good clinical practice - harshad more
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Good Clinical Practice
(GCP)
Presented by
Harshad More
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What is GCP?
Good Clinical Practice (GCP) is defined as a
µstandard for the design, conduct, performance,
monitoring, auditing, recording, analyses andreporting of clinical trials that provides
assurance that the data and reported results
are credible and accurate, and that the rights,
integrity and confidentiality of trial subjects are
protected¶
(ICH GCP)
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GCP principles summary (1)
Rights, safety & well being of subjects prevailover interests of science and society
Individuals involved in trial should be qualifiedby education, training and experience toperform his/her tasks
Trials shall be scientifically sound and guided
by ethical principles in all their aspects Necessary procedures to secure the quality
of every aspect of the trial shall be compliedwith
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GCP principles summary (2)
Available non-clinical and clinical information
on an IMP shall be adequate to support the
trial
Conducted according to Helsinki Declaration
(1996)
Protocol shall provide inclusion and exclusion
criteria, monitoring and publication policy Investigator/sponsor shall consider all
relevant guidance
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GCP compliance
ICH GCP section 5.18.3 allows individual
researchers to assess the needs of their trial
and apply GCP appropriatelyµcentral monitoring in conjunction with
procedures such as investigators¶ training
and meetings and extensive written guidance
can assure appropriate conduct of the trial inaccordance with GCP.¶
On-site monitoring not compulsory
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Who must comply with GCP?
All individuals involved in any aspect of the
trial must be suitably µqualified¶ to be able to
comply with GCP. Sponsors/CIs are responsible for ensuring
that all staff are able to comply with GCP.
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What counts as qualified?
According to GCP each individual involved in
conducting a trial µshall be qualified by
education, training, and experience to performhis or her respective task(s)¶ (GCP ± principle 8)
Education
Training
Experience
There is no GCP µqualification¶
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Education
Individuals must be educated to be able
to competently perform their specific trial
task.
± Clinicians must be clinically qualified
± Statisticians must be qualified
± Managers must be appropriately educated
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Training
There are a variety of courses and seminars
currently available
± Employer induction courses ± Industry courses
± E-learning (Institute of Clinical Research)
± Private courses (usually run by freelanceconsultant)
± Host institution courses
± Trial specific workshops
± Investigators meetings
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Rationale and documentation
As there is no formal qualification it is
essential to keep up to date records of
training.
Describe the rationale for the methods of
GCP µtraining¶ used in the trial
Document courses/seminars/meetingsattended by staff on a training file
Keep it up to date
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Approvals and permissions
Ethics committee approval
Clinical Trials Authorisation (IMPs)
R & D permission
Sponsor approval
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Trial Master File
Essential documents are defined as documents which individually and collectively permit evaluation of the conduct of atrial and the quality of the data produced and should be retainedin the Trial Master File
Documents to be contained in the Master File will varyaccording to the trial
Trial Master File should be held at the principal site by the Chief Investigator or at the Co-ordinating Centre
Investigator¶s Site Files are held by the Principle Investigators atsites and contains copies of the essential documents, localapprovals, signed consent forms and completed data forms.
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Standard Operating Procedures
There should be a written description of all trial management
systems and conventions. This documentation forms the
operating procedures, often referred to as Standard Operating
Procedures (SOPs).
SOPS are usually generic to the Trials Unit or
Institution.
A trial specific operating procedure must be developedfor each trial. These may be called MOPs (Modified Operating
Procedures) or TSOPs (Trial Specific Operating Procedures).
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Trial monitoring
ICH-GCP Extent and Nature of Monitoring
The sponsor should ensure that the trials are adequately monitored. The
sponsor should determine the appropriate extent and nature of monitoring.
The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity,
blinding, size,and endpoints of the trial. In general there is a need for on-
site monitoring, before, during, and after the trial; however, in exceptional
circumstances the sponsor may determine that central monitoring in
conjunction with procedures such as investigators¶ training and meetings,
and extensive written guidance can assure appropriate conduct of the trial
in accordance with GCP. Statistically controlled sampling may be an
acceptable method for selecting the data to be verified.
5.18.3
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Informed consent
Informed consent ± personal autonomy
µ«a competent individual should have the right
to determine those discretionary risks he/sheis willing to accept for whatever benefitshe/she perceives may result .¶
W eil WB. Informing and Consenting
In Silverman W .Where¶s the evidence? OUP 1997
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Informed consent
Following the second world war and the Nuremberg trials, theNuremberg Code and Declaration of Helsinki was agreed worldwide asa charter to protect people/patients against human experimentation
Up until 1995 USA, Japan and Europe worked to different standards inthe conduct of clinical trials
1995 ICH-GCP was implemented ± a global standard
2001 EU Directive set out regulations for clinical trials of medicinesconducted within the EU
2004 (May) the UK implemented the Directive and the UK Regulationsbecame law
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Consent
Ethics committee must approve all information givento the trial participant
Statements to comply with Data Protection Act mustalso be included in the PIL
Consent forms and patient information leaflets musttake into account recent legislation
SOPs required describing who is authorised toconduct consent procedure
Centre personnel who participate in the consentprocedure should be listed on the delegation log,provide CVs and be trained!!
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Consent
Decision time: confusing
ICH states µample time to decide¶
The Directive does not state any time-frame
µ6-day rule¶ in Ireland (being revised in 2006)
UK has no time -frame
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Consent procedures Given freely
Face to face
Telephone
Watch
Listen
Learn What works well?
Share
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Safety reporting
Adverse events (annual)
Serious Adverse Events (SAEs)
(within 7 days)
Serious Adverse Reactions (SARs)
(within 7 days)
Suspected Unexpected Serious Adverse
Reactions (SUSARs)
(expedited)
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Expedited reporting
Fatal or life threatening SUSARS:
not later than 7 days after the person
responsible for pharmacovigilance receivedinformation that the case fulfilled the criteria
for a fatal or life threatening SUSAR, and any
follow up information within a further 8 days.
All other SUSARs:not later than 15 days after the sponsor for
pharmacovigilance had information that the
case fulfilled the criteria for a SUSAR.
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Archiving
Essential documents NOT used in a
regulatory submission must be retained for at
least FIVE years after the end of the trial Destruction of essential documents and a
record of the destruction must also be
retained for a further FIVE years
Local R&D offices may also impose a
retention period