OMB Meeting Book_9-11-14

Vitamin A & E MLT Protocol For ERP Use Only DO NOT DISTRIBUTE

Deviations

As many written documents are subject to interpretation, a collaborator may feel that there are instructions that may be ambiguous.

a) If there are general questions about the study itself, please contact the Study Director for assistance.

b) If there are, in your opinion, questions about the methodology that you feel will seriously jeopardize the study, you may contact the Study Director.

c) It is recommended that a second experienced analyst take part in an initial review of the method, and be consulted prior to any course of action with regard to interpretations and subsequent deviations. d) In the event that parts of the method appear to be subject to interpretation, take the most reasonable course, then note the step or instruction that was in question. Record what exactly was done, and indicate why this step or instruction was thought to be ambiguous. Providing notes concerning ambiguous instructions will help to produce a clearly written final method for publication.

Method, Materials and Resources

You will find a copy of the method in Appendix 1

a) Review the written method, taking note of the list of materials and reagents. Be sure to note materials and supplies not specifically mentioned in the method. It is preferable to have all the required items in place when the shipment of study materials arrives. b) It is the stated policy of the AOAC to not require specific brands or vendors for materials, reagents and supplies, except in limited cases. The term “or equivalent” is used in conjunction with the recommended suppliers. It is important that the equivalency of other products be carefully determined prior to use. c) Although it is feasible to analyze all samples in two days, a minimum of approximately 4 analyst-days or more should be resourced for this study. A similar amount of additional instrument time should also be reserved. It is recommended that, due to the time and expense involved in conducting this study, an experienced analyst be assigned. The analyst should be competent in HPLC techniques. The analyst should also be adept at interpreting and implementing new procedures. d) It is very strongly recommended that a single analyst and a single instrument be dedicated to the study for a period of time. The use of multiple analysts, instruments or time intervals should be avoided.

Safety

Safety instructions are documented in the method. In general the solutions used in this study require routine laboratory safety practices such as the wearing of a lab coat, safety glasses and rubber gloves however special precaution should be taken when handling papain as inhalation may produce health damage. It is a possible respiratory and skin sensitizer and should be handled in a fumehood or wearing a respirator.

Please read AOAC Official Methods of Analysis (2003), Appendix B Laboratory Safety; http://www.eoma.aoac.org/app_b.pdf

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