ࡱ> egd` Ibjbj .TD iBBBB8.J(42BBBB ''''''')h7,x']!"!!'BBBBuU(###!BlBB'#!'##VZ$@,$B& F7bT"$ $k(0($ ,"d,$,$0 #9 {   ''@#^   (!!!!$BBBBBB  SEQ CHAPTER \h \r 1 QUALIFIED INVESTIGATOR UNDERTAKING An undertaking must be completed by the qualified investigator responsible for the conduct of the clinical trial at the site specified below. The completed undertaking must be retained by the clinical trial sponsor for a period of 25 years. Please note that the Qualified Investigator Undertaking should not be submitted to Health Canada unless requested. PART 1 - Clinical Trial Protocol Information Please check one of the following: Clinical Trial Application (CTA) o Clinical Trial Application Amendment (CTA-A) o1. Clinical Trial Protocol Title 2. Clinical Trial Protocol Number (If Applicable)PART 2 - Drug Product / Sponsor InformationA) Drug Product Information3. Brand Name 4. Proper or Common Name B) Sponsor of Clinical Trial5. Company Name (Full Name - No Abbreviations)6. Street / Suite / PO Box 7. City / Town8. Prov. / State9. Country10. Postal/ZIP CodeC) Contact for THIS Clinical Trial11. Contact Name 12. E-mail13. Company Name (Full Name - No Abbreviations) 14. Street / Suite / PO Box 15. City / Town16. Prov. / State17. Country18. Telephone No. 19. Fax No.20. Postal/ZIP Code  PART 3 - Qualified Investigator InformationA) Clinical Trial Site21. Name of Site (Full Name - No Abbreviations)22. Street / Suite / PO Box 23. City / Town24. Province25. Postal CodeB) Qualified Investigator26. Name27. Title28. Language Preferred o English o French29. Street / Suite / PO Box 30. City / Town 31. Province32. Postal Code33. E-mail 34. Tel. No. 35. Fax No.  In respect of the identified clinical trial, I certify, as the qualified investigator for this site that: I am a physician or dentist and a member in good standing of a professional medical or dental association as defined in Part C Division 5 of the Food and Drug Regulations; I will supervise the medical care and medical decisions respecting this clinical trial at this site; I will conduct this clinical trial in accordance with Good Clinical Practices; and I will immediately on discontinuance of the clinical trial by the sponsor, in its entirety or at a clinical trial site, inform both the clinical tria;1 4 6 8 F D H    ; = n p q r   N O ͸͸؆~hbmH sH hbCJmH sH hb5CJmH sH h 5CJmH sH "hUCJOJQJ^JaJnH tH (hUhUCJOJQJ^JaJnH tH hb5CJmH sH hbCJmH sH hb5mH sH hbmH sH hbjhbU1<=0 1 8 $7$8$H$IfgdU !$1$If !,$1$If H.Z/Z1$.Z/Z1$ FIII & F zz $.Z/Z1$If !$1$If !F$1$If\kd/$$If`$P% t04 `aF H &\kd$$If`$P%  t04 `a $.Z/Z1$Ifokd$$If`0$g    t04 `a  /\kd$$If`$P% t04 `a $.Z/Z1$If F$1$If\kd,$$If`$P% t04 `a    < = /\kd! $$If`$P%  t04 `a\kdz $$If`$P%  t04 `a $.Z/Z1$If I$1$If= o p q r 9\kdo $$If`$P% t04 `a\kd $$If`$P% t04 `a $.Z/Z1$Ifr $.Z/Z1$If dVU$1$If VJ $.Z/Z1$Ifkd $$If`r }u$    n {  t04 `a  $.Z/Z1$If A$1$If\kd $$If`$P%  t04 `a  L M N vv $.Z/Z1$If dVA$1$Ifokd $$If`0}$s t04 `aN O l m ~ $.Z/Z1$If dVA$1$If\kd$$If`$P% t04 `aO l m } ~ N$Z "$yldjhbUhb5<CJmH sH hb<mH sH hb<CJmH sH (hUhUCJOJQJ^JaJnH tH hb5CJmH sH hb5mH sH j>hbCJUmH sH hb5<CJmH sH hb<CJmH sH hbmH sH hbCJmH sH hbmH sH hbCJmH sH $ i]]]] $.Z/Z1$Ifkd.$$If`\J }$ 3  t04 `a |uulliiicccdV1$1$ !1$.Z/Z1$kdA$$If`FJ $    t0    4 `a P\kda$$Ifl$h%   t04 la$1$If1$PR.\kd$$Ifl$h% t04 la$1$Iflkd$$Ifl$h%   t 04 lap 6X$1$If `!$1$If\kdL$$Ifl$h% t04 laXZia$1$Ifkd$$Ifl\ }>$)      t04 la$ $1$If$1$Iflkd$$Ifl$h%   t 04 lap $&^`|phpphhh$1$If 8$1$Ifkd$$IflF >$)  t0    4 laiaaaaaa$1$Ifkd$$Ifl\ }>$)  t04 la "&|ymyddd[T.Z/Z1$ !1$ `!1$ &d 1$P 1$kdi$$IflF}>$ t0    4 la $&HHHH/I0I^`> .Z/Z1$l subjects and the Research Ethics Board for this site of the discontinuance, provide them with the reasons for the discontinuance, and advise them in writing of any potential risks to the health of clinical trial subjects or other persons. 36. Signature of Qualified Investigator37. 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