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Riz vi N A, Mazieres J, Pla nc har d D, et al. A cti vit y a n d safet y of ni v ol u ma b, a n a nti- P D - 1 i m m u ne c hec k p oi nt i n hi bit or, f or patie nts wit h a d v a nce d, refract or y s q u a m o us n o n-s mall-cell l u n g ca ncer ( C hec k M ate 0 6 3): a p hase 2, si n gle- ar m trial. L a ncet O nc ol . 2 0 1 5; 1 6( 3): 2 5 7- 2 6 5.  
ose B S, J e o n g J H, Nat h S K, L u S M, Mell L K. P o p ulati o n- base d st u d y of c o m peti n g m ortalit y i n hea d a n d nec k ca ncer. J Cli n O nc ol . 2 0 1 1 Se p 1 0; 2 9( 2 6): 3 5 0 3- 9.  
R ose nt hal D. I m p act of p 1 6 stat us o n t he res ults of t he p hase III cet u xi ma b (cet)/r a di ot hera p y  
( R T). J Cli n O nc ol . 3 2: 5s, 2 0 1 4 s u p pl; a bstr 6 0 0 1.  
R u bi n Gra n dis J, Mel he m M F, G o o di n g W E, et al. Le v els of T G F-al p ha a n d E G F R pr otei n i n he a d a n d n ec k s q ua m o us cell carci n o ma a n d p atie nt s ur vi val. J N atl C a ncer I nst . 1 9 9 8; 9 0( 1 1):  
8 2 4- 8 3 2.  
c ott- Br o w n M, et al., E vi de nce- b ase d re vie w: q u alit y of life f oll o wi n g h ea d a n d nec k i nte nsit ym o d ulate d ra di ot hera p y. R a di ot her O nc ol . 2 0 1 0; 9 7( 2): 2 4 9- 5 7.  
Sei wert T Y. A p has e I b st u d y of M K- 3 4 7 5 i n patie nts wit h h u ma n pa pill o ma vir us ( H P V)-  
ass ociate d a n d n o n- H P V- ass ociate d hea d a n d n ec k ( H/ N) ca ncer. Cli n O n c ol. 3 2: 5s, 2 0 1 4 s u p pl; a bstr 6 0 1 1 Sei wert T Y, et al. Safet y a n d cli nical acti vit y of pe m br oliz u ma b f or treat me nt of rec urre nt or metastatic s q ua m o us cell carci n o ma of t he hea d a n d nect ( K E Y N O T E- 0 1 2): a n o pe n-la b el, m ultice ntre, p hase 1 b trial. L a ncet O nc ol. 2 0 1 6; 1 7( 7): 9 5 6- 6 5.  
har ma M R, Maitla n d M L, Ratai n MJ. R E CI S T: N o l o n ger t he s har pest t o ol i n t he o nc ol o g y cli nical trials t o ol b o x. C a ncer Res . 2 0 1 2; 7 2( 2 0): 1- 5.  
ie gel R, Nais ha d h a m D, J e mal A. Ca ncer statistics 2 0 1 3. C A C a ncer J Cli n . 2 0 1 3; 6 3( 1): 1 1- 3 0.  
S pa n os W C, et al. I m m u ne res p o nse d uri n g t h era p y wit h cis plati n or ra diati o n f or h u ma n pa pill o ma vir us-relate d h ea d a n d n ec k ca ncer. Arc h Ot ol ary n g ol . 2 0 0 9; 1 3 5( 1 1): 1 1 3 7- 4 6.  
S pratt D E, Sa kae M, Ria z N, et al. Ti me c o urse a n d pre dict ors f or ca n cer-relate d fati g ue i n a series of or o p h ar y n geal c a ncer patie nts treat e d wit h c he m ora diati o n t hera p y. O nc ol o gist .  
2 0 1 2; 1 7( 4): 5 6 9- 7 6. d oi: 1 0. 1 6 3 4/t he o nc ol o gist. 2 0 1 1- 0 4 3 7. E p u b 2 0 1 2 Mar 7.  
ri vasta va R M, Lee S C, A n dra de Fil h o P A, et al. Cet u xi ma b-acti vate d nat ural killer a n d de n dritic cells c olla b orat e t o tri g ger t u m or a nti ge n-s pecific T-cell i m m u nit y i n hea d a n d nec k ca ncer patie nts. Cli n C a ncer Res . 2 0 1 3; 1 9: 1 8 5 8- 1 8 7 2.  
Sta mell E F, et al. T he a bsc o pal effect ass o ciate d wit h a s yste mic a nti- mela n o ma i m m u ne res p o nse. IJ R O B P. 2 0 1 3; 8 5( 2): 2 9 3- 5.  
Stra ns k y N, et al. T he m utati o nal la n dsca pe of hea d a n d nec k s q ua m o us cell carci n o ma. Sci e nce .  
2 0 1 3; 3 3 3( 6 0 4 6): 1 1 5 7- 6 0.  
tr o me S E, et al. B 7- H 1 bl oc ka de a u g m e nts a d o pti ve T-cell i m m u n ot hera p y f or s q ua m o us cell carci n o ma. C a n cer Res . 2 0 0 3; 6 3( 1 9): 6 5 0 1- 5.  
Ta u be J M, A n ders R A, Y o u n g G D, et al. C ol ocaliz ati o n of i nfla m mat or y res p o nse wit h b 7- h 1 e x pressi o n i n h u ma n mela n oc ytic lesi o ns s u p p orts a n a da pti ve resista nce m ec ha nis m of i m m u ne esca pe. S ci Tr a nsl Me d . 2 0 1 2; 4( 1 2 7): 1 2 7ra 3 7.  
Ta yl or C, Hers h ma n D, S ha h N, et al. A u g me nt e d H E R- 2 s pecific i m m u nit y d uri n g tr eat me nt wit h tra st uz u ma b a n d c he m ot hera p y. Cli n C a ncer Res . 2 0 0 7; 1 3( 1 7): 5 1 3 3- 5 1 4 3.  
Te n g F, Li K, M e n g X, et al. Ra di ot hera p y c o m bi ne d wit h i m m u ne c hec k p oi nt bl oc ka de i m m u n ot hera p y: A c hie ve me nts a n d c halle n ges. C a ncer Letters . 2 0 1 5; 3 6 5( 1): 2 3- 3 9.  
T herasse, P. et al. Ne w g ui deli nes t o e val uate t he res p o nse t o treat me nt i n s oli d t u m ors. J N atl C a ncer I nst. 2 0 0 0: 9 2( 3): 2 0 5- 2 1 6.  
T o pa lia n S L, et al. Safet y, acti vit y, a n d i m m u ne c orrelates of a nti-P D - 1 a nti b o d y i n c a ncer.  
N EJ M . 2 0 1 2; 3 6 6( 2 6): 2 4 4 3- 5 4.  
b) T o palia n S L, Dra k e C G, Par d oll D M. Tar geti n g t he P D- 1/ B 7- H 1( P D- L 1) pat h wa y t o a cti vate nti-t u m or i m m u nit y. C urr O pi n I m m u n ol . 2 0 1 2; 2 4( 2): 2 0 7- 1 2.  
Tze n g H T, et al. P D- 1 bl oc ka ge re verses i m m u ne d ysf u n cti o n a n d he patitis B viral persiste nce i n a m o use a ni mal m o del. P L O S o ne . 2 0 1 2; 7( 6): e 3 9 1 7 9.  
Ur ba S, Gatz J, S he n W, et al. Q ualit y of life sc ores as pr o g n ostic fact ors of o verall s ur vi val i n a d va nce d hea d a n d nec k ca ncer: a nal ysis of a p has e III ra n d o mize d trial of pe metre x e d pl us cis plati n vers us cis plati n m o n ot hera p y. Or al O nc ol . 2 0 1 2; 4 8( 8): 7 2 3- 9. d oi:  
1 0. 1 0 1 6/j. oral o nc ol o g y. 2 0 1 2. 0 2. 0 1 6. E p u b 2 0 1 2 Mar 1 1.  
Ver br u g ge I, et al. Ra di ot hera p y i ncreas es t he per missi ve ness of esta blis he d ma m mar y t u m ors t o rejecti o n b y i m m u n o m o d ulat or y a nti b o dies. C a ncer Res . 2 0 1 2; 7 2( 1 3): 3 1 6 3- 7 4.  
Ve r m or ke n J B, et al. Plati n u m- base d c he m ot hera p y pl us cet u xi ma b i n hea d a n d nec k ca ncer.  
N EJ M. 2 0 0 8; 3 5 9( 1 1): 1 1 1 6- 2 7.  
alz P C, B us h M L, R o bi nett Z, Kirsc h C F E, Welli n g B D, T hree- di me nsi o nal se g m e nte d v ol u metric a nal ysis of s p ora dic vesti b ular s c h wa n n o mas: C o m paris o n of se g me nte d a n d li near meas ure me nts. Ot ol o gy a n d Ne ur ot ol o gy . 2 0 1 2; 1 4 7 ( 4): 7 3 7- 7 4 3.  
ater b oer T, et al. M ulti ple x h u ma n pa pill o ma vir us ser ol o g y b ase d o n i n sit u- p urifie d gl utat hi o ne s-tr a nsferase f usi o n pr otei ns. Cli n C he m . 2 0 0 5; 5 1( 1 0): 1 8 4 5- 5 3.  
W hitesi de T L. I m m u ne cells i n t he t u m or micr oe n vir o n me nt. Mec ha nis ms res p o nsi ble f or f u ncti o nal a n d si g nali n g defects. A d v Ex p Me d Bi ol . 1 9 9 8; 4 5 1: 1 6 7- 7 1.  
ilc o x R A, et al. Si g nali n g t hr o u g h N K cell- ass ociate d C D 1 3 7 pr o m otes b ot h hel per f u ncti o n f or C D 8 + c yt ol ytic T cells a n d res p o nsi ve ness t o I L- 2 b ut n ot c yt ol ytic acti vit y. J I m m u n ol .  
2 0 0 2; 1 6 9( 8): 4 2 3 0- 6.  
Willi ms k y G, et al. Vir us-i n d uce d he p at ocell ular carci n o mas ca use a nti ge n-s pecific l oc al t olera nce. J Cli n I nvest . 2 0 1 3; 1 2 3( 3): 1 0 3 2- 4 3.  
W u A W, J ac o bs o n K D, Fric k D L, et al. Vali dit y a n d res p o nsi ve n ess of t he E Q- 5 D as a meas ure of healt h-relate d q ualit y of life i n pe o ple e nr olle d i n a n AI D S cli nical trial. Q u al Life Res . 2 0 0 2; 1 1( 3) : 2 7 3- 8 2.  
Xia o C, Ha nl o n A, Z ha n g Q, et al. S y m pt o m cl usters i n patie nts wit h hea d a n d nec k ca ncer recei vi n g c o n c urre nt c he m ora di ot hera p y. Or al O n c ol . 2 0 1 3; 4 9( 4): 3 6 0- 6. d oi:  
1 0. 1 0 1 6/j . oral o nc ol o g y. 2 0 1 2. 1 0. 0 0 4. E p u b 2 0 1 2 N o v 1 7.  
Ye wale C, Bara dia D, V h ora I, Patil S, Misra A. pi der mal gr o wt h fact or rece pt or tar geti n g i n ca ncer: a r e vie w of tre n ds a n d strate gies. Bi o m ateri als 2 0 1 3; 3 4( 3 4): 8 6 9 0- 8 7 0 7.  
Za k eri K, R ose B S, G ula ya S, D' A mic o A V, Mell L K. C o m peti n g e v e nt ris k stratificati o n ma y i m pr o ve t he desi g n a n d efficie nc y of cli nical trials: sec o n dar y a nal ysis of S W O G 8 7 9 4. C o nte m p Cli n Tri als . 2 0 1 3 J a n; 3 4( 1): 7 4- 9.  
el e n M. T he ra n d o mizati o n a n d stratificati o n of p atie nts t o cli nical trials. J C hr o n Dis . 2 7: 3 6 53 7 5, 1 9 7 4.  
e n g J, et al. A nti-P D - 1 bl oc ka de a n d stere ota ctic ra diati o n pr o d uce l o n g-ter m s ur vi val i n mice wit h i ntracra nial gli o mas. IJ R O B P. 2 0 1 3; 8 6( 2): 3 4 - 9.  
Z ha o B, O x nar d G R, M os k o witz C S, et al. A pil ot st u d y of v ol u me me as ur e me nt as a met h o d of t u m or res p o nse e v al uati o n t o ai d bi o mar ker de v el o p me nt. Cli n C a ncer Rese arc h . 2 0 1 0; 1 6: 4 6 4 75 3.
r t o g f
r t o g 3

1 O B J E C TI V E  
T he o bjecti ve of t his pr o ce d ure m a n ual is t o pr o vi de t he st u d y site wit h cl ear a n d det aile d i nf or mati o n f or t he st ora ge, h a n dli n g, pre parati o n a n d a d mi nistrati o n of Ni v ol u ma b use d i n t he R T O G 3 5 0 4/ C A 2 0 9- 4 1 0 st u d y
r t o g f
2 b m s c

f c o ncer ns re gar di n g t he q ualit y or a p p eara nce of t he st u d y dr u g, or q uesti o ns re gar di n g a d mi nistrati o n arise, d o n ot dis pe nse t he st u d y dr u g a n d c o ntact t he Brist ol- M yers S q ui b b i m me diatel y:  
Q uesti o ns wit h re gar d t o dr u g pre parati o n a n d p har mac y ma n ual c o nte nt:  
```
Peter Tri m b oli, R P h

P har mac y Ser vices, Dr u g S u p pl y M a na ge me nt

Brist ol- M yers S q ui b b Researc h a n d De v el o p me nt

Tele p h o ne: 6 0 9- 2 5 2- 4 8 6 2

E ma il: p har mac yser vices @ b ms.c o m


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r t o g f
3 ni v o l

| Pr o d uct N a                                                                                                                                                                                                                                 | me                                                                        | Ni v ol u ma b I nje cti o n ( B   | M S 9 3 6 5 5 8), 1 0 0 m g/ vial ( 1 0 m g/ m L)   |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------|
| P ack a gi n g:                                                                                                                                                                                                                                | Vials ass e m ble d i nt o w hite dis pe nsi n g b o x es c o ntai ni n g |                                    |                                                     |
| 1 0 0 m g vials.  Vi als: 1 0 cc T y pe I gl ass vial. 2 0 m m st o p per a n d seal, res pecti vel y.  A p pe ar a nce: Cle ar t o o p alesce nt, c ol orless t o pale yell o w li q ui d,  li g ht (fe w) partic ulates m a y b e pres e nt. |                                                                           |                                    |                                                     |
| Pr o d uct I n gr e die nts                                                                                                                                                                                                                    | Eac h vial c o ntai ns 1 0 0 m g Ni v ol u ma b                           |                                    |                                                     |
| Pr o d uct des cri pti o n  a n d P ac k a gi n g                                                                                                                                                                                              |                                                                           |                                    |                                                     |
r t o g f
3. 1. 2 h a

As wit h all i njecta ble dr u gs, care s h o ul d b e ta ke n w he n ha n dli n g a n d pre pari n g Ni v ol u ma b.  
W he ne ver p ossi ble, Ni v ol u ma b i nf usi o ns s h o ul d be pre pare d i n a l a mi nar fl o w h o o d, gl o ve b o x, or sa fet y ca bi net usi n g sta n dar d pr o ce d ures f or t h e safe h a n dli n g of i ntra ve n o us a ge nts a p pl yi n g ase ptic tec h ni q ues. Gl o ves are re q uir e d. If ni v ol u ma b s ol uti o n c o mes i n c o ntact wit h t he s ki n or m uc osa, i m me diatel y a n d t h or o u g hl y w as h wit h s oa p a n d wat er.  
D ose Pre p ar ati o n a n d a d mi nistr ati o n Vis uall y i ns pect dr u g pr o d uct s ol uti o n f or partic ul ate matter a n d dis c ol orati o n pri or t o A P P E N DI X I (c o nti n ue d)
a d mi nistrati o n. Ni v ol u ma b is a clear t o o palesce nt, c ol orless t o pale yell o w s ol uti o n. Discar d t he vial if t he s ol uti o n is cl o u d y, disc ol or e d, or c o ntai ns e xtra ne o us partic ulate matter ot her t ha n a  
```
fe w tra nsl uc e nt-t o- w hite, pr otei nace o us p articles. D o n ot s ha ke t he vial.

Pre p ar ati o n

it h dra w t he re q uire d v ol u me of Ni v ol u ma b a n d tra nsfer i nt o a n i ntra ve n o us

o ntai ner.

Dil ut e Ni v ol u ma b wit h eit her 0. 9 % S o di u m C hl ori de I nj ecti o n, U S P or 5 %

De xtr ose I nje cti o n, U S P t o pre pare a n i nf usi o n wit h a fi nal c o nce ntrati o n ra n gi n g

fr o m 1 m g/ m L t o 1 0 m g/ m L (see e x a m ple bel o w)

Mi x dil ute d s ol uti o n b y ge ntle i n versi o n. D o n ot s ha ke.

Disc ar d partiall y us e d vials or e m pt y vi als of Ni v ol u ma b.

St or a ge of I nf usi o n

T he pr o d uct d oes n ot c o ntai n a preser vati ve. After pre parati o n, st ore t he Ni v ol u ma b

i nf usi o n eit her:

t r o o m te m perat ur e f or n o m ore t ha n 4 h o urs fr o m t he ti me of

pre parati o n. T his i ncl u des r o o m te m perat ur e st ora ge of t he i nf usi o n i n t he

I V c o ntai ner a n d ti me f or a d mi nistrati o n of t he i nf usi o n

or

u n de r refri gerati o n at 2° C t o 8° C ( 3 6° F t o 4 6° F) f or n o m ore t ha n 2 4 h o urs

fr o m t he ti me of i nf usi o n pre parati o n.

D o n ot f reeze.

A d mi nistr ati o n

A d mi nister t he i nf usi o n o ver 3 0 mi n utes t hr o u g h a n i ntra ve n o us li ne c o nt ai ni n g a sterile, n o np yr o ge nic, l o w pr otei n bi n di n g i n-li ne filter ( p ore siz e of 0. 2 micr o meter t o 1. 2 micr o meter). D o

n ot c oa d mi nister ot her dr u gs t hr o u g h t he s a me i ntr a ve n o us li ne. Fl us h t he i ntr a ve n o us li ne at

e n d of i nf usi o n wit h a p pr o pri ate a m o u nt of dil ue nt ( e. g. 1 5- 2 0 ml) t o e ns ure t h at t he t ot al

ose is a d mi nistere d. T ot al i nf usi o n a n d fl us h ti me s h o ul d e q u al t o 3 0.

D ose selecti o n f or Ni v ol u ma b s h o ul d be assi g n e d per s u bject as o utli ne d i n t he cli nical pr ot oc ol

st u dy dr u g d osi n g secti o n of t he cli nical pr ot oc ol. T he ex a m ples b el o w use a t ot al v ol u me of 6 0

ml t o all o w f or a pr actic al a d mi nistr ati o n r ate, h o wever ot her v ol u m es m ay be use d f or

iv ol u m a b pre p ar ati o n s o as l o n g as t he fi n al c o nce ntr ati o n re m ai n bet wee n 1 - 1 0 m g/ ml (e. g.

1 0 0 ml)

N O T E: W he n Niv ol u m a b Pl ace b o is re q uire d, pl ace b o s h all be c o nsi dere d a n e q u al v ol u m e of

dr u g dil ue nt al o ne ( N S, D 5 W) w hic h is st a n d ar d t o site pr actice f or mi xi n g active Niv ol u m a b

( 6 0 ml, or 1 0 0 ml) a n d s h o ul d be i nf use d at t he s a m e r ate ( 3 0 mi n utes).

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a p p e n
3. 1. 2 h a

Pre parati o n e x a m ple 2 4 0 m g d ose; Niv ol u m a b 2 4 0 m g ( 2 4 ml Niv ol u m a b 1 0 m g/ ml s ol uti o n, l oc al r o u n di n g r ules a p plic a ble) m ay b e mixe d wit h 3 6 ml N S or D 5 W t o a t ot al v ol u me = 6 0 ml w hic h c a n be i nf use d over 3 0 mi n utes at 2 ml/ mi n f oll o we d by fl us h.  
re parati o n e x a m ple 4 8 0 m g d ose; Niv ol u m a b 4 8 0 m g ( 4 8 ml Niv ol u m a b 1 0 m g/ ml s ol uti o n, l oc al r o u n di n g r ules a p plic a ble) m ay b e mixe d wit h 1 2 ml N S or D 5 W t o a t ot al v ol u me = 6 0 ml w hic h c a n be i nf use d over 3 0 mi n utes at 2 ml/ mi n f oll o we d by fl us h.
a p p e n
3. 1. 3 p r

Ni v ol u ma b 1 0 0 m g vials f or i njecti o n s h o ul d be refri gerat e d at 2° C t o 8° C ( 3 6° F t o 4 6° F).  
Pr otecte d fr o m li g ht a n d s h o ul d n ot be fr oze n. D o n ot use be y o n d t he e x pirati o n date o n t he vial. Pr otect t he vials fr o m li g ht b y st ori n g i n t he ori gi nal pac ka ge u ntil ti me of use. Vials d o n ot c o nta i n preser vati ve a n d t h us are i nte n d e d f or si n gle use o nl y a n d s h o ul d be discar de d after use a n d pr o d uct rec o n ciliati o n.  
Ni v ol u ma b s h o ul d n ot be i nf use d c o nc o mita ntl y i n t he sa me i ntra ve n o us li n e wit h ot her a ge nts.  
N o p h ysic al or bi oc he mi cal c o m pati bilit y st u dies ha ve bee n c o n d uct e d t o e val uate t he c od mi nistrati o n of Ni v ol u ma b wit h ot her a ge nts.
a p p e n
4 s i t e

Dr u g m ust be st ore d u n d er t he pr o per c o n diti o ns as liste d o n t he cli nical s u p pl y la bel. If a n y te m perat ur e e x c ursi o ns are e nc o u nt ere d d uri n g o n site st ora ge, pleas e re p ort t hese t o B M S f or assess me nt as o utli ne d i n t he Brist ol- M yers S q ui b b, "I n vesti gati o nal Me dici nal Pr o d uct (I M P)  
ha n dli n g at I n v esti gati o nal Sites: S hi p me nt, Re cei pt, St ora ge, Use Dat e E xte nsi o n a n d Ret ur n/ Destr ucti o n" g ui d eli ne usi n g t he Te m perat ure E x c ursi o n Res p o nse F or m. See F or m 1 Pr o per st or a ge c o n diti o ns m ust be m ai nt ai ne d d uri n g m o ve me nt of i n ve nt or y wit hi n a n i n vesti g ati o n al site. St ora ge c o n diti o ns f or me dicati o ns re q uiri n g st or a ge at 2º C t o 8º C ( 3 6º F4 6º F ) m ust be mai ntai ne d t hr o u g h o ut t he tr a ns p ort wit h d oc u me ntati o n mai ntai ne d wit hi n t he site files. W here c o ntr oll e d st ora ge c o n diti o ns (f or e x a m ple, te m perat ur e, relati ve h u mi dit y, li g ht, etc.) are re q uire d d uri n g tra nsit, t he necessar y e n vir o n me ntal c o ntr ols m ust be i n place t o e ns ure t hat t he dr u g pr o d uct r e mai ns wit hi n t he acce pt a ble te m perat ure ra n ge. Te m perat ure m o nit ori n g de vices s uc h as mi n ma x de vice m ust be i m ple me nte d d uri n g tr a nsit.
a p p e n
5 p r o d

S hi p me nt I ns pecti o n I nstr ucti o ns 1. O pe n b o x i m me di at el y u p o n recei pt.  
2. Caref ull y i ns pect kits e ns uri n g all of t he s u p plies were recei ve d i n g o o d c o n diti o n, c orrect q ua ntit y recei ve d, a n d all of t he c o ntai ner I D \#s were recei ve d as n ote d o n pac ki n g sli p.  
3. i g n a n d date ( date of recei pt) pac ki n g sli p a n d fil e wit h st u d y-s p ecific d o c u me nts.
a p p e n
acc o u nt a

It is t he res p o nsi bilit y of t he i n vesti gat or t o e ns ure t hat a c urre nt dis p ositi o n rec or d of i n vesti gati o nal pr o d uct acc o u nta bilit y a n d rec o nciliati o n is mai ntai ne d at eac h st u d y site w h ere st u d y dr u g is i n ve nt orie d a n d dis pe nse d.  
I n a d diti o n, rec or ds or l o gs m ust c o m pl y wit h l oc al re g ulati o ns a n d g ui deli nes f or t he c o n d ucti o n a n d ha n dli n g of cli nical s u p plies s h o ul d i ncl u de b ut n ot li mite d t o o:  
A m o u nt recei ve d a n d pla ce d i n st ora ge area A m o u nt c ur re ntl y i n st ora ge area a b el I D n u m ber or bat c h n u m ber A m o u nt dis pe nse d t o a n d ret ur ne d b y s u bject, i ncl u di n g u ni q ue s u bject i de ntifiers A m o u nt t ra nsferre d t o a n ot her area/site f or dis pe nsi n g or st ora ge N o n -st u d y dis p ositi o n (e. g. l ost, waste d)  
A m o u nt destr o ye d at st u d y site, if a p plica ble A m o u nt re t ur ne d t o t he S p o ns or, if a p plica ble Da tes a n d i nitials of pers o n res p o nsi ble f or I n v esti gati o nal Pr o d uct (I P)  
Dis pe nsi n g/a cc o u nta bilit y, as p er t he Site Si g n at ure a n d D ele gati o n L o g.
a p p e n
st u d y dr

St u d y dr u gs ca n be d estr o ye d o n site if l oc al p olicies all o w t o d o s o. It is t he I n v esti gat or's res p o nsi bilit y t o e ns ure t hat arra n ge me nts ha v e bee n ma de f or t he dis p osal, pr oce d ures f or pr o per dis p osal ha ve bee n esta blis he d acc or di n g t o a p plica ble re g ulati o ns, g ui deli nes a n d i nstit uti o nal pr oce d ures, a n d a p pr o pri ate rec or ds of t he dis p osal ha ve bee n d o c u me nte d.  
```
F or m 1

B rist ol- M yers S q ui b b

Te m per at ure E x c ursi o n Res p o nse F o r m f or I n vesti g ati o n al Me dici n al Pr o d ucts

Secti o n A. T o be c o m pl ete d b y t he site at t he ti me of Site St or a ge Te m pe r at ure E x c ursi o n:

Pr ot oc ol N u m ber: Site N u m ber/I n vesti g at or N a me/ C o u ntr y:


```  
| Descri pti o n of Dr u g Pr o d ucts i n v ol ve d i n E x c ursi o n: B atc h n u m ber (s) pri nte d o n l a bel:   | C o nt ai ner n u m bers:   |
|-----------------------------------------------------------------------------------------------------------------------|-----------------------------|  
Descri pti o n of E x c ursi o n (te m p er at ure hi g hs/l o ws a n d d ur ati o n):  
B el o w l a bel st or a ge l o w er li mit …...° C D ur ati o n: … … … …. L o w e xtre me t°: …..° C  
A b o ve l a bel st or a ge u p pe r li mit ….. ° C D ur ati o n: … … …... Hi g h e xtre me t°: …..° C  
Re as o n f or e x c ursi o n:  
H as t he iss ue bee n res ol ve d ?  
H a ve t hese s pecific c o nt ai ners bee n i n v ol ve d i n a pr e vi o us e x c ursi o n ? N O Y E S  
If y es, ple ase pr o vi de:  
B atc h n u m ber (s): C o nt ai ner n u m bers: Te m per at ure hi g hs/l o ws a n d d ur ati o n E x c ursi o n i nf or m ati o n s u b mitt e d b y: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ D ate: _ _ _ _ _ _ _ _ _ _ _ _  
Pri nt/ Si g n at ure/ Title of site st aff Secti o n B. Us a ge Decisi o n t o be m a de b y B rist ol- M y ers S q ui b b:  
Te m per at ure e x c ursi o n det ails f or t he pr o d ucts liste d a b o ve h a ve bee n e v al u ate d. Us a ge decisi o n is b ase d o n t he te m per at ure d at a t h at w ere m a de a v ail a ble b y t he i n vesti g ati o n al site.  
C o ncl usi o n ( a n d c o m me nts)  
All pr o d ucts ar e s uit a ble f or c o nti n ue d use  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
All pr o d ucts ar e N O T s uit a ble f or f urt he r dis pe ns ati o n. Ple ase re m o ve s u p plies fr o m a v ail a ble i n ve nt or y a n d w or k wit h y o ur Site M a n a ger/ Site M o nit or t o h a ve s u p plies dest r o ye d a n d I V R S u p d ate d if a p plic a ble.  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
Assess me nt c o m pl ete d b y: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ D ate _ _ _ _ _ _ _ _ _ _ _  
Pri nt/ Si g n at ure/ Title  
| If y es, ple ase pr o vi de: B atc h n u m ber (s):                                                 | C o nt ai ner n u m bers:   | Te m per at ure hi g hs/l o ws a n d d ur ati o n   |
|-----------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------------------------------|
| W he n is t he ne xt pl a n ne d p atie nt visit w he n t hes e s u p plies m a y be dis pe nse d ? |                             |                                                     |  
T e m pl at e s a s pr o vi d e d vi a s e p ar at e att a c h m e nt or b el o w m a y s er v e a s a s a m pl e f or d o s a g e c al c ul ati o n s a n d m a y b e pri nt e d o ut a n d u s e d t o d o c u m e nt a n y c al c ul ati o n s a n d i nf u si o n ti m e s a s r e q uir e d b y t h e cli ni c al st u d y t e a m. C o nt e nt i n t hi s att a c h m e nt m a y b e a d d e d or o mitt e d.  
| Dr u g D os e a n d V ol u                                                                                                                                                                      | m e C alc ul at or   |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| f or I V I nf usi o n                                                                                                                                                                           |                      |
| Dr u g Pr o d uct : Pr ot oc ol n u m b er P ati e nt n a m e or I D:                                                                                                                           |                      |
| Pr e p ar ati o n d at e a n d ti m e:                                                                                                                                                          |                      |
| Dr u g Str e n gt h ( m g/ mL) S u bj ect b o d y w ei g ht ( k g) D os e i n m g V ol u m e of Dr u g ( mL) T ot al V ol u m e of i nf usi o n ( mL) V ol u m e of Dil u e nt ( mL) N S or D 5 | W                    |
| I nf usi o n d ur ati o n ( mi n) I nf usi o n R at e ( mL/ mi n) I nf usi o n h a n g ti m e I nf usi o n c o m pl eti o n ti m e                                                              |                      |  
N ot e: If r e q uir e d, fl us h li n e wit h s e p ar at e v ol u m e of s a m e dil u e nt ( e. g. 1 5 2 0 ml) as o utli n e d i n t h e st u dy p h ar m acy m a n u al
r t o g 3
a p p e n

```
F F P E S peci me ns:

Sli des s h o ul d be s hi p pe d i n plastic sli de h ol der/sli de b o x. Place a s mall wa d of pa d di n g

i n t o p of t he c o ntai ner. If y o u ca n hear sli des s ha ki n g t he y ca n brea k d uri n g s hi p pi n g.

F P E Bl oc ks ca n be s hi p pe d i n a plastic bl oc k h ol der or wra p pe d wit h pa per or place d

i n a pa per e n vel o pe, a n d place d i n a car d b oar d b o x wit h pa d di n g. D o n ot wra p bl oc ks

wit h b u b ble wra p or ga uze. Place pa d di n g i n t o p of c o ntai ner s o t hat if y o u s ha ke t he

c o ntai ner t he bl oc ks are n ot s ha ki n g. If y o u ca n h ear bl oc ks s ha ki n g t he y ma y brea k

d uri n g s hi p pi n g. D uri n g war m weat her m o nt hs t he use of c ol d p ac ks is rec o m me n de d

t o pre ve nt wa x fr o m melti n g.

li des, Bl oc ks, or Pl u gs ca n be s hi p pe d a m bie nt or wit h a c ol d pac k eit her b y U nite d

States P ostal Ser vice ( U S P S) t o t he U S P S a d dress ( 9 4 1 4 3) or b y C o urier t o t he Street

A d dress ( 9 4 1 1 5). D o N O T s hi p o n Dr y Ice .

Ur ge nt o ver ni g ht s hi p me nts (ce ntral r e vie w) s h o ul d al wa ys be se nt b y C o urier.

f patie nts c o nse nt e d t o ba n ki n g D O N O T s hi p F F P E s peci me ns wit h a ret ur n re q uest.

We ca n n ot acce pt or ba n k sa m ples t hat we ca n n ot kee p. Al wa ys s e n d w hat ca n be

ba n ke d ( d u plicat e H & Es, Bl oc ks or p u n c hes or u nstai ne d as s pecifi e d i n t he pr ot oc ol).

We ca n p u nc h a n d ret ur n bl oc ks if n ote d i n t he pr ot oc ol. P u nc h kits ca n be re q ueste d

fr o m us b y e mail (R T O G @ ucsf.e d u ) f or sites t hat wis h t o p u nc h t he bl oc k t he msel ves.


```  
F or Q uesti o ns re g ar di n g c ollecti o n/s hi p pi n g ple ase c o nt act t he Bi os peci me n B a n k at U C S F b y e- m ail: R T O G @ ucsf.e d u or p h o ne: 4 1 5- 4 7 6- 7 8 6 4 or F a x: 4 1 5- 4 7 6- 5 2 7 1.
r t o g 3
a p p e n

S hi p pi n g I nstr ucti o ns f or F F P E: ( See A p pe n di x III f or pr ocessi n g a n d s hi p pi n g i nf or mati o n f or peri p heral bl o o d)  
| U S P ost al Ser vi ce                                                                                                   | M aili n g A d dress:   |                              |                                                                                               |            |
|--------------------------------------------------------------------------------------------------------------------------|-------------------------|------------------------------|-----------------------------------------------------------------------------------------------|------------|
| Use o nl y f or n o n                                                                                                    | ur ge nt a              | m bie nt                     |                                                                                               |            |
| s peci                                                                                                                   | me ns                   | F F P Es, sli des, bl oc ks: | C o urier A d dress ( Fe d E x, U P S, etc.): F or Fr oze n, Ur ge nt or Tr ac k a ble S peci | me ns:     |
| Bi os peci                                                                                                               | me n B a n k            | at U C S F                   |                                                                                               |            |
| U C S F                                                                                                                  | B o x 1 8 0 0           |                              |                                                                                               |            |
| 2 3 4 0 S utter St, r o o                                                                                                | m S 3 4 1               |                              |                                                                                               |            |
| S a n Fr a ncisc o, C A 9 4 1 4 3                                                                                        | 1 8 0 0                 | Bi os peci                   | me n B a n k                                                                                  | at U C S F |
| U ni versit y of C alif or ni a S a n Fr a ncisc o 2 3 4 0 S utter St, r o o m S 3 4 1 S a n Fr a ncisc o, C A 9 4 1 1 5 |                         |                              |                                                                                               |            |  
I n cl u de all re q uire d s peci me n pa per w or k i n p oc ket of bi o hazar d ba g.  
C hec k t hat t he S peci me n Tra ns mittal ( S T) F or m h as bee n c o m plet el y fille d o ut C hec k t hat all sa m ples are la bele d wit h t he st u d y a n d case n u m ber, a n d i ncl u de date of c ollecti o n as well as c ollecti o n ti me p oi nt (e. g., pretreat me nt, p ost-tr eat me nt).  
N ot e: See A p pe n di x I II f or pr ocessi n g a n d s hi p pi n g i nf or m ati o n f or peri p her al bl o o d.
a p p e n
kit c o nte nts

F o ur 1 0 ml or fi ve 8 ml He pari n Bl o o d ( gree n t o p) dra w t u bes T u be h ol der O uter b o x f or t u be h ol der Sec o n dar y plastic b a g wit h a bs or be nt St u d y s p ecific S T F or m Fe d E x Cli nical Pa k wit h la bels a n d stic kers I nstr u cti o ns h o w t o pac k a n d s hi p t he sa m ples S hi p t he bl o o d at r o o m te m perat ure f or o ver ni g ht deli ver y sa me d a y t o Dr Ferris's la b.  
```
a b el is pr o vi de d o n t he Cli nical Pa k.

1 0. If sites dra w t h e bl o o d sa m ple late i n t he da y, t he site s h o ul d refri gerate t he sa m ple u ntil

it is s hi p pe d a n d n ote t he st ora ge c o n diti o ns o n t he S T f or m.


```  
S hi p pi n g A d dress: N ote: D o N O T s hi p peri p h eral bl o o d t o Bi os peci me n Ba n k at U C S F.  
Ferris L a b or at or y Att n.: S a n dr a P o ve d a Gi bs o n R o o m 2. 2 6 Hill m a n Res e arc h P a vili o n 5 1 1 7 Ce ntre A ve n ue Pitts b ur g h, P A 1 5 2 1 3 F or q uesti o ns, c o nt act: S a n dr a Gi bs o n ( Ferris L a b), 4 1 2- 6 2 3- 7 7 3 8 or 4 1 2- 4 4 3- 8 6 7 3 ;  
p o ve d as @ u p mc.e d u Alter nati vel y, c o nta ct Dr. Ferris: 4 1 2- 2 9 8- 7 0 0 2; ferrisrl @ u p mc.e d u  
```
Pr o cessi n g:

1. Sites s h o ul d o nl y dra w bl o o d sa m ples o n M o n da y- We d nes da ys a n d o nl y s hi p M o n da yWe d nes da ys.

2. Dr a w bl o o d i n f o ur 1 0 ml or fi ve 8 ml gree n t o p ( he pari n) t u bes.

3. Mi x ge ntl y.

4. lace t u bes i n st yr of oa m t u be h ol der a n d o uter b o x pr o vi de d wit h Kit.

5. eal u p t u be h ol der b o x a n d place i n sec o n d ar y plastic ba g wit h a bs or be nt. Use of

a m bie nt gel pac ks wit h i ns ulate d pac ks are e n c o ura ge d d uri n g c ol d wi nter a n d h ot

s u m mer m o nt hs.

6. lace S T f or m i n p o uc h of ba g.

7. lace ba g wit h t u be bo x i n t he Fe d E x Cli nical Pa k pr o vi de d.

8. lace pr o vi de d fe d e x la bel i n s hi p pi n g p o uc h, a n d stic k t o Fe d E x e n vel o pe.

9. lace " kee p a w a y fr o m h eat" a n d " peris h a ble" Stic kers pr o vi de d wit h kit o n e n vel o pe


```