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"pproving Official: Clinical (n$estigator ############################### %ame "Printed# ############################### Signature ############################## !itle ############################## Date of Appro$al
Your Research Site SOP No.: SOP-CO-03 Revision: Original Effective Date: Confidential & Proprietary Information
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All material presented is -ritten and o-ned .y Your Research Site& /aterial pro$ided herein is confidential property and copyright protected .y Your Research Site& %o part of said material can .e reproduced or transmitted in any form or .y any means0 electronic or mechanical0 including photocopy0 recordings0 emailing0 or any information storage and retrie$al system no- or to .e in$ented0 -ithout permission in -ritten form from Your Research Site
Your Research Address Your Research City
Your Research Site SOP No.: SOP-CO-03 Revision: Original Effective Date: Confidential & Proprietary Information
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"ttach!ent(s):
Attachment A Attachment 2 Attachment C Attachment D Attachment ' CAPA Assessment !rac3ing 6og CAPA Assessment Plan CAPA 9orm Completed ':ample of a CAPA 9orm (ssue !rac3ing 9orm
2.
Position Signature of (n$estigators include any other indi$idual mem.er ofDate that Signed team according toDescription the )1 C9R Re$ision"s#< Date of 40&3"d# and 31)&3 definitions& Clinical Research Coordinators "CRCs# at Your Research Site Re$ision"s#< %ote if are listed as Su.-(n$estigators on the 9orm 9DA-145)0 Statement of (n$estigator& Signature"s# is for Reappro$al Only /edical Director .. %"C/0RO,ND !he Clinical (n$estigator and Clinical Research Director must maintain the CAPA Program Director of Clinical Research for continual systems e$aluations and process impro$ements for o$erall clinical operations& !he Clinical (n$estigator is responsi.le for the o$erall conduct of a research study at the clinic0 ho-e$er< delegation allo-s the clinical research team mem.ers to perform =defined> study acti$ities and procedures under the direct super$ision of the Clinical (n$estigator in the implementation and conduct of a Clinical (n$estigation& Clinical research team mem.ers can not perform medical and protocol procedures a.o$e their medical ;ualifications& $his procedure is conducted in accordance 1ith: )1 C9R Parts 11"if applica.le#0 400 410 4?0 31)0 and 311 9DA Compliance Programs 5317&7080 5317&710 and 5317&711 (C+ *uideline '? *ood Clinical Practice Office of (nspector *eneral /andates for /inimi@ing Conflict of (nterest A&S&C& !itle 17 Selected State la-s0 additional 9ederal la-s "OS+A#0 and local regulations for the protection of human research su.Bects Si: Sigma for Pharmaceutical Products
Reapproval Personnel responsi.le Clinical (n$estigator and0 when delegated by the Investigator: All Docu!entation clinical research team members collectively referred to as Sub-Investigators & Su.-
Your Research Site SOP No.: SOP-CO-03 Revision: Original Effective Date: Confidential & Proprietary Information
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Your Research Site SOP No.: SOP-CO-03 Revision: Original Effective Date: Confidential & Proprietary Information
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Additional Comments
Your Research Site SOP No.: SOP-CO-03 Revision: Original Effective Date: Confidential & Proprietary Information
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dentified ssue:
Section
Casual "nalysis:
Section
Proposed Resolution(s):
Section *
Your Research Site SOP No.: SOP-CO-03 Revision: Original Effective Date: Confidential & Proprietary Information
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Section *
######################################## Corrective "ction Plan Preparer8s Signature ,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, Clinical nvestigator8s Signature
Your Research Site SOP No.: SOP-CO-03 Revision: Original Effective Date: Confidential & Proprietary Information
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dentified ssue:
Su.Bect %S/ F 001 is a su.Bect of child .earing potential and .egan study participation on Decem.er 130 )001& During an A2C sponsor audit0 Dr& Eohnson -as made a-are that su.Bect 001 did not ha$e a screening pregnancy test completed& Section
Causal "nalysis:
!his incident is .eing reported on /ay 30 )004 -hich is fi$e "4# months after the pregnancy testing -ith no correcti$e action regarding the lac3 of a pregnancy test .eing documented& !he issue has .een noted in a monitoring follo--up letter dated /arch 150 )004& !here -as no documentation on file that the (R2 -as informed of the de$iation& Records -ere re$ie-ed and end of the study pregnancy results indicated the su.Bect -as not pregnancy .y urine testing& !here -as no documentation to indicate the employees in$ol$ed -ere retrained or corrected on pre$entati$e measures& Re$ie- of this incident indicates that the la. re;uisition -as not mar3ed as child.earing potentialDthat a pregnancy test -as re;uested& Section
Proposed Resolution(s):
/onitoring letters -ill .e re$ie-ed for all protocol de$iations upon receipt to address correcti$e and pre$entati$e issues& Retraining of employees in$ol$ed -ill .e completed& CRCs -ill .e responsi.le for issuing orders for all la.s& All protocol de$iations -ill .e reported in a timely manner to the (R2& Su.Bects -ill .e as3ed to return to the site for testing -hen critical testing is missed& !rac3ing of de$iations -ill .e instituted on a Protocol !rac3ing 6og and maintained .y the Clinical Research Director per study& Section *
Your Research Site SOP No.: SOP-CO-03 Revision: Original Effective Date: Confidential & Proprietary Information Continuing to 5e Revie1ed: /ay 30 )004 /ay140 )004
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'$ent Reoccurrence Address reoccurrences and further pre$entati$e measures and retraining and process impro$ements& Section *
Clinical nvestigator8s Revie1 or Corrective "ction Plan and "c3no1ledge!ent of Continual !prove!ent:
(0 Dr& Eohnson0 ha$e read and agree -ith the CAPA plan and ac3no-ledge my agreement to super$ise and implement immediate correcti$e action to secure compliance& /y staff -as retrained on /ay 100 )004 and ( -as in attendance to participate and recei$e retraining& Ge -ill again measures ho- -e are progressing on /ay 140 )004 and ( -ill recei$e continue to re$ie- monitoring letters and compliance issues since this last occurrence to measure our compliance outcomes& ,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, Clinical nvestigator8s Signature ######################################## Corrective "ction Plan Preparer8s Signature ,,,,,,,,,,,,, Date of Revie1 ############### Date of Signature
Your Research Site SOP No.: SOP-CO-03 Revision: Original Effective Date: Confidential & Proprietary Information
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Re$ie-er"s# ,,,,,,,,,,,,,,,
Prepared 2y ,,,,,,,,,,, Date ,, ,,,,,,,,,,
Protocol %um.er"s# ,,,,,,,,,,,,,,,, Corrective "ction Revie1: Clinical Research Director ,,,,,,,,,,,,,,,,,, Clinical (n$estigator ,,,,,,,,,,,,,,,,,,,,,,, Date ,,,,,,,, Date ,,,,,,,,
O.ser$ation"s#
Recommendation
Correcti$e Action
Responsi.le Person"s#
Completion Date