A change of terminology
Evolving language to better articulate and explain the current clinical trial landscape
"...aiming to equip stakeholders with relevant guidance in how to operate within a digital world."
Many of the changes discussed within this eBook will focus specifically on retention-related topics. We will start though exploring some of the important general updates to language and terminology used within the guidance and explore their significance to long-term retention.
A change of terminology
R2’s language reflected a predominantly paper-based approach to record keeping. This can be seen in the extensive use of the phrase ‘documents’ throughout.
R3 sees a shift to the predominant use of records management and data. Albeit a crude comparison, R3 references data well over 300 times in the draft guideline, compared to just under 130 in R2.
Why is this important? Well, it demonstrates a significant shift away from paper to digital record management, driven largely by the wider digital transformation seen in the industry in recent years. It is also crucially perhaps the main driving force behind this update, and aiming to equip stakeholders with relevant guidance in how to operate within a digital world.
"R2’s language reflected a predominantly paper-based approach to record keeping."
"Instead of just clinical trial documents (e.g. the TMF), these ‘essential records’ should remain accessible to inspectors for the entire retention period."
Essential Documents to "Essential Records"
Another major terminology change is the use of the term ‘essential records’ over ‘essential documents’. This might seem quite a small change, but in reality, the implication, especially from a retention perspective is large.
The phrase ‘essential records’ was not used once within R2, but is now the standard phrase describing all records, documents and data important to the conduct of the trial. In R3 we see a broadening of the of what is considered essential for the conduct of the trial to include a range of type of data in study data, source data, captured data, supplier qualification information, training records and information relating to drug manufacture and distribution. In total within the guidance there are 13 reference essential records for trials and another 38 potentially essential.
From a retention perspective, this has dramatically increased the scope of what the ICH is recommending that relevant stakeholders such as sponsors and investigators retain. Instead of just clinical trial documents (e.g. the TMF), these ‘essential records’ should remain accessible to inspectors for the entire retention period.
Let’s now take a look in more detail about what R3 says specifically about retention requirements and good practice.
"In R3 we see a broadening of the of what is considered essential for the conduct of the trial..."
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