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Focus on Quality

Author: Sean Philip Tagged in: Resources

Regular monitoring and robust auditing are at the heart of a successful quality control process. They work symbiotically to ensure the quality of your trial data and the protection of your participants. Developing a quality assurance process based on solid principles can help you avoid common research mistakes and could shorten the time taken for new drug development. Quality control is established and safeguarded by two important processes: monitoring and auditing. EPL Archives have reviewed these processes and the industry best practices to help you implement them easily in your project strategy.

Every clinical trial is based on fundamental principles preserved in the Good Clinical Practice (GCP) guidelines[1]. The trial sponsor is responsible for implementing and maintaining quality assurance systems with standard operating procedures (SOPs) to ensure that their trials are conducted appropriately and that the data that is generated, documented and reported complies with the protocol, GCP, and any applicable regulatory requirement(s).[2]

Within every successful trial is a robust quality assurance strategy based on regular monitoring and auditing. The quality assurance process aims to achieve two things:

  • Enhance human subject protection
  • Establish the quality of clinical trial data”[3]

What is monitoring?

“Monitoring is a quality control tool for determining whether study activities are being carried out as planned, so that deficiencies can be identified and corrected,”[4] says the FDA. It states that effective monitoring is “critical to the protection of human subjects and the conduct of high-quality studies.”[5]

The process involves regular scheduled on-site visits by monitors who check whether data is being collected[6], handled, analysed and reported according to established protocols, SOPs and the GCP guidelines, as well as any other relevant domestic or international regulation.

An inspection will check that:[7]

  1. Procedures are consistent and safe for each participant throughout the trial.
  2. Stringent checks on data collection and procedures provide high quality data and credible results.
  3. There is enough oversight to help the trial reach its objectives within the specified time frames.

If issues are identified they can be escalated for review by the Clinical Teams and Quality Assurance (QA) Departments who can manage any potential deviation. This could involve risk assessments and reparatory actions in the case of minor breaches or self-reporting to regulators where larger and more serious problems are identified.

What is auditing?

Auditing is the process by which a regulator (in this case the FDA) evaluates all “practices and procedures of sponsors, CROs, and monitors in the particular study(s), using the investigational plan in the research or marketing application/submission, applicable regulations, and any specific directives in the inspection assignment.”[8]

During the audit process, investigators take ‘snapshots’ of trial progress and explore specific areas to evaluate their effectiveness. The auditors will use this information to evaluate whether the trial is on track. If not, the FDA has the power to issue warning letters and demand corrective action.[9]

Your auditing team is responsible for overseeing and reporting on all aspects of the research to ensure that it remains compliant and within regulatory standards. Your team will work with the auditors to facilitate access and manage the process.

While the announcement of an audit may sound alarming to CRAs, the process should be a positive one which aims to improve standards and compliance. Ultimately, the process should lead to a better study which produces the most reliable results.[10]

Monitoring, auditing and quality control

Monitoring and auditing are two fundamental building blocks of a robust quality assurance strategy. They sit alongside the quality control process which mandates periodic checks within each functional area to assess adherence to established protocols, SOPs and the GCP guidelines.

Quality is everyone’s responsibility, a principle established in the development of a Clinical Trial Quality Management Plan (QMP). This systematizes the approach to quality within the wider strategy and ensures that it is considered at the planning and execution stages of all research projects.

Your QMP provides a complete view of quality assurance throughout the lifetime of the trial. In some cases, this process may have been overlooked when trials are being designed, which is why EPL’s on-site advisory services are valued by those who want an expert insight into the quality control processes of your study. EPL’s compliancy services ensure that quality control is at the heart of your research strategy.

Driven by a coherent strategy to embed quality improvement processes into your trial, your monitoring and auditing teams can work together to ensure the highest possible standards across the board. This will help to remove potential research barriers and reduce costly delays, shortening the time it takes for your new formulation to reach the market.


[1] Good Clinical Practice (GCP) : ICH. (2019). Ich.org. Retrieved 5 May 2019, from https://www.ich.org/products/guidelines/efficacy/efficacy-single/article/integrated-addendum-good-clinical-practice.html

[2] 5.1 Quality Assurance and Quality Control | ICH GCP. (2019). Ichgcp.net. Retrieved 5 May 2019, from https://ichgcp.net/51-quality-assurance-and-quality-control/

[3] Oversight of Clinical Investigations — A Risk-Based Approach. (2019). Fda.gov. Retrieved 5 May 2019, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oversight-clinical-investigations-risk-based-approach-monitoring

[4] Oversight of Clinical Investigations — A Risk-Based Approach. (2019). Fda.gov. Retrieved 5 May 2019, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oversight-clinical-investigations-risk-based-approach-monitoring

[5] Oversight of Clinical Investigations — A Risk-Based Approach. (2019). Fda.gov. Retrieved 5 May 2019, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oversight-clinical-investigations-risk-based-approach-monitoring

[6] Valania, M. (2010). Quality Control and Assurance. [online] Applied Clinical Trials. Available at: http://www.appliedclinicaltrialsonline.com/quality-control-and-assurance?id=&pageID=1&sk=&date= [Accessed 7 May 2019].

[7] P, M. (2019). Monitoring clinical trials: a practical guide. – PubMed – NCBI . Ncbi.nlm.nih.gov. Retrieved 7 May 2019, from https://www.ncbi.nlm.nih.gov/pubmed/27631784

[8] PART III – INSPECTIONAL. (2019). Fda.gov. Retrieved 5 May 2019, from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/part-iii-inspectional

[9] Links to enforcement/compliance info. (2018). Fda.gov. Retrieved 7 May 2019, from https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/clinical-investigations-compliance-enforcement

[10] Weiss, R., & Tuttle, S. (2006). Preparing for Clinical Trial Data Audits. Journal Of Oncology Practice, 2(4), 157-159. doi:10.1200/jop.2006.2.4.157

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