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GCP What Is It And Why Is It Important Eddie Pensom

What is GCP ?. GCP or Good Clinical Practice is an ethical and scientific quality standard for the design, conduct, recording and reporting of clinical trials that involve the participation of human subjects. GCP comprises 14 principlesProtect participantsEnsure credibility of dataThese princi

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GCP What Is It And Why Is It Important Eddie Pensom

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    1. GCP What Is It And Why Is It Important? Eddie Pensom

    2. What is GCP ? GCP or Good Clinical Practice is an ethical and scientific quality standard for the design, conduct, recording and reporting of clinical trials that involve the participation of human subjects

    3. GCP comprises 14 principles Protect participants Ensure credibility of data These principles have their origin in Declaration of Helsinki (1964) ethical principle for medics on human experimentation Informed consent Nuremburg Code (1947) Provides public assurance that rights, safety and wellbeing of trial subjects are protected What is GCP ?

    4. What is GCP ? In 1980s GCP was adopted by ICH International Conference On Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use This enabled clinical trials to be performed to a consistent standard across regions U.S, Europe, Japan Reducing replication of similar research within individual regions in turn reducing unnecessary patient exposure and expediting approvals The European Clinical Trials Directive (2001/20 EU) Adopted in UK national legislature as statutory instrument April 2004 its the law !! The Medicines for Human Use (Clinical Trials) Regulations www.mhra.gov.uk

    5. What is GCP ? How does this apply to us in Primary care ? in the business of promoting research in Primary Care in the UK Competing against fresher European neighbours PCRN/PCIS We perform clinical trials for two reasons To provide good quality clinical data and in turn further advance the frontiers of medical science To earn money To do either of these we need to know and work to GCP standards

    6. What is GCP ? The good news: compassionate, ethical, diligent, precise, transparent, Already embracing the principles of GCP Although essentially the tool of the drug development industry, these are our principles of patient care. To work with the industry, we still have to jump thru the hoops No way around this nor should there be We must work to GCP ! GCP is there to protect our patients and the quality of the drugs with which we treat them

    7. What is GCP? The industry has some incentives to ensure we do work to GCP Site selection processes QC/QA GCP auditors Random/ for cause MHRA GCP inspectorate

    8. What is GCP ? What do you need to do ? Proper GCP training at least annually All study team including sub investigators Companies may help Training records Up to date CV reflecting most recent GCP Training PCRN Professional bodies ICR journals/ web based modules RCN RDSU

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