There could be times that when someone has been put to be in-charged at a particular clinical research site, they mostly would lead to their interest of ensuring for the quality management system. There have been reports where they could find the lack of site-level quality management systems. In fact, most of the clinical sites have audited some standard clinical procedures. It is essential that a clinical site must have its own quality management system since this will help them ensure the consistency of the processes, training of the staffs, maintenance of the needed documents, and the readiness for inspections and audit. There are activities included in the clinical site quality management system. This pertains to the training standard operating procedure requirements that is used for training, continuity standard operating procedures, informed consent process, good documentation process, source documents, internal assessment, and inspection readiness. But wait, there’s more to this. It won’t be complete without having a solid quality management plan.
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1. Clinical Quality Management Plan Sample
2. Clinical Research Quality Management Plan
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4. Standard Clinical Quality Management Plan
5. Clinical Quality Management Plan Format
6. Professional Clinical Quality Management Plan
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What is a Clinical Quality Management Plan?
A clinical quality management plan is considered as a management tool used to describe the state of the quality control and quality assurance processes that are usually implemented by clinical sites for the purpose of evaluation and documentation. This will be used to guarantee the efficiency of the site performance and protocol procedures. It also helps in identifying problems and finding corresponding solution at an early stage. Evert clinical quality management plan should be expected to make site staffs be responsible of verifying compliance with regards to the implemented protocols, ensuring the data privacy and the completeness of the data, protecting the welfare and rights of human, and ensuring that they have good clinical practice standards and even met the regulatory requirements.
Let us define terms that are related to clinical quality management plan, so that you would be able to fully understand the context.
- Quality management – this usually refers to overall system that requires activities involved in the concept of quality assurance and quality control. It also includes roles and specific responsibilities, reporting results, and resolution of the problems that have been identified.
- Quality control – this is considered to be the observation and documentation of work processes. You have to make sure that all the necessary procedures are followed.
- Quality assurance – this is an objective and comprehensive examination of the overall work effort. This will help you determine the level of compliance in relation to the good clinical practices standards.
- Clinical quality management plan – this plan is a written document that is specifically pertaining to a clinical research setting. It gives full details of the scope, quality indicators, sample size, etc.
Aside from the abovementioned definitions, think of clinical quality management plan as also a collection of various programs that allows you to put an emphasis over the leadership, commitment to quality performance, organizational culture, and evaluation of clinical performance improvement activities.
What are the types of activities included in securing a clinical quality management?
It includes structured processes that speaks about design, measure, assess, and improve the health care status and the quality of services in relation to health care aspects.
What is usually done when preparing for having a clinical quality management plan?
It includes clinical performance measurement and improvement, credentials and clinical privileging, risk management, adverse action, and patient safety as well.
Who is assigned to conduct a regulatory file and participant chart review?
It is assigned to a trained quality management reviewer.
If you want to see more samples and format, check out some clinical quality management plan samples and templates provided in the article for your reference.
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