What can Game of Thrones teach us about eTMF?

July 24, 2014

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No one can argue that Game of Thrones is about power in the often dark and threatening world of the Seven Kingdoms.   But within the darkness, there are a number of hopeful themes which surface that provide optimism and renewed belief in rewards for good and positive action.  Unaided, the process of Trial Master File may seem opaque and daunting.  With a disciplined business process implemented through a well-honed eTMF application, that process becomes clear, manageable and enabling.  eTMF is about power; the power to increase your efficiency, take charge of your clinical trial documentation and ensure your TMF is complete, consistent and compliant.

 GameofeTMF

Driven by Principle

Like the main characters of Westeros and Essos, eTMF is driven by principles.  Ned Stark must fulfil his duty and become the King’s Hand, Brienne of Tarth honors her word and returns the Kingslayer to King’s Landing and of course, a Lannister always pays his debts.   There are fundamental truths that dictate and drive belief and behavior.   Likewise eTMF is based on fundamental propositions which ensure the integrity and value of the system and all of the content managed therein.  Ensuring thorough QC inspection of content, enforcing data consistency and integrity to CTMS and validated full adherence to 21 CFR part 11 are principled eTMF attributes that ensure the end result remains true to the business objective.

A Wall of Protection

Castle Black, the men of the Night’s Watch and The Wall are all purposefully designed to keep the hostile wildlings and other unseen aggressors in check and insulated from decent society.  Likewise, eTMF is designed to keep chaos out and ensure everything within the protective walls of eTMF remain manageable and well ordered.   Within the confines of a well-structured eTMF, there are no White Walkers upsetting the natural order of men or clinical trial evidence.    Like the Wall, the planning, tracking and adherence to process that eTMF provides ensures that trial content remains well-structured and secure.

Coming of Age

Game of Thrones is undoubtedly not intended for children and yet some of the most prominent characters are very young.  Bran, Arya and Sansa Stark and, of course, our beloved King Joffrey are all mere children.  As the story unfolds, we watch them grow up and mature often through the ordeal of facing and surviving a series of crises. We see them become young adults.  We see them come of age.  eTMF also has recently come of age, maturing from a unplanned archival process to an active and dynamic, forward looking, planning and management tool.  Through this renewed focus on trial execution and the collection and use of study metrics, eTMF too has recently come of age.

Triumph through Adversity

At times, the plight of our heroes seems dire, unrelenting and offers little hope.  Yet, we see triumph through adversity and can recognize that perseverance and hard work is rewarded and that the light at the end of the tunnel is indeed very bright.  As the current season (season 4) draws to a close, after many challenging and perilous situations Arya Stark finds herself triumphant against her enemies including The Hound and has arranged passage to The Wall to find her half-brother and best friend Jon Snow.  Although her journey continues, she has endured and persevered and emerged victorious – at least for the moment.   At times, TMF may seem like a perilous journey of epic proportions.  But, through conscious effort, adherence to principles and the support of a capable eTMF, the onslaught of paper and electronic content is quickly mastered and structure and capability triumphs over disorder and ineffectiveness.

Conclusion

eTMF is a principle based discipline that has come of age offering a protective wall against the chaos and perils of disorganized trial content at times requiring perseverance and hard work but resulting in triumph and a well defensible set of clinical trial evidence.    At the end of Game of Thrones season 2, we see our favorite character Tyrion Lannister saving King’s Landing from a naval assault using the powerful secretive agent Wildfire.    Perhaps similarly, we too are beloved heroes, defending our clinical trial results using the potent power of eTMF.