GCP Oversight Simplified: A Quick Guide

By Daniele Novara

Good Clinical Practice (GCP) compliance is a foundational expectation for all clinical trials. Yet, many sponsors still grapple with finding the right balance between ensuring oversight and avoiding counterproductive micromanagement of CROs. As regulatory expectations evolve, particularly with the upcoming ICH E6(R3) guidance, regulators expect sponsors to proactively manage and demonstrate control over outsourced clinical activities. The key lies in structured oversight that fosters accountability, not redundancy.

Sponsors are outsourcing more than ever. According to a Tufts Center for the Study of Drug Development (CSDD) study, over 75% of clinical trial activities are now conducted by CROs.¹ With this shift comes greater regulatory scrutiny. Recent FDA warning letters have cited inadequate CRO oversight as a repeat issue,² often resulting from poor documentation, unclear delegation of responsibilities, and lack of proactive quality management. These risks become even more pronounced in decentralized or hybrid trial models, where trial operations span countries, vendors, and technologies.

This article outlines practical, real-world strategies for sponsors to operationalize GCP oversight in a way that is collaborative, measurable, and scalable.

The Oversight Mandate: What Has Changed?

While GCP obligations have always applied to sponsors, recent regulatory inspections and draft ICH guidance highlight increased emphasis on documented sponsor oversight. Sponsors must demonstrate:

• clear delegation of duties
• ongoing performance evaluation
• risk-based quality management
• defined escalation pathways.

Gone are the days of set-it-and-forget-it CRO contracts. Instead, regulators expect a living oversight model where sponsors continuously engage with CROs through structured interactions and documented governance. The ICH E6(R3) draft makes this expectation explicit, requiring not just oversight in name but in traceable, actionable behavior.³

How To Oversee CROs Without Micromanaging Them

Micromanagement creates inefficiencies and erodes trust. The goal is oversight that enables autonomous execution within well-defined guardrails. Here’s how:

1. Define Roles Using RACI Matrices
   Before the trial starts, establish a responsibility assignment (RACI) matrix that outlines who is responsible, accountable, consulted, and informed for each critical activity. This prevents duplication and sets expectations early. For example, during site start-up, the sponsor may be accountable for country-level strategy while the CRO manages site feasibility and contract negotiations.
2. Develop a CRO Oversight Plan
   Treat this as a living document, not a checkbox. It should include:
   • performance metrics (e.g., data query resolution time, source data verification rate)
   • communication cadence (e.g., weekly calls, quarterly governance meetings)
   • audit and quality check intervals
   • escalation procedures and thresholds.
3. Use KPIs to Monitor Without Hovering
   Establish key performance indicators (KPIs) that are specific, measurable, and reviewed routinely. Examples include:
   • protocol deviation rates by site
   • enrollment against forecast
   • timeliness of safety reporting
   • monitoring visit frequency and follow-up timeliness.
4. Implement Tiered Governance Structures
   A three-tier model works well:
   • Operational Level: Weekly check-ins with study teams
   • Tactical Level: Monthly meetings with CRO functional leads
   • Strategic Level: Quarterly executive governance meetings
5. Perform Oversight Visits
   Sponsor-side clinical or quality representatives should attend site visits or co-monitor periodically. Observational visits during key milestones (e.g., first patient in, data lock) provide valuable insights.

Common CRO Oversight Pitfalls

Even well-meaning sponsors can fall into traps that undermine effective oversight:

• Over-standardization: One-size-fits-all templates for all studies, regardless of risk
• Delayed escalation: Ignoring early warning signs such as poor data quality
• Blurring of roles: Unclear division of labor between sponsor and CRO
• Siloed communication: Lack of alignment across sponsor teams

Oversight In A Decentralized Trial Environment

Decentralized and hybrid trials complicate the oversight landscape. More data sources, remote monitoring tools, and third-party vendors (e.g., eConsent, ePRO, telemedicine platforms) add layers of complexity.

To adapt, sponsors should:

• integrate tech oversight into their CRO plans (e.g., audit logs from eCOA platforms)
• use digital dashboards to consolidate data flow and query management
• apply risk-based strategies to monitor technology vendor performance.

For example, in a decentralized rare disease trial, the sponsor implemented a centralized monitoring tool to track consent form timeliness, home visit compliance, and ePRO completion rates. Oversight was integrated across tech providers and CROs, with clear accountability assigned at each touchpoint.

More Lessons From The Field

In one study, a real-time dashboard was used to track key performance indicators and flag delays in areas such as query resolution and TMF completeness. When performance began to decline in a particular region, the data supported a targeted intervention and the implementation of a recovery plan, without disrupting overall collaboration.

In contrast, another approach required approvals for every document and attendance at all monitoring visits. This introduced delays, increased site staff frustration, and ultimately impacted the study timeline.

Final Thoughts

Effective oversight is not about control; it’s about clarity, collaboration, and accountability. By defining responsibilities, monitoring with meaningful metrics, and engaging at the right level, sponsors can fulfill their GCP obligations while enabling CROs to execute efficiently.

With ICH E6(R3) on the horizon, now is the time to reevaluate internal oversight models. Clinical leaders who invest in thoughtful oversight frameworks will not only meet regulatory expectations but also build stronger, more resilient outsourcing partnerships.

With the right framework, oversight becomes a partnership, not a power struggle.

Editor’s note: The views expressed in this article are those of the author and do not necessarily reflect the position or recommendations of any company or organization.

References:

1. Tufts Center for the Study of Drug Development. “Outsourcing Trends in Clinical Trials.” Tufts CSDD Impact Report, 2023.
2. U.S. Food and Drug Administration. “Warning Letters.” Accessed July 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
3. International Council for Harmonisation (ICH). “ICH E6(R3) Draft Guideline on Good Clinical Practice.” 2023. https://www.ich.org/page/efficacy-guidelines

About The Author:

Daniele Novara is a passionate and results-driven clinical operations professional with a foundation in life sciences, developed through his pharmacy degree and refined through hands-on experience in clinical research. With a track record in global clinical studies, he has supported the development and implementation of robust, GCP-compliant processes and tools across a range of therapeutic areas, including oncology and infectious diseases. Daniele has led feasibility assessments, engaged with KOLs, and actively contributed to trial awareness and site engagement. He has also successfully managed internal and external stakeholders and has been responsible for study-specific training for operational teams.