ALCOA principles: ‘healthy’ guidelines for data integrity – 3 –

Welcome back to our ‘masterclass‘ on data integrity that has meanwhile brought us to the Contemporaneous principle. Simply put, contemporaneous data are data recorded at the time they are generated or observed. Much like the previous element of Legibility, this principle translates into more practical requirements than you would expect at first glance. In just a few minutes you will ‘C’ what we mean.

Waste basket check

Always record research data onto the required/standard form or medium without delay. This includes signatures of responsible colleagues too. In other words: no temporary registration, for instance using post-it notes, is allowed. Mind you, several warnings have already been issued on this aspect because inspection authorities even emptied waste baskets! Even a shopping list may raise suspicion from authorities. In recording data digitally, there should be no possibility for lab personnel to manipulate the date and time entry. Installing special software, for example Secure Desktop, can be really helpful here as it only allows users to execute certain predefined actions.

Time manipulation

This solution automatically cuts of the possibility for users to antedate the system via Explorer. In general and for the sake of segregation of duties, employees with administrator rights, who can manipulate date and time registrations, should not have any involvement or interest in the recorded data. Moreover, date and time recording should be done automatically in case of manual research activities such as weighing. To avoid ambiguity in an online world, the time zone in which the observation is done should be clearly specified too. In case of a system breakdown or computer crash, it may be appropriate to temporarily switch to paper work. If, for some reason, it is decided otherwise and data will be entered after a while, authorities may ask for proof of the breakdown.

Ongoing training

In many so-called clean rooms, where analysts work in a conditioned environment wearing special clothes and protection, special devices are in use with limited, custom functionality. Here, delayed registration is often allowed provided there is an explanation as to why this is done and who is responsible for verifying the registration. In some cases, this can be avoided by implementing custom forms that are partially pre-completed and only require filling in numbers and digits. Finally, ongoing training of lab staff is crucial in developing behavior that becomes second nature. Like our mothers already told us a hundred times: ‘Never put off till tomorrow what you can do today.’ Make them proud!