Ensuring Quality in Risk-Based Monitoring and Data Protection

Meghan Hosely
July 28th, 2020

Tracking and maintaining high-risk data is critical in any phase during the research process. Protecting the rights, safety, and welfare of study participants adheres to the Food and Drug Administration (FDA) guidelines and is essential to maintaining Good Clinical Practice (GCP) in any study. Ensuring proper maintenance of high-risk data keeps data accurate and in line with the protocol as it moves through the phases. The industry has moved towards risk-based monitoring as a risk-based approach ensures quality while focusing time and effort on critical areas; however, there is still a lot of different terminology when it comes to quality. This article breaks down risk-based monitoring (RBM), as well as other data protection terms falling underneath it.

RBM in Clinical Research

The International Council of Harmonisation (ICH) GCP guidelines define trial monitoring as “the act of overseeing the progress of a clinical trial and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirements.” As a way to fulfill regulatory requirements, TransCelerate Biopharma developed RBM in 2012. The FDA further released statements on RBM in 2013, ensuring participant safety during a trial.

A relatively new method for ensuring the quality and fit for the purpose of clinical data, there are many advantages to opting into adopting RBM. With its focus on analytics and other activities that can be conducted remotely, and a de-emphasis on traditional source document verification (SDV), RBM requires less travel, which not only also saves on trial costs, but is especially beneficial during the current COVID-19 pandemic. In the age of shifting to more virtual-friendly options during trials, RBM makes it easier for research staff to handle data while still moving the trial forward virtually.

Within RBM, there are other terms related to data protection: source data review (SDR) and source data verification (SDV).

Source Data Review in Clinical Research

Within RBM, SDR is the review of the source documentation to check on quality, compliance, staff involvement, and other areas not associated with a case report form (CRF) data field.

According to TransCelerate Biopharma, SDR involves:

  • Review of source documentation to check quality of source
  • Review of protocol compliance
  • Ensuring that the Critical Processes and source documentation are adequate
  • Ascertaining Investigator involvement and appropriate delegation
  • Assessing compliance to other areas

SDV in Clinical Research

Conversely, SDV is the process by which data within the CRF, are compared to the original source of information, confirming accurate data transcription (or, as TransCelerate refers to SDV, transcription checking).

The National Center for Biotechnology Information notes while it’s been assumed that SDV can lead to an enhanced quality of data, it is costly – typically, SDV takes up about 25% of an entire clinical trial budget. On top of that, it can be challenging for research staff to justify applying SDV to a study fully, leading to a difficult cost-benefit evaluation. 

Especially during the COVID-19 pandemic, it’s important to understand the differences in types of data monitoring and what works for each site. While study teams can adopt different monitoring methods for SDV, the common denominator for each method is in-person visits. Knowing your site’s needs and tailoring them to the best way to track and maintain high-risk data will not only streamline the process now but set your site up for success in any trials that may come your way in the future.