Field trials audits

Quality assurance activities actually begin early in the drug development process—in the analytical phase. United States requirements5 are established as early as non-clinical laboratory studies. At this early phase, the audit program concentrates on in vivo and in vitro experiments, focusing on early drug entities. These drug entities are tested under laboratory conditions to determine their potential safety risk. At this phase, human subjects (e.g., clinical studies) or field trials in animals are not involved. 

The form or format of the notebook is not as critical from a GLP compliance standpoint as the completion of the record in an accurate, timely, readable, and attributable manner. Company and PI conventions typically have evolved into cost-effective and very efficient data notebooks for field residue trials. These notebooks contain the actual raw data for the trial and once begun become extremely valuable legal parts of the study record. The notebooks should be audited by QA during the field phase of the study as well as at the end of the trial before the notebook is returned to the sponsor organization. The quality of the trial is easily refiected in the quality of the field notebook at the end of the season. 

In the author s experience, field residue trials can be conducted in Latin America under complete compliance with all ERA guidelines and recommendations. More time does need to be spent in planning and preparation to ensure that the personnel involved in the testing have been trained in GLP and that this training, as well as the compliance of equipment, storage and archival sites, standard operating procedures (SOPs), and quality assurance (QA) audits, are properly documented. 

Mackintosh DR, Zepp VJ. Detection of negligence, fraud and other bad faith efforts during field auditing of chnical trial sites. Drug Inf ] 1996 30 645-53. 

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