GCP Auditing

“Our GCP Auditing team helps you identify risks and strengthen institutional oversight”

Michael Belotto, PhD, CCRC, CCRA,
Sr. Director, Research Education

CONTACT US

Services
GCP Compliance Auditing
Outsourced Research Compliance Programs
Investigator-Initiated Research Start-up and Support

Resources

Case Study: Considerations When Changing a Trial’s Principal Investigator

Template: Delegation of Responsibility/Site Signature Log

Checklist: Informed Consent Process Guidance

Checklist: Eligibility Criteria Compliance

Regulatory Checklist

Study Personnel Worksheet

Best Practices: Guidance for Conducting Clinical Research

Sample Subject Enrollment Note

Maintaining Good Clinical Practices (GCP)

Essential Regulations for Ensuring Human Subject Protection
We offer expertise in human subjects protection and regulatory compliance including:
• Title 45 CFR Part 46, Protection of Human Subjects
• Title 21 CFR Part 50, Protection of Human Subjects
• Title 21 CFR Part 11, Electronic Records; Electronic Signatures
• Title 21 CFR Part 56 – Institutional Review Boards
• Title 21 CFR Part 312 Investigational New Drugs
• Title 21 CFR Part 812 – Investigational Device Exemptions
• Title 21 CFR Part 49 – Transportation – Subchapter C, Part 173 Hazardous Materials Regulations
• ICH/FDA Good Clinical Practice (GCP) Guidelines, E6(R2)
• Association for the Accreditation of Human Research Protection Programs (AAHRPP) Standards

BRANY’s GCP auditing services enable researchers to maintain the highest standards of compliance and ethical research conduct.

Experienced Team

BRANY offers cost-effective and high quality GCP auditing services.

Our team members have a deep understanding of FDA regulations, ICH standards, and OHRP guidelines. BRANY’s Quality Assurance (QA) team offers your staff methods for mitigating risks and ensuring compliance with relevant laws, regulations, and internal policies

Tricia Singh, RPA-C, CCRC, Senior Director, Quality Assurance & Monitoring
Haleigh Waite, CCRA, Senior Research Compliance Auditor
Leah Persky, MS, CCRC, Clinical Research Compliance Auditor
Christopher Chadwick, MPH, Quality Assurance & Monitoring

Good Clinical Practice (GCP) and Compliance AuditingAudit is defined as, “A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s)” (ICF E6 Section 1.6).

BRANY’s GCP audits provide a compliance snapshot. The purpose of auditing a trial is to review the overall processes for some or all of the subject files to:

  • Ensure the protection of subjects enrolled in clinical trials
  • Increase confidence that the data collected and subsequently submitted is valid
  • Confirm eligibility criteria per protocol was met for subjects enrolled
  • Ensure proper documentation of the informed consent process
  • Verify compliance with the regulations, the IRB’s requirements, and good clinical practice (GCP)

Outsourced Research Compliance

Institutions may lack resources to be able to conduct GCP or compliance audits. Our team can provide this service and can help to identify and mitigate any developing systemic issues. Our auditors have the lens of “eagle-eyes” that can identify problems and compliance issues and can give recommendations to improve study conduct.

The coaching and mentoring philosophy inherent in our approach to research compliance creates an educational experience for all involved. This enables your team to gain new knowledge and skills, which strengthens the research skills at your institution.

Audit Services Tailored to Your Needs

BRANY offers flexible auditing solutions tailored to the size, scope, and risk profile of your studies. Whether you require routine compliance audits, for-cause reviews, or pre-inspection assessments, our auditors deliver clear, actionable reports that help you enhance quality and reduce risk. We work collaboratively with your team to ensure audit findings are not only addressed, but translated into long-term process improvements that support ongoing regulatory readiness.