Importance decision and their confidentiality. This is because the

Importance of GCP to ensure patient safety during clinical trials:

–         
GCP is an international quality standard that
has been provided by the ICH

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–         
It involves protecting the human rights of
all the subjects participating in clinical trials, ensuring that the products
to be tested are or a certain level of safety and efficacy

–         
GCP describes how the trials should be
carried out and what the clinical trial sponsors, clinical research
investigators and monitors are in charge of.

–         
It assures us that the results obtained from the trials are
reliable since fixed steps are being followed.

–         
In short, the purpose of GCP is to ensure
that clinical trials are correctly conducted

–         
This is done through sticking to the principles
of GCP which fundamentally revolves around the following:

1.      
Clinical trials are carried out ethically

2.      
The potential benefits of
carrying out the trials is greater than the foreseeable risks that are
involved.

3.      
There is sufficient
clinical and nonclinical information to backup the trial

4.      
The trial is scientifically
sound and steps of the trial are listed clearly and in detail.

5.      
Personnel involved in
conducting the trial have a certain level of education, experience and
training.

6.      
Before the trials are
carried out, freely given informed consent must be obtained from the
participants.

7.      
Confidentiality of the
participants are protected such that they cannot be identified.

8.      
Clinical trial information are
recorded and archived in a manner that allows accurate analysis

9.      
Products involved in the
trial adhere to the applicable GMP (good manufacturing practices)

10.  
Necessary steps are taken
to ensure the quality of the products used in the trial.

–         
With the GCP adhered to, the safety and
health of the subjects can thus be monitored more carefully during the trial so
that if any adverse events occur, they will be appropriately documented and reported,
and necessary actions can be taken to ensure that the wellbeing of the subjects
(current and future) are being protected.

–         
The wellbeing of the subjects are also
protected in terms of their rights to make a free and informed decision and
their confidentiality. This is because the GCP requires patients involved to be
provided for complete and accurate information before they are asked to make a
decision on whether they would like to become subjects of the trial.

–         
The quality of the trial related activities
are also being kept on check via Quality control systems. Auditing is also
consistently carried out to check if activities involved in the trials were
properly conducted, and are recorded and analysed accurately, and also reported
to the respective authorities in a timely manner. One of the areas that is also
recorded is compliance as this largely determines the results that are collected
at the end of the trial.

–         
Inspection of organisation and clinical
investigator sites are also conducted to ensure that the facilities are in
proper conditions.

–         
The presence of the ethics committee also
further emphasises the need to protect the human rights of the subjects who are
involved. This is done through promoting decision making that is shared between
patients and the clinicians in charge, hence enabling us to work towards
patient-centred outcomes.

 

 

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