Study to Evaluate Boston Scientific Vercise Cartesia 16-contact Directional Lead (X/HX) With Deep Brain Stimulation (DBS) Systems for the Treatment of Parkinson's Disease (PD)
Phase: NA
Conditions: Parkinson Disease
Sponsor: Boston Scientific Corporation



 
               
                                                 
 
                                                                                                                               P a g e  3 0  of  7 4 
 
  
 
P a g e  3 0  o f  7 4

 
               
                                                 
 
  
P a g e  3 1  o f  7 4

F or  m/ T e  m pl at e  9 0 7 0 2 6 3 7    R e v/  V er  A      
               
                                                 
 
                                                                                                                               P a g e  6 9  of  7 4 
 
  
2 2. 2   T er  mi n ati o n  of  St u d y  P arti ci p ati o n  b y t h e I n v esti g at or  or   Wit h dr a  w al  of   E  C 
A p pr o v al 
A n y i n v esti g at or,  or   ass o ci at e d  I  R  B/ E  C/  R EB  or r e g ul at or y  a ut h orit y   m a y  dis c o nti n u e 
p arti ci p ati o n i n t h e st u d y  or   wit h dr a  w  a p pr o v al  of t h e st u d y, r es p e cti v el y,   wit h s uit a bl e 
writt e n  n oti c e t o   B ost o n  S ci e ntifi c.   I n v esti g at ors,  ass o ci at e d I  R  Bs/ E  Cs/  R E  Bs,  a n d r e g ul at or y 
a ut h oriti es,  as  a p pli c a bl e,   wil l  b e  n otifi e d i n   writi n g i n t h e  e v e nt  of t h es e  o c c urr e n c es. 
2 2. 3.   R e q uir e  m e nts f or   D o c u  m e nt ati o n  a n d  S u bj e ct   F oll o  w- u p  
I n t h e  e v e nt  of  pr e  m at ur e st u d y t er  mi n ati o n  a   writt e n st at e  m e nt  as t o   w h y t h e  pr e  m at ur e 
t er  mi n ati o n  h as  o c c urr e d will    b e  pr o vi d e d t o  all  p arti ci p ati n g sit es b y   B ost o n  S ci e ntifi c.  T h e 
E  C  a n d r e g ul at or y  a ut h oriti es,  as  a p pli c a bl e , will    b e  n otifi e d.   D et ail e d i nf or  m ati o n  o n  h o  w 
e nr oll e d s u bj e cts   will  b e   m a n a g e d t h er e aft er  will  b e  pr o vi d e d  .  
I n t h e  e v e nt  a n E  C  t er  mi n at es  p arti ci p ati o n i n t h e st u d y,  p arti ci p ati n g in v esti g at ors, 
ass o ci at e d  E  Cs,  a n d r e g ul at or y  a ut h oriti es,  as  a p pli c a bl e,   will  b e  n otifi e d i n   writi n g . D et ail e d 
i nf or  m ati o n  o n  h o  w  e nr oll e d s u bj e cts   will  b e   m a n a g e d t h er e aft er   will  b e  pr o vi d e d  b y   B ost o n 
S ci e ntifi c.  
I n t h e  e v e nt a  Pri n ci p al I n v esti g at or  t er  mi n at es  p arti ci p ati o n i n t h e st u d y, st u d y r es p o nsi bilit y 
will  b e tr a nsf err e d t o  a  n ot h er i n v esti g at or, if  p ossi bl e. I n t h e  e v e nt t h er e  ar e  n o  o p p ort u niti es 
t o tr a nsf er Pri n ci p al I n v esti g at or  r es p o nsi bilit y;  d et ail e d i nf or  m ati o n  o n  h o  w  e nr oll e d 
s u bj e cts   will  b e   m a n a g e d t h er e aft er   will  b e  pr o vi d e d  b y   B ost o n  S ci e ntifi c. 
T h e  Pri n ci p al I n v esti g at or  or  his/ h er  d esi g n e e  m ust r et ur n  all   st u d y-r el at e d d o c u  m e nts  a n d 
i n v esti g ati o n al  pr o d u ct t o   B ost o n  S ci e ntifi c,  u nl ess t his  a cti o n   w o ul d j e o p ar di z e t h e ri g hts, 
s af et y,  or   w elf ar e  of t h e s u bj e cts.  
2 2. 4   Crit eri a f or  S us p e n di n g/ T er  mi n ati n g  a  St u d y   Sit e  
B ost o n  S ci e ntifi c   r es er v es t h e ri g ht t o st o p t h e i n cl usi o n  of s u bj e cts  at  a st u d y sit e at  a n y ti  m e 
aft er t h e st u d y i niti a ti o n  visit if  n o s u bj e cts  h a v e  b e e n  e nr oll e d  f or  a  p eri o d  b e y o n d  6   m o nt hs 
aft er  sit e i niti ati o n,  or if t h e sit e h as   m ulti pl e  or  s e v er e  pr ot o c ol  vi ol ati o ns/ n o n c o  m pli a n c e 
wit h o ut j ustifi c ati o n  a n d/ or f ails t o f oll o  w r e  m e di al  a cti o ns.   
I n t h e  e v e nt  of t er  mi n ati o n  of sit e  p arti ci p ati o n, all  st u d y  d e vi c es a n d t esti n g  e q ui p  m e nt,  as 
a p pli c a bl e,  will  b e r et ur n e d t o   B S  C    u nl ess t his  a cti o n   w o ul d j e o p ar di z e t h e ri g hts, s af et y  or 
w ell  - b ei n g  of t h e s u bj e cts. T h e   E  C  a n d r e g ul at or y  a ut h oriti es,  as  a p pli c a bl e, will    b e n otifi e d . 
St u d y  p arti ci p a nts   will  b e  c o nt a ct e d,  as  a p pli c a bl e,  a n d  b e i nf or  m e d  of  c h a n g es t o st u d y  visit 
s c h e d ul e. 
2 3.  St u d y   R e gist r ati o n  a n d   R es ults  
2 3. 1.  St u d y   R e gistr ati o n  
T o  c o  m pl y   wit h  a p pli c a bl e l a  ws  a n d r e g ul ati o ns, t h e st u d y   will  b e r e gist er e d  o n  a  p u bli cl y 
a c c essi bl e  d at a b as e.  
P a g e  6 9  o f  7 4