Capturing and Reporting Electronic Data by Willa Garner, Rodney M. Bennett, Markus Jensen

By Willa Garner, Rodney M. Bennett, Markus Jensen

This quantity experiences present information assortment platforms, examines precise methods to information assortment and garage, and gives the most recent details on regulatory matters on facts seize, garage, and reporting.

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Daniel Perspective Consulting, 1034 Greystone Lane, Sarasota, FL 34232 Historically all Good Laboratory Practice (GLP) compliant field data have been collected manually and documented in an organized manner in a Field Notebook prepared by the Sponsor or Field Management Company. The paper Field Notebooks have generally been well organized and logistically easy to audit. In the past several years software programs have been developed that are capable of generating GLP field data electronically. Programs currently in use are American Agricultural Services (AASI) Advantage™ and Astrix FieldNotes.

The entire procedure was probably more work than the manual method, but at least the print-outs were neat and it was a start on computerization. We later borrowed a remote terminalfromthe University and tried data input over the telephone line, but that setup did not always work. I was later transferred to the Sandoz national headquarters in New Jersey, where I was able to make use of the company mainframe for this calculation and printing. My next experience with computerization of residue studies came many years later when the Astrix Software gentleman came to the AgrEvo Research Center and demonstrated their product, FieldNotes, to several of us.

Three to 20 trials are required per crop, depending upon the acreage grown and the importance of the crop commodities as human food. It is very common for registrants to use the crop group approach for registrations. Representative crops in a crop group are tested and the registrant gets a registration for all crops in the group. GLP and GALP (Good Automated Laboratory Practice) standards apply to these studies. Major registrants, such as Bayer Corporation, conduct as many residue trials as possible on their own research farms and contract the remainder to independent research companies which range in size from those that may have several research farms to husband and wife teams with only one site under their control.

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