Good Clinical Practice for Drug Clinical Trials (2026 Revision)

Chapter 1 General Provisions

Article 1

These Guidelines are formulated to ensure the standardization of the clinical trial process, protect the rights and safety of trial participants, and ensure that data and results are scientific, authentic, and reliable, in accordance with the *Drug Administration Law of the People’s Republic of China*, the *Vaccine Administration Law of the People’s Republic of China*, the *Regulations on the Implementation of the Drug Administration Law of the People’s Republic of China*, and the *Measures for the Administration of Drug Registration*.

Article 2

These Guidelines apply to clinical trials of drugs conducted for the purpose of drug development that have been approved or filed with the drug regulatory authority of the State Council. Activities related to clinical trials of drugs shall comply with these Guidelines.

Article 3

The Good Clinical Practice (GCP) for Drug Clinical Trials sets forth the ethical, scientific, and quality standards that must be followed throughout the entire process of drug clinical trials. The entire process of drug clinical trials includes planning, initiation, conduct, documentation, monitoring, evaluation, analysis, and reporting.

Article 4

Clinical trials of drugs shall comply with the principles of the World Medical Association’s Declaration of Helsinki and relevant ethical requirements. The rights and safety of trial participants are the primary considerations and take precedence over scientific and societal benefits. Ethical review and informed consent are important measures to safeguard the rights and safety of trial participants.

Article 5

Clinical trials of drugs shall be scientifically sound and reasonable, balancing the expected risks and benefits to trial participants and society. A clinical trial may be initiated or continued only when the expected benefits are reasonable in relation to the risks.

Article 6

The design and conduct of clinical trials shall incorporate the “Quality by Design” approach, identify key quality factors and associated risks, and implement commensurate risk control measures to protect the rights and safety of trial participants and ensure the reliability of results.

Article 7

The clinical trial protocol shall be clear, concise, scientifically sound, and feasible, and may be implemented only after approval by the ethics review committee. During the conduct of a clinical trial, to ensure its ethical and scientific integrity, the protocol may be amended as necessary, but such amendments may be implemented only after obtaining renewed approval from the ethics review committee.

Article 8

All personnel involved in clinical trials shall possess the educational background, training, and practical experience necessary to perform their duties and shall adhere to the trial protocol throughout the clinical trial. Roles and responsibilities in clinical trials shall be clearly defined and properly documented. Any medical judgments or decisions shall be made by qualified clinicians.

Article 9

All paper and electronic records of clinical trials shall be properly documented, processed, and preserved to ensure the reliability and traceability of data. The privacy and security of trial participants’ personal information shall be protected in accordance with China’s relevant requirements regarding the protection of personal information. Systems and processes used for data collection, management, and analysis shall be fit for their intended purpose and commensurate with the risks to trial participants and the importance of the data collected.

Article 10

The preparation of investigational drugs shall comply with the relevant requirements for the quality management of investigational drug production; their use and management shall comply with laws and regulations and meet the requirements of the trial protocol and related documents.

Article 11

Quality management of clinical drug trials shall be implemented throughout the entire clinical trial process to protect the rights and safety of trial participants, ensure the reliability of clinical trial results, and comply with relevant laws and regulations.

Article 12

The conduct of drug clinical trials shall adhere to the principle of avoiding conflicts of interest to prevent any adverse impact on the rights and safety of trial participants or the reliability of trial results.

Article 13

The use of new technologies and methods in conducting clinical trials of drugs shall comply with ethical, scientific, and relevant legal and regulatory requirements.

Chapter II Ethics Review Committee

Article 14

The responsibility of the ethics review committee is to protect the rights and safety of trial participants. The ethics review committee shall review the ethical and scientific aspects of clinical trials, paying particular attention to the protection of vulnerable trial participants. The ethics review committee shall conduct its ethical review in accordance with the relevant provisions of the competent health authorities and the requirements of these Guidelines.

(1) The documents reviewed by the ethics review committee include: the trial protocol, the informed consent form, the methods and information used to recruit trial participants, other materials provided to trial participants, the investigator’s brochure and current scientific information, safety data, documents containing information on compensation for trial participants, documentation of the principal investigator’s qualifications, reports on major protocol deviations, progress and final reports, and other documents necessary for the ethics review committee to fulfill its duties.

(2) The ethics review committee shall pay particular attention to the following special circumstances to assess whether the rights and safety of trial participants are adequately protected: In clinical trials where participants are not expected to derive any benefit, informed consent is provided on their behalf by their legal representative. Trial participants who lack full legal capacity or have limited legal capacity. Where minors are involved, The ethics review committee shall review the informed consent information specific to minors and comprehensively consider the trial participant’s age, cognitive maturity, psychological state, and applicable regulatory requirements. The trial protocol must explicitly state that enrollment is permitted in emergency situations where neither the trial participant nor their legal representative is able to sign the informed consent form prior to the trial.

(3) The ethics review committee shall verify that there are no circumstances in which trial participants are influenced to participate in the clinical trial through coercion, inducement, or other means. The ethics review committee shall verify that the informed consent form does not contain any provisions requiring trial participants or their legal representatives to waive their lawful rights and interests, nor shall it contain any provisions exempting the principal investigator, the clinical trial institution, the sponsor, or relevant service providers from their responsibilities.

(4) The ethics review committee shall ensure that the information regarding compensation for trial participants—including the method, amount, and plan—contained in the informed consent form and other materials provided to trial participants is reasonable.

(5) The ethics review committee shall pay close attention to and promptly review the following situations: serious adverse events reported by the principal investigator during the clinical trial; deviations from or modifications to the trial protocol made during the conduct of the clinical trial to eliminate an immediate threat to trial participants; serious and persistent non-compliance issues; changes that increase the risk to trial participants or significantly affect the conduct of the clinical trial; and new information that may adversely affect the safety of trial participants or the conduct of the clinical trial. With regard to suspected and unexpected serious adverse reactions reported by the sponsor, other information on potential serious safety risks, and information related to safety update reports during drug development, The ethics review committee’s review process shall be commensurate with the urgency of the measures required and changes in the safety profile of the investigational drug.

(6) The ethics review committee shall conduct periodic follow-up reviews of ongoing clinical trials; the frequency of such reviews shall be determined based on the risk level of the trial, with intervals not exceeding 12 months.

(7) The ethics review committee shall complete the review or filing process for clinical trial-related materials within a reasonable timeframe and issue a clear written review opinion or filing acknowledgment that includes information on the version of the review document. The ethics review committee’s review opinions include: approval, disapproval, approval with modifications, re-review after modifications, continuation of the study, suspension, or termination of the study.

(8) The ethics review committee has the authority to suspend or terminate a clinical trial that is not being conducted in accordance with relevant requirements, or in which a trial participant suffers an unexpected serious harm.

(9) The ethics review committee shall accept and properly address relevant complaints from trial participants.

Article 15

The ethics review committee shall establish ethics review work systems and standard operating procedures, improve conflict-of-interest management mechanisms and ethics review quality control mechanisms, and ensure that the ethics review process is independent, objective, and impartial.

Article 16

The ethics review committee shall retain all records of ethics reviews, including written records of ethics reviews, committee member information, submitted documents, meeting minutes, and relevant correspondence. For clinical trials conducted to support a drug registration application, all records shall be retained for at least 5 years after the investigational drug is approved for marketing. For clinical trials conducted to support a drug registration application where the investigational drug is not approved, as well as for clinical trials not conducted to support a drug registration application, all records shall be retained for at least 5 years after the clinical trial is terminated.

Article 17

The ethics review committee shall promptly provide the principal investigator and the sponsor with relevant written review documents, including the name and address of the ethics review committee, a list of committee members who participated in the review of the project, the review opinion, and a statement confirming compliance with these Guidelines and relevant laws and regulations. When necessary, the principal investigator, the sponsor, or the drug regulatory authority may request that The ethics review committee provide its standard operating procedures.

Chapter III Principal Investigators and Clinical Trial Institutions

Article 18

When conducting clinical trials, a clinical trial institution shall establish a clinical trial quality management system and ensure its effective operation.

Article 19

The principal investigator is the person with ultimate responsibility at the clinical trial site and is accountable for the rights and safety of trial participants as well as the quality of the clinical trial. The principal investigator shall possess the appropriate professional qualifications for practice at the clinical trial institution, as well as the educational background, training, and practical experience required for the clinical trial; shall be familiar with the trial protocol, investigator’s brochure, and information related to the investigational drug provided by the sponsor; shall be familiar with relevant technical guidelines for clinical trials; and shall comply with these Guidelines and relevant laws and regulations.

Article 20

When the principal investigator and the clinical trial institution authorize individuals or entities to assume relevant responsibilities and functions related to the clinical trial, they shall establish comprehensive work procedures, implement effective supervision and management, and ensure that such individuals or entities possess the appropriate qualifications and are capable of properly fulfilling the relevant responsibilities and functions. If the principal investigator and the clinical trial institution indeed need to delegate responsibilities and functions related to the clinical trial to entities outside the clinical trial institution, they shall also obtain the sponsor’s prior consent. The principal investigator and the clinical trial institution bear ultimate responsibility for the matters they authorize or delegate.Decision-making and key confirmations for clinical trials under the principal investigator’s responsibility, as well as formal reporting to the ethics review committee, the clinical trial institution, and the sponsor, shall not, in principle, be delegated.

Article 21

The principal investigator and the clinical trial institution shall possess the necessary conditions required to complete the clinical trial:

(1) The principal investigator shall have sufficient time and capacity to organize and conduct the clinical trial, and to enroll a sufficient number of trial participants who meet the protocol requirements within the timeframe specified in the clinical trial contract.

(2) The principal investigator shall have the authority to use the facilities required for the clinical trial, as well as the authority to direct and supervise the researchers participating in the clinical trial, in order to conduct the clinical trial correctly and safely.

Article 22

Communication between the principal investigator and the ethics review committee shall include:

(1) Prior to the initiation of a clinical trial, the principal investigator shall obtain approval for the clinical trial protocol from the ethics review committee.

(2) Before, during, and after the clinical trial, the principal investigator shall report to the ethics review committee as required and provide all documents necessary for ethical review.

(3) The principal investigator shall promptly implement the review opinions of the ethics review committee.

Article 23

The principal investigator and authorized researchers shall comply with the trial protocol.

(1) Clinical trials shall be conducted in accordance with the protocol approved by the ethics review committee. Any deviations from the protocol shall be documented; significant protocol deviations shall be explained, and appropriate corrective and preventive measures shall be taken, with reports submitted to the ethics review committee and the sponsor.

(2) To eliminate an immediate hazard to trial participants, if a deviation from the trial protocol occurs without the consent of the ethics review committee, the principal investigator shall promptly report the matter to the ethics review committee and the sponsor, providing a justification.

(3) The principal investigator shall conduct unblinding in accordance with the requirements of the trial protocol. In the event of accidental unblinding or emergency unblinding, this shall be recorded immediately, and the reasons shall be explained in writing to the sponsor.

Article 24

In the event of early termination or suspension of a clinical trial, the principal investigator shall promptly notify the trial participants and provide them with appropriate treatment and follow-up care. If the principal investigator, the sponsor, or the ethics review committee terminates or suspends the clinical trial early, the principal investigator shall immediately report this to whichever of the sponsor and ethics review committee did not initiate the termination, and shall also notify the clinical trial institution and provide a written explanation.

Article 25

A principal investigator who is a qualified clinician, or a clinician authorized by the principal investigator, shall provide appropriate medical care to trial participants and assume responsibility for medical judgments or decisions related to the clinical trial.

Article 26

The principal investigator’s safety report shall meet the following requirements:

(1) Adverse events and abnormal test results required for safety evaluation shall be reported to the sponsor in accordance with the requirements and timelines specified in the trial protocol.

(2) Except for serious adverse events specified in the trial protocol or other documents (such as the investigator’s brochure) as not requiring immediate reporting, the principal investigator shall immediately report all serious adverse events in writing to the sponsor and the ethics review committee upon becoming aware of them, and shall subsequently provide a detailed, written follow-up report in a timely manner.

(3) For reports involving fatalities, if the sponsor, The ethics review committee, or the drug regulatory authority requests additional necessary materials—such as autopsy reports or final medical reports—the principal investigator shall provide them promptly upon receipt.

(4) Upon receiving safety information from the sponsor—including suspected and unexpected serious adverse reactions, information on other potential serious safety risks, and safety update reports during drug development—the principal investigator shall review and sign off on such information in a timely manner, consider whether to adjust the treatment of trial participants accordingly, and, if necessary, communicate with the trial participants as early as possible.

Article 27

The implementation of informed consent shall comply with the ethical principles of the Declaration of Helsinki, ensuring that trial participants voluntarily participate in the clinical trial and, through the informed consent process, receive adequate information:

(1) Prior to participation in a clinical trial, the principal investigator or an authorized researcher shall fully inform the trial participant or their legal representative of matters related to the clinical trial, obtain and document the informed consent of the trial participant or their legal representative, and use the latest version of the informed consent form approved by the ethics review committee, as well as other information provided to the trial participant.

(2) When the principal investigator obtains new information that may affect a trial participant’s willingness to continue participating in the clinical trial, the principal investigator shall promptly inform the trial participant or their legal representative and make corresponding records. If necessary, the informed consent form shall be signed again.

(3) The principal investigator and authorized researchers shall not use improper means, such as coercion or inducement, to influence a trial participant’s decision to participate in or continue participating in the clinical trial.

(4) Materials provided to trial participants, such as the informed consent form, shall be written in plain and accessible language and phrasing so that trial participants, their legal representatives, and impartial witnesses can easily understand them.

(5) Prior to signing the informed consent form, the principal investigator or an authorized researcher shall provide the trial participant or their legal representative with sufficient time and opportunity to understand the details of the clinical trial and shall fully answer any questions raised by the trial participant or their legal representative regarding the clinical trial.

(6) The trial participant or their legal representative, as well as the researcher administering the informed consent, shall each sign and date the informed consent form. If the trial participant does not sign the form personally, the relationship between the signatory and the participant shall be noted. The specific time and personnel involved in obtaining the trial participant’s informed consent shall be recorded in the medical record.

(7) If a trial participant or their legal representative lacks the ability to read, an impartial witness shall be present to witness the entire informed consent process. The contents of the informed consent form and other materials shall be explained in detail to the trial participant or their legal representative and the impartial witness. If a trial participant or their legal representative gives verbal consent to participate in the clinical trial, they should, to the extent possible and when capable, sign the informed consent form. The impartial witness must also sign and date the informed consent form to certify that the trial participant or their legal representative has received an accurate explanation of the informed consent form and other materials, understands the relevant content, and consents to participate in the clinical trial.

(8) The trial participant or their legal representative shall receive the original copy of the informed consent form, signed and dated, as well as other materials provided to the trial participant, and shall continue to receive subsequent updated versions throughout the duration of their participation in the trial.

(9) If a trial participant lacks full legal capacity, written informed consent must be obtained from their legal representative; if a trial participant has limited legal capacity, written informed consent must be obtained from both the participant and their legal representative. When a legal representative provides informed consent on behalf of a trial participant, they must inform the participant of the relevant information regarding the clinical trial to the extent the participant can understand it, and should, to the extent possible, have the participant personally sign and date the informed consent form. When a minor serves as a trial participant, informed consent must be obtained from their legal representative, who must sign the informed consent form. If the minor is capable of making the decision to participate in the clinical trial, their own consent must also be obtained. If the minor trial participant refuses to participate in the clinical trial or decides to withdraw from it midway, the minor’s own decision shall prevail, even if the legal representative has already consented to participation or wishes to continue participation. Unless the clinical trial is a therapeutic trial for a serious or life-threatening disease, and the principal investigator and the legal guardian determine that the minor trial participant’s life would be at risk if they did not participate, in which case the legal guardian’s consent alone is sufficient for the trial participant to join or continue participating; if, during the course of the clinical trial, a minor trial participant meets the criteria to sign the informed consent form, the trial may only continue after the minor has personally signed the form. For individuals with limited capacity for civil conduct, once their capacity is restored, their informed consent must be obtained again to secure their voluntary agreement to continue or withdraw from the relevant clinical trial.

(10) In emergency situations where it is impossible to obtain the trial participant’s informed consent prior to participation in a clinical trial, the participant’s legal representative may provide informed consent on the participant’s behalf. If the legal representative is also unavailable, the procedures for enrolling the trial participant shall be clearly outlined in the trial protocol and other documents that have already been approved in writing by the ethics review committee. The trial participant or their legal representative shall be informed of the trial details as soon as possible, and informed consent shall be obtained in a timely manner.

(11) When a trial participant takes part in a clinical trial with no anticipated benefit, the informed consent form shall, in principle, be signed by the trial participant personally.

Article 28

The principal investigator and the clinical trial institution shall be responsible for managing the investigational drug provided by the sponsor.

(1) The principal investigator and the clinical trial institution shall designate a dedicated person with appropriate qualifications to manage the investigational drug. The clinical trial institution shall comply with relevant regulations and maintain records regarding the receipt, handling, storage, distribution, use, recall, return, and destruction of the investigational drug. The principal investigator shall ensure that the investigational drug is used in accordance with the trial protocol and shall explain the correct method of use to the trial participant.

(2) The principal investigator shall randomly select and retain samples of investigational drugs used in bioequivalence trials, retain such samples for at least two years after the drug’s market authorization, and establish corresponding management systems. The clinical trial institution may entrust the retention of such samples to a qualified independent third party, but shall not return them to the sponsor or any third party with a conflict of interest.

Article 29

Records and reports of clinical trials shall meet the following requirements:

(1) The principal investigator shall supervise data collection at the trial site and the performance of duties by all research personnel to ensure the reliability of the data.

(2) The principal investigator shall ensure that all clinical trial data are derived from the source records of the clinical trial and guarantee their reliability and traceability.Source records shall be attributable, legible, contemporaneous, original, accurate, and complete. Any amendments to source records shall be traceable, shall not obscure the original record, and shall include a rationale for the amendment. For clinical trials involving patients as trial participants, the relevant medical records shall be entered into the outpatient or inpatient medical record system.

(3) The principal investigator and the clinical trial institution shall properly retain trial documentation in accordance with the relevant regulatory requirements of the drug regulatory authorities. For clinical trials used to support a drug registration application, the essential records of the clinical trial shall be retained for at least 5 years after the investigational drug is approved for marketing; for clinical trials used to support a drug registration application but where the investigational drug was not approved, as well as for clinical trials not used to support a drug registration application, the essential records shall be retained for at least 5 years after the clinical trial is terminated.

(4) During the processing of clinical trial data and trial participant information, care must be taken to prevent any illegal or unauthorized collection, storage, use, alteration, transmission, disclosure, publication, or deletion. The recording, processing, and retention of clinical trial data must ensure the security of the records and trial participant information.

(5) The transfer of ownership of essential records must comply with the requirements of relevant laws and regulations.

Article 30

The principal investigator shall submit a clinical trial report.

(1) The principal investigator shall submit progress and final reports in accordance with the requirements of the ethics review committee.

(2) Upon completion of the clinical trial, the principal investigator shall promptly submit a written report to the clinical trial institution.

(3) The principal investigator shall provide the sponsor with the clinical trial-related reports required by the drug regulatory authorities.

Article 31

The principal investigator and the clinical trial institution shall accept monitoring and audits organized by the sponsor, as well as inspections by the drug regulatory authority, and shall cooperate by providing the required records related to the clinical trial.

Chapter IV Sponsors

Article 32

As the party ultimately responsible for activities related to clinical trials, the sponsor shall regard the protection of the rights and safety of trial participants and the reliability of data as fundamental considerations in clinical trials.

Article 33

When designing a clinical trial protocol, the sponsor shall base it on sufficient safety and efficacy data, incorporate the “Quality by Design” approach, and ensure the scientific rigor, reliability, and feasibility of the clinical trial.

Article 34

The sponsor shall select appropriately qualified personnel based on the needs of the clinical trial, establish a research and management team to conduct the clinical trial, and provide guidance and supervision throughout the entire clinical trial process. The sponsor shall establish effective communication channels to ensure that all participants can communicate promptly throughout the clinical trial and shall document the content of key communications. The sponsor shall have medical personnel on staff to promptly address medical questions related to the clinical trial.

Article 35

The sponsor shall conduct a prior assessment and select principal investigators and clinical trial institutions that meet the requirements to fulfill the needs of conducting the clinical trial.

Article 36

When the sponsor engages a service provider, the following requirements must be met:

(1) The sponsor may delegate some or all of the clinical trial tasks to qualified service providers, but shall supervise and manage the service providers and their further subcontracting activities, and bear ultimate responsibility. If the service provider subcontracts any tasks, it shall obtain the sponsor’s prior written consent.

(2) Prior to the commencement of clinical trial activities, the sponsor shall enter into a clinical trial contract with all relevant parties participating in the clinical trial—including the principal investigator, the clinical trial institution, and any service providers commissioned by the sponsor—to clearly define the roles, responsibilities, rights, and obligations of each party, as well as any potential conflicts of interest that the parties must avoid. The clinical trial contract shall contain clear and comprehensive terms, and the trial budget shall be reasonable and consistent with market principles.

(3) The requirements for sponsors set forth in these Guidelines also apply to service providers undertaking tasks on behalf of the sponsor.

Article 37

The sponsor is responsible for selecting laboratories that comply with relevant regulations and possess the appropriate qualifications to conduct the testing and analysis of biological samples, and for overseeing the laboratory’s quality management throughout the entire process—including the management, testing, analysis, transportation, storage, and destruction of biological samples collected during the clinical trial. The performance of biological sample testing unrelated to the trial protocol approved by the ethics review committee (such as genetic testing) is prohibited. The sponsor shall clearly specify in the informed consent form the circumstances regarding the continued storage or potential future use of remaining biological samples after the conclusion of the clinical trial, including the duration of storage, data confidentiality issues, and the circumstances under which data and biological samples may be shared.

Article 38

Prior to the commencement of a clinical trial, the sponsor shall submit relevant clinical trial documentation to the State Council’s drug regulatory authority to obtain a clinical trial authorization or complete the filing for bioequivalence trials. The sponsor shall promptly obtain the relevant records from the ethics review committee and implement The ethics review committee’s recommendations as required.

Article 39

The sponsor shall prepare documents such as the clinical trial protocol, investigator’s brochure, and informed consent materials, update them in a timely manner, and provide the latest versions to the principal investigator and the ethics review committee. The informed consent form shall be comprehensive, complete, and easy to understand, and shall comply with relevant requirements, including those for ethics review.

Article 40

The sponsor shall, based on risk, adopt an appropriate system to manage the quality of the entire clinical trial process, effectively design and conduct the clinical trial, and monitor the entire clinical trial process. The scope and extent of the sponsor’s monitoring measures shall be appropriate to the purpose and commensurate with the complexity and risks of the clinical trial.

Article 41

The sponsor shall implement quality assurance and quality control for the clinical trial.

(1) The sponsor is responsible for establishing, implementing, and promptly updating written standard operating procedures related to quality assurance and quality control for clinical trials, ensuring that the conduct of the clinical trial, as well as the generation, recording, and reporting of data, comply with the trial protocol and meet the requirements of these Guidelines and regulatory requirements.

(2) Quality assurance shall be integrated throughout the entire clinical trial process, employing a risk-based strategy to identify causes of serious noncompliance with the trial protocol and violations of these Guidelines and regulatory requirements, thereby enabling the implementation of corrective and preventive actions. The sponsor shall conduct audits in a manner commensurate with the risks associated with the conduct of the clinical trial. The sponsor’s audits shall be independent of routine monitoring or quality control functions and are intended to assess whether trial management, conduct, and relevant participants comply with the trial protocol, these Guidelines, and regulatory requirements.

(3) The sponsor shall adopt a risk-based approach to quality control at every stage and in every aspect of clinical trial conduct to ensure procedural compliance and data reliability. In clinical trials, monitoring and data management are the primary quality control activities. The sponsor shall appoint qualified monitors to conduct monitoring of the clinical trial.

Article 42

The sponsor shall conduct risk management for the clinical trial.

(1) The sponsor shall, prior to the start of the trial and throughout its duration, identify risks that may have a significant impact on critical quality factors, and assess the likelihood of such risks occurring, the extent to which they can be detected, and their impact on the protection of trial participants and the reliability of trial results.

(2) Risk control measures shall be commensurate with the significance of the risk’s impact on the welfare and safety of trial participants and on the reliability of trial results. Where critical quality factors that may affect the safety of trial participants or the reliability of trial results are involved, the sponsor shall establish acceptable risk control limits in advance and, when these limits are exceeded, assess whether measures need to be taken.

(3) The sponsor shall document identified risks and corresponding mitigation measures, and communicate with personnel involved in implementing these measures or affected by such activities.

(4) The sponsor shall periodically review risk control measures in light of new knowledge and experience gained during the clinical trial to ensure the effectiveness and applicability of current quality management activities, and shall consider implementing additional risk control measures as necessary.

(5) The sponsor shall summarize and report significant quality issues in the clinical trial report, including deviations from the predefined acceptable range and corrective actions.

Article 43

The sponsor shall ensure compliance with the clinical trial.

(1) Take appropriate corrective measures in cases where the principal investigator, the clinical trial institution, the sponsor’s staff, or service providers fail to comply with the trial protocol, standard operating procedures, these Guidelines, or regulatory requirements during the clinical trial.

(2) Upon discovering non-compliance issues that have or may have a significant impact on the rights and safety of trial participants or on the reliability of trial results, the sponsor shall promptly analyze the root causes, take appropriate and sufficient corrective and preventive measures, and promptly report in writing to the ethics review committee.

(3) Upon discovering serious or persistent non-compliance issues, the sponsor shall consider terminating the continued participation of the principal investigator, clinical trial institution, or service provider in the clinical trial, promptly report the matter in writing to the ethics review committee, and take measures to minimize the impact on trial participants and the reliability of the trial results. If violations of the trial protocol or these Guidelines are severe, the sponsor may hold the relevant personnel accountable and report the matter to the drug regulatory authorities.

Article 44

The sponsor shall conduct ongoing safety assessments during the course of a clinical drug trial and submit reports in accordance with the required standards and timelines.

(1) The sponsor shall review and evaluate available safety information. The sponsor shall promptly notify the principal investigator, the clinical trial institution, and the ethics review committee of any newly identified issues that may affect the safety or willingness to participate of trial participants, may affect the conduct of the clinical trial, or may alter The ethics review committee’s approval decision; ensure that trial participants are promptly informed; and make necessary updates to documents such as the trial protocol, investigator’s brochure, and informed consent materials in accordance with regulations.

(2) Upon receiving safety-related information from any source, the sponsor shall immediately analyze and evaluate it, including its severity, relevance to the investigational drug, and whether it constitutes an expected event.

(3) The sponsor shall expedite reporting of suspected and unexpected serious adverse reactions, as well as other information regarding potential serious safety risks, to the Center for Drug Evaluation of the National Medical Products Administration; the method of expedited reporting shall comply with relevant requirements. The sponsor’s method of submitting reports of suspected and unexpected serious adverse reactions to the principal investigator and the ethics review committee shall be commensurate with the urgency of the required actions and changes in the safety profile of the investigational drug. Risk management requirements issued by drug regulatory authorities, other information regarding potential serious safety risks, and urgent safety issues requiring immediate attention or action shall be reported to the ethics review committee and the principal investigator in accordance with the time limits for rapid reporting.

(4) The sponsor shall periodically submit safety update reports to the Center for Drug Evaluation of the National Medical Products Administration during the drug development period and, as required, communicate relevant information to the principal investigator and the ethics review committee.

(5) If safety issues or other risks are identified during a clinical trial, the sponsor shall promptly amend the protocol, suspend or terminate the clinical trial, and report the matter to the Center for Drug Evaluation of the National Medical Products Administration.

Article 45

The sponsor shall provide investigational medicinal products to trial participants free of charge and shall pay for medical testing costs related to the clinical trial. The sponsor shall take appropriate measures to ensure that compensation or indemnification can be provided to trial participants and the principal investigator. The sponsor shall provide legal and financial insurance or guarantees to compensate or indemnify for damages related to the clinical trial, commensurate with the nature and degree of risk of the clinical trial, excluding damages caused by the negligence of the principal investigator or the clinical trial institution itself. The sponsor shall bear the medical expenses for harms related to a trial participant’s participation in the clinical trial, as well as the corresponding compensation or indemnification. The sponsor and the principal investigator shall promptly provide compensation or indemnification to trial participants. The methods and procedures for providing compensation or indemnification shall comply with relevant laws and regulations.

Article 46

The sponsor is responsible for providing investigational drugs to the principal investigator and the clinical trial institution. The preparation, supply, and management of investigational drugs shall comply with the following requirements:

(1) The sponsor shall ensure that investigational drugs are manufactured and released under conditions that comply with the relevant quality management requirements for the production of investigational drugs; the labels of investigational drugs shall indicate that they are for clinical trial use only, and shall include information regarding the clinical trial and the investigational drug; investigational drugs shall remain blinded in blinded trials.

(2) The sponsor shall clearly specify the storage and transportation conditions, shelf life, and methods of use for investigational drugs to ensure that the drugs are not contaminated or deteriorated during transportation and storage. The sponsor shall provide the principal investigator and the clinical trial institution with corresponding written instructions and retain relevant records. Where investigational drugs are vaccines, their procurement, storage, transportation, and administration shall also comply with relevant regulations governing vaccines.

(3) After a clinical trial has been approved by an ethics review committee and licensed or filed with the State Council’s drug regulatory authority, the sponsor shall promptly provide the investigational drug to the principal investigator and the clinical trial institution.

(4) The sponsor shall establish procedures for the supply and management of investigational drugs, including systems for the receipt, handling, storage, distribution, use, recall, and destruction of such drugs. Investigational drugs recovered from trial participants and unused investigational drugs at the clinical trial institution shall be returned to the sponsor or disposed of in other ways authorized by the sponsor. The entire management process of all investigational drugs shall be documented in writing, and accurate counts shall be maintained throughout the process.

(5) In blinded trials, procedures and mechanisms for emergency unblinding shall be established to enable rapid identification of the investigational drug when unblinding is necessary due to a medical emergency, while maintaining the blinding of treatment assignments for other trial participants.

(6) The sponsor shall take measures to ensure the stability of investigational drugs during the clinical trial, ensure that they are provided only within their expiration dates, and retain sufficient quantities of investigational drug samples; the quantity, method, and duration of sample retention shall comply with the relevant requirements.

Article 47

In blinded trials, the sponsor shall establish operational procedures to ensure that blinding is maintained throughout all phases of the clinical trial and to prevent and identify unblinding.

Article 48

The sponsor shall fulfill its data governance responsibilities to ensure the reliability, traceability, and security of data.

(1) The sponsor shall ensure that any electronic data management systems deployed or used in the clinical trial meet the requirements for computerized systems; the sponsor shall also confirm that the computerized systems used by the principal investigator, his or her authorized researchers, and the clinical trial institution meets the requirements for the clinical trial.

(2) The sponsor shall not alter data entered by the principal investigator, the principal investigator’s authorized researchers, or trial participants, unless there is a valid reason to do so; in such cases, the sponsor shall obtain the principal investigator’s written consent prior to making any changes and shall document such changes.

(3) The sponsor shall use the trial participant’s identification code to identify all clinical trial data for each trial participant. After the clinical trial is unblinded, the sponsor shall provide the principal investigator with treatment information for participants in blinded trials.

(4) The sponsor shall develop a statistical analysis plan consistent with the trial protocol, implement appropriate quality control over statistical programming, data processing, and analysis, and document these processes.

(5) The sponsor shall retain the necessary records related to the clinical trial in accordance with regulatory requirements and shall inform the principal investigator, clinical trial institutions, and service providers in writing of the requirements for retaining trial records.

Article 49

The sponsor shall clearly define access rights to trial records.

(1) The sponsor shall specify in the trial protocol or other written contracts that the principal investigator, clinical trial institutions, and service providers shall permit monitors, auditors, reviewers from the ethics review committee, and inspectors from the drug regulatory authority to directly access source records related to the clinical trial.

(2) The sponsor shall ensure that each trial participant has provided written consent allowing monitors, auditors, members of the ethics review committee, and inspectors from the drug regulatory authority to directly access source records related to the clinical trial.

Article 50

If a change in the sponsor occurs during a clinical trial, the sponsor shall obtain approval from the State Council’s drug regulatory authority in accordance with regulations. If the sponsor suspends or prematurely terminates an ongoing clinical trial, or if a change in the sponsor occurs during the trial, the sponsor shall promptly notify the principal investigator, the clinical trial institution, and the ethics review committee in writing, providing an explanation of the reasons. The sponsor shall submit a clinical trial report to the drug regulatory authority in accordance with regulatory requirements. The clinical trial report shall comprehensively, completely, and accurately reflect the results of the clinical trial, and the clinical trial data shall be consistent with the source records.

Chapter V Data Governance

Article 51

The sponsor, principal investigator, and clinical trial institution shall assume responsibility for data governance within the scope of their respective duties. Data governance spans the entire lifecycle of clinical trial data to ensure the accurate reporting, verification, and interpretation of information related to the clinical trial.

(1) Data obtained from any source, including data collected directly in computerized systems, shall be accompanied by corresponding metadata, including audit trails.

(2) The sponsor, principal investigator, and clinical trial institution shall employ appropriate methods to apply, evaluate, access, and manage metadata, and shall establish procedures for reviewing data and metadata.

(3) The sponsor and clinical trial institutions shall establish procedures for correcting data errors; the sponsor and principal investigator shall promptly correct data errors that may affect the reliability of trial results and ensure the traceability of the correction process.

(4) The sponsor, principal investigator, and clinical trial institution shall establish validated processes to ensure the reliability, traceability, and security of electronic data (including associated metadata) transmitted between computerized systems, and to prevent data loss or tampering.

(5) The sponsor shall define interim and final analysis data that meet quality standards and implement timely and reliable processes for data collection, reconciliation, validation, review, and error correction, as well as, where possible, rectify omissions that could have a significant impact on the safety of trial participants or the reliability of trial results. Prior to statistical analysis, the data set shall be finalized in accordance with pre-established procedures; the determination of data extraction and analysis sets shall follow the statistical analysis plan and be documented.

Article 52

In blinded trials, blinding integrity shall be maintained throughout all applicable phases of the clinical trial, and appropriate blinding management measures shall be implemented to prevent trial bias resulting from accidental unblinding. Prior to the commencement of a clinical trial, all relevant parties shall define the roles, responsibilities, and procedures for accessing unblinded information and maintain records thereof; during the trial, instances of unblinding or accidental unblinding shall be documented, their impact on trial results assessed, and appropriate and necessary measures taken.

Article 53

All parties involved in a clinical trial shall ensure that the computerized systems used in the clinical trial meet the requirements for the reliability, traceability, and security of trial data.

(1) Standard operating procedures for the configuration, installation, and use of computerized systems shall be established, clearly defining the responsibilities of all parties involved in the clinical trial when using such systems, to ensure their proper use during the collection, processing, and management of clinical trial data. All personnel using computerized systems shall undergo training.

(2) Data security management for computerized systems shall cover the entire data lifecycle of trial data and records, ensure that security controls are implemented for the computerized systems, and continuously take measures to prevent, detect, and mitigate security vulnerabilities. Adequate backups of trial data generated by computerized systems shall be made in a timely manner, and contingency measures shall be implemented in the event of system failure to prevent data loss or inaccessibility.

(3) Computerized systems used by all parties involved in clinical trials shall undergo reliable system validation to ensure they meet their intended use and predefined technical performance specifications, thereby guaranteeing the reliability of trial data and ensuring that the system remains in a validated and effective state throughout the entire trial.

(4) All parties involved in clinical trials shall establish workflows to record, evaluate, and manage issues arising in computerized systems; periodically review collected issues to identify recurring or systemic problems; and address them appropriately based on their severity.

(5) Computerized systems shall have comprehensive user management, access control, and audit trails to ensure that only authorized users may access and use the system, thereby enabling traceability of access and operations. Where electronic signatures are used, they shall comply with China’s relevant requirements regarding electronic signatures. User permissions shall be consistent with their job responsibilities, blinding protocols, and the organization to which they belong. Authorized users and their permissions shall be clearly documented, maintained, and retained.

Chapter VI Supplementary Provisions

Article 54

The following terms used in these guidelines shall have the following meanings:

(1) Trial participant, also known as a subject, refers to an individual participating in a clinical drug trial who is expected to receive the investigational drug or be enrolled in the control group.

(2) “Principal Investigator” means the head of the clinical trial research team at a clinical trial site, who is responsible for the rights and safety of trial participants at the site and for the reliability of clinical trial data during the conduct of the clinical trial.

(3) “Other potential serious safety risk information” refers to information that significantly affects the benefit-risk assessment of a drug, may alter the drug’s usage, or impact the overall drug development process.

(4) Quality management of clinical trials refers to the management of the quality of clinical trials, including the establishment of a quality management system and the implementation of specific quality management activities. The purpose is to protect the rights and safety of trial participants, ensure that data and results are scientific, authentic, and reliable, and ensure that the entire trial process complies with the trial protocol, these guidelines, and relevant laws and regulations.

(5) A quality management system for clinical trials refers to a mechanism for managing quality throughout the entire clinical trial process. With the protection of trial participants and data reliability at its core, it defines responsibilities, standards, and procedures; uses a risk-based approach to prevent, identify, and address abnormal events; and promotes continuous improvement to achieve established quality management objectives. In addition to the terms and definitions included in this clause, other terms and definitions relevant to this guideline may be found in the glossary of the Chinese version of ICH E6(R3). This guideline shall take effect on September 1, 2026.