4 Considerations to Achieve eTMF Compliance Through Proactive Planning

July 9, 2013

  • eTMF Best Practices

In a traditional trial master file, those in charge often find themselves at a loss as to whether or not their documentation is complete.  These study managers have an idea of what has been collected, but no means of tracking what should have been included.  However, if a study manager takes the time at the beginning of each trial to set up the foundation of the TMF, he or she can have more confidence in the trial’s compliance. Fortunately, a combination of automation and well-designed processes can ease this task when using an eTMF system.  These are four ways you, as a study manager can proactively plan for your trials in an electronic trial master file.

Create a master list of all TMF documentation.

First, generate a list of all possible TMF documents associated with any type of trial you plan to execute.  Review your  organization’s SOPs and archived studies, and consult industry experts to generate this list.  You may also want to incorporate the TMF Reference Model, either as is or with adjustments to reflect the specifics of your organization.  This step requires time and analysis. It provides the building blocks for a successful eTMF.

Develop automated list generation based on study criteria

After you’ve defined your master list, begin drafting questions applicable to the types of trials you run.  These questions should guide you through determining what documents are required based on the study’s specific characteristics, such as whether it is a blinded study, what types of committees are used, etc. Then, assign the document types to the answers for each question.  Complete this step on the study, country and site levels.

Enlist auto-maintenance

Important information about your clinical trial can change often.  Sites are added, milestones can change.  You’re probably keeping track of these events in your CTMS, but they have repercussions in the TMF as well.  You’ll need whole sets of documents for new sites, additional CVs for new investigators and updates to due dates for documents when associated milestone dates change change.  Automate these changes by integrating your eTMF and CTMS systems to share the important intel.

Expect the unexpected

As you probably know from experience, it is good to have a plan for everything during a clinical trial.   It’s likely that there will be protocol amendments, but of course you don’t know in advance how many will occur or when.  For each,  additional documentation – not just the amendment itself – will be needed for the remainder of the trial.    Identifying the possible events that can occur, and the set of required and optional documents for each, will help to ensure that all required documents are collected in a uniform manner for an ongoing trial.

For further detail and explanation on planning your eTMF, register for our upcoming webinar: Plan for Success: How eTMF tools can help you to plan, maintain and monitor your Trial Master File.

eTMF Planning Webinar