Good Clinical Practices

What is good clinical practice?

The 2002 Good Clinical Research Practice (GCP) Manual of the World Health Organization (WHO) states that to establish
the safety and effectiveness of specific health and medical products and practices, it is necessary to conduct clinical
research. Randomized controlled clinical trials (designed to answer important scientific and healthcare questions) have
contributed to much of what we now know regarding the safety and effectiveness of specific products and treatments.
However, the Manual emphasizes that 'such research can only be relied upon if it is carried out in accordance with the
principles and standards collectively called 'Good Clinical Practice' (WHO, 2002).

GCP is defined by the International Conference on Harmonization (ICH) 2016 Good Clinical Practice guideline as ' a
standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of trials clinical
trials that provide assurance that the data and results reported are credible and accurate, and that the rights, integrity,
and confidentiality of test subjects are protected .”

GCP principles are concerned with the safety, rights and well-being of participants and the validity and quality of research
data. The thirteen principles of the 2016 ICH-GCP guidelines are as follows:
1. Principle 1: The study should be conducted in accordance with the Declaration of Helsinki and in compliance
with GCP and all applicable regulatory requirements.
2. Principle 2: Any foreseeable risks and inconveniences to the subject must be weighed against the anticipated
benefits.
3. Principle 3: The rights, safety and well-being of participants always take priority over the interests of science and
society.
4. Principle 4: The clinical and non-clinical information available on the investigational medicinal product being
used should be adequate to support the study.
5. Principles 5 + 6: Research must be scientifically sound and described in a clear and detailed protocol that has
received Independent Ethics Committee (IEC)/Institutional Review Board (IRB) approval and must be followed
6. Principle 7: Medical care must be provided by a qualified physician.
7. Principle 8: Persons involved in career studies must be qualified by education, training, and experience to
perform their tasks.
8. Principle 9: Informed consent must be freely given by each participant.
9. Principles 10 + 11: Information should be recorded, managed and stored in a manner that allows for accurate
reporting, interpretation and verification and that ensures the confidentiality of participant records. This applies to
all records, regardless of the type of media used.
10. Principle 12: Investigational products should be used in accordance with the approved protocol.
11. Principle 13: Systems that ensure the quality of all aspects of the trial should be implemented with a focus on
ensuring subject protection and reliability of trial results.

Who is involved with GCP?

Everyone involved in clinical research must understand GCP, but there are three key roles that must be defined to
understand why adherence to GCP is so important for clinical research. They are the sponsor, the investigator and the
subinvestigator :
➢ Sponsor: individual, company, institution or organization that assumes responsibility for initiating, managing
and/or financing a clinical trial.
➢ Investigator: person responsible for carrying out the clinical trial at a trial center. If a trial is carried out by a team
of people at a trial site, the investigator is the responsible leader of the team and may be called the principal
investigator.
➢ Subinvestigator: Any individual member of the clinical trial team designated and supervised by the investigator
at a trial site to perform critical trial-related procedures and/or make important trial-related decisions (e.g. e.g.,
associates, residents, research fellows).
GCP Recognition
In some regions, such as Europe and the USA. In the US, the requirements of the 2016 ICH-GCP guidelines are
incorporated into your legislation. However, although this requirement is limited to specific studies, such as interventional
trials with investigational drugs, the sponsor and many other organizations (e.g., funding agencies, publishers) request that
studies be conducted in accordance with the principles of BPC to ensure a similar 'standard'. .

It is important that researchers in low- and middle-income countries clearly demonstrate that they are pragmatically
adopting GCP principles and therefore working to this same standard. This ensures that their studies provide assurance that
their participants were protected and that the results are as reliable as the results of research conducted in any other GCP-
compliant study around the world.

Be GCP qualified
The researcher must know and comply with GCP as applicable to his or her particular study and must be familiar with all
regulatory and ethical requirements, both national and local.

All persons involved in the implementation of any aspect of a clinical research study must be appropriately qualified to be
able to perform their tasks in accordance with GCP requirements. According to GCP, being 'qualified' means that each
individual involved in implementing a part of the research study must be able to do their job through their:
● education
● training
● experience

It is important to note that while there are many GCP training courses offered by different organisations, there is no actual
GCP 'qualification'. This course will explain what the GCP responsibilities of a researcher are. It is being aware of these
responsibilities that generally defines someone as “trained” in GCP. Investigators and study staff should already be
appropriately trained in their field and then receive protocol-specific training on study-related activities.

GCP responsibilities of researchers

The GCP guidelines advise that the following aspects of a study are the responsibility of the researcher:
❏ Obtain informed consent from study participants
❏ Randomization and unblinding procedures, when necessary
❏ Medical care of study participants
❏ Communication with IEC/IRB
❏ Handling and handling of research products on site
❏ Compliance with study protocol
❏ Qualified personnel and agreements
❏ Records and Report Management
❏ Security reports
❏ Ensure adequate resources
❏ Management of premature termination or suspension of a study
❏ Progress reports and final reports

Obtain informed consent from study participants

The researcher must always comply with international and local ethical and regulatory requirements for the informed
consent process.

A key condition is that before the start of the study, the investigator must obtain written approval from the IEC/IRB.
During the consent process, the participant (or their acceptable legal representative) must be fully informed of all relevant
aspects of the study, including IEC/IRB approval. All oral and written communication and information provided to them
must be in non-technical and understandable language. Oral or written study information should never waive the rights of a
participant or exempt those involved in conducting the research from liability for negligence.

If the person cannot read, an impartial witness must be present. The 2002 Council of International Organizations of
Medical Sciences (CIOMS) guidelines emphasize that if the person taking consent does not speak or read the participant's
language, that person is not permitted to give consent without a witness who understands the language. of the participant.

The witness signs the Informed Consent Form (ICF) to confirm that they observed that the information sheet was explained
to the participant, that they understood the information, that their questions were answered, and that they freely consented.
The participant provides their mark/fingerprint and the person taking the consent writes their name.

The participant must have signed/checked the consent form before being able to participate in the study. A signed/marked
copy of the consent form must be given to the participant; A copy of a blank form is not acceptable to document consent.
The entire informed consent process, including all documentation related to the communication of new information, must
be documented in the medical records/source file.

The 1996 ICH GCP guideline specifies what should be included in the information provided to a potential participant. This
includes:
● information about all applicable parts of the study, such as its purpose, duration, how many will be recruited,
procedures required (including randomization, if applicable), the fact that it is research, not individualized medical
treatment, and key contacts;
● the reassurance that the individual can always ask the research team for additional information at any time and
that, if they change their mind about participation, they can withdraw from the study without obligation to explain
why;
● an explanation of the benefits and risks involved in participating, the costs involved and any compensation that
may be provided;
● details of what is expected of them, the duration of their participation, what steps will be taken if they suffer a
study-related injury and whether there are alternative treatments/options available to them;
● information about who has the authority to see your personal data and how this information will be handled;
● an explanation that if a better treatment is developed or the study is determined to be unsafe, the study may be
stopped and your participation may be terminated.

The person taking consent must allow the individual sufficient time and opportunity to ask about the details of the study
and decide whether or not to participate. All questions about the study must be answered to the person's satisfaction. A
potential participant should never be coerced or unduly influenced into consenting to participate.

The investigator must obtain sponsor approval (if any) of any suggested revision, before submitting it for approval to the
IEC/IRB. If important new information becomes available that may be relevant to participants, any written materials they
may receive should be revised to reflect this information. IEC/IRB approval is needed for these amendments. Participants
must be informed, in writing, in a timely manner about new information and this must be documented.

Vulnerable subjects - Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the
expectation, justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
hierarchy in in case they refuse to participate. For example, members of a group with a hierarchical structure, such as
medical, pharmacy, dental and nursing students, subordinate staff in hospitals and laboratories, employees of the
pharmaceutical industry, members of the armed forces, and detainees. Other vulnerable subjects include patients with
incurable diseases, people in nursing homes, unemployed or impoverished people, patients in emergency situations,
minority ethnic groups, homeless people, nomads, refugees, minors and those incapable of giving consent.
When studies include people who cannot give consent themselves (e.g. minors, people with mental disabilities), the person
should be informed in a way they can understand and, if capable, should assent and sign/mark a consent form. The
informed consent form will then be signed and dated by your legal representative.

In emergency situations, when the participant's prior consent is not possible, the consent of his or her legally acceptable
representative must be sought. When prior participant consent is not possible and the representative is not available,
recruitment procedures should be described in the protocol or other IRB/IEC approved documents and will typically
involve the use of an impartial witness. The subject or the subject's legal representative must be informed as soon as
possible and provide consent to continue and other consent as appropriate. This typically applies to studies that might
enroll trauma victims.

Greater consideration must be taken when taking informed consent from a vulnerable person or population. According to
CIOMS (Guideline 13, CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects,
2002), in the context of research ethics, vulnerable people are those who are relatively or absolutely unable to protect their
own interests. More formally, they may not have enough power, intelligence, education, resources, strength, or other
attributes necessary to protect their own interests. The full ICH-GCP definition of a vulnerable subject is available by
clicking here: (1.61, ICH GCP 2016)

Special justification is required to invite vulnerable people to participate in research. If they are selected, their rights and
well-being must be strictly protected and participation is only justified if the research responds to their or their
community's needs and priorities.

Randomization and unblinding procedures

The investigator must follow randomization and blinding procedures as outlined in the study protocol.

Randomization of intervention is introduced in controlled research studies with the goal of reducing the possibility of
selection bias so that participants in one group are not somehow different from those in another group. Several methods of
randomization are available, and usually the statistician will decide the method appropriate for the research question and
study design. The researcher must strictly follow the randomization scheme to ensure unbiased assignment of participants
to comparable groups.

Blinding (also called masking) is introduced in controlled research studies to avoid conscious or subconscious observation
bias of the parties involved, invalidating the results. Blinding can be single-blind so that only the participants do not know
what they are receiving, or double-blind so that neither the participants nor the researchers know the treatment in each
group. Another form of blinding is to keep only observers who evaluate certain criteria blinded, such as laboratory staff or
clinical staff who evaluate efficacy or safety endpoints.

There are times when it may be necessary to unmask the intervention a participant has received. Lu and Davis (2010) state
that "there are very few appropriate reasons to break study blinding, but they include situations in which a participant's
course of treatment depends on knowledge of which study agent was administered."

The protocol should contain the procedure to follow when unblinding is required and the investigator should be familiar
with and follow these procedures. If unblinding is necessary, GCP guidelines suggest that the investigator adhere to the
following:
● unmasking is carried out only in accordance with the protocol.
● The sponsor must be notified immediately and, where appropriate, may need to be contacted before the
unmasking procedure can be carried out. However, it is important to remember that a pragmatic approach should
be taken, for example it may not be practical to do so in emergency situations, in which case the sponsor should
be notified as soon as possible after unblinding is carried out.
● There is complete documentation of the clarification that must include the justification for the action.
Medical care of participants
Principle 7 of the ICH GCP guideline recommends the involvement of a qualified physician in the conduct of a trial. The
physician must be an investigator or subinvestigator and is responsible for the medical care provided to participants and for
all medical decisions related to the study.

It is essential to remember that the rights, safety and well-being of research participants always take precedence over the
interests of science and society. Therefore, study participants should be monitored and any suspected adverse events (AEs)
should be addressed by the study physician.

Adverse event: Any adverse medical event in a patient or clinical research subject who was administered a pharmaceutical
product and which does not necessarily have a causal relationship with this treatment. Therefore, an adverse event (AE)
can be any unfavorable and unintentional sign (including an abnormal laboratory finding), symptom or disease temporally
associated with the use of an (investigational) drug, whether or not related to the drug (in investigation).

GCP recommends that this physician ensure that appropriate care is provided in the case of an AE or clinically significant
abnormal laboratory values. They must inform the participant if medical care is needed for an illness that occurs between
or during the study interventions. It is also advisable that they inform the person's doctor (if any) of their participation in
the study, if the participant agrees.

Any clinically significant AEs, illnesses, or abnormal laboratory values, actions taken, and treatments provided should be
documented. It must also be recorded if the individual withdraws, and this must include the reason for withdrawal, if the
participant is willing to provide one.

IEC/IRB Communications and Approvals

All proposed trials must be reviewed and approved by an IEC. Review the trial protocol and any documentation intended
for the trial subject, such as the patient information sheet, consent form, and questionnaires.

The requirements for the composition and functioning of an Independent Ethics Committee (IEC) and an Institutional
Research Board (IRB) are set out in the ICH and WHO GCP guidelines.
● IEC - An independent body (a review board or committee, institutional, regional, national or supranational), made
up of medical professionals and non-medical members, whose responsibility is to ensure the protection of rights,
safety and well-being. of human subjects involved in a trial and to provide public assurance of that protection by,
among other things, reviewing and approving/providing a favorable opinion on the trial protocol, the suitability of
the investigator(s), the facilities and the methods and material used. will be used to obtain and document informed
consent from trial subjects.
● IRB - An independent body constituted of medical, scientific and non-scientific members, whose responsibility is
to ensure the protection of the rights, safety and well-being of human subjects involved in a trial, among other
things, by reviewing, approving, and providing a ongoing review of the trial protocol and amendments and of the
methods and materials that will be used to obtain and document informed consent from trial subjects.

IEC/IRB approval must be sought for all procedures involving participants. This includes approval of recruitment
procedures (including advertisements), any documents that will be given to potential participants before or during the
informed consent procedure, and anything given to participants once they are involved in the study. . This approval covers
any planned compensation for time, inconvenience, etc. and any other written materials or information provided to
participants. Other documents submitted for review include the study protocol, investigator brochure.

The study cannot begin until IEC/IRB approval has been obtained. Once approval is granted, evidence of approval should
be kept that clearly indicates which documents were submitted for approval. Care should be taken to ensure that the
approval clearly mentions and covers all required elements.
During the trial, the investigator must ensure that all updates to approved documents are submitted to the IEC/IRB for
review. Some IEC/IRBs require an annual renewal of approval and a summary report after the end of the test. The
investigator must submit an annual study progress report to the IECIRB.

Research product management

An investigational product is a dosage form of an active ingredient or placebo that is used in a clinical study that includes
variations of an already approved product. The ICH GCP guidance states that the investigator is responsible for
investigational product liability at the site being used in the study. However, the investigator may assign the duties to a
qualified pharmacist.
The researcher is responsible for:
● maintain records of investigational products that include information on quantities delivered, dispensed, and
returned/destroyed;
● Ensure proper storage conditions are maintained and documented, including details of dates, quantities, batch
numbers, expiry dates
● ensure that investigational products are only used as specified by the approved protocol;
● maintain a list of randomization code numbers assigned to participants;
● explain the correct use of the investigational products to the participants; and
● reconcile all research products received.

Compliance with study protocol

Typically, both the investigator and the sponsor will have signed the protocol to confirm their agreement. It is essential that
the investigator does not deviate from the processes and procedures established in the protocol or make any changes to the
protocol prior to IEC/IRB and sponsor approval.

Chin and Lee (2008) state that "ideally, a protocol should be so well written, and should anticipate all contingencies so
well, that there is no need for a protocol amendment or any exemption in the course of the study." In this case, the
interpretability of the study is maximum. However, this is not usually the case . '

The study must be performed in accordance with the approved protocol, GCP, and applicable regulatory requirements. The
agreement to follow the protocol must be documented in a contract or similar document, and must be signed by the
investigator/institution and the sponsor. If, during the course of the study, it is found that changes are necessary, then
approval should be sought again from the same IEC/IRB that approved the first version. With some exceptions, for
example, where urgent security measures are required, approval must be obtained before implementing the amendment.

It is important to understand the difference between a substantial and non-substantial protocol amendment. Substantial
modifications are those that could affect:
● security or physical or mental integrity of the participants
● scientific value of the study
● conducting or managing the study
● quality or safety of any medicine used for clinical trials

Non-substantive amendments are those that do not impact these factors and are generally things like administrative
changes, for example the member joining or leaving the Steering Committee. The IEC/IRB only needs to be notified in
writing of this type of amendment.

According to the 2016 ICH GCP guideline, it is acceptable to deviate from the protocol when the purpose of the deviation
is to eliminate an immediate danger to participants. If such a deviation is necessary, the sponsor, IEC/IRB and, if
necessary, the regulatory authority should be informed as soon as possible after the event.

Any deviations from the protocol, whether under the investigator's control or not, and the reasons for them, should be
documented in detail.
Investigator Qualifications and Agreements
Additionally, the investigator must be completely familiar with the protocol and the investigational product as described in
the investigator's brochure, product information, and any other product literature.

For marketed products, the researcher should be familiar with the product information, such as the Summary of Product
Characteristics and what it is normally used for, contraindications, etc.

The investigator may delegate functions to appropriately qualified study personnel; For example, a qualified pharmacist
may be in charge of the daily storage and delivery of the IMP, but the overall responsibility for that duty rests with the
researchers. Any delegated responsibility should be clearly recorded in the study's delegation record.

The investigator must allow the study to be monitored, audited and inspected to allow oversight by the sponsor and
regulatory authorities.

● Monitoring – The act of monitoring the progress of a clinical trial and ensuring that it is conducted, recorded and
reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practices (GCPs)
and applicable regulatory requirements.
● Audit: A systematic and independent examination of trial-related activities and documents to determine whether
the evaluated trial-related activities were carried out, and the data were accurately recorded, analyzed and reported
in accordance with the protocol, the sponsor's standard operating procedures (SOPs) and good clinical practices.
(GCP) and applicable regulatory requirements.
● Inspection: the act of a regulatory authority or authorities of carrying out an official review of documents,
facilities, records and any other resources that the authorities consider related to the clinical trial and that may be
located at the trial site, in the facilities of the sponsor and/or contracted research organization (CRO), or at other
establishments deemed appropriate by regulatory authorities.

Records and Report Management

It is the investigator's responsibility to ensure that all records are maintained accurately and that all reports are completed
and submitted on time.
➢ Source data: All information in original records and certified copies of original records of clinical findings,
observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.
Source data is contained in source documents (original records or certified copies).
➢ Source Documents – Original documents, data, and records (e.g., hospital records, clinical and office charts,
laboratory notes, memos, subject diaries or assessment checklists, pharmacy dispensing records, recorded
instrument data automated, copies or transcripts certified after verification as exact copies, microfiche,
photographic negatives, microfilms or magnetic media, x-rays, subject files and records kept in the pharmacy, in
the laboratories and in the medical-technical departments involved in the clinical trial.

The researcher must retain sufficient source data; This must be accurate and describe all relevant observations about each
of the trial subjects. Source data must be attributable, legible, contemporaneous, original, accurate and complete. Changes
to the source data must be traceable and explained, if necessary, and the clarity of the original data must be maintained.

All information required for each trial subject as specified in the protocol is recorded on a Case Report Form (CRF); It is
usually a printed, optical or electronic document.

The CRF data must be:

● informed accurately, complete, legible and timely;
● consistent with the original documents;
● clearly marked where corrections were made, with a date, initial, and explanation without obscuring the original
entry; and
 ● available for access when required by appropriate bodies (e.g. auditor, sponsor, IEC/IRB, etc.)

Additionally, the investigator must retain all essential documents and retain them for the time stipulated by the sponsor
after the completion of the trial. The financial aspects of the study should be documented as agreed between the sponsor
and the investigator.

The clinical monitor, auditor, IRB/IEC and regulatory authority must have direct access to all documents related to the
trial. The investigator must submit summary reports to the IRB/IEC on the progress of the study at least once a year.
Written reports of major amendments to the study or increased risk to participants should be reported immediately to the
sponsor, IRB/IEC, and relevant bodies. Upon completion of the trial, the investigator must provide the sponsor with all
required reports before providing a final summary report of the study and its results to the IRB/IEC, regulatory bodies, and
the community from which participants were recruited.

Security reports
Adverse drug reactions (ADRs), unexpected adverse reactions and serious adverse events (SAEs). An ADR is when there
is a reasonable possibility that an AE has a causal relationship with the drug being tested. An unexpected ADR is when an
adverse reaction is inconsistent with the characteristics of the drug or its applicable product information}.

Serious adverse events (SAEs) or serious adverse drug reactions (serious ADRs): any adverse medical event that, at any
dose:
● results in death,
● It is potentially fatal,
● requires hospitalization or extension of existing hospitalization,
● results in a persistent or significant disability/incapacity, or
● It is a congenital anomaly/birth defect

The researcher must:

● Report AEs/laboratory abnormalities that are critical to safety assessments as established in the protocol.
● Report all SAEs immediately to the sponsor.
● Promptly submit detailed written monitoring reports on EAGs
● provide additional information on reported deaths

Individual security reports should not identify the individual, but should carry the subject's code numbers for identification.

The investigator must ensure that relevant site personnel are aware of safety reporting and recording requirements.

The 2005 WHO Draft Guidelines for 'Adverse Event Reporting and Learning Systems' advise that non-serious adverse
events are recorded on study case report forms along with other data.

SAEs are usually collected on a specially designed form. Typically, SAEs must be reported to the sponsor within 24 hours.
If a Data Monitoring Committee (DMC)/Data Safety Monitoring Board (DSMB) is established, the researcher must inform
them, usually within a week (Hackshaw, 2009). However, this will depend on the study and the committee/board will
indicate accordingly.

SAEs that are life-threatening or resulted in death, and that are unexpected and possibly related to the study intervention
should be reported to the IEC/IRB generally within seven calendar days, other SAEs within 15 calendar days. of the study
which SAEs should not be reported immediately and what constitutes unexpected ADRs.

Ensure adequate resources

To conduct a solid and valid study, the researcher must be able to demonstrate that there is:
● reasonable potential to recruit the required number of people for the study. As Jekel (2007) points out, recruiting
an adequate number of participants is crucial for the study to answer the question it has posed.
 ● the appropriate amount of time scheduled to effectively conduct and complete the study
● an adequate provision of appropriately qualified personnel and appropriate facilities for the duration of the study
to achieve a successful and safe conclusion. Toto and McPhaul (2011) state that 'the researcher must invest in
building a research team that is made up of people (e.g. e.g., study coordinator, co-investigators, biostatistician,
laboratory and research technicians, and administrative support) who have the level of experience required to
navigate through the various challenges of the study
● Appropriate training on the study protocol, any investigational products and their functions to enable staff to carry
out their tasks safely and effectively.
● appropriate supervision of any individual or group to whom the investigator assigns trial-related duties at the trial site.
● assurance that any person or party contracted to perform tasks related to the trial is appropriately qualified to
perform those tasks. Systems must be implemented to ensure the integrity of the test-related tasks performed and
any data generated.

Handling premature termination or suspension of a trial

highlights that "the termination or suspension of a study has many implications, especially for patient safety."

Once a decision is made to terminate or suspend a study, all relevant bodies should be notified as soon as possible, stating
the reasons for the suspension or termination.

Following the decision to end or suspend the study, the researcher must:
● inform all participants promptly and as appropriate, for example by telephone, letter, etc.
● assess treatment requirements and develop a follow-up program for all participants
● make an appointment with participants individually, if necessary
● inform the institution, sponsor, IEC/IRB and other relevant bodies involved and provide a detailed written report,
as appropriate

Progress reports and final reports

The investigator must submit summaries of trial progress annually, or as needed, to the IRB/IEC. All changes that may
significantly affect trial procedures or increase risk to participants must be described in a written report and submitted to
the sponsor and the IRB/IEC.

The investigator must provide the IRB/IEC and regulatory authorities with a final summary of the trial results upon
completion. The investigator must also provide the sponsor with all required reports at the end of the trial.

Practical application of GCP

Researchers must apply GCP pragmatically so that it meets the needs of the community and the study. This makes the
operational and administrative conduct of the study ethical and realistic.

It is important to remember that GCP requirements as set out by the 2016 ICH are 'guidelines' and are not always
mandatory if the requirements are not implemented in national laws as they are in the US. USA And the EU. For example,
'on-site monitoring' is not mandatory, section 5.18.3 of the ICH GCP guideline states that 'central monitoring together with
procedures such as training and meetings of investigators and extensive written guidance can ensure the proper conduct of
the test in accordance with GCP. '

Key points to remember

● GCP is defined as an international ethics and quality standard for the design, conduct, performance, monitoring,
auditing, recording, analysis and reporting of clinical trials that provides assurance that data and results reported
are credible and accurate, and that the rights, safety and well-being of study participants are protected.
● The rights, safety and well-being of study participants always take priority over everything else.
● Studies must be scientifically sound, guided by a protocol, and respect ethical principles in all aspects.
● Individuals involved in career studies must be qualified by education, training, and experience to perform their
tasks.
● GCP is a legal requirement in Europe and the US. USA For specific types of studies; however, all types of clinical
studies should adopt the principles to ensure that all research is conducted to a similar standard.
● The researcher must always comply with national and local ethical requirements and expectations for the
informed consent process.
● Informed consent must be freely given by the participant, without undue influence, after receiving all information
about the study relevant to their participation.
● There are only a few appropriate reasons to unblind and one is where the medical management of the participant
depends on knowing what intervention they received.
● In any intervention study there must be a qualified physician who makes all medical decisions related to the study.
● IEC/IRB approvals must be obtained after review of all relevant documentation and materials intended to be
delivered to study participants.
● A protocol amendment that may have an impact on the safety of participants or the conduct of the study requires
IEC/IRB approval. Administrative changes do not require approval, but the IEC/IRB must be informed about
them.
● All SAEs must be reported to the sponsor as defined in the protocol and to the IEC/IRB according to their
requirements.
● The researcher must be able to demonstrate that the study is valid and robust by demonstrating that the required
number of people can be recruited, that sufficient time has been scheduled, that appropriately qualified personnel
and adequate facilities are available, and that adequate training has been provided to allow staff to carry out their
tasks safely and efficiently.
● If a study is suspended or terminated, the investigator must notify all relevant agencies and all participants as soon
as possible.
● GCP should be applied pragmatically, taking into account the needs and requirements of the community in which
the research is carried out.