E-Newsletter - March 2022
Spotlight on Alliance Audit Committee

NEWLy IMplemented Changes to Improve Alliance audit process


Scott H. Okuno, MD
Mayo Clinic
Chair, Alliance Audit Committee


Kurombi Wade-Oliver, CCRP
Director, Alliance Quality Management and Audit Program


For some, notification of an upcoming Alliance audit may illicit joy and anticipation to highlight the great work your research staff are doing to conduct clinical trials. For the rest of us, the thought of having an audit brings fear and anxiety as the Alliance auditors are coming to judge the work that we do each day, and it might not measure up. Whatever emotion you may feel, Alliance Audit team members have felt the same emotions as we are active in our own institutional research activities, and all have been audited.

Over the past several years, there has been significant changes on how the Alliance Audit Committee conducts audits. What has not changed is the committee’s goal to review and ensure member sites are conducting clinical trials (regulatory, patient case review, and pharmacy) in compliance with NCI’s Clinical Trials Monitoring Branch (CTMB) guidelines in an educational and non-putative setting. Our goal is to help sites succeed and improve their clinical research.

Let’s discuss the two major changes from the Alliance Audit Committee:

  1. Pre-work prior to the audit
  2. Conduct of the audit

One major change in the conduct of the clinical trial is the pre-work prior to the actual audit date. We can blame many things on the COVID-19 pandemic, but pre-work of regulatory and pharmacy started prior to 2020, and will continue. Having the site submit regulatory and pharmacy data and documents prior to the audit allows the audit team during the audit to focus on issues for clarification and instruction. Even though, the time during the audit focusing on regulatory and pharmacy is reduced, we know the effort for pre-audit is huge and we appreciate all the effort.

We can thank the COVID-19 pandemic for the other major change in the conduct of the Alliance audit. Prior to the pandemic, our committee had limited experience with virtual audits – mainly due to travel issues and bad weather conditions that made it difficult for our auditors to visit some sites. Due to adjustments made during the pandemic, the Alliance Audit Committee and many of you, now know how to conduct audits virtually.


  1. Less travel and cost to the audit team
  2. More flexibility in engaging auditors half days to complete parts of the audit instead of full days in-person


  1. Preparation time for site to allow auditor access to EMR is huge
  2. Preparation of uploading Patient Care Review documents is time consuming
  3. Auditor training and access to site EMR burdensome
  4. Loss of observing staff interaction and collegiality
  5. Audit team building and reflections on the day’s work

Yes, the pendulum will swing again to cherish the face-to-face in-person audits, but we will continue to work through the logistics of virtual as well as hybrid audits.

We would like to thank Alliance Audit Committee members, both past and present, for your time, effort, and friendship. For the sites, we look forward to getting to know you and what great things you are doing to support clinical trials for our patients


For other articles in this issue of the Alliance E-News newsletter, see below.