Quality Processes at Carolina's GI Research

Our research team is committed to the highest standards of performance in the conduct of clinical trials completed at our facility. We adhere stringently to all GCP and ICH guidelines, Federal regulations and the study protocol. Every study is assigned a primary, as well as secondary, research coordinator that is fully prepared to assume the duties of the primary coordinator on a temporary or permanent basis. We perform quality assurance audits on all trials which may include the examination of the investigator site file, source documents, case report forms, patient informed consent, inclusion/exclusion criteria, compliance with SOPs, monitoring reports and query resolution process. All results are discussed with appropriate team members.

We have a complete list of SOPs that govern the performance of all procedures of a clinical trial unless replaced by a specific study protocol or SOP. The topics covered are listed below.

  • Pre-study visit
  • Patient screening and telephone interviewing
  • Study initiation procedures
  • Developing and obtaining informed consent
  • Case report form completion & DCF resolution
  • Source documentation procedures
  • Drug accountability & dispensation
  • Electronic records & electronic signatures
  • Serious adverse event reporting
  • Regulatory binder & study files maintenance
  • Monitoring visit
  • Quality assurance
  • Study closeout procedures
  • HIPAA compliance policy
  • CRO/Sponsor audit preparation
  • Minimum necessary use & disclosure of PHI
  • FDA audit preparation
  • Verification requirements for disclosure of PHI
  • Patient/volunteer recruitment
  • Individual’s request for access to PHI
  • Protocol specific training
  • Amendment of protected health information
  • Employee training
  • Authorizations for use and/or disclosure of PHI
  • Maintenance of equipment
  • Notice of privacy practices
  • Physician recruitment
  • Fire evacuation procedures
  • Liability insurance
  • Non-compliance/disciplinary action
  • Company structure & delegation
  • Computerized systems used in clinical investigations
  • SOP preparation and revision