capa mock sop

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

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%ame"Printed# !itle

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Signature Date of Appro$al


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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

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$"%E O' CON$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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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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"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


6/11

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"ttach!ent %

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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 *

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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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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

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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

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"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