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COVID-19 Implications on Clinical Trial Site Auditing

September 17, 2021

The COVID-19 pandemic has had unprecedented implications on clinical trials and research, ranging from the actual data collection process to site audits.

As COVID-19 presented unique situations and public health concerns, authorities have enforced control measures to uphold public safety and welfare: limited in-person contact, social distancing, travel restrictions, and quarantine. This has limited the participant’s ability to visit the clinical trial sites, thereby compromising the process's integrity. Moreover, fighting increasing rates of COVID-19 hospitalizations shifted the focus of resource allocation at the investigational sites.

At the same time, following regulatory recommendations,\(^1\) on-site audits had to be avoided or postponed in general. As a consequence, sponsors were recommended to conduct remote monitoring and assessment of sites, including source data verification. 


The Introduction of Remote Auditing Solutions

To address the challenges regarding compliance with the trial quality management plans, the hybrid remote and semi-remote site audit solutions have presented unique benefits to the traditional approach during the COVID-19 pandemic. The use of virtual tools and electronic systems facilitate remote access to trial documentation. It is recognized that digital tools have allowed on-site participants to spend their time more efficiently, increasing flexibility and eliminating travel time as well as the associated expenses. This approach is also used by the regulatory authorities who have shifted from traditional to hybrid inspection, involving both on-site and remote inspection.\(^2\) 

However, there is still a significant variability among the trial sites when it comes to the use of digital solutions. 

     

Problems and Solutions for Remote Access to Trial Sites 

Remote trial audits curtail the achievement of regular and reliable communication with site staff,\(^3\) including quality of the network and possible differences in time zones.\(^4\) Advanced tools such as software and white-boarding apps and electronic systems enable researchers to share and access information, as well as manage documentation and trial audit reports. In addition to streamlining reporting, trial managers have also embraced modern communication channels to convey and receive trial-related information effectively. Site staff must be tech-savvy to implement such technology solutions associated with remote audits, inspections and communication. 

Last, but not least, the quality of internet connection during a remote site audit is of utmost importance.

On the other hand - a trial site with the paper-based trial documentation or mix of paper and electronic data presents a significant challenge and limitations to remote auditing. This is especially relevant in terms of the source data.


Tailored Approach to the Site Auditing

An audit can range from a classic on-site approach to a fully remote method. The chosen procedure will be adjusted according to:

  • Local regulatory requirements, especially if they prevent the exchange of electronic data
  • The site’s readiness for remote procedures 
  • Whether they use electronic document management systems
  •  Any ongoing travel or contact restrictions in the area

For the majority of sites, a hybrid model of auditing that combines  remote and on-site activities is the best fit (unless a full close-down applies at the site, regional or national levels). 

This model allows the auditor to stay remote while supported on-site by a local clinical trials professional, who is independent from the trial/site team. Depending on the particular situation, this model allows combining review activities in parallel sessions that otherwise would be carried out consecutively by the same auditor.


Benefits of Hybrid Approach To Clinical Trial Audits

  • Remote auditing minimizes travel logistics and the associated costs, thereby impacting directly on the turnover rates. 
  • Audit time can be effectively utilized combining remote and on-site activities. 
  • Local support could tackle both, on-site documents review as well as local language translation. 



Key Takeaways 

The COVID-19 pandemic has significantly compromised clinical trial audits and compelled site managers to consider remote or semi-remote auditing approaches. Travel restrictions, social distancing, and quarantine have limited the number of subjects, CROs, and sponsors that can be on-site. While these changes have been mostly adverse, remote and semi-remote auditing may be beneficial in the long-run. 

However, to achieve high-quality auditing without compromising the subjects' safety, rights, and welfare, the site management team must embrace site-specific initiatives. These include training site staff, establishing and updating adequate electronic systems for documentation and reporting, and creating elaborate remote platforms for file sharing and communication. In the meantime, the composition of the audit team should remain flexible. Including local support may be an option of choice for a successful audit approach.     


How Dokumeds can help

Dokumeds has been conducting hybrid audits since 2019 and was one of the first CROs in the region to offer hybrid audits to its clients. Dokumeds’ monitoring teams cover all of Europe and can provide on-site support to our quality team and independent auditors whenever necessary. Years of conducting business on an international scale have enabled Dokumeds to design efficient systems for remote collaboration and accountability. Dokumeds’ experience spreads across many countries with different regulatory bases. We help clients find an optimal solution based on local regulations and accumulated know-how, keeping the trial data quality and integrity. 



References

  1. GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC, Version 4 04/02/2021
  2. Lynn, S. (2020). Adjusting to the FDA’s New Hybrid Audit and Inspection Model. Available online at https://www.mastercontrol.com/gxp-lifeline/adjusting-to-the-fda-s-new-hybrid-audit-and-inspection-model/
  3. Farrell B, Kenyon S, Shakur H. Managing clinical trials. Trials. 2010;11:1–6.
  4. EMA, 2020. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-remote-gcp-inspections-during-covid-19-pandemic_en.pdf

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