ATTACHMENT 4_ SOW-APPENDIX 3.pdf

ATTACHMENT 4

Appendix 3 – Performance Qualification Process

To qualify the performance of the system the Contractor shall create a study in the system that recapitulates the RACB study design and a study that recapitulates the MOG design. These two studies shall be in the hosted system which the NTP and contract labs shall use. After the studies are created, the contractor shall obtain test data from the NTP in order to enter into the system following the prompts given by the system, as if the data were that collected during an in-life study. The data shall be a subset of an actual RACB study, and a merged MOG study containing all anticipated cohorts.

The data may be entered using a application to alter the system date, so that it is possible to collect the data from a two year study in a shorter actual time period. An application such as Time Machine is acceptable for this purpose.

The data shall encompass 6 animals per group, and cover in-life observations, feed / water weight, body weights, organ weight collection, gross observations and histopathology. For the RACB, there shall be three consecutive pairing, evidence of mating, and littering events, with litter observations as described in the RACB protocol. Data for the MOG study shall include neurotoxicology observations, fetal pathology observations, clinical pathology, and animal shipping. For both studies there shall be data to support the validation of the dominant lethal pairing and cross over pairings included in the protocols. The data entry for this qualification shall be validated by raw data report by a person other than the person entering the data. A report summarizing the validation process shall be delivered to the NTP at the end of the performance qualification.