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GxP compliance is an umbrella term that includes several other compliance-related activities under it. However, there’s one such activity that holds primary significance in the field, the Good Clinical Practice.
GCP is a set of internationally recognized scientific and ethical standards that one must adhere to while conducting, reporting, designing, or recording any sort of clinical trial that involves human beings. These standards ensure that all data and reported results are rational and reliable. It also ensures that the confidentiality, rights, and integrity of the trial subjects are protected and respected.
Goals of Good Clinical Practice (GCP)
The goals of Good Clinical Practice (GCP) were formulated to protect the safety, welfare, and rights of the human subjects engaging in clinical research. Amidst the various types of research carried out by the medical community, these goals act as a safe haven for human subjects as it provides them with a uniform set of regulations to ensure ethical treatment. The primary goals of Good Clinical Practice (GCP) are:
- To guarantee the integrity, quality, and reliability of the data collected through the experiments.
- To ensure that good clinical practice is achieved by combining ethics and the quality of data
- To preserve the safety, rights, and welfare of the human subjects participating in the research
- To layout steady guidelines and standards for carrying out clinical research without causing any harm to the subjects associated with the research.
Foundation for Ethical Conduct of Clinical Research
The foundation for the ethical conduct of clinical research as we know it today was formed with the help of six main documents over the course of time. These documents are:
- The Nuremberg Code of 1947
- The Declaration of Helsinki of the year 1964
- The Belmont Report of 1979
- Code of Federal Regulations
- International Conference of Harmonization (ICH-GCP)
- International Standards Organization 14155
Who is Responsible for Ensuring Full Compliance of GCP?
Any person or entity involved in collecting data throughout the lifecycle of the research is responsible for GCP compliance. This includes:
- The sponsor of the study
- Nurses involved in the research process
- Clinical Investigators (CIs)
- Data entry personnel
- Clinical Research Coordinates (CRCs)
- Independent Ethics Committees (IECs) or Institutional Review Boards (IRBs)
- Contract Research Organizations (CROs)
- Medical monitors
- Clinical Research Associates (CRAs)
- Others
MWA Consultancy Services for Comprehensive GCP compliance
With non-partisan GCP audits for every vendor and preliminary site, MCW clinical consultancy services are one of the most preferred GCP consultancy service providers. MWA can provide organizations with an all-inclusive service that can be altered to suit the requirements of the GCP-compliant organization. These requirements can include:
- Cent percent review of quality control: Get access to accurate reports as each of the audit reports reviewed by project managers or decision-makers to ensure quality.
- Experienced auditors: MWA ensures that all the auditors are well versed in their jobs with the required experience.
- Competent GCP Management: MWA assigns experienced and competent project managers for the carry out the auditing procedures to facilitate effective quality management.
- Alteration of audit procedures: MWA approaches the clinic before finalizing the contract to discuss the methods and procedures of carrying out the audits.
How does the MWA consultation service help with GCP compliance
MWA consultation services provide clinics with expert and objective project plans as well as strategize audits and manage the entire project on behalf of the client. Here are a few concerns that can be addressed through GCP compliance consultancy from MWA:
- MWA ensures safeguarding of the rights, safety, and welfare of the preliminary subjects.
- Ensuring that all preliminary oversights are controlled and conducted with adherence to relevant SOPs, regulations, and protocols.
- MWA ensures that a vendor or organization not only has the knowledge of the federal regulations governing the clinical trials but also adheres to the regulations.
- MWA ensures that the organization has required quality systems to manage the trial.
The significance of GCP is determined by the question of ‘why’ and ‘how’ the GCP trials are conducted. The guidelines laid out by the ICH-GCP works as a holy book for clinical trials. MWA consultation services are equipped with the best data centers to facilitate effective data management. MWA ensures the audit report adheres to all quality standards before handing it over to the organization.
