SPADA Draft Documents

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3.1 Study Sponsor

The sponsor is the entity that defines the study’s objectives. The sponsor’s principal 70 responsibility with respect to culture verification, is to approve the index cultures to which each 71 of the test cultures must relate. This is generally accomplished by specifying the manufacturer 72 and lot number of each of the study’s index cultures. 73 When approving index cultures, the sponsor should be aware of how their decision will 74 impact project costs. Limited availability of singled-sourced cultures or capable culture providers 75 can drive verification costs upwards. Furthermore, the paucity of producer-supplied provenance 76 records and test data could make it costly, if not impossible, for the performer to adequately 77 demonstrate the relationship between the test and index cultures. 78 80 to provide the performer with any nonproprietary but adequate information that can help the 81 performer demonstrate the relatedness of the test and index cultures. It is understood that the 82 culture producer may not have or be able to release all of the information that the performer 83 needs to complete a culture verification statement. However, the lack of supporting data may 84 drive the sponsor or performer to select different sources for their index and test cultures. 85 87 It’s the performer’s responsibility to demonstrate to the sponsor’s satisfaction that they are using 88 test cultures that are sufficiently related to the index cultures to support meaningful comparisons 89 and conclusions within the scope of the extensible study. The performer meets this obligation by 90 providing the sponsor with a Culture Verification Statement for each of their test cultures. The 91 3.2 Culture Producer 79 It is the responsibility of the culture producers, who manufacture the test and index cultures, 3.3 Study Performer 86 Organization(s) that are tasked with conducting the scientific study fill the role of performer.

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