Quality Assurance Coordinators: Ensuring Quality at the Site Level

NOTE: The quality assurance coordinator role outlined in this article is based on how such a position has been implemented in real-world settings.

Does risk-based monitoring (RBM) always provide the highest quality in data, compliance, and subject safety? The short answer is no. In 2013, the U.S. Food and Drug Administration (FDA) published guidance to encourage alternative approaches, such as RBM, to traditional onsite monitoring,1 and although RBM has become very popular in recent years, some have noted that the approach leaves room for improvement.2

In essence, the RBM approach focuses on maximizing efficiency and effectiveness in monitoring in an attempt to save resources (e.g., time and money). Some have claimed that, in certain situations, RBM can reduce costs over traditional monitoring approaches by 20% or more.3,4 RBM relies on the assumption that many risks can be determined before a study begins, and that resources should be directed away from low-risk areas to ones that are of high risk.

Further, one of the primary ways by which RBM plans save money is through reducing onsite monitoring visit duration or frequency. However, although RBM may be a useful approach, our sense is that it doesn’t necessarily lead to the highest level of quality.

A common focus within the RBM perspective is a move away from 100% source data review and source data verification. There is also a shift toward a more targeted and centralized monitoring approach. Targeted approaches, by nature, however, can miss the mark and overlook critical data points. Centralized, or remote, monitoring can fall short in the detection of data entry errors.

In addition to quality issues, remote monitoring may even increase costs for sites by increasing the amount of time that study coordinators have to prepare for and deal with monitoring activities.5 Remote monitoring may increase the cost of study coordinators for a typical study by more than three times the cost seen with traditional monitoring.{5} This increased time burden for coordinators may come from file transfer activities and repeated requests for documents.

Looking Beyond the Challenges to the QAC Solution

Despite some challenges, RBM can be a helpful guide in designing monitoring plans. Cost reduction is a real and valid concern for sponsors, and the risk assessment aspect of RBM is a useful tool in decreasing costs. However, we should also acknowledge that it’s impossible to precisely predict the future, and that it’s wise to utilize methods that help safeguard against situations where RBM might miss the target.

With the above in mind, one way to enact safeguards and increase quality is for sites to employ onsite quality assurance coordinators (QACs) as part of their clinical quality management plans (CQMPs). QACs, also known as quality coordinators or quality management coordinators, perform a variety of monitoring and quality-related functions, including source document review, source data verification, pharmacy and lab audits, staff training, and regulatory file review, but they work at the site for the investigator.

QACs also focus on process improvement. They might conduct walkthroughs, or “dry runs,” with site staff to address risks and procedural issues in advance of initiating the protocol. They can help with developing source documents to not only capture the protocol-required data, but also to assure data are documented using good documentation practice.

QACs also work on developing tools and checklists to assist the site in collecting data and following the tenets of Good Clinical Practice (GCP); may develop plans for conducting regular and current assessments of subject charts; and maintain standard operating procedures (SOPs) that reflect the site’s initiatives for maintaining quality standards.

The QAC role can be filled by various types of research staff—coordinators, nurses, research managers, and other study team members may act as QACs for one or more studies. However, some sites hire individuals specifically for this role. There appears to be a growing use of QACs, as this position can play an integral role in managing CQMPs for sites.

QACs in Action

One organization that often utilizes QACs as part of its CQMPs is the National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID). NIAID require that sites conducting DMID-funded studies establish a CQMP that encompasses both quality control (QC) and QA processes, which often are supported by the QAC role.

QA is defined as planned, systematic, and periodic actions that are established to ensure that the trials are performed and data are generated, documented, and reported in compliance with GCP and applicable regulatory requirements.6 QC, on the other hand, is defined as real-time operational techniques and activities undertaken within a QA system to verify that the requirements of trial-related activities have been fulfilled.6

CQMPs are detailed documents that include the procedures that encompass QA and QC. They describe who is responsible for conducting the day-to-day activities to ensure that the data collected are accurate and complete, the protocol was followed, principles of good documentation practice are incorporated, and the rights and welfare of human subjects are protected. CQMPs also address plans for periodic assessments to be conducted at scheduled periods during trials.

In addition to QA and QC, plans should include the details of any required training for study team members. Plans can be tailored for each protocol or can be developed as one plan that addresses all clinical trials conducted at an individual site. The goal is to make sure the study team members, including the QACs, continually assess potential trial risks and ensure that the CQMPs address these risks.

For example, new study team members may require more oversight than seasoned study coordinators. Plans can factor in QC procedures that include an independent assessment by the QAC of the first few subjects that new coordinators enroll. Another example includes the initiation of a new protocol; there is a higher chance for error with the start of new protocols, and QACs may conduct independent assessments after the enrollment of the first few subjects to assess for confusion with following the protocol, randomization issues, errors with investigational product preparation and administration, or study data entry.

Eyes on the Prize

The goal is to have a systematic plan in place that addresses potential risks of each trial while filling in the gaps where site monitoring might fall short. Outcomes of both QC and QA activities should be regularly reported to the study team, in order to address any findings and possibly the need for corrective and preventive actions. The CQMP should also be evaluated regularly and updated to make sure it continues to address study risks.

In addition to their various other functions, QACs can play a role in creating, overseeing, and evaluating CQMPs, which makes them an important part of quality-related activities at the site. All of this means that the benefits of QACs touch on areas include the following:

  • Real-time monitoring: QACs review source documents before any monitors, so safety events, deviations, and other concerns are caught sooner. This can lead to better patient safety outcomes and faster reporting.
  • Better compliance with local regulations, internal organizational policies, and site SOPs: Because QACs are site staff, they may be more knowledgeable of the local regulations and policies at the site. In order for sites to remain operational, they must comply with rules and regulations that are sometimes outside the purview of sponsors or contract research organizations (CROs).
  • Greater access to data and information: QACs may have direct access to electronic medical records and institutional review board systems where other monitors or QA associates might not. Having access to these systems may increase QA/QC efficiency. It may also increase the scope of quality/monitoring activities into organization-specific systems of which monitors may not be aware.
  • Improved work flow: QACs focus efforts on process improvement activities, which can translate into greater efficiency, effectiveness, and compliance for the entire site.

On the other hand, the risks presented by using QACs can include:

  • Cost: QAC positions may require an additional hire for which the site and/or sponsor will have to pay. However, at this point, QAC positions are often entry-level monitoring and QA positions, so salaries may be lower than those for established monitors and QA auditors.
  • Bias: Because QACs work under the site investigator, they may not be as objective as would be ideal in their reviews; however, this can be mitigated to some degree by having QACs report findings to the sponsor or CRO as part of the CQMP.

In the long run, the work of QACs can offer a cost-effective approach for both sponsors and sites. It helps to ensure quality at the site in areas where RBM plans may fall short. The process improvement efforts of the QAC, combined with real-time reviews of subject charts, will prevent the site from having to invest additional time in reporting deviations, writing notes to file, or having to make multiple corrections on documents. Lastly, with a focus on delivering accurate data and promoting subject safety, this approach will bolster the site’s reputation with sponsors.

PEER REVIEWED

References

  1. S. Food and Drug Administration. 2013. Guidance for Industry: Oversight of Clinical Investigations–A Risk-Based Approach to Monitoring. www.fda.gov/downloads/Drugs/…/Guidances/UCM269919.pdf
  2. Causey JM. 2015. Risk-based monitoring: hope or hype? Clin Res 29(5):59–62.
  3. Underwood T. 2016. The rise of risk based monitoring of clinical trials. Quanticate CRO Blog. quanticate.com/blog/the-rise-of-risk-based-monitoring-in-clinical-trials
  4. QuintilesIMS™. Risk-based monitoring. quintiles.com/services/riskbased-monitoring
  5. Kassin M, Goldfarb NM. 2016. The cost to sites of remote monitoring. J Clin Res Best Pract 12(10).
  6. National Institute of Allergy and Infectious Diseases/Division of Microbiology and Infectious Diseases. 2016. Policy on DMID Clinical Quality Management (Version 6.0). https://www.niaid.nih.gov/sites/default/files/qualitymgmtplan.pdf

[DOI: 10.14524/CR-16-0025]

Bryan A. Moore, MA, CCRP, (bmoore31@jhmi.edu) is a senior compliance monitor with Johns Hopkins University School of Medicine in Baltimore, Md.

Olga Pizov, RN, MSN, CCRP, (OPizov@clinicalrm.com) is a senior quality assurance specialist with ClinicalRM in Hinckley, Ohio.