Good Clinical Practice Workshop

8/3/2019 Good Clinical Practice Workshop

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Good Clinical Practice

(GCP)


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What is GCP?

Good Clinical Practice (GCP) is defined as a

standard 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

Information recorded, handled and stored to allowaccurate reporting, interpretation and verification and

confidentiality of subjects records


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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 appropriately central 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 qualified 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 shall be qualified by

education, training, and experience to performhis or her respective task(s)(GCP principle 8)

Education

Training

Experience

There is no GCP qualification


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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 freelance

consultant) Host institution courses

Trial specific workshops

Investigators meetings


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Experience

On-the-job learning

Discovering what is required

Doing the job (sometimes wrongly)

Cascading information and knowledge

through teams/units

Talking to other trialists


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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 training 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 whichindividually 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 ChiefInvestigator or at the Co-ordinating Centre

Investigators 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 developed

for 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 trialin 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

a competent individual should have the right

to determine those discretionary risks he/sheis willing to accept for whatever benefitshe/she perceives may result .

Weil WB. Informing and Consenting

In Silverman W. Wheres the evidence? OUP 1997


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Informed consent

Following the second world war and the Nurembergtrials, the Nuremberg Code and Declaration of Helsinkiwas agreed worldwide as a charter to protectpeople/patients against human experimentation

Up until 1995 USA, Japan and Europe worked todifferent standards in the conduct of clinical trials

1995 ICH-GCP was implemented a global standard

2001 EU Directive set out regulations for clinical trialsof medicines conducted within the EU

2004 (May) the UK implemented the Directive and theUK Regulations became law


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Consent

Ethics committee must approve all information given tothe 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 ample time to decide The Directive does not state any time-frame

6-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 received information that the case

fulfilled the criteria for a fatal or life threateningSUSAR, and any follow up information within a further

8 days.

All other SUSARs:

not later than 15 days after the sponsor forpharmacovigilance 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 furtherFIVE years

Local R&D offices may also impose a

retention period


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Good Clinical Practice in Practice

Be pragmatic in your approach to GCP

Use your Rick Assessment to justify your

approach Document the rationale behind the decisions

Be brave

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