labqaqcmod7 - Module 7 Protocols Page 1 of 10 Printable...

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Print Save to File Printable View of: Module 7: Protocols File: Overview Overview Module 7: Study Protocols Overview Study protocols are frequently required for FDA and EPA studies and are used to define all the experimental parameters within the particular study. These parameters include, but are not limited to: criteria for inclusion in study numbers of test subjects or samples doses statistical methods The SOPs for the analysis of compounds of interest are also specified in the protocol. Protocols are usually not required for laboratories that perform analyses for others. Objectives At the end of this module students should: Understand the difference between a protocol and an SOP Know the components of a study protocol Know when a study protocol is necessary Assignments Please note: The assignment is listed below and again on the final page of this module. You should consider the assignment questions as you read through the module content, then submit your assignment using the assignment submission form on the final page of this module. Decide whether a protocol is required for each of the situations presented below. Which participant(s) is responsible for providing the protocol, SOP, consent forms, approvals, etc. for a proposed study of the problem. In other words, what is each participant required to provide in the way of paperwork. (In this context, participant may be an individual or it may be a laboratory, organization, or collaborators in a study.) When a protocol is needed, briefly describe what information should be included. During the last five years, the alligator population has diminished significantly in Lake Apopka. It has been postulated that pesticides used in the area accumulate in alligator eggs thereby causing a reduced birth rate. 1. In order to study this problem, the principal investigator will collect the alligator eggs and give them to the departmental GCMS laboratory that will determine the levels of pesticides in the egg yolks. Using this data, the investigator will see if there is a correlation between alligator population and pesticide usage. Ace Pharmaceutical Company is developing a new antihypertensive drug that has been found to lower hypertension and have low toxicity in rats. At this point Ace plans to initiate studies on the effect of the drug on monkeys at several universities. If results from these animal studies show promise, clinical studies will be initiated at five sites. 2. Page 1 of 10 Module 7: Protocols 8/2/2009 ..
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File: Study Protocol and SOP Study Protocol and SOP Module 7: Study Protocols Study Protocol and SOP Definition The exact meaning of the word protocol depends upon the context in which it is used.
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labqaqcmod7 - Module 7 Protocols Page 1 of 10 Printable...

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