Good Clinical Practice

Introduction

Not learn what is right,
but to practice what is right.

As an overview, Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the conduct of trials involving human participants.

Consistent with the Declaration of Helsinki, clinical trials conducted in accordance with this standard will help to assure the rights, safety and well-being of trial participants are protected.
The term "trial conduct" includes processes from planning to reporting, including planning, initiating, performing, recording, oversight, evaluation, analysis and reporting activities as appropriate.

GCP applies to interventional clinical trials of investigational products that are intended to be submitted to regulatory authorities.

From a regulatory perspective, a GCP certificate is generally not required to carry out a cross-sectional or retrospective study (which does not involve any intervention).
However, local institutional ethics committees may still prefer researchers to hold a GCP certificate as proof of ethical training.

Key Principles

Clinical trials are a fundamental part of clinical research that support the development of new medicines or uses of existing medicines.

Well-designed and conducted clinical trials help answer key questions in healthcare and drug development.
Their results are essential for evidence-based healthcare decisions.

Trials with inadequate design and/or poorly conducted trials may place participant safety at risk, yield inadequate or unreliable results and are unethical.

They waste resources and the efforts and time of investigators and participants.

Hence, GCP encourages thoughtful consideration and planning to address specific and potentially unique aspects of an individual clinical trial.

This includes evaluation of trial characteristics, such as the design elements, the investigational product being evaluated, the medical condition being addressed, the characteristics of the participants, the setting in which the clinical trial is being conducted, and the type of data being collected.
Clinical trials should be scientifically sound for their intended purpose and based on adequate and current scientific knowledge and approaches.
Clinical trials should be described in a clear, concise, scientifically sound, and operationally feasible protocol.

The use of innovative trial designs (after obtaining perspectives of interested parties such as patients and their communities, healthcare professionals) and technologies (e.g. wearables and sensors) may enable the inclusion of a wider and more diverse population of participants and thereby broaden the applicability of trial outcomes.

Investigational products used in a clinical trial should be manufactured in accordance with applicable Good Manufacturing Practice (GMP) standards and be managed in accordance with the product specifications and the trial protocol (e.g. shipping, storage, dispensing, returning and disposing).

In summary, while the primary purpose of medical research is to generate new knowledge based on reliable results, the rights, safety and well-being of the participants are the most important considerations and should prevail over interests of science and society.

The safety of the participants should be reviewed in a timely manner as new safety information becomes available, which could have an impact on participant safety, their willingness to continue in the trial or the conduct of the trial.
Foreseeable risks and inconveniences should be weighed against the anticipated benefits for the individual participants and society. A trial should be initiated and continued only if the anticipated benefits justify the known and anticipated risks.

Tripartite Guideline

Often, GCP is described as a tripartite guideline because it discusses the responsibilities of 3 parties

Institutional Review Board/Independent Ethics Committee (IRB/IEC)
Investigator
Sponsor

Institutional Review Board/Independent Ethics Committee

Should include

At least 5 members.
At least 1 member whose primary area of interest is not in medical science.
At least 1 member who is independent of the institution/trial site.

Purpose

Safeguard the rights, safety, and well-being of all trial participants.

Responsibilities

Review a proposed clinical trial, where applicable:

Protocol and amendments
Informed consent material (s), assent material (s), where applicable and any updates
Investigator's Brochure or current scientific information.
Other trial-related information to be provided to the trial participant(s)
Advertisement for participant recruitment (if used) and information on the recruitment process
Plans to compensate participants (if any)
Ongoing updates to safety information
Investigator's current curriculum vitae and/or other documentation evidencing qualifications
Any other documents that the IRB/IEC may need to fulfil its responsibilities.

Within a reasonable time, document its view in writing (i.e. approval, modifications required prior to its approval, disapproval or termination).
Conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects (i.e., at least once a year).
If minors are to be included in a trial, review the assent information considering the age, maturity and psychological state of the minor population intended to be enrolled, as well as applicable regulatory requirements.
Review both the amount and method of payment to subjects to assure that neither presents problems of coercion or undue influence on the trial subjects.

Payments to a participant should be timely, prorated and not wholly contingent on completion of the trial by the participant.
Reasonable reimbursement of expenses incurred by participants, such as for travel and lodging, is not coercive.

Ensure information regarding payment, including the methods, amounts and schedule of payment to trial participants, is set forth in the written informed consent form and any other written information to be provided to subjects.

Should retain all relevant records for a period of at least 3 years after completion of the trial and make them available upon request from the regulatory authority(ies).

Investigator

An investigator should be qualified by education, approved training including Good Clinical Practice, and experience to assume responsibility for the proper conduct of the trial.

To become an investigator, you will need to attend a local GCP workshop and pass the examination.
The investigator should also be familiar with the appropriate use of the current investigational product(s) as described in the protocol, in the current Investigator's Brochure, in the product information and/or in other information sources provided by the sponsor.

The investigator should have adequate resources (e.g. potential for recruiting the required number of eligible participants within the agreed recruitment period, sufficient time, an adequate number of available and qualified staff, and adequate facilities) for the foreseen duration of the trial to conduct the trial properly and safely.
Responsibilities:

Retains the ultimate responsibility and should maintain appropriate oversight of the persons or parties undertaking the activities delegated to ensure that the rights, safety and well-being of the trial participants and the reliability of the data.
Ensure that persons or parties to whom the investigator has delegated trial-related activities are appropriately qualified and are adequately informed about the relevant aspects of the protocol.
Maintain a record of the persons and parties to whom the investigator has delegated trial-related activities.
Permit monitoring and auditing by the sponsor, inspection by the appropriate regulatory authority(ies) and, in accordance with applicable regulatory requirements, review by IRB/IEC(s).

Before initiating a trial, the investigator/institution should have a documented and dated approval/favourable opinion from the IRB/IEC for the trial protocol, informed consent materials, participant recruitment procedures (e.g., advertisements) and any other trial-related information to be provided to participants.

The investigator or the sponsor should promptly communicate to the IRB/IEC and, where applicable, to the institution any changes significantly affecting the conduct of the trial and/or increasing the risk to participants.

The investigator should conduct the trial in compliance with the protocol agreed by the sponsor, GCP and applicable regulatory requirements.

Compliance to protocol includes investigational product management, trial's randomisation procedures and recording of trial data.
In case of deviations undertaken to eliminate immediate hazard to trial participants, the investigator should inform the sponsor promptly.

If the trial is prematurely terminated or suspended for any reason, the investigator should

Promptly inform the trial participants and should ensure appropriate therapy and follow-up for the participants.
Promptly inform the sponsor, the IRB/IEC and the regulatory authorities and should provide an appropriate and detailed explanation.

A qualified physician (or dentist, when appropriate), who is an investigator or a subinvestigator for the trial, should be responsible for all trial-related medical (or dental) decisions.
Adverse events and/or abnormal test results required for safety evaluations should be reported to the sponsor according to the reporting requirements and within the time periods specified in the protocol.
Although a participant is not obliged to provide a reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the participant’s rights.

The investigator should consider if a discussion with the participant or the participant’s legally acceptable representative is appropriate. This discussion should focus on the reasons for withdrawal to determine if there are ways to address the concerns such that the participant could reconsider their withdrawal without unduly influencing the participant’s decision.
The investigator or delegated investigator site staff should consider explaining to the participant the value of continuing their participation to minimise trial participants withdrawal. In this process, the investigator should ensure that it does not interfere with the participant’s decision to refuse or withdraw participation at any time.

The investigator/institution should maintain adequate source records that include pertinent observations on each of the trial participants under their responsibility.

Source records should be attributable, legible, contemporaneous, original, accurate and complete.
Changes to source data should be traceable, should not obscure the original entry, and should be explained if necessary (e.g., via an audit trail).
Unnecessary transcription steps between the source record and the data acquisition tool should be avoided.

Essential documents should be retained until at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product.

These documents should be retained for a longer period however if required by the applicable regulatory requirements or until the sponsor informs the investigator that these records are no longer needed, whichever is longest.
The investigator should take measures to ensure availability, accessibility and readability and to prevent unauthorised access and accidental or premature destruction of these records.

Sponsor

Entails the implementation of risk-proportionate approaches to ensure the rights, safety and well-being of the trial participants and the reliability of the trial results throughout the clinical trial life cycle.

Trial design
Resources
Allocation of activities
Qualification and training
Financing
Agreements
Investigator selection
Communication with IRB/IEC and regulatory authorities
Sponsor oversight
Quality management
Quality assurance and quality control
Safety assessment and reporting
Insurance/Indemnification/Compensation to participants and investigators
Investigational product(s)
Data and records

A sponsor may transfer any or all of the sponsor’s trial-related activities to a service provider (i.e. Contract Research Organization, CRO) in accordance with applicable regulatory requirements; however, the ultimate responsibility for the sponsor’s trial-related activities, including protection of participants’ rights, safety and well-being and reliability of the trial data, resides with the sponsor.

Any service provider used to perform clinical trial activities should implement appropriate quality management and report to the sponsor incidents that might have an impact on the safety of trial participants or/and trial results.

The sponsor should provide the potential investigator(s)/institution(s) with the protocol and an up-to-date Investigator's Brochure as well as sufficient time for the review of the protocol and the information provided.
The sponsor should ensure that trial processes are conducted in compliance with the trial protocol and related documents as well as with applicable regulatory requirements and ethical standards.
The sponsor is responsible for the ongoing safety evaluation of the investigational product(s)

The sponsor should review the available emerging safety information to assess whether there is any new data that may affect the participant’s willingness to continue in the trial, impact the conduct of the trial, or alter the approval/favourable opinion of the IRB/IEC and/or regulatory authority(ies), as applicable.
Any information of this nature should be communicated to the participants, investigator, IRB/IEC, and regulatory authorities, as applicable, in a timely manner.

Should inform the investigator(s)/institution(s) and service providers, when appropriate, in writing of the requirements for the retention of essential records and should notify the investigator(s)/institution(s) and service providers, when appropriate, in writing when the trial-related records are no longer needed in accordance with applicable regulatory requirements.

Data Governance

Both investigators and sponsors are responsible for appropriate management of data integrity, traceability and security, thereby allowing the accurate reporting, verification and interpretation of the clinical trial-related information.

The quality and amount of the information generated in a clinical trial should be sufficient to address trial objectives, provide confidence in the trial's results and support good decision making.

The following key processes should address the full data life cycle with a focus on the criticality of the data and should be implemented proportionately and documented appropriately:

Processes to ensure the protection of the confidentiality of trial participants’ data;
Processes for managing computerised systems to ensure that they are fit for purpose and used appropriately;
Processes to safeguard essential elements of the clinical trial, such as randomisation, dose adjustments, and blinding;
Processes to support key decision making, such as data finalisation prior to analysis, unblinding, allocation to analysis data sets, changes in clinical trial design and, where applicable, the activities of, for example, an IDMC.

Informed Consent

Informed consent is an integral feature of the ethical conduct of a trial.

Clinical trial participation should be voluntary and based on a consent process that ensure participants (or their legally acceptable representatives, where applicable) are well-informed.
In the event that a minor is a participant, assent should be collected from that minor, as appropriate, and in accordance with local regulatory requirements.
A process for consent should be considered if, during the course of the trial, the minor reaches the age of legal consent, in accordance with applicable regulatory requirements.

The process and information provided should be designed to achieve the primary objective of enabling potential trial participants to evaluate the benefits, risks, and burden of participating in the trial and to make an informed decision on whether or not to participate in the trial.

The information provided during the informed consent process should be clear and concise so as to be understandable by potential participants or legally acceptable representatives.
The informed consent process should take into consideration relevant aspects of the trial, such as the characteristics of the participants, the trial design, the anticipated benefits and risks of medical intervention(s), the setting and context in which the trial will be conducted (e.g., trials in emergency situations), and the potential use of technology to inform participants (or their legally acceptable representatives) and obtain informed consent.
If a participant or the legally acceptable representative is unable to read, an impartial witness should be present (remotely or in-person) during the entire informed consent discussion.

Varied approaches (e.g., text, images, videos, and other interactive methods) may be used in the informed consent process including for providing information to the participant.

The characteristics of the potential trial population (e.g., participants may lack familiarity with computerised systems) and the suitability of the method of obtaining consent should be taken into consideration when developing the informed consent materials and process.
When computerised systems are used to obtain informed consent, trial participants may be given the option to use a paper-based approach as an alternative.
Obtaining consent remotely may be considered where appropriate.

Prior to trial participation, the informed consent form should be signed and dated by the participant or by the participant’s legally acceptable representative and, where appropriate, by an impartial witness and by the investigator or delegated investigator site staff who conducted the informed consent discussion.

By signing the consent form, the investigator or delegated investigator site staff attests that the informed consent was freely given by the participant or the participant’s legally acceptable representative and the consent information was accurately explained to and apparently understood by the participant or the participant’s legally acceptable representative.
The informed consent process may involve a physical or an electronic signature and date.

In the event that new information becomes available that may be relevant to the participant's willingness to continue trial participation (e.g. emerging safety concerns), the revised informed consent materials should receive the IRB/IEC's approval in advance of use.

The participant or the participant's legally acceptable representative should then be informed in a timely matter to obtain a re-consent.
The communication of this information and confirmation of the willingness to continue trial participation should be documented.

NOTE: Parental consent is required for minors below the age of 18 years old. Assent is required for respondents between 7 years old to 18 years old.

Adverse Drug Reaction Reporting

Adverse Event is any unfavourable medical occurrence in a trial participant administered the investigational product.

The adverse event does not necessarily have a causal relationship with the treatment.

Adverse Drug Reaction

In the pre-approval clinical experience with a new investigational product or its new usages (particularly as the therapeutic dose(s) may not be established): unfavourable and unintended responses, such as a sign (e.g. laboratory results), symptom or disease related to any dose of an investigational product where a causal relationship between a medicinal product and an adverse event is a reasonable possibility. The level of certainty about the relatedness of the adverse drug reaction to an investigational product will vary.
For marketed medicinal products: a response to a drug that is noxious and unintended and that occurs at a dose normally used in humans for prophylaxis, diagnosis or therapy of diseases or for modification of physiological function.

Serious Adverse Event (SAE) = Any unfavourable medical occurrence that is considered at any dose if:

Results in death,
Is life-threatening,
Requires inpatient hospitalization or prolongation of existing hospitalization,
Results in persistent or significant disability/incapacity, or
Is a congenital anomaly/birth defect.

Reporting of Suspected Serious Unexpected Adverse Reactions (SUSAR) needs to be done

To sponsor within 24 hours and
To regulatory authorities within 7 days of awareness following death and life-threatening cases (followed by full report within 8 additional calendar days) and within 15 days of awareness for other SUSAR.

Urgent safety issues requiring immediate attention or action should be reported to the IRB/IEC and/or regulatory authority(ies) and investigators without undue delay and in accordance with applicable regulatory requirements.

If the sponsor identifies a significant safety trend from overseas data (an "aggregate" of reactions), this should be treated as an Urgent Safety Issue and reported within 48 hours to the Drug Control Authority (DCA).

Clinical Trial Exemption and Clinical Trial Import Licence

Clinical Trial Exemption (CTX) is an approval by the DCA authorizing the applicant to manufacture any local product for the purpose of clinical trial.

Clinical Trial Import Licence (CTIL) is a license in Form 4 in the schedule of The Control of Drugs and Cosmetics Regulations of 1984, authorizing the licensee to import any product for purposes of clinical trials, notwithstanding that the product is not a registered product.

Summary

We are moving beyond an era of simply conducting research to answer questions; we must now design high-quality clinical trials that produce meaningful, reliable results.

The focus has shifted from automatically excluding vulnerable populations (e.g. pregnant women, children or the elderly) to adopting a risk-proportionate approach that balances potential benefits and harms.

These key points are extracted from the Malaysian Guideline for Good Clinical Practice, 2026.

If there is any doubt, please refer to the source document for full details. All relevant guidelines are available here.

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