Quality evaluation of the research is needed for proper analysis of the data. Monitoring and audit play a key role in assuring quality throughout the trial. Quality assurance refers to systemic and independent audit of all activities and documents related to a clinical trial. This is performed by quality assurance personnel who are not involved in the research to determine whether the trial was conducted and that the collection, analysis and reporting of data were in accordance with the protocol, standard operating procedures SOPs and Good Clinical Practices GCP.
In short, this process assesses the efficiency of quality control processes carried out by the sponsors. The trial specific quality assurance audits include audits of the trial protocol, case report form CRF , trial sites, trial database, graphs, tables and statistics and trial report. One important aspect of quality assurance in clinical trials is good clinical practice GCP which can be defined as a set of ethical and scientific quality guidelines that must be observed globally for planning, conducting, recording and reporting clinical trials which involve the participation of human subjects.
The quality plan defines how the quality control and quality assurance processes are abided by throughout the clinical trial and describes various quality related tasks in the study. It documents quality practices, resources and activities that are specific to a project. For more information please go through the links below:.
The ICH GCP definition of 'audit' focuses on compliance assessment, and this is also an expectation of the regulatory authorities. However, auditing in clinical research has evolved over the years to be far more value-added to an organisation than only assessing compliance with regulations.
The clinical auditor, whilst conducting a vast array of different audits, also acts as a consultant and quality adviser to the functions involved in the drug development process, providing 'trouble-shooting' advice and interpretation of regulations and guidelines. The extent of interactions will depend on the size and organisational structure of the company.
Externally, QA interacts with a diverse range of groups such as third party service providers, CRAs, Investigators, Study Nurses and other study site personnel, and in the event of inspections the regulatory inspectors. If the company is a third party service provider, there may also be frequent contact with sponsor companies to co-ordinate routine audits.
The GCPQA professional has an important role in training clinical research personnel in Good Clinical Practices and in the regulations covering clinical research activities. The training role may be covered by a specific training department in some companies, however GCPQA is usually called upon to provide advice on the interpretation and application of the regulatory requirements. Clinical researchers frequently ask GCPQA for advice in resolving non-compliance issues, and it is therefore important that QA is seen as an approachable group that can provide professional and pragmatic answers.
A career in GCPQA provides an opportunity to understand the complete clinical development process from clinical development planning to the preparation of the registration dossier. There are no other roles within research and development that can offer this breadth of experience.
Not only does the GCPQA professional gain insight into the whole development process, but they can also gain a wide knowledge of different therapeutic areas and branches of medicine.
It is very important that the QA professional maintains an up to date knowledge of the regulatory environment, so self study and attendance at appropriate conferences and workshops is extremely important, as is networking with other GCPQA professionals.
For further information on these and other courses visit www. GCPQA is a people-orientated role and therefore excellent written and verbal communication skills are keys to success. Your interpersonal skills will be put to the test on many occasions throughout your career in QA.
Clinical research is a global function, therefore it is inevitable that the GCPQA professional has to travel extensively to perform their tasks. The extent and scope of travel will depend on the organisation you work for and the role you have within GCPQA. Most auditors work on an international basis although they may cover specific regions such as Europe. Some auditors work on a worldwide basis, and may be required to undertake several long-haul trips each year.
It is important to determine what the travel expectation is of the company you plan to work for to ensure that it fits in with your lifestyle and commitments. International travel is often one of the attractions of becoming a GCPQA professional, and adds another aspect to the diversity the role has to offer, meeting different people and experiencing a variety of cultures.
The GCPQA professional must be capable of juggling several balls at once as they are usually working on more than one audit project at any time. They may be planning a systems audit at the same time as performing a series of site audits for a particular protocol, whilst following up responses to findings following a third party service provider audit. Also, several of these audits will be conducted overseas, which adds another layer of complexity to the process.
The course will also cover the logistics of distribution of the CTM to the clinical sites globally. Important tools, such as outsourcing vendors for packaging and labeling and Interactive Response Technology will be covered to ensure familiarity with all the necessary concepts.
After taking this course, you will be better prepared to manage every aspect of CTM for your clinical trials!
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