Study Director

Kendall, H. W. Study Director, 1977, The Risks of Nuclear Power Reactors Union of ( Scientists, Cambridge, MA, August. 

Following the completion of the trial, each participating contract laboratory provides a report of their results to the method trial Study Director. The government laboratory(ies) provide their results to the CVM method trial coordinator. The sponsor compiles the final results from participating laboratories into a summary report. A final version of the SOP is also provided that includes any revisions made because of observations made during the trial. The summary report, electronic and hard copies of all laboratory results, work sheets, and reports from each of the participating laboratories are sent to CVM for final review and acceptance. This should include electronic copies of all information necessary to verify all of the results. 

Pesticides used on crops grown on the test site in previous seasons may also have an impact on the outcome of a field residue trial. Carryover of prior pesticide applications could contaminate samples in a new trial, complicate the growth of the crop in a trial, or cause interference with procedures in the analytical laboratory. For this reason, an accurate history of what has transpired at the potential test site must be obtained before the trial is actually installed. The protocol should identify any chemicals of concern. If questions arise when the history is obtained, they should be reviewed with the Study Director prior to proceeding with the test site. In most annual crop trials, this will not be a significant issue owing to crop rotations in the normal production practices, because the use of short residual pesticides and different chemical classes is often required for each respective crop in the rotation. However, in many perennial crops (tree, vines, alfalfa, etc.) and monoculture row crops (cotton, sugarcane, etc.), the crop pesticide history will play a significant role in trial site selection. 

Application of the test substance to the test system is without doubt the most critical step of the residue field trial. Under-application may be corrected, if possible and if approved by the Study Director, by making a follow-up application if the error becomes known shortly after the application has been made. Over-application errors can usually only be corrected by starting the trial again. The Study Director must be contacted as soon as an error of this nature is detected. Immediate communication allows for the most feasible options to be considered in resolving the error. If application errors are not detected at the time of the application, the samples from such a trial can easily become the source of undesirable variability when the final analysis results are known. Because the application is critical, the PI must calculate and verify the data that will constitute the application information for the trial. If the test substance weight, the spray volume, the delivery rate, the size of the plot, and the travel speed for the application are carefully determined and then validated prior to the application, problems will seldom arise. With the advent of new tools such as computers and hand-held calculators, the errors traditionally associated with applications to small plot trials should be minimized in the future. The following paragraphs outline some of the important considerations for each of the phases of the application. 

In-life or critical phase audits must be completed in a timely and efficient manner. They must not detract from the conduct of the study or interfere with the execution of critical activities within the study. However, QA must be able to clearly determine the actual progress of the study. Audit reports must clearly identify the actual findings of the audit. The reports must be relayed to the Study Director and to study management in a timely manner. If deviations occur or if minor findings are reported, they must... 

The Study Director must prepare a study plan and carry out the following duties ... 

For each regulatory study, a written plan must exist prior to initiation of the study. The study plan must be approved by dated signature of the Study Director and verified for GLP compliance by QA personnel. 

A final report should be prepared for each regulatory study. In the case of short-term studies, a standardized final reporf accompanied by a sfudy-specific extension may be prepared. Reports of Principal Investigators or scientists involved in the regulatory study should be signed and dated by them. They should contain a Principal Investigator statement and QA statement if the Principal Investigator is not linked to the Study Director organization. 

Corrections and additions to a final report should be in the form of amendments. Amendments should clearly specify the reason for the corrections or additions and should be signed and dated by the Study Director. 

A quality assurance program statement listing the types of inspections made and their dates, including the phases inspected, and the dates when any inspection results were reported to management, to the Study Director, and to any Principal Investigators, if applicable. This statement would also serve to confirm that the final report reflects the raw data. 

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