Quality assurance unit. A t es t i n g fa ▇▇▇▇ ▇ ▇ ▇ ▇ ▇ ll h a ve a q u a li t y a ss ur a n ce un i t w h ic h s h a ll be r espo n s ible fo r m o n i t o r i n g e a c h s t u d y t o a ss ur e m a n a ge m e n t t h a t t h e fa cili- t ies, eq u ip m e n t , pe r so nn el, m e t h ods, p r a c t ices, r eco r ds, a n d co n t r ols a r e i n co nfo r m a n ce wi t h t h e r eg u l a t io n s i n t h i s p a r t . F o r a ny give n s t u d y , t h e q u a li t y a ss ur a n ce un i t s h a ll be e n t i r el y sep a r a t e f r o m a n d i n depe n de n t of t h e pe r so nn el e n g a ged i n t h e di r ec t io n a n d co n d u c t of t h a t s t u d y . T h e q u a li t y a s- s ur a n ce un i t s h a ll co n d u c t i n spec t io n s a n d m a i n t a i n r eco r ds a pp r op r i a t e t o t h e s t u d y .
Appears in 3 contracts
Sources: Testing Consent Agreements and Test Rules, Testing Consent Agreements and Test Rules, Testing Consent Agreements and Test Rules