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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 and reporting 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)
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 in accordance with GCP. On-site monitoring not compulsory
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
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
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
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 onsite 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
Informed consent
Informed consent personal autonomy a competent individual should have the right to determine those discretionary risks he/she is willing to accept for whatever benefits he/she perceives may result .
Weil WB. Informing and Consenting In Silverman W. Wheres the evidence? OUP 1997
Informed consent
Following the second world war and the Nuremberg trials, the Nuremberg Code and Declaration of Helsinki was agreed worldwide as a charter to protect people/patients against human experimentation Up until 1995 USA, Japan and Europe worked to different standards in the conduct of clinical trials 1995 ICH-GCP was implemented a global standard 2001 EU Directive set out regulations for clinical trials of medicines conducted within the EU 2004 (May) the UK implemented the Directive and the UK Regulations became law
Consent
Ethics committee must approve all information given to the trial participant Statements to comply with Data Protection Act must also be included in the PIL Consent forms and patient information leaflets must take into account recent legislation SOPs required describing who is authorised to conduct consent procedure Centre personnel who participate in the consent procedure should be listed on the delegation log, provide CVs and be trained!!
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
Consent procedures
Given freely Face to face Telephone Watch Listen Learn What works well? Share
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)
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 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.
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