Data & Documents

This chapter will cover:

Data & document preparation
Data & document requirements
ALCOA++ principles
Key considerations for data & document management

During an inspection, inspectors require access to all relevant documents for all studies or trials identified for inspection.

As simple as this sounds, documents need to be readily available, accessible, readable and usable, which means that it also needs to be understandable, verifiable, and ultimately trustworthy.

To ensure this, data and documents should have been prepared in compliance with good documents practice guidance, data integrity recommendations, and adhere to the ALCOA principles. This equips inspectors with the ability to question, verify, understand, and trust the data and documents.

As well as presenting factual accounts of activities and outputs, data and documents need to provide context and meaning if they are to have [evidential] value.

It is worth remembering that the integrity and reliability of (and trust in) data and documents arise as a consequence of a combination of technology, process, people, and culture: it is folly to focus solely on the data or documents themselves.

Elements such as traceability, audit trails, and other relevant metadata are critical to understanding the “who, what, why, where, when, and how” i.e., the story of the development of the data and documents as well as the conduct and progress of the study (or trial).

This helps prove compliance and establish the validity of the data, documents, and study or trial conduct.

ALCOA++ Principles	Definition
Attributable	Information needs to evidence who created it and where was it created.
Legible	Information must be human readable; inspectors do not want to be presented with a programming language that needs to be deciphered.
Contemporaneous	Information needs to be that which was captured at the point of generation. If not, the information is not “source data” but “copy data”.
Original	The information (data especially) needs to be original, as first recorded.
Accurate	Information needs to be without error. This is not to say data cannot be corrected, but any corrections or modifications need to be readily apparent and traceable so that they can be questioned, challenged, and the data verified.
+Complete	The information includes all the required elements e.g. dates, signatures, audit trails, metadata etc.
+Consistent	The information was generated in the expected sequence.
+Enduring	The information must remain accessible, available, readable, and (where necessary) usable over time. For example, EU Regulation 536/2014 mandates a minimum retention period of 25-years from the end of the study for GCP records.
+Available	The information must be readily available upon request by inspectors.
++Corroborated and Credible	The information should be based on provably reliable facts and evidence. This can be achieved through the use of validated technology and robust supporting information governance frameworks.

When creating and managing data and documents, it is important to understand the purpose for which -and context in which -the data and documents are being created and will be used both during and after the study.

Click the elements below to view the key considerations to focus on:

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