“Life starts all over again when it gets crisp in the fall.”
This famous passage from Fitzgerald’s novel, The Great Gatsby, suggests that the fall season is a time of renewal rather than the last hurrah before the dead of winter. As we celebrate fall and contemplate winter, we should also consider the changing seasons of a TMF and how these seasons impact the documents within. Many professionals may think of the TMF’s timeline in a seasonal progression: spring is the start of a trial, summer is the heated peak of enrollment, fall is the harvest of close out, and winter is when the TMF is delivered and the trial’s story comes to an end. But in an age where the TMF is rapidly changing and the normal TMF timeline is frequently disrupted, does this metaphor still hold true?
In 2010, four principles were added to the ICH mnemonic for the basic standards by which clinical documents are created and maintained, ALCOA: attributable, legible, contemporaneous, original, and accurate. These standards form the foundation of Good Document Practices, or GDP. The four new GDP principles: complete, consistent, enduring, and available, in conjunction with the existing ALCOA principles, have become known as ALCOA-C or ALCOA+. These new principles were adopted, at least partially, because of the changing seasonality of the TMF. Simply put, we’ve entered an era of the perennial TMF, where the lifecycle of a TMF never truly ends:
Complete: The golden rule of clinical research is, “if it’s not written down, it didn’t happen”. An incomplete TMF therefore, is the greatest transgression of a TMF. It doesn’t matter what was written down, if nobody can find the document it was written on. We’ve discussed how to prevent and recover from a TMF completeness crisis before. Both blogs deliver the message that the complexity of the modern eTMF has damaged relationships between stakeholders, as well as the ability of stakeholders to gain visibility on the entire TMF. These new challenges greatly threaten a TMF that must be complete from the first moments of a trial and well into the distant future.
Consistent: The final days before trial close-out can tempt a clinical trial professional into complacency, but if there is little left to do other than collect the last few documents, do we really need to worry about document quality, even at the end of a trial? What if a trial has multiple periods of activity and inactivity? Every clinical trial has its own logical sequence of cause and effect. The documents within your TMF must accurately reconstruct this sequence, therefore consistency of TMF deliverables like filing frequency, completeness, and accuracy is essential. Maintaining consistency, however, when a trial has a non-traditional progression can be a challenge. TMF leaders must anticipate how new and innovative protocol designs impact the viability of TMF processes.
Available and Enduring: The clinical trial industry has spent years, millions of dollars, and countless hours migrating TMFs from one format to another. “Available and enduring” were added to ALCOA to reflect the lessons learned from this process. Electronic media formats and clinical application platforms change quickly. Format or system changes mid-stream are growing more common, therefore TMF leaders must have a plan of action to ensure documents and data are locatable and readable in the future. Even the most up-to-date media format may be as impractical as the 8-track tape in a few short years.
As the seasons fly by clinical research will change to reflect advances in science and technology. ALCOA and GDP must continue to adapt. The golden rule of clinical research, of course, will still apply, but new forms of media and the new perennial nature of the TMF will continue to impact the seasons of the TMF. Perhaps, in the future, data and document collection will be a “year-round” endeavor, where trials never fully begin or end and the written word on a page will be replaced with new and innovative data streams. No matter the coming changes, TMF leaders must continually renew the TMF to meet the unknown and increasingly complex needs of the future. Embracing the principles of ALCOA and ALCOA+, however, is a timeless place to start.
To learn more about the basics of GDP, register for LMK’s upcoming complementary webinar on Good Clinical Documentation Practices. This free webinar, held remotely on Thursday October 17th at 10am, will provide further information on the ALCOA+ principles, as well as valuable GDP insights and best practices for anyone who creates or collects TMF documents.