AOAC RI ERP E-Book - DS DF

OMA 2014.10 C: Collaborative Study Manuscript Expert Review Panel Use Only September, 2017

2013 Dietary Starch in Animal Feeds Collab Study Protocol 072513

protocol, you have any questions, please contact me prior to starting either the pre-trial samples or the actual study materials. Pre-Trial Samples Pre-trial samples will be provided to the laboratories and will serve a number of purposes. These samples will allow the study sponsors to sort out shipping, importation and handling issues prior to the shipment of actual trial samples. The samples will also confirm that the laboratories are capable of carrying out the method as prescribed. It is by no means a reflection on the lab if the results are questionable. The pre-trial will give the Study Director and the laboratory an opportunity to iron out issues that the lab is having with the method to ensure the success of the study. In order to participate in the study, participants will need to complete the pre-trial samples and provide all required importation documentation. Materials The test materials were prepared from commercially available animal feedstuffs with a broad range of dietary starch contents. The collaborative samples will be sent to your lab via priority post using the shipping company of your choice provided that it is available. Samples will most likely be shipped on a Monday in an attempt to have samples arrive as quickly as possible. Laboratories will be notified when the samples are shipped. The test materials will require storage at freezing temperatures (-20°C). Materials will arrive with a ‘Receiving Status Form’. Immediately upon arrival, inspect the materials to ensure that they have arrived in a timely manner and that the materials have not been compromised (eg., torn sample bags, etc.). Complete and submit the ‘Receiving Status Form’ describing the condition of the samples upon arrival at your laboratory. If the Study Director identifies an issue with the condition of the sample upon receipt, the lab will be notified and a replacement set will be dispatched. If there are obvious problems with the samples when they arrive please notify the sponsors of the study IMMEDIATELY. Once you have completed your required sample receiving procedures, place materials in the appropriate storage locations as indicated on the label. Analytical Protocol The key to the success of a collaborative study is for participants to follow the method precisely. Analysis of the pre-trial samples will allow the laboratories to take the time to set up and become familiar with the method prior to the analysis of the study materials. The pre-trial samples will also allow the laboratory to resolve any analytical issues with the method with assistance from the Study Director. The following are suggested steps to follow for implementing the method in collaborating laboratories and carrying out the analysis on the pre-trial specimens and collaborative study materials. Analysis of Pre-trial samples  Prepare all reagents, solutions and standards as specified in the method  It is important to follow the mixing and incubation protocols to allow optimal action of the enzymes.  Verify the calibration of all devices used to add reagents or transfer samples -- the accuracy of the method relies on the carefully quantitative handling of liquids.  Please allow sufficient time to carry out the method prior to the deadline for returning pre-trial data to the Study Director.  Thoroughly mix samples to allow for appropriate subsampling.  Complete the reporting form for the pre-trial samples and return to the Study Director by e- mail. AOAC Research Institute ERP Use Only

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