Abstracts and presentations submitted to congresses

[Irene Barriocanal]

Dears,
Where would you file the abstracts submitted for congresses and the presentations showed during congresses? For example: study design communication, primary endpoint results…
Thank you very much for your advice.

[Eldin Rammell]

Hi Irene,

There is generally no regulatory requirement to file presentations in the trial master file. For this reason, there is no artifact listed in the Reference Model.

TMFs are typically closed and locked to secure the content once the trial has ended, all queries resolved and the content confirmed to be complete. As presentations may take place for a significant period of time following closure, continually adding presentations might create a data integrity risk. For this reason, they are typically filed elsewhere.

Kind regards,
Eldin.

[Author]

Posts