From Feasts to Files: Thanksgiving Traditions and TMF Standards

As the crisp, frost-kissed mornings of autumn embrace us, the passage of time seems to accelerate. In the blink of an eye, we transition from fall’s embrace to the glittering threshold of New Year’s Eve. This swift journey through the holidays prompts a moment of reflection on the fluid nature of life. It’s not just the shifting of seasons, the evolving array of dishes adorning our Thanksgiving tables, or even the dynamic regulations shaping your Trial Master File (TMF) – it’s the very essence of change itself. This change, ever-present and inevitable, also brings into focus the constants in our lives, those precious elements for which we hold deep gratitude.”

The traditional Thanksgiving menu has been far from static. Like most traditions, the ‘Thanksgiving Story’ and the meal contained within are more legend than historical reality—Americans did not fully embrace Thanksgiving nationally until the 1860s. As far as the existing historical accounts go, there are quite a few myths to be busted:

  1. There is no historical mention of turkey as the centerpiece of the original Thanksgiving (where English colonists and Wampanoag Native Americans joined together for a harvest festival in 1621). There is only mention of ‘wild fowl’ – which could have been any game bird. Venison, in fact, is the only protein specifically mentioned.
  2. Although semi-wild pumpkins and cranberries were native to the New World, both would probably have been prepared much differently than today, as the colonists would have coped with a limited availability of sweeteners to round out their bitterness.
  3. Corn was bountiful and well known to Native Americans, but was harder and starchier than today’s sweet corn. The colonists would have ground and boiled the dried corn into mush with some salt. As colonies became more established in the New World, they would have sweetened it with expensive imported molasses.
  4. Fish and shellfish would have played a dominant role in the first Thanksgiving. Oysters, specifically, were one of the few foods colonists would have found familiar and abundant.
  5. Sorry, no mashed potatoes for you! Although native to North America, Europeans discovered the tuber by way of Europe when brought back by the Spanish. Although the Wampanoag would have eaten similar wild starchy roots, the colonists have been suspicious of these often-bitter roots unless seriously hungry.

Like the dishes on the Thanksgiving table, the regulation of clinical trials and the TMF is far from set in stone; the recent emphasis on the ICH GCP, EMA Clinical Trial Regulation and Guidance, the MHRA Gray Guide, and FDA 21 CFR Part 11 is a testament to this constant change. These regulations form the foundation of every TMF and therefore every clinical trial. They emphasize the growing importance and complexity of TMF, indicating a heightened focus on regulatory compliance in clinical trials. Here are some of the basic principles of good document practices as outlined in these regulations:

  1. The sponsor and investigator should maintain a record of the locations of their respective essential documents. The storage system should provide for document identification, version history, search, and retrieval.
  2. The essential documents for a specific trial should be supplemented or may be reduced as appropriate.
  3. Sponsors should ensure that the investigator has control of and continuous access to the case report form data.
  4. When a copy is used to replace an original document, it should fulfill the requirements for certified copies outlined in the guidelines.
  5. Investigators should have control of all essential documents and records generated by the investigator before, during, and after the trial.

Change can be uncomfortable, but oftentimes it’s for the best (aren’t we all glad that corn mush is no longer on the Thanksgiving table?). The advancement of new technology and the regulations to support it, specifically surrounding the TMF, can seem relentless, but with this relentless pace comes the promise of accelerated clinical development. At LMK, we’re happy to see this progress, but firmly believe that technology alone is never the best solution. We’re truly thankful it’s our job to be the ambassadors of change in our industry; empowering the best people with the right tools—and ultimately uniting patients with life-changing treatments.