Introduction

In the global landscape of pharmaceutical development and regulatory harmonization, the International Council for Harmonisation’s Good Clinical Practice (ICH-GCP) guidelines have become the cornerstone of clinical trial regulation worldwide. Unlike Good Manufacturing Practice (GMP) and Good Supply Practice (GSP), which primarily govern internal pharmaceutical operations, the GCP compliance framework exhibits remarkable multiplicity and complexity. It encompasses sponsors, investigators, clinical trial sites, Contract Research Organizations (CROs), ethics committees, and trial participants, forming an intricate web of responsibilities.

As ICH E6 evolves from R2 to R3, and regulatory practices deepen across major jurisdictions including China, the United States, and the European Union, clarifying responsibility boundaries and improving regulatory mechanisms within this multi-stakeholder system have become paramount for ensuring trial quality and protecting participant rights. This article examines the ICH-GCP framework, analyzes the legal obligations and ethical responsibilities of each stakeholder, compares regulatory practices across jurisdictions, and explores emerging challenges and trends in GCP compliance amid digital transformation.

I. The Multifaceted Nature of GCP Compliance and Regulatory Complexity

Clinical trials, serving as the critical bridge between basic research and clinical application, present quality management characteristics distinctly different from GMP and GSP. While GMP and GSP primarily regulate internal pharmaceutical production and distribution with relatively straightforward responsibility chains and clear regulatory pathways, GCP-governed clinical trial activities involve the intersection of medical institutions, research facilities, regulatory bodies, and commercial entities, creating a complex ecosystem.

This complexity manifests in three dimensions. First, stakeholder multiplicity: clinical trials require coordinated collaboration among sponsors, investigators, trial sites, CROs, and ethics committees, each bearing independent statutory duties while maintaining interdependent relationships. Second, multi-layered regulatory mechanisms encompass not only pharmaceutical regulatory oversight but also health authority management of medical institutions and ethics review, alongside industry self-regulation and social supervision. Third, the complexity of interests involves scientific research, commercial benefits, public health, and individual rights, necessitating a balance among diverse value propositions.

ICH-GCP establishes the fundamental principle that “the rights, safety, and well-being of trial participants must prevail over the interests of science and society,” providing a common framework for national GCP compliance systems. However, differences in legal systems, regulatory traditions, and healthcare structures have led to varied institutional arrangements and regulatory models in implementation.

Since joining ICH in 2017, China has rapidly elevated GCP compliance through revised regulations, enhanced supporting frameworks, and strengthened inspections. The United States maintains a mature clinical trial regulatory mechanism through comprehensive federal regulations and the FDA’s specialized oversight. The EU achieves coordinated regulation among member states through the unified Clinical Trials Regulation (CTR). These diverse regulatory practices provide rich institutional models for understanding and improving GCP compliance systems.

II. Sponsors’ Core Responsibilities and Quality Assurance Obligations

Within the GCP compliance framework, sponsors, as trial initiators and funders, bear the most comprehensive and fundamental legal responsibilities. According to ICH-GCP and national regulations, sponsors maintain ultimate responsibility for overall trial quality and participant safety—a non-transferable obligation that persists even when work is delegated to CROs or other organizations.

Quality Management Systems

Sponsors must establish comprehensive quality management systems covering all trial phases. ICH E6(R2) explicitly requires the implementation of Risk-Based Quality Management Systems, identifying critical processes and data from the design phase, assessing potential risks, and developing appropriate control measures. This proactive quality management philosophy demands that sponsors focus not merely on post-hoc problem correction but on systematic risk assessment and preventive measures to ensure quality from the outset.

China’s GCP mandates that sponsors establish clinical trial quality management systems, develop standard operating procedures for quality control and assurance, and strictly implement them throughout the trial. This encompasses not only technical controls for protocol design, data collection, and drug management but also management elements, including personnel training, document management, and communication mechanisms, embodying total quality management principles.

Investigator and Site Selection

Sponsors bear significant responsibility for selecting and managing investigators and research institutions. Beyond formal qualification reviews, sponsors must conduct substantive assessments of actual capabilities. US 21 CFR 312.50 explicitly requires sponsors to select qualified investigators and to provide sufficient information to ensure proper trial conduct.

In Chinese regulatory practice, sponsors must comprehensively evaluate investigators’ professional backgrounds, research experience, and institutional facilities, clarifying mutual rights and obligations through written agreements. Sponsors must continuously monitor investigator performance through regular monitoring and data verification, ensuring trials proceed according to protocol requirements. When investigators demonstrate non-compliance or incompetence, sponsors must implement corrective actions, including termination when necessary.

Participant Protection

Sponsors bear fundamental responsibility for safeguarding participant rights, reflected not only in scientific and ethical trial design but also in providing necessary medical care and compensation. ICH-GCP requires sponsors to provide insurance or establish compensation mechanisms according to applicable regulations, ensuring reasonable compensation for trial-related injuries.

Chinese GCP explicitly requires sponsors to purchase clinical trial insurance or provide treatment and/or compensation for trial-related injuries or deaths. This compensation framework embodies risk-benefit matching principles—sponsors, as ultimate beneficiaries, should bear corresponding risk responsibilities. Additionally, sponsors must ensure protocol designs adequately consider participant safety, including reasonable inclusion/exclusion criteria, detailed safety monitoring plans, and rapid serious adverse event reporting mechanisms.

III. Investigators’ Direct Responsibilities and Professional Obligations

As on-site trial executors, investigators’ responsibilities focus on ensuring standardized implementation and direct participant protection. Typically qualified physicians or researchers, investigators’ professional judgment and ethics directly impact trial quality and participant safety.

Medical Care Responsibilities

Investigators bear direct medical care responsibilities for participants, stemming from the special nature of the physician-patient relationship. Even within clinical trials, investigators remain primarily healthcare professionals who must prioritize participant’s health and safety. US 21 CFR 312.60 explicitly states that investigators are responsible for protecting the rights, safety, and well-being of participants under their care.

This means investigators must maintain professional judgment when executing protocols, having both the right and the obligation to implement necessary deviations when protocols may endanger participants. Chinese GCP specifies that, to protect participant rights and ensure safety, investigators may deviate from or modify protocols without prior ethics committee approval in emergencies, though they must promptly report and explain these deviations to ethics committees and sponsors afterward. This emergency deviation provision fully embodies the principle of participant protection priority, granting investigators autonomous decision-making authority in specific circumstances.

Informed Consent Process

Investigators bear a crucial responsibility for ensuring compliant informed consent processes. Informed consent represents the ethical core of clinical trials, requiring investigators to personally obtain or supervise the obtaining of each participant’s informed consent. This extends beyond document signing to substantive communication and information transfer.

Investigators must use language participants can understand, detailing trial purposes, procedures, potential risks and benefits, alternative treatments, and participant rights, ensuring participants make voluntary decisions based on full understanding. For special populations, such as minors or cognitively impaired individuals, investigators must follow additional protective procedures, obtaining legal representative consent while seeking participant assent when possible. Investigator performance during informed consent represents a regulatory inspection focus, with any coercion, inducement, or information concealment potentially constituting serious violations.

Data Integrity

Investigators bear a direct responsibility for data authenticity and completeness. As primary data collectors and recorders, investigators must ensure the accuracy, timeliness, and traceability of all trial data. This includes correctly completing case report forms (CRFs), properly maintaining source documents, and promptly reporting adverse events.

With the proliferation of the electronic data capture system, investigators must master relevant systems to ensure electronic data security and integrity. Recent Chinese clinical trial audits have revealed numerous data authenticity issues, including fabricated participants, falsified laboratory data, and concealed adverse events—violations not only of GCP requirements but potentially constituting academic misconduct or criminal offenses. Therefore, investigators must establish strict data management systems, thoroughly train research teams, and ensure every data point withstands audit and verification.

IV. CROs’ Delegated Responsibilities and Compliance Boundaries

Contract Research Organizations, as professional clinical trial service providers, play increasingly important roles in modern drug development. As trial complexity increases and specialization deepens, more sponsors delegate partial or complete trial management to CROs. However, the legal nature and responsibility allocation of these delegation relationships remain key GCP compliance issues.

Derivative and Limited Responsibilities

CRO responsibilities exhibit derivative and limited characteristics. According to ICH-GCP and national regulations, CRO responsibilities stem from sponsor delegation and are limited to explicitly contracted items. Chinese GCP clearly states: “Work delegated by sponsors to CROs requires written contracts... work not explicitly delegated remains the sponsors’ responsibility.” US 21 CFR 312.52 similarly provides that sponsors may transfer some or all obligations to CROs through written agreements, with non-covered obligations remaining sponsors’ responsibilities.

This institutional arrangement ensures the integrity of the responsibility chain—regardless of outsourcing arrangements, clear responsible parties remain accountable to regulators. Simultaneously, this requires CROs to possess appropriate professional capabilities and quality management systems to fulfill delegated responsibilities according to sponsor standards.

Regulatory Compliance Requirements

CROs must comply with regulations equivalent to those of sponsors when executing delegated tasks. CROs cannot lower compliance standards or evade responsibilities by claiming to be “merely service providers.” For instance, CROs responsible for clinical trial monitoring must develop monitoring plans per GCP requirements, deploy qualified monitors, implement risk-based monitoring strategies, and promptly report identified issues to sponsors.

CROs managing data must establish regulatory-compliant electronic data capture systems, implement data validation procedures, and ensure data integrity and traceability. In Chinese and US regulatory practice, CROs fall within the regulatory inspection scope, with authorities conducting direct on-site inspections and implementing regulatory measures for violations. This direct oversight mechanism strengthens CRO compliance awareness, promoting independent quality management systems rather than simple reliance on sponsor management.

Contractual Responsibility Delineation

CRO-sponsor responsibility boundaries require clear contractual arrangements. Comprehensive delegation contracts must specify not only the work scope and technical requirements but also quality standards, oversight mechanisms, information communication, issue resolution, and responsibility allocation. Particularly regarding quality issues or regulatory violations, responsibility distribution requires contractual clarity.

In practice, some sponsors attempt to transfer all responsibilities to CROs through contractual provisions, while CROs seek to avoid responsibilities through disclaimers—approaches regulators reject. Regulators consistently maintain the principles of sponsor ultimate responsibility while requiring CROs to be accountable for the actual work undertaken. This dual responsibility mechanism ensures that clinical trial quality management doesn’t create vacuums through outsourcing.

V. Ethics Committees’ Independent Oversight and Protective Functions

Ethics committees, as independent third-party review bodies, fulfill unique and critical roles in GCP compliance. Their core function involves ensuring that trials comply with ethical principles and protecting participants’ rights, safety, and well-being through independent ethical review and continuous oversight. The establishment of the ethics committee reflects the multifaceted nature of clinical trial regulation, forming an additional defense beyond administrative oversight.

Independence as a Foundation

Ethics committee independence forms the foundation and lifeblood of their function. ICH-GCP explicitly requires ethics committees to remain independent from sponsors, investigators, and regulators, free from undue influence. This independence manifests organizationally, in personnel composition, and in decision-making.

Organizationally, ethics committees typically operate within medical institutions or independent review organizations with autonomous charters and operating procedures. The personnel composition should include members from medical, pharmaceutical, ethical, legal, and other professional backgrounds, plus non-medical community representatives, ensuring comprehensive and impartial review. Decision-making should rely on scientific and ethical standards through democratic discussion and voting, without sponsor or investigator interference.

China’s updated GCP strengthens ethics committee independence requirements, explicitly prohibiting members from accepting undue influence from sponsors or investigators and requiring recusal when reviewing their own trials. These institutional arrangements provide structural guarantees for the independent function of the ethics committee.

Comprehensive Review Functions

Ethics committee review functions span the entire clinical trials process. Before trial, committees comprehensively review protocols, informed consent forms, investigator qualifications, and site conditions, assessing scientific validity, ethical appropriateness, and feasibility. This review extends beyond formal checks to a substantive evaluation of design rationality, risk-benefit appropriateness, and participant protection adequacy.

During trials, committees conduct continuing review, including regular progress assessments, timely protocol amendment reviews, and expedited serious adverse event reviews. When trials present major risks or violate ethical principles, committees may require suspension or termination. This continuous oversight ensures that ethical review isn’t a one-time gatekeeping but is dynamic throughout trials. Post-trial, committees review final reports, evaluating overall implementation and participant protection.

Vulnerable Population Protection

Ethics committees bear special responsibilities for vulnerable population protection. Clinical trial vulnerable groups include children, pregnant women, mentally impaired individuals, and economically disadvantaged populations who may face greater risks or pressure due to cognitive capacity, economic status, or social position.

Ethics committees must give special attention to trials involving vulnerable populations, ensuring additional protective measures. For pediatric trials, committees evaluate whether adult data exist, whether risks are minimized, and whether direct benefits are possible. For economically disadvantaged participants, committees assess the reasonableness of compensation and potential undue inducement. China has developed specific ethical review points for pediatric drug trials, requiring strict ethics committee oversight to ensure children’s best interests. These differentiated review requirements reflect ethical review’s refinement and specialization trends.

VI. Clinical Trial Sites’ Platform Responsibilities and Management Functions

Clinical trial sites, as venues and platforms for trial implementation, fulfill important support and management functions in GCP compliance. Beyond simply providing facilities, sites must establish complete management systems ensuring all trials conducted on-site comply with GCP requirements. This platform responsibility directly impacts trial quality and participant safety.

Organizational Management Systems

Sites must establish robust organizational management systems. According to China’s “Regulations on the Management of Clinical Trial Institutions,” medical institutions conducting drug trials should meet qualification conditions, including dedicated clinical trial management departments, full-time management personnel, and comprehensive management systems. This organizational support extends beyond formal institutional setup to effective management mechanisms.

Institutional management departments must uniformly manage their sites’ clinical trial activities, including project review, contract signing, resource allocation, quality control, and archive management. Particularly in large medical institutions conducting multiple simultaneous trials, institutional management becomes more prominent. Sites must rationally allocate research resources, preventing investigator overload; coordinate participant recruitment across trials, avoiding duplicate enrollment; coordinate facility and equipment use, ensuring necessary support for all trials. This coordination function, irreplaceable by individual investigators or sponsors, embodies sites’ unique platform value.

Investigator Management and Support

Sites bear important responsibilities for investigator management and support, providing not only necessary hardware facilities and personnel but also managing and supervising investigator qualifications and performance. For qualification management, sites must establish investigator credentialing and training systems, ensuring only capable personnel serve as principal investigators or participate in trials.

For performance oversight, sites must monitor investigators’ protocol execution and GCP compliance, promptly correcting identified issues. Chinese regulatory inspections frequently reveal inadequate investigator management at some sites, leading to investigators simultaneously leading excessive trials, over-delegating work, or neglecting trial management. Site management departments bear undeniable responsibility for these issues. Therefore, strengthening institutional investigator management represents a crucial element in improving trial quality.

Systematic Participant Protection

Sites bear systematic responsibilities for participant protection. As medical institutions, trial sites already bear statutory duties for patient safety, which are extended and strengthened within clinical trials. Sites must establish comprehensive participant protection systems including independent ethics committees, participant complaint mechanisms, and emergency medical treatment guarantees.

Particularly when handling trial-related adverse events, sites’ medical treatment capabilities and emergency response mechanisms prove crucial. Sites must also establish participant privacy protection systems, ensuring proper protection of personal information and medical data. Chinese regulatory practice shows that major participant harm events often expose systematic deficiencies in institutional participant protection, such as perfunctory ethical review, improper adverse event handling, or non-standard informed consent processes. Addressing these issues requires sites to approach system construction, personnel training, and process management comprehensively, building all-encompassing participant protection systems.

VII. Inter-jurisdictional Regulatory Comparison and China’s Path

Different jurisdictions exhibit significant variations in GCP regulatory mechanism design and implementation, reflecting diverse legal traditions, regulatory philosophies, and industry development stages. Comparing regulatory practices across China, the United States, and the European Union provides a better understanding of GCP regulation’s diversity and trends.

United States: Mature Legal Framework

The US GCP regulatory system distinguishes itself through high legalization and mature enforcement. The US codifies GCP requirements through federal regulations (21 CFR), granting clear legal effect. The FDA, as the specialized regulatory agency, established the comprehensive Bioresearch Monitoring Program (BIMO), supervising clinical trials through risk-based inspection strategies.

US regulation emphasizes sponsor primary responsibility and self-management, encouraging companies to establish robust quality systems, ensuring compliance through proactive risk assessment and process control. Simultaneously, the US imposes substantial penalties for violations including warning letters, injunctions, and criminal prosecution, creating powerful deterrence. The US also maintains transparent regulatory information disclosure, publicly releasing FDA inspection reports and warning letters, serving both as warnings to violators and industry education.

European Union: Unified Flexibility

EU regulatory models balance uniformity with flexibility. Through Clinical Trials Regulation (CTR) implementation, the EU has achieved high regulatory uniformity with all member states applying identical rules and standards. However, member states retain implementation autonomy, developing detailed rules per national circumstances.

EU innovation lies in establishing unified clinical trial information systems and approval platforms, achieving coordinated multinational trial management. EMA, as central coordinator, doesn’t directly enforce regulations but supports member state regulatory work through guideline development, training organization, and inspection coordination. This model ensures regulatory standard consistency while respecting member state regulatory sovereignty, providing valuable experience for transnational regulatory cooperation.

China: Rapid Evolution

Chinese GCP regulation has undergone rapid development and profound transformation recently. Beginning with the “7.22 clinical trial data verification storm” in 2015, Chinese regulators strengthened clinical trial oversight with unprecedented intensity, exposing widespread data falsification through strict on-site verification, driving industry-wide standardization.

After joining ICH in 2017, China rapidly aligned regulations with international standards, with the 2020 GCP version essentially meeting ICH E6(R2) requirements. Chinese regulation features government leadership, strict enforcement, and rapid improvement. Through frequent unannounced inspections, severe penalties, and public criticism, China significantly elevated clinical trial compliance levels quickly.

China also explores nationally-appropriate regulatory innovations such as clinical trial institution filing systems, implied consent systems, and regional ethics committee construction. These measures both incorporate international experience and consider Chinese circumstances, forming distinctive regulatory pathways.

VIII. ICH E6 Evolution and Future Trends

ICH E6 guidelines, as global GCP benchmarks, profoundly influence national regulatory practices and industry development with each revision. The evolution from E6(R2) to the ongoing E6(R3) implementation reflects new challenges and opportunities facing clinical trials.

E6(R2): Risk-Based Quality Management

E6(R2)’s core contribution introduced risk-based quality management concepts. This philosophy requires sponsors to begin systematic risk identification and assessment from the trial design, concentrating limited resources on critical elements that most impact trial quality and participant safety. Risk-based approaches improve quality management efficiency while providing new regulatory inspection approaches.

Regulators can determine inspection frequency and depth based on trial risk levels, achieving targeted regulation. R2 also strengthened requirements for electronic systems and data integrity, addressing challenges from clinical trial digitalization. These new requirements appear in national regulatory updates, driving overall global clinical trial quality management improvements.

E6(R3): Revolutionary Upgrade

E6(R3) represents a revolutionary GCP guideline upgrade. Rather than a simple revision, R3 restructures the entire guideline architecture. Through introducing principle and annex dual-layer structures, R3 provides greater flexibility, enabling GCP adaptation to different research types and scales.

R3’s comprehensive embrace of digital technology represents its highlight, including guidance for decentralized clinical trials, electronic informed consent, and wearable device data collection. These additions transcend simple technical specifications, fundamentally reconsidering clinical trial models. R3 also emphasizes patient-centric concepts, encouraging patient participation in trial design and improving result feedback to patients, reflecting clinical trials’ shift from investigator-led to multi-stakeholder participation. This transformation challenges traditional responsibility allocation and regulatory models, requiring all parties to reconsider and adjust.

Looking forward, GCP compliance systems will continue evolving toward more scientific, efficient, and inclusive directions. Artificial intelligence, big data, blockchain, and other emerging technologies will profoundly change trial conduct methods while presenting new regulatory requirements. Real-world evidence emergence blurs boundaries between clinical trials and practice, requiring new quality standards and regulatory frameworks. Globalization trends in multinational trials need better international coordination mechanisms, promoting mutual recognition and standard unification. Additionally, COVID-19 highlighted the clinical trial system fragility and adaptation insufficiencies, driving the development of decentralized trials and other new models. These changes all require continuous GCP compliance system evolution and improvement.

IX. Reflections and Recommendations for Improving China’s GCP Regulatory System

At this new historical juncture, China’s GCP regulatory system construction faces both rare opportunities and serious challenges. Key questions include maintaining regulatory strictness while improving scientific rigor, promoting innovation while ensuring safety, and achieving international alignment while preserving Chinese characteristics.

Regulatory Modernization

China should accelerate regulatory framework modernization. While China has essentially established an ICH-aligned GCP regulatory system, improvement opportunities remain in legal hierarchy, system completeness, and operability. We recommend developing specialized “Clinical Trial Management Regulations” under the Drug Administration Law framework, elevating clinical trial regulation’s legal status and clarifying stakeholder legal responsibilities.

Simultaneously, China should promptly follow ICH E6(R3) requirements, actively introducing new concepts and methods while maintaining regulatory continuity. Particularly for digital clinical trials, real-world studies, and other new models, corresponding technical guidelines and regulatory standards should be developed quickly, providing institutional guarantees for innovative development. During regulation development, input from all stakeholders, particularly industry and research institutions, should ensure scientific validity and feasibility.

Professional and Scientific Enhancement

China should continuously improve regulatory professionalization and scientific standards. Clinical trial regulation requires highly specialized work, demanding that regulatory personnel possess multidisciplinary knowledge spanning medicine, pharmacy, statistics, and law. We recommend strengthening professional regulatory team construction, establishing systematic training systems, and regularly updating knowledge and skills.

Additionally, information technology should be fully utilized to improve regulatory efficiency, establishing comprehensive clinical trial information platforms enabling real-time trial data monitoring and intelligent analysis. Regulatory methods should comprehensively implement risk-based strategies, applying differentiated regulation based on trial risk levels, sponsor credit records, and institutional management levels, focusing limited regulatory resources where most needed.

Multi-stakeholder Governance

China should construct diverse co-governance regulatory patterns. GCP compliance cannot rely solely on government regulation but requires industry self-regulation, social supervision, and other participatory forces. We recommend fully utilizing industry associations to develop self-regulatory standards, conduct training and exchanges, and promote best practices.

Support establishing third-party certification and evaluation mechanisms, conducting capability assessments and quality certifications for clinical trial institutions and CROs, providing references for sponsor partner selection. Strengthen information disclosure and social supervision, regularly publishing clinical trial regulatory reports, disclosing violations and penalties, and accepting societal oversight. Establish incentive-compatible institutional designs, providing policy preferences and facilitation measures for well-performing compliant entities, creating positive incentive mechanisms.

International Cooperation

China should strengthen international exchange and cooperation. Under globalization, clinical trial regulation must maintain an international perspective. We recommend active participation in ICH and other international organizations, deep involvement in international rule-making, and an enhanced Chinese voice in global drug regulatory systems.

Strengthen bilateral and multilateral cooperation with other national and regional regulatory agencies, promoting mutual recognition and inspection result sharing, reducing redundant regulation, and improving efficiency. Support Chinese enterprises and research institutions in participating in international multicenter trials, learning advanced international experience through practice and improving capabilities. Simultaneously, summarize successful Chinese regulatory practices, contributing Chinese wisdom to global GCP development.

Conclusion: Institutional Pathways for Strengthening Regulatory Mechanisms and Professional Service Synergy

Improving GCP compliance systems requires systematic regulatory mechanism strengthening deeply integrated with professional support services. Currently, Chinese clinical trial regulation stands at a critical transition from strict enforcement to scientific regulation. Pure administrative regulatory forces cannot address increasingly complex compliance challenges alone, while market-based professional services without regulatory guidance can easily deviate from standards. Therefore, constructing regulator-led multi-party collaborative governance mechanisms has become an institutional requirement for elevating GCP compliance levels.

From a regulatory system construction perspective, regulators should incorporate professional compliance services as organic regulatory framework components through institutional design. We suggest explicitly requiring sponsors, clinical trial institutions, CROs, and other responsible parties to establish internal compliance management systems appropriate to their business scale and risk levels within pharmaceutical management regulations, deploy compliance management personnel with corresponding professional qualifications, and conduct regular compliance assessments producing written reports.

For special category trials involving innovative drugs, rare disease medications, pediatric drugs, and complex projects like multinational multicenter trials, regulators could require parties to engage independent third-party professional organizations for compliance assessment and continuous supervision, using professional assessment reports as important regulatory review references. This institutional arrangement doesn’t simply increase market entities’ compliance costs but also helps enterprises and institutions more accurately understand and implement regulatory requirements through professional intervention, preventing violation risks at the source.

Simultaneously, regulators should establish qualification certification and credit management systems for professional service organizations and personnel. Professional organizations providing false assessment opinions or exhibiting major oversights should face legal accountability and credit blacklisting, ensuring professional service independence, objectivity, and reliability.

Regulatory mechanism optimization also requires enforcement strategies embodying incentive compatibility principles. For market entities that actively strengthen compliance management, engage professional organizations for compliance guidance, and maintain good historical compliance records, regulators can provide appropriate facilitation and preferences in administrative licensing, supervision and inspection, and policy application, such as simplified approval procedures, reduced inspection frequency, and priority inclusion in innovation policy pilots.

Conversely, for entities with weak compliance awareness, absent management systems, and frequent violations, regulatory intensity should increase with higher inspection frequency. When necessary, entities could be required to engage professional organizations for time-limited compliance remediation, with remediation outcomes serving as important bases for subsequent regulatory measures. This classified and graded regulatory model creates clear policy guidance, transforming market entity compliance management from passive response to active engagement and professional services from emergency measures to routine guarantees.

Within collaborative governance frameworks, professional service providers should accurately position their roles, serving market entities while bearing social responsibility for promoting industry standardization. Professional organizations and personnel should not only provide compliance consultation, risk assessment, and system construction services but also leverage their professional advantages to participate in regulatory policy formulation and improvement.

Through industry associations, expert committees, and other channels, they should promptly report practical issues to regulators, propose policy recommendations, and promote scientific and operational regulatory rules. In frontier areas like new technology applications and novel trial designs, professional practitioners’ research and practical experience provides valuable reference for regulatory policy formulation. Simultaneously, professional service providers should maintain professional ethics, preserving independent judgment amid conflicts of interest, neither accommodating clients with opinions violating regulatory requirements nor assisting clients in regulatory evasion or violation concealment.

Looking ahead, with comprehensive ICH E6(R3) implementation and deepening digital transformation, GCP compliance will face numerous new situations and challenges. Regulators need to further improve regulatory systems, clarify compliance requirements for new technology applications, and establish regulatory mechanisms adapted to innovative development. Additionally, support for professional talent cultivation should increase through cooperation with universities, research institutions, and industry organizations, establishing systematic GCP compliance talent training systems, providing the industry with more professionals understanding both regulations and practice.

Through continuous regulatory mechanism optimization and professional service capability improvement, gradually construct a GCP compliance ecosystem featuring strong government regulation, effective industry self-regulation, adequate professional services, and sufficient social supervision. This multi-party collaborative, professionally-supported governance model will provide solid institutional guarantees for standardized, internationalized development of Chinese clinical trials, ultimately achieving multiple objectives of protecting participant rights, ensuring data quality, and promoting medical innovation. In this process, every participating entity should recognize their responsibilities and mission, collectively advancing Chinese clinical trial endeavors toward higher quality development stages.