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Presentation
at a capacity building program in scientific writing’ held at Qassim Health
Department Training Program on April 30, 2014 by Prof Omar Hasan Kasule
THE PRINCIPLES OF ICH GCP 1:
- Basic principles: Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable local / national regulatory requirement(s). [Royal decree M/59 of 1431]
- Risks vs benefits: Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
- Patient rights: The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
THE PRINCIPLES OF ICH GCP 2:
- Information on the investigational product: The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
- Scientific basis: Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
- Protocol: A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
THE PRINCIPLES OF ICH GCP 3:
- Medical care decisions: The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
- Investigator qualifications: Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
- Informed consent: Freely given informed consent should be obtained from every subject prior to clinical trial participation.
THE PRINCIPLES OF ICH GCP 4
- Information collection: All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
- The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
THE PRINCIPLES OF ICH GCP 5
·
Investigational products should be
manufactured, handled, and stored in accordance with applicable good
manufacturing practice (GMP). They should be used in accordance with the
approved protocol.
·
Quality control: Systems with procedures that
assure the quality of every aspect of the trial should be implemented.
INVESTIGATOR'S QUALIFICATIONS 6
·
Qualifications: The
investigator(s) should be qualified by education, training, and experience to
assume responsibility for the proper conduct of the trial
·
Evidence
of qualifications: Investigators should provide evidence of such qualifications
through up-to-date curriculum vitae and/or other relevant documentation
requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies).
·
Knowledge
of the drug: The investigator should be thoroughly familiar with the
appropriate use of the investigational product(s),
INVESTIGATOR’S
AGREEMENT TO COMPLY
·
Regulations: The
investigator should be aware of, and should comply with, GCP and the applicable
regulatory requirements.
·
Monitoring
and auditing: The investigator/institution should permit monitoring and
auditing by the sponsor, and inspection by the appropriate regulatory
authority(ies).
·
Delegation: The
investigator should maintain a list of appropriately qualified persons to whom
the investigator has delegated significant trial-related duties.
INVESTIGATOR RESOURCES
·
Recruitment: The investigator should be able to demonstrate
(e.g., based on retrospective data) a potential for recruiting the required
number of suitable subjects within the agreed recruitment period.
·
Time for research: The investigator should have sufficient time to
properly conduct and complete the trial within the agreed trial period.
·
Enough staff: The investigator should have available an
adequate number of qualified staff and adequate facilities for the foreseen
duration of the trial to conduct the trial properly and safely.
·
Full information for staff: The investigator
should ensure that all persons assisting with the trial are adequately informed
about the protocol, the investigational product(s), and their trial-related
duties and functions.
GETTING APPROVAL FROM IRB/IEC
·
Documents needed: Before initiating a trial, the
investigator/institution should have written and dated approval/favourable
opinion from the IRB/IEC for the trial protocol, written informed consent form,
consent form updates, subject recruitment procedures (e.g., advertisements),
and any other written information to be provided to subjects.
·
Investigator brochure: As part of the
investigator's/institution’s written application to the IRB/IEC, the
investigator/institution should provide the IRB/IEC with a current copy of the
Investigator's Brochure. If the Investigator's Brochure is updated during the
trial, the investigator/institution should supply a copy of the updated
Investigator’s Brochure to the IRB/IEC.
COMPLIANCE WITH PROTOCOL ..1
·
Full compliance: The investigator/institution should conduct the
trial in compliance with the protocol agreed to by the sponsor and, if
required, by the regulatory authority(ies) and which was given
approval/favourable opinion by the IRB/IEC. The investigator/institution and
the sponsor should sign the protocol, or an alternative contract, to confirm
agreement.
·
Protocol deviations: The investigator should not implement any
deviation from, or changes of the protocol without agreement by the sponsor and
prior review and documented approval/favourable opinion from the IRB/IEC of an
amendment, except where necessary to eliminate an immediate hazard(s) to trial
subjects, or when the change(s) involves only logistical or administrative
aspects of the trial (e.g., change in monitor(s), change of telephone
number(s)).
COMPLIANCE
WITH PROTOCOL ..2
·
Documenting deviations: The investigator,
or person designated by the investigator, should document and explain any
deviation from the approved protocol.
·
Approval of deviations: The investigator
may implement a deviation from, or a change of, the protocol to eliminate an
immediate hazard(s) to trial subjects without prior IRB/IEC approval/favourable
opinion.
·
As soon as
possible, the implemented deviation or change, the reasons for it, and, if
appropriate, the proposed protocol amendment(s) should be submitted: to the
IRB/IEC for review and approval/favourable opinion,
INFORMED CONSENT OF TRIAL SUBJECTS ..1
·
Approval of ICF: In obtaining and documenting informed consent,
the investigator should comply with the Prior to the beginning of the trial,
the investigator should have the IRB/IEC's written approval/favourable opinion
of the written informed consent form and any other written information to be
provided to subjects.
·
Voluntary consent: Neither the investigator, nor the trial staff,
should coerce or unduly influence a subject to participate or to continue to
participate in a trial.
·
Revision of ICF: The written informed consent form and any other
written information to be provided to subjects should be revised whenever
important new information becomes available that may be relevant to the
subject’s consent. Any revised written informed consent form, and written
information should receive the IRB/IEC's approval/favourable opinion in advance
of use.
INFORMED CONSENT OF TRIAL SUBJECTS ..2
·
Updating ICF information: The subject or
the subject’s legally acceptable representative should be informed in a timely
manner if new information becomes available that may be relevant to the
subject’s willingness to continue participation in the trial. The communication
of this information should be documented.
·
Consent does not waive rights:
None of the oral and written information concerning the trial, including the
written informed consent form, should contain any language that causes the
subject or the subject's legally acceptable representative to waive or to
appear to waive any legal rights, or that releases or appears to release the
investigator, the institution, the sponsor, or their agents from liability for
negligence.
INFORMED CONSENT OF TRIAL SUBJECTS ..3
·
Full disclosure: The investigator, or a person designated by the
investigator, should fully inform the subject or, if the subject is unable to
provide informed consent, the subject's legally acceptable representative, of
all pertinent aspects of the trial including the written information and the
approval/ favourable opinion by the IRB/IEC.
·
Non technical language: The language used
in the oral and written information about the trial, including the written
informed consent form, should be as non-technical as practical and should be
understandable to the subject or the subject's legally acceptable representative
and the impartial witness, where applicable.
INFORMED CONSENT OF TRIAL SUBJECTS ..4
·
Enough time for consent: Before informed
consent may be obtained, the investigator, or a person designated by the
investigator, should provide the subject or the subject's legally acceptable
representative ample time and opportunity to inquire about details of the trial
and to decide whether or not to participate in the trial. All questions about
the trial should be answered to the satisfaction of the subject or the subject's
legally acceptable representative.
·
Signing and dating the consent:
Prior to a subject’s participation in the trial, the written informed consent
form should be signed and personally dated by the subject or by the subject's
legally acceptable representative, and by the person who conducted the informed
consent discussion.
INFORMED CONSENT OF TRIAL SUBJECTS ..5
·
Witnesses to consent for the illiterate:
If a subject is unable to read or if a legally acceptable representative is
unable to read, an impartial witness should be present during the entire
informed consent discussion.
·
Witnessing information disclosure:
After the written informed consent form and any other written information to be
provided to subjects, is read and explained to the subject or the subject’s
legally acceptable representative, and after the subject or the subject’s
legally acceptable representative has orally consented to the subject’s
participation in the trial and, if capable of doing so, has signed and
personally dated the informed consent form, the witness should sign and
personally date the consent form.
·
Witness signature: By signing the consent form, the witness attests
that the information in the consent form and any other written information was
accurately explained to, and apparently understood by, the subject or the
subject's legally acceptable representative, and that informed consent was
freely given by the subject or the subject’s legally acceptable representative.
INFORMED CONSENT OF TRIAL SUBJECTS ..6:
INFORMATION DISCLOSURE
·
That the trial
involves research.
·
The purpose of the trial.
·
The trial
treatment(s) and the probability for random
assignment to each treatment.
·
The trial procedures to be followed,
including all invasive procedures.
·
The subject's responsibilities.
INFORMED CONSENT OF TRIAL SUBJECTS ..7:
INFORMATION DISCLOSURE
·
Those aspects of
the trial that are experimental.
·
The reasonably
foreseeable risks or inconveniences
to the subject and, when applicable, to an embryo, fetus, or nursing infant.
·
The reasonably
expected benefits. When there is no
intended clinical benefit to the subject, the subject should be made aware of
this.
·
The alternative procedure(s) or course(s)
of treatment that may be available to the subject, and their important
potential benefits and risks.
INFORMED CONSENT OF TRIAL SUBJECTS ..8:
INFORMATION DISCLOSURE
·
The compensation and/or treatment available
to the subject in the event of trial-related injury.
·
The anticipated
prorated payment, if any, to the
subject for participating in the trial.
·
The anticipated expenses, if any, to the
subject for participating in the trial.
·
That the subject's
participation in the trial is voluntary
and that the subject may refuse to participate or withdraw from the trial, at
any time, without penalty or loss of benefits to which the subject is otherwise
entitled.
INFORMED CONSENT OF TRIAL SUBJECTS ..9:
INFORMATION DISCLOSURE
·
That the
monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will
be granted direct access to the
subject's original medical records for verification of clinical trial
procedures and/or data, without violating the confidentiality of the subject,
to the extent permitted by the applicable laws and regulations and that, by
signing a written informed consent form, the subject or the subject's legally
acceptable representative is authorizing such access.
·
That records
identifying the subject will be kept confidential
and, to the extent permitted by the applicable laws and/or regulations,
will not be made publicly available. If the results of the trial are published,
the subject’s identity will remain confidential.
INFORMED CONSENT OF TRIAL SUBJECTS ..10:
INFORMATION DISCLOSURE
·
That the subject or
the subject's legally acceptable representative will be informed in a timely
manner if information becomes available that may be relevant to the subject's
willingness to continue participation in the trial.
·
The person(s) to
contact for further information regarding the trial and the rights of trial
subjects, and whom to contact in the event of trial-related injury.
·
The foreseeable
circumstances and/or reasons under which the subject's participation in the
trial may be terminated.
INFORMED CONSENT OF TRIAL SUBJECTS ..11:
INFORMATION DISCLOSURE
·
The expected
duration of the subject's participation in the trial.
·
The approximate
number of subjects involved in the trial.
·
Prior to
participation in the trial, the subject or the subject's legally acceptable
representative should receive a copy of the signed and dated written informed
consent form and any other written information provided to the subjects.
·
During a subject’s
participation in the trial, the subject or the subject’s legally acceptable
representative should receive a copy of the signed and dated consent form
updates and a copy of any amendments to the written information provided to
subjects.
INFORMED CONSENT OF TRIAL SUBJECTS ..12:
INFORMATION DISCLOSURE
·
When a clinical
trial (therapeutic or non-therapeutic) includes subjects who can only be
enrolled in the trial with the consent of the subject’s legally acceptable
representative (e.g., minors, or patients with severe dementia), the subject
should be informed about the trial to the extent compatible with the subject’s
understanding and, if capable, the subject should sign and personally date the
written informed consent.
·
A non-therapeutic
trial (i.e. a trial in which there is no anticipated direct clinical benefit to
the subject), should be conducted in subjects who personally give consent and
who sign and date the written informed consent form.
CONDITIONS FOR NON THERAPEUTIC TRIALS 1
·
The objectives of
the trial cannot be met by means of a trial in subjects who can give informed
consent personally.
·
The foreseeable
risks to the subjects are low.
·
The negative impact
on the subject’s well-being is minimized and low.
·
The trial is not
prohibited by law.
CONDITIONS FOR NON THERAPEUTIC TRIALS 2
·
The
approval/favourable opinion of the IRB/IEC is expressly sought on the inclusion
of such subjects, and the written approval/ favourable opinion covers this
aspect.
·
Such trials, unless
an exception is justified, should be conducted in patients having a disease or
condition for which the investigational product is intended.
·
Subjects in these
trials should be particularly closely monitored and should be withdrawn if they
appear to be unduly distressed.
EMEREGENCY RESEARCH
·
In emergency
situations, when prior consent of the subject is not possible, the consent of
the subject's legally acceptable representative, if present, should be
requested.
·
When prior consent
of the subject is not possible, and the subject’s legally acceptable
representative is not available, enrolment of the subject should require
measures described in the protocol and/or elsewhere, with documented
approval/favourable opinion by the IRB/IEC, to protect the rights, safety and
well-being of the subject and to ensure compliance with applicable regulatory
requirements.
·
The subject or the
subject's legally acceptable representative should be informed about the trial
as soon as possible and consent to continue and other consent as appropriate
(see 4.8.10) should be requested.
RECORDS AND REPORTS 1
·
The investigator
should ensure the accuracy, completeness, legibility, and timeliness of the
data reported to the sponsor in the CRFs and in all required reports.
·
Data reported on
the CRF, that are derived from source documents, should be consistent with the
source documents or the discrepancies should be explained.
·
Any change or
correction to a CRF should be dated, initialed, and explained (if necessary)
and should not obscure the original entry (i.e. an audit trail should be
maintained); this applies to both written and electronic changes or corrections
RECORDS AND REPORTS 2
·
The
investigator/institution should maintain the trial documents as specified in
Essential Documents for the Conduct of a Clinical Trial and as required by the
applicable regulatory requirement(s).
·
The
investigator/institution should take measures to prevent accidental or
premature destruction of these documents.
·
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 or
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.
RECORDS AND REPORTS 3
·
These documents
should be retained for a longer period however if required by the applicable
regulatory requirements or by an agreement with the sponsor.
·
It is the
responsibility of the sponsor to inform the investigator/institution as to when
these documents no longer need to be retained The financial aspects of the
trial should be documented in an agreement between the sponsor and the
investigator/institution.
·
Upon request of the
monitor, auditor, IRB/IEC, or regulatory authority, the
investigator/institution should make available for direct access all requested
trial-related records.
PROGRESS REPORTS
·
The investigator
should submit written summaries of the trial status to the IRB/IEC annually, or
more frequently, if requested by the IRB/IEC.
·
The investigator
should promptly provide written reports to the sponsor, the IRB/IEC (see 3.3.8)
and, where applicable, the institution on any changes significantly affecting
the conduct of the trial, and/or increasing the risk to subjects.
SAFETY REPORTING 1
·
All serious adverse
events (SAEs) should be reported immediately to the sponsor except for those
SAEs that the protocol or other document (e.g., Investigator's Brochure)
identifies as not needing immediate reporting.
·
The immediate
reports should be followed promptly by detailed, written reports.
SAFETY REPORTING 2
·
The immediate and
follow-up reports should identify subjects by unique code numbers assigned to
the trial subjects rather than by the subjects' names, personal identification
numbers, and/or addresses.
·
The investigator
should also comply with the applicable regulatory requirement(s) related to the
reporting of unexpected serious adverse drug reactions to the regulatory
authority(ies) and the IRB/IEC.
SAFETY REPORTING 3
·
Adverse events
and/or laboratory abnormalities identified in the protocol as critical to
safety evaluations should be reported to the sponsor according to the reporting
requirements and within the time periods specified by the sponsor in the
protocol.
·
For reported
deaths, the investigator should supply the sponsor and the IRB/IEC with any
additional requested information (e.g., autopsy reports and terminal medical
reports).
PREMATURE TERMINATION OR SUSPENSION OF A TRIAL 1
·
If the trial is
prematurely terminated or suspended for any reason, the
investigator/institution should promptly inform the trial subjects, should
assure appropriate therapy and follow-up for the subjects, and, where required
by the applicable regulatory requirement(s), should inform the regulatory
authority(ies). In addition:
·
If the investigator
terminates or suspends a trial without prior agreement of the sponsor, the
investigator should inform the institution where applicable, and the
investigator/institution should promptly inform the sponsor and the IRB/IEC,
and should provide the sponsor and the IRB/IEC a detailed written explanation
of the termination or suspension.
PREMATURE TERMINATION OR SUSPENSION OF A TRIAL 2
·
If the sponsor
terminates or suspends a trial (see 5.21), the investigator should promptly
inform the institution where applicable and the investigator/institution should
promptly inform the IRB/IEC and provide the IRB/IEC a detailed written
explanation of the termination or suspension.
·
If the IRB/IEC
terminates or suspends its approval/favourable opinion of a trial (see 3.1.2
and 3.3.9), the investigator should inform the institution where applicable and
the investigator/institution should promptly notify the sponsor and provide the
sponsor with a detailed written explanation of the termination or suspension.
FINAL REPORT(S) BY INVESTIGATOR
Upon completion of the trial, the investigator should inform the following:
·
institution;
·
The regulatory
authority
·
provide the
IRB/IEC with a summary of the trial’s outcome,
·
and the
regulatory authority(ies) with any reports required.