capa mock sop
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8/12/2019 Capa Mock Sop
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Your Research Site Page 1 of 11
SOP No.: SOP-CO-03
Revision: Original
Effective Date:
Confidential & Proprietary Information
Your Research Site
Your Research AddressYour Research City
Standard Operating Procedure
Confidential & Proprietary nfor!ation
Department Clinical Operations !herapeutic Your !herapeutic Area"s#
!itle Correcti$e and Pre$entati$e Actions SOP %o& SOP-CO-03
'ffecti$e Date Re$ision Original
"pproving Official: Clinical (n$estigator
############################### ##############################
%ame"Printed# !itle
############################### ##############################
Signature Date of Appro$al
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SOP No.: SOP-CO-03
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Confidential & Proprietary Information
Your Research Site
COPYR(*+! %O!(C'
,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,
All material presented is ritten and oned .y Your
Research Site& /aterial pro$ided herein is confidentialproperty and copyright protected .y Your Research Site& %o
part of said material can .e reproduced or transmitted in any
form or .y any means electronic or mechanical including
photocopy recordings emailing or any information storage
and retrie$al system no or to .e in$ented ithout
permission in ritten form from
Your Research SiteYour Research Address
Your Research City
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SOP No.: SOP-CO-03
Revision: Original
Effective Date:
Confidential & Proprietary Information
$"%E O' CON$EN$S
1& Purpose Page
)& Scope Page
3& 2acground Page
& Procedure Page 4
4& Re$ision !racing or Reappro$al Page 5
Documentation
"ttach!ent(s):
Attachment A CAPA Assessment !racing 6og Page 7Attachment 2 CAPA Assessment Plan Page 8
Attachment C CAPA 9orm Page 10
Attachment D Completed ':ample of a CAPA 9orm Page 1)
Attachment ' (ssue !racing 9orm Page 1
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SOP No.: SOP-CO-03
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Confidential & Proprietary Information
CORREC$*E "ND PRE*EN$"$*E "C$ONS
+. P,RPOSE
!o esta.lish a Correcti$e and Pre$entati$e Actions "CAPA# Program for conducting and
documenting internal acti$ities for continual assessment of compliance ith clinical trial
protocols esta.lished regulations (C+ *CP guidelines internal standard operatingprocedures and policies to acti$ely see ;uality process impro$ements& *lo.ally this
system is esta.lished as the Correcti$e and Pre$entati$e Actions "CAPA# Program of Your
Research Site&
-. SCOPE
!his procedure is applica.le to the Correcti$e and Pre$entati$e Actions "CAPA# Program
and Clinical Operations functional areas& Applies to all clinical research team mem.ers
in$ol$ed in the regulatory implementation and coordination of Clinical (n$estigations&
!his procedure is applica.le to all internal continual CAPA re$ies and assessments
managed .y the Clinical Director and under the direct super$ision of the Clinical(n$estigator& 9unctions can .e delegated to Clinic /anagers and the clinical research team
mem.ers under the direction of the Clinical Director&
Applies to all clinical research team mem.ers in$ol$ed in the implementation andcoordination of clinical in$estigations&
Personnel responsi.le Clinical (n$estigator and when delegated by the Investigator: Allclinical research team members collectively referred to as Sub-Investigators& Su.-
(n$estigators include any other indi$idual mem.er of that team according to the )1 C9R
40&3"d# and 31)&3 definitions& Clinical Research Coordinators "CRCs# at Your Research Siteare listed as Su.-(n$estigators on the 9orm 9DA-145) Statement of (n$estigator&
. %"C/0RO,ND
!he Clinical (n$estigator and Clinical Research Director must maintain the CAPA Program
for continual systems e$aluations and process impro$ements for o$erall clinical operations&
!he Clinical (n$estigator is responsi.le for the o$erall conduct of a research study at theclinic hoe$er< delegation allos 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$etheir medical ;ualifications&
$his procedure is conducted in accordance 1ith:
)1 C9R Parts 11"if applica.le# 40 4 4? 31) and 31
9DA Compliance Programs 537&708 537&710 and 537&711(C+ *uideline '? *ood Clinical Practice
Office of (nspector *eneral /andates for /inimi@ing Conflict of (nterest
&S&C& !itle 17Selected State las additional 9ederal las "OS+A# and local regulations for the
protection of human research su.BectsSi: Sigma for Pharmaceutical Products
2. Revision $rac3ing or
Reapproval
Docu!entationPosition Signature Date Signed Description of
Re$ision"s#< Date of
Re$ision"s#< %ote ifSignature"s# is for
Reappro$al Only/edical Director
Director of Clinical Research
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SOP No.: SOP-CO-03
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Confidential & Proprietary Information
"ttach!ent "
E4a!ple Only
C"P" "ssess!ent $rac3ing og
Sponsor Protocol
Nu!5er
ist and Descri5e
Docu!ent6 Syste!6 or
'acility nspection
Perfor!ed
Clinical Research
$ea! 7e!5er
Perfor!ing
Revie1
Date(s) of
Revie1
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SOP No.: SOP-CO-03
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Effective Date:
Confidential & Proprietary Information
"ttach!ent %
E4a!ple Only
C"P" "ssess!ent Plan
Protocol %um.er ,,,,,,,,,,,,,, Assessment Plan (ssued Date ,,,,,,,,,,
Sponsor ,,,,,,,,,,,,,,,,,,,,, (ssuer>s (nitials ,,,,,,,,,,,,Date"s# of Re$ie ,,,,,,,,,,,,,,,,
Re$ieer"s# ,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,
O$erall Purpose of the Assessment
Descri.e the System Documents andor 9acility to 2e Assessed
6ist Clinic Research !eam /em.ers to .e (n$ol$ed
6ead Re$ieer
Additional Comments
':pected (nitial Preliminary !imeline
(nitial pdate
':pected Completion
,,,,,,,,,,,,,,,,,,,,,,,,, ,,,,,,,,,,,,,,,,,Clinic Director Signature Date of Signature
,,,,,,,,,,,,,,,,,,,,,,,,, ,,,,,,,,,,,,,,,,,Clinical (n$estigator Signature Date of Signature
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SOP No.: SOP-CO-03
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"ttach!ent C
E4a!ple Only
Section
Section
Section
Section *
ssued Resolved On: ####################
Continuing to 5e Revie1ed: ############## Ne4t Planned "ssess!ent: ###################
CORREC$*E and PRE*EN$"$*E "C$ONS
(C"P") 'OR7
dentified ssue:
Casual "nalysis:
Proposed Resolution(s):
'inal Root Causal "nalysis
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CORREC$*E and PRE*EN$"$*E "C$ONS(C"P") 'OR7
Section *
/em.ers Re;uired to Attend Retraining
Attach Attendance Sheet ith /inutes
Section *
Section *
'$ent Reoccurrence
Address reoccurrences and further pre$entati$e measures and retraining and process impro$ements&
Section *
######################################## #########################
Corrective "ction Plan Preparer8s Signature Date of Signature
,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, ,,,,,,,,,,,,,,,,,,,,,,,,,
Clinical nvestigator8s Signature Date of Revie1 and "pproval
Continual Process !prove!ent:
nvestigator8s Revie1 or Corrective "ction Plan and "c3no1ledge!ent of Continual
!prove!ent:
Docu!entation of Staff Retraining:
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"ttach!ent D
'or! E4a!ple 9 Co!pleted C"P"
Protocol A2C 58 (n$estigator A& Eohnson
CRC R& Eacson Date of Report /ay 3 )004
Section
Section
Section
Section *
CNC" N*ES$0"$OR8S
CORREC$*E "C$ON RESO,$ON 'OR7
dentified ssue:Su.Bect %S/ F 00 is a su.Bect of child .earing potential and .egan study participation on Decem.er 13
)00& During an A2C sponsor audit Dr& Eohnson as made aare that su.Bect 00 did not ha$e a screening
pregnancy test completed&
Causal "nalysis:!his incident is .eing reported on /ay 3 )004 hich is fi$e "4# months after the pregnancy testing ith no
correcti$e action regarding the lac of a pregnancy test .eing documented& !he issue has .een noted in amonitoring follo-up letter dated /arch 15 )004& !here as no documentation on file that the (R2 asinformed of the de$iation& Records ere re$ieed 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$ie of this incident indicates that the la.re;uisition as not mared as child.earing potentialthat a pregnancy test as re;uested&
Proposed Resolution(s):
/onitoring letters ill .e re$ieed for all protocol de$iations upon receipt to address correcti$e andpre$entati$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$iations ill .e reported in a timely manner to the (R2& Su.Bectsill .e ased to return to the site for testing hen critical testing is missed& !racing of de$iations ill .e
instituted on a Protocol !racing 6og and maintained .y the Clinical Research Director per study&
'inal Root Causal "nalysis:!he la. re;uisition as not completed properly that led to su.Bect 00 not ha$e a screening serum pregnancyresult&
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SOP No.: SOP-CO-03
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Effective Date:
Confidential & Proprietary Information
Continuing to 5e Revie1ed: /ay 3 )004
Ne4t Planned "ssess!ent: /ay14 )004
Section *
/em.ers Re;uired to Attend RetrainingAttach Attendance Sheet ith /inutes
Section *
'$ent ReoccurrenceAddress reoccurrences and further pre$entati$e measures and retraining and process impro$ements&
Section *
,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, ,,,,,,,,,,,,,
Clinical nvestigator8s Signature Date of Revie1
######################################## ###############
Corrective "ction Plan Preparer8s Signature Date of Signature
Continual Process !prove!ent:Continual re$ie ill .e completed to re$ie each incoming monitoring letter for protocol de$iation andsignificant performance study issue& Su.Bect safety ill continue to .e reinforced at eely staff meetings&
6a. tests ill only .e scheduled as designed .y the protocol .y CRCs& Protocol de$iations ill .e re$ieed
and traced .y the Clinical Research Director for root causal analysis for compliance concerns&
Docu!entation of Staff Retraining:All clinical research team mem.ers ere retrained on la. re;uisition procedures for completing la. test
re;uest monitoring $isit procedures and reporting protocol de$iations& !he training as documented ineach employee file& Signature sheet for attendees are attached&
Clinical nvestigator8s Revie1 or Corrective "ction Plan and "c3no1ledge!ent of
Continual !prove!ent:( Dr& Eohnson ha$e read and agree ith the CAPA plan and acnoledge my agreement to super$ise and
implement immediate correcti$e action to secure compliance& /y staff as retrained on /ay 10 )004 and as in attendance to participate and recei$e retraining& Ge ill again measures ho e are progressing on
/ay 14 )004 and ( ill recei$e continue to re$ie monitoring letters and compliance issues since this las
occurrence to measure our compliance outcomes&
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SOP No.: SOP-CO-03
Revision: Original
Effective Date:
Confidential & Proprietary Information
"ttach!ent E
E4a!ple Only
ssue Co!pletion $rac3ing og
Assessment Date Re$ieer"s# ,,,,,,,,,,,,,,,(n$estigator ,,,,,,,,,,,,,,,,,, Prepared 2y ,,,,,,,,,,, Date ,, ,,,,,,,,,,
Protocol %um.er"s# ,,,,,,,,,,,,,,,,
Corrective "ction Revie1:
Clinical Research Director ,,,,,,,,,,,,,,,,,, Date ,,,,,,,,
Clinical (n$estigator ,,,,,,,,,,,,,,,,,,,,,,, Date ,,,,,,,,
O.ser$ation"s# Recommendation Correcti$e Action
Completion
!arget Date
Responsi.le
Person"s#
Completion
Date
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