ࡱ > c a bjbj ؎U\؎U\q- ' T T ( " <$ m ) 0 ( 1 1 1 1 4 36 l !l !l !l !l !l !l $ ^o r El ) 6 1 1 6 6 El 1 1 nm D D D 6 1 1 l D 6 l D D of k 1 `Isj : v ?h 4 l m 0 m sh p 4s W> ( 4s h k 4s k ( 6 6 D 6 6 6 6 6 El El D 6 6 6 m 6 6 6 6 4s 6 6 6 6 6 6 6 6 6 T > : Form 1
APPLICATION FORM
Application for a Recognised Research Ethics Committee (REC) Opinion
on a Clinical Trial on a Medicinal Product for Human Use.
This application form should be completed and submitted by the Chief Investigator (the person who takes primary responsibility for the conduct of the clinical trial). It should be filled out in language comprehensible to a lay person.
A. TRIAL IDENTIFICATION
A.1EudraCT No. FORMTEXT T i t l e o f C l i n i c a l T r i a l F O R M T E X T S u b m i s s i o n D a t e F O R M T E X T
A . 2 T r i a l D u r a t i o n P r o p o s e d S t a r t D a t e ( f i r s t p e r s o n f i r s t v i s i t ) F O R M T E X T d d / m m / y y y y P r o p o s e d E n d D a t e ( l a s t p e r s o n l a s t v i s i t ) F O R M T E X T d d / m m / y y y y E x p e c t e d D u r a t i o n ( y e a r s / m o n t h s ) F O R M T E X T Y e a r s F O R M T E X T M o n t h s
B . A P P L I C A N T I D E N T I F I C A T I O N
B . 1 C h i e f I n v e s t i g a t o r N a m e : F O R M T E X T T i t l e : F O R M T E X T P o s i t i o n : F O R M T E X T Q u a l i f i c a t i o n s : F O R M T E X T A d d r e s s : F O R M T E X T T e l : F O R M T E X T F a x : F O R M T E X T E - m a i l : F O R M T E X T ( P l e a s e s u b m i t a 2 p a g e C V f o r t h e C h i e f I n v e s t i g a t o r )
B . 2 S p o n s o r N a m e : F O R M T E X T S t a t u s o f S p o n s o r : F O R M T E X T C o m m e r c i a l : F O R M T E X T N o n - C o m m e r c i a l F O R M T E X T A d d r e s s : F O R M T E X T T e l : F O R M T E X T F a x : F O R M T E X T E - m a i l : F O R M T E X T
C . D E T A I L S O F T H E C L I N I C A L T R I A L
C . 1 H a s t h i s o r a s i m i l a r a p p l i c a t i o n b e e n p r e v i o u s l y s u b m i t t e d f o r r e v i e w t o t h i s o r a n y o t h e r E t h i c s C o m m i t t e e i n t h e R e p u b l i c o f I r e l a n d ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o I f y e s , p l e a s e g i v e d e t a i l s F O R M T E X T
C . 2 M u l t i C e n t r e C l i n i c a l T r i a l s I s t h i s t r i a l a M u l t i - C e n t r e T r i a l ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o I f Y e s , p l e a s e s u b m i t a l i s t o f a l l p r o p o s e d s i t e s i n I r e l a n d a n d p r o p o s e d I n v e s t i g a t o r s i n c l u d i n g c o n t a c t n o . / e - m a i l . F O R M T E X T
D o e s t h i s t r i a l i n v o l v e t h i r d countries? FORMCHECKBOX Yes FORMCHECKBOX NoHave you received permission from each of the above sites in Ireland to conduct this trial? FORMCHECKBOX Yes FORMCHECKBOX No
(Please note that a site specific assessment for each site in Ireland must be submitted before the committee can validate an application for ethical review.)
C.3 Please name the substance/medical device, which you propose to administer during the clinical trial. (Please include details of all medicinal products i n c l u d i n g p l a c e b o . ) F O R M T E X T
I f t h e c l i n i c a l t r i a l d o e s n o t i n v o l v e S o m a t i c C e l l T h e r a p y , G e n e T h e r a p y o r G e n e t i c a l l y M o d i f i e d C e l l s p l e a s e s k i p t o C . 6 .
C . 4 S o m a t i c C e l l T h e r a p y I f t h e c l i n i c a l t r i a l i n v o l v e s S o m a t i c C e l l T h e r a p y ( n o g enetic modification) please specify the origin of cells: Autologous FORMCHECKBOX Yes FORMCHECKBOX NoAllogeneic FORMCHECKBOX Yes FORMCHECKBOX NoXenogeneic FORMCHECKBOX Yes FORMCHECKBOX NoIf xenogeneic, please specify the species of origin FORMTEXT
C . 5 G e n e T h e r a p y o r G e n e t i c a l l y M o d i f i e d C e l l s C . 5 . 1 I f t h e c l i n i c a l t r i a l i n v o l v e s G e n e T h e r a p y p l e a s e s p e c i f y t h e g e n e ( s ) o f i n t e r e s t . F O R M T E X T
C . 5 . 2 P l e a s e s p e c i f y t h e t y p e o f g e n e t h e r a p y i n v o l v e d . I n v i v o g e n e t h e r a p y F O RMCHECKBOX Yes FORMCHECKBOX NoEx vivo gene therapy FORMCHECKBOX Yes FORMCHECKBOX No
C.5.3Please specify the gene transfer product that will be used.Nucleic acid (e.g. plasmid) FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, please specify: FORMCHECKBOX Naked FORMCHECKBOX ComplexedViral Vector FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, please specify the type (e.g. adenovirus): FORMTEXT O t h e r s F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o I f Y e s , p l e a s e s p e c i f y : F O R M T E X T
C . 5 . 4 I f t h e c l i n i c a l t r i a l i n v o l v e s G e n e t i c a l l y M o d i f i e d C e l l s p l e a s e s p e c i f y t h e i r o r i g i n . A u t o l o g o u s F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o A l l o g e n e i c F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o X e n o g e n e i c F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o I f x e n o g e n e i c , p l e a s e s p e c i f y t h e s p e c i e s o f o r i g i n F O R M T E X T
C . 5 . 5 P l e a s e s p e c i f y t h e t y p e o f g e n e t i c a l l y m o d i f i e d c e l l s ( e . g . h e m a t o p i e t i c s t e m c e l l s ) . F O R M T E X T
C . 6 P l e a s e s p e c i f y t h e p r i m a r y r e s e a r c h q u e s t i o n / o b j e c t i v e . F O R M T E X T
C . 7 P l e a s e s p e c i f y t h e s e c o n d a r y r e s e a r c h q u e s t i o n s / o b j e c t i v e s . F O R M T E X T
C . 8 W h a t i s t h e s c i e n t i f i c j u s t i f i c a t i o n f o r t h e c l i n i c a l t r i a l ? F O R M T E X T
C . 9 G i v e a b r i e f d e s c r i p t i o n o f t h e m e t h o d s a n d d e s i g n o f t h e p r o p o s e d c l i n i c a l t r i a l e . g . r a n d o m i s e d , c o n t r o l l e d . T h i s s h o u l d a l s o i n c l u d e d e t a i l s o f t h e d u r a t i o n o f r e s e a r c h p a r t i c i p a n t i n v o l v e m e n t a n d e x a c t l y w h a t p r o c e d u r e s t h e y w i l l u n d e r g o . F O R M T E X T
C . 1 0 W i l l t r e a t m e n t b e w i t h h e l d f r o m r e s e a r c h p a r t i c i p a n t s a s a r e s u l t o f t a k i n g p a r t i n t h e c l i n i c a l t r i a l ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o I f Y e s , p l e a s e g i v e d e t a i l s F O R M T E X T
C . 1 1 W h a t a r e t h e p o t e n t i a l a d v e r s e e f f e c t s , r i s k s o r h a z a r d s f o r r e s e a r c h p a r t i c i p a n t s e i t h e r f r o m g i v i n g o r w i t h h o l d i n g m e d i c a t i o n s , d e v i c e s , i o n i s i n g r a d i a t i o n , o r f r o m o t h e r i n t e r v e n t i o n s , w h i c h m a y c a u s e i n c o n v e n i e n c e o r c h a n g e s t o l i f e s t y l e ? F O R M T E X T
C . 1 2 W h a t a r e t h e p o t e n t i a l b e n e f i t s f o r r e s e a r c h p a r t i c i p a n t s ? F O R M T E X T
C . 1 3 W h a t p r o c e d u r e s a r e i n p l a c e t o m o n i t o r t h e h e a l t h o f t h e r e s e a r c h p a r t i c i p a n t s d u r i n g t h e t r i a l o r w h e n t h e y a r e n o l o n g e r i n v o l v e d i n t h e t r i a l ? F O R M T E X T
D . D E T A I L S O F T R I A L P A R T I C I P A N T S
D . 1 H o w m a n y r e s e a r c h p a r t i c i p a n t s a n d c o n t r o l s a r e e x p e c t e d t o p a r t i c i p a t e a t e a c h s i t e i n I r e l a n d ? F O R M T E X T
D . 2 H o w w i l l r e s e a r c h p a r t i c i p a n t s / c o n t r o l s b e i d e n t i f i e d a n d r e c r u i t e d ? F O R M T E X T
( I f r e c r u i t m e n t i n c l u d e s a d v e r t i s e m e n t s o r w r i t t e n c o r r e s p o n d e n c e p l e a s e p r o v i d e c o p i e s a n d / o r T V / r a d i o s c r i p t s a n d l e t t e r s . )
D . 3 W h a t a r e t h e i n c l u s i o n c r i t e r i a ? F O R M T E X T
D . 4 W h a t a r e t h e e x c l u s i o n c r i t e r i a ? F O R M T E X T
D . 5 W h a t c r i t e r i a e x i s t f o r w i t h d r a w i n g r e s e a r c h p a r t i c i p a n t s p r e m a t u r e l y ? F O R M T E X T
D . 6 W i l l t h e p a r t i c i p a n t s b e f r o m a n y o f t h e f o l l o w i n g g r o u p s ? ( t i c k a s a p p r o p r i a t e ) Children under 16 FORMCHECKBOX Adults with learning disabilities FORMCHECKBOX Adults who are unconscious FORMCHECKBOX Adults who have a terminal illness FORMCHECKBOX Adults in emergency situations FORMCHECKBOX Adults with mental illness FORMCHECKBOX Pregnant women / women of child bearing age FORMCHECKBOX Prisoners FORMCHECKBOX Adults suffering from dementia FORMCHECKBOX Healthy volunteers FORMCHECKBOX Those who could be considered to be vulner
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( N B . P a r t s 4 a n d 5 o f S c h e d u l e 1 o f t h e E u r o p e a n C o m m u n i t i e s ( C l i n i c a l T r i a l s o n M e d i c i n a l P r o d u c t s f o r H u m a n U s e ) R e g u l a t i o n s 2 0 0 4 c l e a r l y o u t l i n e t h e c o n d i t i o n s a n d p r i n c i p l e s w h i c h a p p l y i n r e l a t i o n t o t h e t r e a t m e n t o f M i n o r s o r I n c a p a c i t a t e d A d u l t s w h o a r e p a r t i c i p a n t s i n m e d i c a l r e s e a r c h . )
D . 7 W i l l r e s e a r c h p a r t i c i p a n t s b e r e i m b u r s e d f o r e x p e n s e s ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o I f Y e s , p l e a s e c l a r i f y F O R M T E X T
D . 8 W i l l t h e y r e c e i v e a n y i n c e n t i v e s f o r t a k i n g p a r t i n t h e c l i n i c a l t r i a l ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o I f Y e s , p l e a s e c l a r i f y F O R M T E X T
D . 9 W i l l t h e p a r t i c i p a n t s g e n e r a l p r a c t i t i o n e r b e n o t i f i e d o f h i s o r h e r p a r t i c i p a t i o n i n t h e t r i a l ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o I f N o , p l e a s e c l a r i f y F O R M T E X T
E . I N F O R M E D C O N S E N T
E . 1 W i l l w r i t t e n i n f o r m e d c o n s e n t b e o b t a i n e d F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o I f Y e s , w h o w i l l b e r e s p o n s i b l e f o r o b t a i n i n g ( q u a l i f i c a t i o n s a n d e x p e r i e n c e ) ? F O R M T E X T I f N o , p l e a s e j u s t i f y . F O R M T E X T
E . 2 G i v e d e t a i l s o f t h e m a n n e r i n w h i c h c o n s e n t w i l l b e o b t a i n e d . P l e a s e a t t a c h c o p i e s o f b o t h t h e I n f o r m a t i o n l e a f l e t a n d C o n s e n t f o r m . F O R M T E X T
E . 3 W h a t a r r a n g e m e n t s h a v e b e e n m a d e f o r r e s e a r c h p a r t i c i p a n t s w h o m i g h t n o t a d e q u a t e l y u n d e r s t a n d v e r b a l o r w r i t t e n i n f o r m a t i o n ? F O R M T E X T
F . C O N F I D E N T I A L I T Y
N B . I n v e s t i g a t o r s s h o u l d b e a w a r e o f t h e i r r e s p o n s i b i l i t i e s a s p r o v i d e d f o r i n t h e D a t a P r o t e c t i o n A c t s 1 9 9 8 a n d 2 0 0 3 .
F . 1 D o e s t h e p r o p o s e d c l i n i c a l t r i a l i n v o l v e t h e r e t e n t i o n o f b i o l o g i c a l m a t e r i a l ( t i s s u e , b o d i l y f l u i d s ) o r d a t a d e r i v e d f r o m t h e m ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o I f Y e s , f o r w h a t p e r i o d o f t i m e w i l l t h e b i o l o g i c a l m a t e r i a l a n d / o r d a t a b e r e t a i n e d ? F O R M T E X T
F . 2 H o w w i l l d a t a s e c u r i t y b e m a i n t a i n e d ? F O R M T E X T
F . 3 W h o w i l l h a v e a c c e s s t o t h e b i o l o g i c a l m a t e r i a l a n d / o r d a t a ? F O R M T E X T
F . 4 I f b i o l o g i c a l m a t e r i a l a n d / o r d a t a a r e t o b e d i s p o s e d o f p l e a s e e x p l a i n h o w a n d b y w h o m t h i s w i l l b e d o n e ? F O R M T E X T
F . 5 H o w w i l l t h e r e s u l t s o f t h e c l i n i c a l t r i a l b e r e p o r t e d a n d d i s s e m i n a t e d ( e . g . p e e r - r e v i e w e d j o u r n a l , r e s e a r c h p a r t i c i p a n t s ) ? F O R M T E X T
G . F I N A N C I A L A R R A N G E M E N T S
G . 1 W h a t a r r a n g e m e n t s h a v e b e e n m a d e f o r c o m p e n s a t i o n i n t h e e v e n t o f a c l a i m m a d e b y o r o n b e h a l f o f a p a r t i c i p a n t ? F O R M T E X T
G . 2 I s i n d e m n i t y i n p l a c e f o r t h e c o n d u c t o f t h i s c l i n i c a l t r i a l ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o I f y e s , p l e a s e s u b m i t a c o p y t o t h e R E C .
G . 3 H a s f u n d i n g f o r t h e c l i n i c a l t r i a l b e e n s e c u r e d ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o I f Y e s , g i v e d e t a i l s o f f u n d i n g o r g a n i s a t i o n ( s ) a n d a m o u n t s e c u r e d a n d d u r a t i o n : O r g a n i s a t i o n : F O R M T E X T C o n t a c t n a m e : F O R M T E X T A d d r e s s : F O R M T E X T T e l : F O R M T E X T F a x : F O R M T E X T E - m a i l : F O R M T E X T A m o u n t : F O R M T E X T I f N o , w h a t a r r a n g e m e n t s h a v e b e e n m a d e t o c o v e r t h e c o s t o f t h e r e s e a r c h ? F O R M T E X T
G . 4 D o e s t h e C h i e f I n v e s t i g a t o r o r a n y o f t h e i n v e s t i g a t o r s h a v e a n y d i r e c t / i n d i r e c t i n v o l v e m e n t i n t h e o u t c o m e o f t h e c l i n i c a l t r i a l t h a t c o u l d i n a n y w a y b e r e g a r d e d a s a p o s s i b l e c o n f l i c t o f i n t e r e s t ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o I f Y e s , p l e a s e e x p l a i n . F O R M T E X T
D e c l a r a t i o n o f t h e C h i e f I n v e s t i g a t o r
T h i s d e c l a r a t i o n m u s t b e s i g n e d a n d s e n t t o t h e R E C t o g e t h e r w i t h t h e r e q u i s i t e f e e b e f o r e t h e a p p l i c a t i o n w i l l b e c o n s i d e r e d a s v a l i d .
I c e r t i f y t h a t t h e i n f o r m a t i o n i n t h i s f o r m i s a c c u r a t e t o t h e b e s t o f m y k n o w l e d g e a n d I t a k e f u l l r e s p o n s i b i l i t y f o r i t .
I u n d e r t a k e t o a b i d e b y t h e e t h i c a l p r i n c i p l e s o u t l i n e d i n t h e D e c l a r a t i o n o f H e l s i n k i , a n d m y o b l i g a t i o n s a s s e t o u t i n t h e I n t e r n a t i o n a l C o n f e r e n c e o n H a r m o n i s a t i o n s G o o d C l i n i c a l P r a c t i c e G u i d e l i n e s ( I C H G C P ) a n d t h e E u r o p e a n C o m m u n i t i e s ( C l i n i c a l T r i a l s o n M e d i c i n a l P r o d u c t s f o r H u m a n U s e ) R e g u l a t i o n s , 2 0 0 4 ( S . I . N o 1 9 0 o f 2 0 0 4 ) .
I f t h e c l i n i c a l t r i a l i s a p p r o v e d I u n d e r t a k e t o a d h e r e t o t h e s t u d y p r o t o c o l a n d t o c o m p l y w i t h a n y c o n d i t i o n s s e t o u t i n t h e l e t t e r o f a p p r o v a l s e n t b y t h e R e c o g n i s e d E t h i c s C o m m i t t e e .
I a m a w a r e o f m y r e s p o n s i b i l i t y t o b e u p t o d a t e a n d c o m p l y w i t h t h e r e q u i r e m e n t s o f t h e l a w r e l a t i n g t o s e c u r i t y a n d c o n f i d e n t i a l i t y o f p a t i e n t o r o t h e r p e r s o n a l d a t a .
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