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