Cast your mind back to the 1980’s or ask your mother if you are too young (I always say that I will ask my Grandmother, but people know that is not true as I have been working in clinical trials since 1979).
So the 1980’s
and by no means least, in the UK a new piece of law was being introduced in 1986 – the UK Data Protection Act. I suppose that it is appropriate that this article should come now as we are full circle back to the future with data protection and the GDPR.
Well it was the 1986 Data Protection Act that led to the formation of the ACDM.
John Shelton, at that time of G D Searle, contacted some of the local heads of statistics (and of course Data Management) of companies in the Thames Valley and suggested a meeting to discuss how we should approach the new law. A meeting was organised at High Wycombe and after sorting out how we should deal with data protection, we dealt with the more important matter of the recognition of data management and the inconsistent way we handled data, and so the seeds were sown for the ACDM. We expanded our team to include some real data managers and not just the heads of department and thus began a search for a name, a committee of volunteers and the topics we wanted to address.
Well I got the job of treasurer, and also the recorder for the sessions. As a minute taker I was commended, not so for balancing the books.
We only charged £5 for membership,
but we started to get European members, who sent cheques, unfortunately it cost £7 in fees to cash cheques on an overseas bank so we ended up with more members than money, but we coped.
Our first meeting in 1987 covered Medical dictionary coding, no MedDRA at that time, more about WHO, SnoMED or homegrown dictionaries.
No one had automated systems, so it was all about looking up the codes – whoever owned the dictionary (paper) ruled.
The transition to what exists now is comparable to the changes in telephones.
The next topic of Data Entry was all consuming but is another area that is rarely mentioned today, as the transition to EDC is almost complete, and in-house data entry is not seen. At that time companies were discussing whether double data entry was needed, or how to compare the double entered data.
The ACDM has progressed as the whole of industry has moved over these past 31 years, and now faces the new data challenges of Risk Based Monitoring, Quality Tolerance Limits and integrating disparate data sources, it will keep you busy for a number of years.
Andy Lawton, Director of Risk Based Approach Ltd (Formerly Global Head of Clinical Data Management at Boehringer Ingelheim)