Records field trials

For studies involving test substance application to soil, there may be a requirement for more soil information than for studies where applications are made to foliage of established crops. The study protocol should describe any specific requirements relative to soil type selection and how to confirm the soil characteristics for the study. Most studies simply require that the soil be identified by its name (e.g., Keystone silt loam) and composition (e.g., percent sand, silt, and clay). This information can typically be acquired from farm records, a soil survey of the local area, or a typical soil analysis by a local soil analysis laboratory. In some instances, a GLP compliant soil analysis must be completed. The study protocol must clearly define what is needed and how it is to be obtained. Unless specified in the protocol, non-GLP sources are adequate to identify the soil and its characteristics. The source of the soil information should be identified in the field trial record. 

Zubr (1988a) reported breaking and lodging of tall stems during storms in Denmark, while Le Cochec and de Barreda (1990) recorded losses due to wind and hail in French field trials. 

Cornwell R L, Jones R M 1968 Field trials in horses with pyrantel tartrate. Veterinary Record 82 586-587 Costa A J, Barbosa O F, Moraes F R et al 1998... 

Records of GMOs and maps of field trial sites and public availability online... 

Varieties are recorded for their susceptibility to the main diseases in field trials. Varieties with a rating of 1, 2 or 3 in the HGCA recotmnended fists are very susceptible compared with those rated 8 or 9 for varieties that are resistant and where the disease is unlikely to reduce yields significantly. 

The trailer thus manufactured with a rated payload was put under field trials and shock measurements were undertaken at the axle and on the bed using B K accelerometers and readings recorded on a magnetic tape. An extract of the readings are as follows... 

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. 

The movement of the test substance during the course of a Held residue study must be tracked to assure that the integrity of the test substance is maintained [40 CFR 160.185(a)(10)]. The COC can be accomplished in a number of ways. In the simplest situation, every person signs their name on a piece of paper that accompanies the test substance when they handle the test substance. Eventually the COC will list the names of all those who handled the test substance during the course of the study. Shipment, receipt, weighing, and final disposition of the test substance container must all be tracked and promptly recorded if an unbroken COC is to be present at the end of the trial. The completed COC becomes an essential part of the field residue trial record. 

Other data such as light intensity, percentage cloud cover, and soil moisture may also be recorded. The use of meteorological equipment, which can measure critical climatic information such as wind speed (current, maximum and average), humidity, air temperature, and dew-forming point, is preferable in the field. Historic weather data in the form of 10-year averages must be reported and are required for comparison of the trial specific data with the normal weather data. 

Records are kept of when a sample was collected, the method of collection, who collected the sample, what the elapsed time was between harvest and freezing, the conditions under which it was stored, how it was shipped to the laboratory, and when it was shipped. When a sample arrives at the laboratory, the condition of the sample is checked and recorded. Then the information on the sample bag (sample number, application rate, preharvest interval, etc.) is compared to the trial information sheets which are submitted along with the samples. Any omissions or discrepancies are corrected at that time. If there is an omission or discrepancy that cannot be easily corrected by a telephone call from the sample processing laboratory to the field scientist, the study director is notified. The study director must make the decision about the validity of the sample and put a note in the data file explaining how the problem was corrected or that the problem could not be corrected and the trial is to be abandoned. If the trial is dropped, Quality Assurance is notified, the trial is deleted from the active Master Schedule, and an explanation is put in the study file. 

Case report form completion All study personnel who will be entering data into the CRF should be present for review. The CRF contains all data required by the protocol. Instructions are provided for correct entry of data into the CRF, and the sites are reminded that all areas of the CRF are to be completed accurately. No data fields should be left blank. The abbreviations UNK, N/A, or ND are to be used when information is not known and whiteout or obliteration of data is not permissible. If a correction is needed in the CRF, study personnel are to strike through the incorrect entry with a single line, record the correct entry, and initial and date the correction. In a multicenter trial with many centers, instructions or guidelines for correct data entry on each page can be included in the CRF. This allows for uniform entry of data across many centers. 

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