2- Quality Assurance

Competency Definition: The individual knows and understands the GCP guidelines (both from the International Conference on Harmonization and their local/national adaptations). They understand the importance of human subject protection in clinical research, and how application of the relevant GXPs seeks to ensure human subject protection and quality of research. They understand the necessity of applying GXPs (e.g. Good Clinical Practice, Good Pharmaceutical Practice, Good Laboratory Practice) to their work, and how to achieve this practically. They are careful to ensure participant confidentiality throughout the research process.

Abilities

  • Understand the requirements for human subject protection under relevant national and international regulations

  • Has a thorough knowledge of the principles of GXP as it applies to their work (e.g. GCLP if they work in a laboratory)

  • Ensure the study is run in compliance with the guidelines of Good Clinical Practice of the International Conference on Harmonization

Related competencies

Tasks based on this knowledge: Developing the QMS and SOPs; Risk and safety management; Working as per the QMS; Controlling quality of research

Similar knowledge: Ethics and human subject protection; Research regulations

 

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Competency Definition: The individual understands the importance of compliance with the protocol and study procedures to ensure quality of research; and acts accordingly on a daily basis. This task requires a thorough knowledge of the protocol, SOPs and quality management system. The individual should seek to attend protocol-specific training to enhance their understanding of the study. They understand how to apply the protocol knowledge and SOP guidelines to their day to day work, and how to report concerns such as protocol non-compliance. They ensure that there is a full set of up-to-date SOPs at their workplace, and coordinate the review and distribution of these documents when required.

Abilities

  • Understand the importance of compliance with the protocol and study procedures/SOPs to ensure quality of research

  • Ensure compliance with protocol and study procedures during day-to-day work, and raise concerns where appropriate when breaches are noticed

  • Have a thorough knowledge of the specific protocol in question

  • Ensure up-to-date SOPs are used at sites and coordinate review of these documents

  • Maintain controlled reading and distribution lists for SOPs

Related competencies

Tasks based on this knowledge: Developing the QMS and SOPs; Controlling quality of research

Knowledge base: Good Clinical (or other) Practice; Research regulations

Skills required: Cognitive skills (attention to detail); Record-keeping

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Competency Definition: The individual understands the importance for quality control in research, and that monitoring is a tool to achieve this. They can take part in monitoring visits at sites, assisting others to resolve any discrepancies found. They understand the importance of documentation and record keeping, and as such keep clear reports of monitoring activities, findings and resolutions. They are able to plan a monitoring or quality control strategy, and coordinate the operationalising of it – which involves diverse activities such as checking source documentation or performing sites visits. Every individual involved in the daily activities of a study should ensure quality of research by consistently applying GXPs, complying with the protocol and to regulations, etc. Monitors will further ensure quality of research by performing audits. 

Abilities

  • Understand that the purpose of monitoring/audit is to improve the quality of conduct of the study, and its integrity, consistency, timeliness, accuracy

  • Promote self-regulation of academic clinical trials by conducting research on research, implementing internal quality management system and conducting audits

  • Plan/Coordinate risk-based monitoring strategies, ensuring consistency across study sites

  • Conduct study visit activities and on-site monitoring and ensure accuracy and completeness of source documents, case report forms, trial master file and other study related documents

  • Identify errors and helps individuals resolve their issues in different ways depending on the situation

  • Review others’ monitoring reports

  • Conduct central monitoring

  • Ensure data and documentation is complete, up-to-date, and appropriately filed and ready for inspection if required

Related competencies

Tasks based on this knowledge: Developing the QMS and SOPs; Risk and safety management; Working as per the QMS; Reporting; Overseeing essential documents; Collecting accurate data

Knowledge base: Good Clinical (or other) Practice; Research regulations

Required skills: Cognitive skills (attention to detail, problem-solving); Record-keeping

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