Avoid Risks to Your Trial by being Proactive from Day 1
The last time your organization underwent a TMF inspection, how did it go? Think about the vibe around the office in the days and hours prior to the inspection – was it one of chaos and panic or one of confidence and assurance?
Most often, regulatory inspections cause stress, tension, and fear in clinical teams. In many instances, inspections are tedious events that take up time, resources, and manpower. The procedural checklists and administrative tasks that accompany inspections are enough to send any team over the edge.
But it doesn’t have to be that way.
The problem with too many clinical teams is that being ready for a TMF inspection is usually done as a reaction-based activity. That is, not enough attention is given to the TMF until an inspector is on his or her way. At this point, panic sets in and documents are suddenly filed in bulk, making the situation ripe for costly errors.
Instead, inspection readiness needs to be a diligent part of your organization’s daily routine from day one. Daily maintenance must be part of the culture of your team in order to gain the most value from it – a culture of compliance. Your organization must change the mindset to promote better, easier inspections from a reactionary one to a proactive, prepared one.
What Inspection Readiness Entails
The main focus for conducting TMF audits is to verify the activities that have been undertaken with regard to supporting your processes. Inspections of your trial master file are mainly focused on records and documents related to the clinical trial at hand.
The key is to operate at a level that is always ready for inspection so that your team won’t have to prepare excessively in the days leading up to it. Organizational policies and procedures are designed to be strictly adhered to so that inspection readiness doesn’t become a “one-time event.” The procedures cover constantly evolving variables of clinical research such as new investigative sites, staff turnover, protocol amendments, new vendors, and more. The idea of making adherence a daily routine instead of a reaction to the news of an inspection is to promote positive outcomes without undue hassle for your team, regardless of the variables.
Standard Operating Procedures
When a routine is established that builds TMF inspection readiness into the process, teams can leverage standard operating procedures (SOPs) to cover proactive TMF management protocol. Strategies for review, accessibility, and remediation should be built in to ensure that expectations are known, followed, and achieved right from the beginning of the study.
It may be a good idea for your team to perform mock inspections every so often to address gaps in data and processing issues to turn out tangible reports to be proactive about inspection day. This is an effective way to avoid having readiness pushed to the wayside and forcing your team to deal with inspections in a reactionary state instead of a preparatory one.
Building inspection readiness into your processes from day one and performing self-compliance checks will help your team identify and correct documentation deficiencies well before an inspector arrives.
In the case of eTMFs, you’ll want to allow remote access to it to be able to study documents from anywhere at any given time, too; this also means you should integrate effective security measures to prevent unwanted changes or deletion of documents. Remote access with robust security features will make TMF upkeep even more easy, convenient, and thorough.
Table of Contents Structure
Every organization should have a Table of Contents (TOC) structure in place for the trial master file that follows the industry standard TMF Reference Model. Continuous filing through the life of the trial, regardless of paper-based TMFs or eTMFs, is critical. Using standard nomenclature and associating content with metadata will also make it easy for an inspector to retrieve documents during an inspection, so that’s another reason to avoid filing a slew of documents at the last minute all at once.
Can You Afford Not to Operate with a Culture of Compliance?
Inspection readiness must be incorporated throughout the life of a clinical trial, right from day one to lay the groundwork for a successful inspection or audit. The alternative is certainly risky – and if that risk turns into a problem, costly consequences like invalid study data, time and effort cost for remediation, or even the halting of the study could come with it.
Switching from a reactionary philosophy to a preparatory one will enable your team to avoid re-work and will benefit stakeholders, as well. The proactive mindset supports three parameters for TMF metrics: timeliness, quality, and completeness. Be sure your team invests in training and support for staff members to enable proper task prioritization and open the door to inspection readiness, improved compliance, and ultimately, clinical trial success.
Be sure to stay up to date with all the latest news and information surrounding trial master file preparedness and management by attending our upcoming trial master file meeting – reserve your seat today.
