Sponsor Compliance and Audit

Sponsor compliance and audit are important components of quality management in clinical research. Sponsors are responsible for ensuring that clinical trials are appropriately designed, conducted, documented and reported in accordance with the protocol, Good Clinical Practice (GCP) and applicable regulatory requirements.

Sponsor oversight extends throughout the clinical trial lifecycle and includes activities performed directly by the sponsor as well as important trial-related activities transferred to service providers.

Sponsor Compliance with GCP

Sponsors should establish and maintain appropriate systems to support compliance with the clinical trial protocol, GCP and applicable regulatory requirements.

Sponsor responsibilities include appropriate trial design and management, investigator selection, safety oversight, monitoring, data management, investigational product management, record keeping and regulatory reporting.

Compliance should be incorporated into trial processes from the beginning rather than assessed only after problems occur.

Quality Management and Risk-Based Approaches

ICH E6(R3) emphasizes a proportionate and risk-based approach to quality management.

Sponsors should identify factors that are critical to trial quality and assess risks that could affect participant rights, safety and well-being or the reliability of trial results.

Risk-control measures should be proportionate to the significance of the identified risks. Sponsors should periodically review whether these measures remain effective and introduce additional controls when necessary.

Important quality issues and appropriate remedial actions should be documented and managed.

These principles are described in the ICH E6 Good Clinical Practice guideline.

Sponsor Oversight of Service Providers

Sponsors may transfer trial-related activities to Contract Research Organizations (CROs) or other service providers in accordance with applicable regulatory requirements.

Transferred activities and responsibilities should be clearly documented in agreements.

However, the sponsor retains ultimate responsibility for sponsor trial-related activities, including the protection of participants’ rights, safety and well-being and the reliability of trial data.

Sponsors should assess the suitability of service providers before selection and maintain appropriate oversight of important transferred activities. This oversight should also address relevant activities that a service provider further subcontracts.

Monitoring and Sponsor Oversight

Monitoring is an important component of sponsor oversight and helps determine whether a clinical trial is being conducted, recorded and reported appropriately.

The monitoring approach should be tailored to the risks and characteristics of the trial and may include on-site monitoring, remote monitoring and centralized monitoring activities where appropriate.

Sponsor oversight should focus particularly on issues that could affect participant safety, trial quality or the reliability of trial results.

Monitoring activities and significant findings should be appropriately documented, followed up and resolved.

Quality Assurance and Quality Control

Sponsors are responsible for establishing, implementing and maintaining appropriate quality assurance and quality control processes.

Quality control consists of operational techniques and activities used to verify that trial-related requirements are being fulfilled.

Quality assurance provides planned and systematic activities designed to provide confidence that trial processes comply with the protocol, GCP and applicable regulatory requirements.

Quality assurance should be applied throughout the clinical trial and should support identification and management of actual or potential serious noncompliance.

Clinical Trial Audits

A sponsor audit is independent of and separate from routine monitoring and quality-control activities.

The purpose of an audit is to evaluate whether the processes established to manage and conduct the clinical trial are appropriate for ensuring compliance with the protocol, GCP and applicable regulatory requirements.

When audits are performed, their nature and extent should be proportionate to the risks associated with the trial.

Auditor Independence and Qualification

Individuals conducting sponsor audits should be independent of the clinical trial activities or processes being audited.

Auditors should also be appropriately qualified through training and experience to perform their responsibilities.

Sponsors should conduct audits according to documented procedures that define how audit activities are planned, conducted, documented and followed up.

Noncompliance and Corrective and Preventive Actions

Sponsors should have processes for identifying and managing noncompliance with the protocol, GCP and applicable regulatory requirements.

When significant issues are identified, the sponsor should evaluate their cause, potential impact and the actions required to address them.

Corrective and Preventive Actions (CAPAs) may be implemented to correct identified problems, address their underlying causes and reduce the likelihood of recurrence.

Serious noncompliance may also require notification to regulatory authorities or other parties in accordance with applicable requirements.

Data Integrity and Trial Records

Sponsors should maintain systems and processes that support the reliability, integrity and traceability of clinical trial data.

Trial records should be appropriately maintained and accessible for monitoring, audits and regulatory inspections as applicable.

Computerized systems used in clinical trials should be fit for purpose, and appropriate controls should be implemented according to their intended use and associated risks.

For more information about maintaining trial documentation under the current GCP framework, see Essential Documents in Clinical Research.

Participant Safety and Safety Reporting

Protection of trial participants is a fundamental sponsor responsibility.

Sponsors should have processes for reviewing relevant safety information, communicating important safety information and meeting applicable expedited and periodic safety-reporting requirements.

Safety oversight should enable emerging risks to be identified, evaluated and appropriately managed throughout the trial.

Importance of Sponsor Compliance and Audit in Clinical Research

Sponsor compliance and audit contribute to participant protection, reliable trial results and confidence in the overall quality of clinical research.

Effective sponsor oversight combines quality management, proportionate risk management, monitoring, service-provider oversight, quality assurance and independent audit activities where appropriate.

Under the current GCP framework, sponsor compliance should therefore be viewed as an ongoing quality-management responsibility throughout the clinical trial rather than simply as preparation for an audit or regulatory inspection.

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