The FDA Called…Are You Prepared?

Karen Olson
October 6th, 2014

Co-authored by Forte team members: Karen Olson, Customer Success Specialist, and Aradhana Uthappa, Director of Allegro Product Management and Services

Clinical research sites are accountable to their patients to follow good clinical practices. Charged with the responsibility to oversee this, the Food and Drug Administration (FDA) conducts audits to ensure the quality and integrity of the data that’s been submitted, as well as to protect patient rights. By complying with numerous regulatory requirements, sites can avoid bad publicity, legal issues, or in extreme cases, being shut down.

What Prompts an Audit?

There are a number of factors that can trigger an FDA audit. Most audits are study-related or “routine,” while others may stem from complaints or sponsor concerns, or “for cause.” Study-related audits can be performed at random or can be targeted, often times towards sites that have particularly high enrollment or are conducting multiple complex studies. Sites that have a new drug application will most likely experience an FDA audit.

A complaint can be filed if it is questionable whether the rights and safety of patients are at risk or the integrity of the data has been compromised. Complaints can identify falsification or unrealistic data, failure to report or delay in reporting adverse effects, inadequate records, or an assortment of other concerns.

Preparing for an Audit

Sites should be ready for an FDA audit at a moment’s notice. This means being constantly prepared. It is helpful to have written standard operating procedures (SOPs) that detail the processes on all research procedures, documentation methods, and the individuals responsible for each activity. Being able to refer back to your site-specific SOPs will assist immeasurably when an audit occurs.

Another effective tool for audit preparation is to routinely conduct “mock audits” with site staff. This can increase inspection readiness and boost confidence during the actual assessment. It can also uncover possible gaps in your SOPs that can then be resolved. The frequency in which these are performed and the level of detail obtained is dependent on the ability of all pertinent staff to actively participate. However, conducting at least two mock audits a year can help significantly. Encouraging staff to raise concerns during the mock audit or even during regular daily activities also provides an opportunity to solve problems before they have the chance to escalate.

Each site’s handles an audit differently, but more often than not, the experience incites stress and anxiety. That said, sites shouldn’t allow these uneasy emotions to overshadow the benefits of an FDA audit. Audits should be regarded as a learning experience, providing insight from an outside party into areas where operations can be improved. However, to minimize any fears, the following should be practiced:

  • Educate staff on how and what to communicate with the auditor
  • Ensure staff understand the protocol completely
  • Identify which staff members are responsible for specific areas of the study
  • Ensure that all study documents are organized, complete, and current

It’s difficult, if not impossible, to track every single activity going at on all times at a site. However, being aware of these key factors may assist in a smooth and quick inspection.

During the audit, it is beneficial to have one point person who will escort the inspector at all times and answer any questions. This will control and clarify all communication relayed to the auditor and reduce the risk of information from others that may be incorrect, repetitive, conflicting or unnecessary. Other members of the team can be involved by preparing and organizing the documentation that is requested by the auditor.

Documentation of the study will be highly scrutinized. At the very least, this documentation needs to be able to verify regulatory compliance, validate staff credentials, confirm informed consent of subjects, and explain any protocol deviations. Additionally, documentation should identify that adverse effects have been reported and that all data submitted is thorough and accurate. If the audit is for-cause, specific documentation addressing the complaint will also be needed.

How a Clinical Trial Management System can Help

A clinical trial management system (CTMS) can help alleviate the hassle of physically tracking study related documents and help ensure that accurate study data is maintained. Because of its electronic nature, there is no need for manual record keeping or reporting, eliminating the risk of human error. A CTMS can also house all documentation for a given study, providing a central location for site staff to easily access various documents when necessary. Specifically, a CTMS can help track the following:

  • Reporting of deviations and violations in the protocol to Institutional Review Board (IRB)
  • Reporting of adverse events, serious adverse events, and safety reports to IRB
  • Records of investigational product accountability
  • Timely completion of case report forms
  • Details of IRB approval on protocols and other essential documents and notifications
  • Records retention and document control

Learn more ways you can be better prepared for your next audit by attending the free webinar, “What you need to know to prepare for FDA audits.”

Karen has had over 20 years experience as a research coordinator and site director before joining Forte as a Customer Success Specialist.

Prior to joining Forte India as the Director of Allegro Product Management and Services, Aradhana acquired over 15 years experience in the pharma and CRO industry and had undergone several audits as well as performed audits.

Editor’s Note: This blog post was originally published on October 2, 2012.