courses. The site will be required to notify the Office of Human Research Protection (OHRP) upon successful completion of additional training. • The site staff will be required to develop and maintain a training file to document completion of any additional clinical resea
