Clinical trials were conducted with the help of paper based case report forms (CRFs) for
decades. This was – being -changed during the last 30 years. In this presentation I show
how the electronic CRFs (eCRFs) superseded the paper based CRFs gradually.
There was a very complex regulation and well established practice for managing of paper
CRFs by the 80’s. It turned out that this regulation and practice cannot be adequately applied
to eCRFs. The processes of randomisation, query handling or adverse event reporting
should have been reconsidered.
Safety concerns are always present with respect to a computer system. But if this system is
for collection of sensitive data in order to obtain a valuable pattern, these concerns are
increased. I give examples how the regulation – Title 21 CFR Part 11 – controls of data
It is also important to understand how other standard, like CDISC (Clinical Data Interchange
Standards Consortium) and their development influence the implementation of eCRFs.
In a study design the choice between a paper based and an electronic CRF is partly an
economical question. This aspect was already investigated in detail, and I will summarize
how costs of the two tools can be compared.
At the end I would like to give a view on the most probable future of the eCRF concept.
Statistical Programing primarily means derivation of Tables, Listings and Graphs (TLGs). This activity is performed with the help of SAS, so Statistical programing practically means programing in SAS. In wider sense statistical programing covers the majority of CDISC-related tasks because SDTM and ADaM data tables are also prepared with the help of SAS.