Case Study: An Enter Once Initiative

Microsoft Word and Excel, although easy to use and enthusiastically adopted by scientists, are not
the best tools for the electronic capture of our data and information, because these files are not
readily re-usable for data mining, analysis or re-analysis, or reporting. The Enter Once Initiative
focuses on the in place, initial electronic capture of our data in structured formats that also designs
for facile electronic movement of the data for efficient and reliable data mining, reporting, and re-use
without re-entry or re-digitisation.

Pharma IQ interviewed Arlene Hamburg, Program Manager at Dow AgroSciences to gain a deeper understanding of how this system works.

Pharma IQ: What was the reason you started this initiative?

A Hamburg: A brief overview of data’s lifecycle visualises the problem to be solved. Typically, for
data required by a regulatory agency, the study to generate that data begins with protocol development and finalisation in Microsoft Word. Then the study director or analyst re-enters subsets of the protocol information into multiple, specialised Microsoft Excel spreadsheets and/or specific, discrete databases to initiate the collection of the experimental data for the study. The aggregated data are usually analysed in Excel prior to reporting. The final report is constructed in pre-formatted Word templates with boilerplate text.

Tables are manually added by cut-n-paste from Excel proformas or database extracts. Overall, data are rehandled or re-entered multiple times from protocol to experimentation to final report.
It doesn’t end here. The established datasets for a chemical and its commercial product(s) are used and reused for answering regulatory or product stewardship questions after the initial registration of the product.

To meet these post-registration needs, individual owners of established datasets compile large Excel “databases” of the information used most frequently by them from the regulatory agency-approved final reports. [Note: The original laboratory, raw data Excel spreadsheets are not useful because generally re-use of the data requires analysis of only the endpoint results and its metadata.] Often Word reports flow from this re-analysis.

The manual ping-ponging of data between Word and Excel over the data’s lifecycle is wasteful of scientists’ time, introduces errors, keeps data in silos, and ensures the re-entry cycle continues. There are smarter ways to do this.

Pharma IQ: What is your current data capture vision?

A Hamburg: In the agricultural world, data is generated in the office, field, and laboratory. Data,
metadata, and information from the office usually ends up in “the ether”. By this I mean the electronic pool, mainly unstructured, of data and information chunks in Microsoft Office files, emails, the internet, files from external research partners, external databases, regulatory agency publications, etc.

The vision is that our current systems or new systems are developed with the driver that when the fingertips hit the keyboard, the information is being capture in an easy to use structured environment. This means our system interfaces must operate electronically where the data gather is. Capture of data on paper or in MS Office files is minimised so digitisation or re-entry is not needed and e-recordkeeping with GLP-validated systems is the norm.

Pharma IQ: What steps are you taking to achieve this vision?

A Hamburg: With our in-place systems, we are adding more connectivity between systems to
minimise entering the same information twice or thrice or sometimes even worse. Connectivity between systems includes the usual historical point-to-point coupling, but also newer technologies such as services and DataStage approaches. We are also adding more familiar and easily accessible web interfaces to improve usability. We are reviewing work and data flows across systems looking for multiple entries of the same information by different people. New systems, either purchased or built from bottom up, are being specified or designed to this vision. Tablet PC’s are being trialed to use in the field and laboratory to enable electronic data capture where the data are being generated.
Pharma IQ: What are your observations on the “current data” pathway?

A Hamburg: Our users are enthusiastic about the Enter Once concept because it means less work for them. After the first phase of implementation we were able to document productivity enhancements with only partial solutions.

Interview conducted by Amber Scorah.