The Octopus Analogy Continues: Diving into the Trial Master File Document Collection and Filing Process
Hello everyone,
Continuing our journey with the Trial Master File (TMF) as our octopus, this week we're exploring the fascinating world of TMF Documentation, specifically the process for document collection and filing.
Just as an octopus uses its tentacles to explore, gather food, and interact with its environment, the TMF uses its 'tentacle' of document collection and filing to gather essential data, maintain regulatory compliance, and ensure a smooth document retrieval process in for your team but also during regulatory inspections and internal audits.
This process involves identifying necessary documents to reconstruct the trial, collecting and receiving them from various sources and stakeholders, reviewing for completeness and accuracy, and finally filing them in the TMF. Each document is like a piece of food that the octopus collects - essential for its survival and well-being.
But, it's not just about gathering; it's also about organizing. The octopus is known for its intelligence and ability to arrange, classify and use its collected items effectively. Similarly, the TMF must be well-organized ideally based on the industry wide accepted CDSIC TMF Reference Model, with every document correctly filed and easily retrievable.
In conclusion, the process of document collection and filing is a vital 'tentacle' of our TMF octopus.
Stay tuned as we continue to explore more 'tentacles' of our TMF octopus in the coming weeks.