blueprint for clinical research sops final

8/13/2019 Blueprint for Clinical Research Sops FINAL

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A Blueprint For ClinicalA Blueprint For ClinicalResearch: StandardResearch: Standard

Operating ProceduresOperating Procedures

Karen Majchrzak, MS, CCRPKaren Majchrzak, MS, CCRP


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What are SOPs?What are SOPs?

International Conference onInternational Conference on

Harmonization (ICH) defines aHarmonization (ICH) defines a

SOP as etailed, !rittenSOP as etailed, !ritteninstr"ctions to achie#e "niformit$instr"ctions to achie#e "niformit$

of the %erformance of a s%ecificof the %erformance of a s%ecific

f"nction&'f"nction&' (ICH CP &**)(ICH CP &**)


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What are SOPs?What are SOPs?

In sim%le terms a SOP is+In sim%le terms a SOP is+ - !ritten %rocess- !ritten %rocess

- !a$ for the clinical site to %erform- !a$ for the clinical site to %erforma task the same !a$ each time it isa task the same !a$ each time it iscom%leted&com%leted&


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SOPs are used to:SOPs are used to:

Identif$ the res%onsi.le %erson forIdentif$ the res%onsi.le %erson for

each task&each task&

escri.e actions (!hat is to .eescri.e actions (!hat is to .ecom%leted)&com%leted)&

/rain staff&/rain staff&

Monitor site %erformance&Monitor site %erformance&


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Are SOPs Required byAre SOPs Required by

La!Regulations?La!Regulations?

SOPs are not s%ecificall$SOPs are not s%ecificall$mentioned in the 0-mentioned in the 0-

re1"lationsre1"lations

"OW#$#R"OW#$#Rthere is 1"idance andthere is 1"idance andre1"lations that infer res%onsi.ilit$ andre1"lations that infer res%onsi.ilit$ andSOPs formalize in#esti1atorSOPs formalize in#esti1ator

res%onsi.ilities&res%onsi.ilities&

2 C0R32&*3 the in#esti1ator !ill2 C0R32&*3 the in#esti1ator !illens"re that all associates, collea1"es,ens"re that all associates, collea1"es,and em%lo$ees assistin1 in the cond"ctand em%lo$ees assistin1 in the cond"ct

of the st"d$ (ies) are informed of theirof the st"d$ (ies) are informed of theiro.li ations in meetin the a.o#eo.li ations in meetin the a.o#e


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Are SOPs Required byAre SOPs Required by

La!Regulations?La!Regulations?

-dditionall$, SOPs are mentioned-dditionall$, SOPs are mentioned

re%eatedl$ in the ICH CPre%eatedl$ in the ICH CP

"idelines&"idelines&

ICH CP 2&3 4ICH CP 2&3 4S$stems !ith

%roced"res that ass"re the5"alit$ of e#er$ as%ect of the trialsho"ld .e im%lemented&'


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Bene%its o% a SOP?Bene%its o% a SOP?

6ns"res that all research6ns"res that all research

cond"cted !ithin the clinical sitecond"cted !ithin the clinical site

follo!s federal re1"lations, ICHfollo!s federal re1"lations, ICHCP, and instit"tional %olicies toCP, and instit"tional %olicies to

%rotect the ri1hts and !elfare of%rotect the ri1hts and !elfare of

h"man st"d$ %artici%antsh"man st"d$ %artici%ants&&


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Pro#ides a"tonom$ !ithin thePro#ides a"tonom$ !ithin the

clinical site&clinical site&

Im%ro#es the 5"alit$ of the dataIm%ro#es the 5"alit$ of the data

collected, there.$ im%ro#in1 thecollected, there.$ im%ro#in1 the

science of the st"d$&science of the st"d$&


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7tilized as a reference and7tilized as a reference and

1"ideline as to ho! research !ill1"ideline as to ho! research !ill

.e cond"cted !ithin the clinical.e cond"cted !ithin the clinicalsitesite

68cellent trainin1 so"rce for ne!68cellent trainin1 so"rce for ne!em%lo$ees and9or fello!sem%lo$ees and9or fello!s


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SOP &opicsSOP &opics

Pre%arin1 and S".mittin1 Initial IR:Pre%arin1 and S".mittin1 Initial IR:oc"mentsoc"ments

Pre%arin1 and S".mittin1 Contin"in1Pre%arin1 and S".mittin1 Contin"in1Re#ie! IR: oc"mentsRe#ie! IR: oc"ments

Pre%arin1 and S".mittin1 -mendmentPre%arin1 and S".mittin1 -mendmentIR: oc"mentsIR: oc"ments

6sta.lishin1 and /rainin1 the Clinical6sta.lishin1 and /rainin1 the Clinical

St"d$ /eam, and ele1atin1St"d$ /eam, and ele1atin1Res%onsi.ilitiesRes%onsi.ilities

6sta.lishin1 St"d$ 0iles6sta.lishin1 St"d$ 0iles 6sta.lishin1 So"rce oc"ments6sta.lishin1 So"rce oc"ments


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St"d$ S".ject Recr"itment PlanSt"d$ S".ject Recr"itment Plan

Contactin1 and Sched"lin1 PotentialContactin1 and Sched"lin1 PotentialSt"d$ S".jects for an Initial ;isitSt"d$ S".jects for an Initial ;isit

O.tainin1 Informed Consent from aO.tainin1 Informed Consent from a

Potential St"d$ S".jectPotential St"d$ S".ject

6nrollin1 a S".ject6nrollin1 a S".ject

Recordin1 S".ject ataRecordin1 S".ject ata

Makin1 Corrections on St"d$Makin1 Corrections on St"d$


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Monitorin1 S".ject Com%liance "rin1Monitorin1 S".ject Com%liance "rin1a St"d$a St"d$

Res%ondin1 to a Clinical Hold OrderRes%ondin1 to a Clinical Hold Order

Recei#in1 and Storin1 In#esti1ationalRecei#in1 and Storin1 In#esti1ationalr"1sr"1s

r"1 and St"d$ S"%%l$ /ransferr"1 and St"d$ S"%%l$ /ransfer

:et!een Sites:et!een Sites is%ensin1 St"d$ r"1s to St"d$is%ensin1 St"d$ r"1s to St"d$

S".jectsS".jects Identif$in1 and Re%ortin1 -d#erseIdentif$in1 and Re%ortin1 -d#erse

6#ents6#ents


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-dditional /o%ics-dditional /o%ics Contact !ith %otential s%onsorsContact !ith %otential s%onsors

:"d1et re#ie! and determinations:"d1et re#ie! and determinations Pre4st"d$ st"d$ site #isitPre4st"d$ st"d$ site #isit Initiation Site ;isitInitiation Site ;isit Monitor ;isitsMonitor ;isits

-"dits-"dits ata mana1ementata mana1ement St"d$ clos"reSt"d$ clos"re


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Writing SOPsWriting SOPs

e#elo% a tem%late for the SOP to .ee#elo% a tem%late for the SOP to .e"sed thro"1ho"t the doc"ment&"sed thro"1ho"t the doc"ment&

Potential elements of the SOPPotential elements of the SOP Header title, ori1inal #ersion date,Header title, ori1inal #ersion date,

re#ision date, effecti#e date, a%%ro#ed .$re#ision date, effecti#e date, a%%ro#ed .$ P"r%ose !h$ one has the %olic$P"r%ose !h$ one has the %olic$ Res%onsi.ilities !ho the %olic$ %ertainsRes%onsi.ilities !ho the %olic$ %ertains

toto

Instr"ction9Proced"res ho! toInstr"ction9Proced"res ho! toaccom%lish the items of the %olic$accom%lish the items of the %olic$

References !hat the %olic$ is .ased onReferences !hat the %olic$ is .ased on -%%endi8 so"rce doc"ments9case re%ort-%%endi8 so"rce doc"ments9case re%ort

formsforms


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Process 'apping %or WritingProcess 'apping %or Writing

SOPsSOPs

etermine !hich clinical site tasketermine !hich clinical site task

needs ma%%in1&needs ma%%in1&


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Process 'apping %or 'a(ingProcess 'apping %or 'a(ing

a Cup o% Co%%eea Cup o% Co%%ee

Primar$ Ste%Primar$ Ste%

6ns"re

thecoffeemaker isread$

-dd the

!ater

/"rn on

themachine

Ser#e

thecoffee

-dd the

coffee

=oodin, K& (2>>?) The CRCs Guide to Coordinating Clinical Research %& @>4@*& Center!atch


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Process 'apping %or 'a(ingProcess 'apping %or 'a(ing

a Cup o% Co%%eea Cup o% Co%%ee

6ns"re

thecoffeemaker isread$

-dd the

coffee

-dd the

!ater

/"rn on

themachine

Ser#e

thecoffee

Secondar$ Ste%Secondar$ Ste%

6ns"rethe

machineis%l"11edin

6ns"recarafe isem%t$

andclean

Place afilter in

the.asket

Meas"rethecoffee

7se thecarafe to

meas"rethe !ater

Place thecarafe onthe

heatin1element

=ait "ntilthe

coffeehassto%%eddri%%in1


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Process 'apping %or WritingProcess 'apping %or Writing

SOPsSOPs

Once $o" ha#e finished ma%%in1,Once $o" ha#e finished ma%%in1,

con#ert $o"r %rocess ma% to ancon#ert $o"r %rocess ma% to an

o"tline for eas$ "se&o"tline for eas$ "se&

Once a task has .een ma%%ed, itOnce a task has .een ma%%ed, it

sho"ld .e tested&sho"ld .e tested&


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SOPs and )uidelinesSOPs and )uidelines

Some SOPs ha#e a t!o4tieredSome SOPs ha#e a t!o4tiered

s$stem that incl"des .oth SOPss$stem that incl"des .oth SOPs

and 1"idelines&and 1"idelines&

SOPs %ro#ide a 1eneral #ie! of allSOPs %ro#ide a 1eneral #ie! of all

the main ste%s !hereasthe main ste%s !hereas1"idelines are si1nificantl$ more1"idelines are si1nificantl$ moredetailed&detailed&


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SOPs and )uidelinesSOPs and )uidelines

One ad#anta1e of a t!o4tieredOne ad#anta1e of a t!o4tiered

s$stem is that SOPs !ill rarel$s$stem is that SOPs !ill rarel$

need to .e chan1ed, !hereasneed to .e chan1ed, !hereas1"idelines ma$ need to .e1"idelines ma$ need to .e

chan1ed or "%dated morechan1ed or "%dated more

fre5"entl$ d"e to chan1es infre5"entl$ d"e to chan1es inor1anizational str"ct"re oror1anizational str"ct"re ore5"i%ment&e5"i%ment&


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*+ple+enting and*+ple+enting and

'onitoring SOPs'onitoring SOPs

SOPs sho"ld .e introd"cedSOPs sho"ld .e introd"ced

1rad"all$&1rad"all$&

Prioritize most rele#ant SOPs andPrioritize most rele#ant SOPs and

%resent them first&%resent them first&

Princi%le In#esti1ator sho"ldPrinci%le In#esti1ator sho"lda%%ro#e all SOPs and desi1natea%%ro#e all SOPs and desi1nate

an effecti#e date&an effecti#e date&


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SOP &rainingSOP &raining

-ll staff sho"ld ha#e SOP trainin1&-ll staff sho"ld ha#e SOP trainin1&

/rainin1 sho"ld .e doc"mented&/rainin1 sho"ld .e doc"mented& SOP sho"ld .e accessi.le to staff&SOP sho"ld .e accessi.le to staff&


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What is the di%%erence beteenWhat is the di%%erence beteen

a SOP and a 'anual o%a SOP and a 'anual o%

Procedures ,'OP-?Procedures ,'OP-?/hese terms ha#e .een "sed/hese terms ha#e .een "sed

interchan1ea.l$&interchan1ea.l$&

:oth %ro#ide a standardization of:oth %ro#ide a standardization of

a %rocess&a %rocess&


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What is the di%%erence beteenWhat is the di%%erence beteen

a SOP and a 'anual o%a SOP and a 'anual o%

Procedures ,'OP-?Procedures ,'OP-? SOP %ro#ides 1eneral informationSOP %ro#ides 1eneral information

that is to .e "tilized thro"1ho"tthat is to .e "tilized thro"1ho"t

an$an$research st"d$&research st"d$& Ho! as a clinical site !e !ill assessHo! as a clinical site !e !ill assessdele1ation of d"ties&dele1ation of d"ties&

MOP is s%ecificall$ !ritten for aMOP is s%ecificall$ !ritten for a%artic"lar research st"d$ !hich%artic"lar research st"d$ !hich!ill!ill incor%orateincor%orateelements of theelements of theSOP&SOP&


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'OP'OP

/he MOP sho"ld .e !ritten so/he MOP sho"ld .e !ritten so

that an$one in $o"r clinical sitethat an$one in $o"r clinical site

can follo! the %roced"res for thatcan follo! the %roced"res for thatst"d$ and find all rele#antst"d$ and find all rele#ant

materials&materials&

/he MOP sho"ld .e e8tremel$/he MOP sho"ld .e e8tremel$

detailed&detailed&


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SOP or 'OPSOP or 'OP

:oth doc"ments are im%ortantB:oth doc"ments are im%ortantB

Start !ith the SOP first& Once $o"Start !ith the SOP first& Once $o"ha#e !ritten 1eneral %roced"res,ha#e !ritten 1eneral %roced"res,

the MOP !ill .e easier&the MOP !ill .e easier&

/his %rocess !ill take lots of time/his %rocess !ill take lots of timeand %atience&and %atience&


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SOP ResourcesSOP Resources

68am%les from ational Cancer Instit"te68am%les from ational Cancer Instit"te

htt%sD99ca.i1&nci&nih&1o#9!orks%aces9C/MS9Meetin1s9SIs9:htt%sD99ca.i1&nci&nih&1o#9!orks%aces9C/MS9Meetin1s9SIs9:

Standard O%eratin1 Proced"res for ood ClinicalStandard O%eratin1 Proced"res for ood ClinicalPractice at the In#esti1ati#e 9 Center!atchPractice at the In#esti1ati#e 9 Center!atch

htt%D99htt%D99!!!&ccr%&com9so%&shtml!!!&ccr%&com9so%&shtmlCost FGG* for sin1le site licenseCost FGG* for sin1le site license

Standard O%eratin1 Proced"res (SOPs) for oodStandard O%eratin1 Proced"res (SOPs) for oodClinical Practice 9 7ni#ersit$ of =ashin1tonClinical Practice 9 7ni#ersit$ of =ashin1ton

htt%D99htt%D99!!!&crc&!ashin1ton&ed"9Reso"rces9CPSOPIn#Sites&as%8!!!&crc&!ashin1ton&ed"9Reso"rces9CPSOPIn#Sites&as%8

Cost F3*Cost F3*
https://cabig.nci.nih.gov/workspaces/CTMS/Meetings/SIGs/Best_Practices/SOPs/SOPshttps://cabig.nci.nih.gov/workspaces/CTMS/Meetings/SIGs/Best_Practices/SOPs/SOPshttp://www.ccrp.com/sop.shtmlhttp://www.ccrp.com/sop.shtmlhttp://www.ccrp.com/sop.shtmlhttp://www.ccrp.com/sop.shtmlhttp://www.crc.washington.edu/Resources/GCPSOPInvSites.aspxhttp://www.crc.washington.edu/Resources/GCPSOPInvSites.aspxhttp://www.crc.washington.edu/Resources/GCPSOPInvSites.aspxhttp://www.crc.washington.edu/Resources/GCPSOPInvSites.aspxhttp://www.crc.washington.edu/Resources/GCPSOPInvSites.aspxhttp://www.crc.washington.edu/Resources/GCPSOPInvSites.aspxhttp://www.ccrp.com/sop.shtmlhttp://www.ccrp.com/sop.shtmlhttps://cabig.nci.nih.gov/workspaces/CTMS/Meetings/SIGs/Best_Practices/SOPs/SOPs


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Co++ents andCo++ents and

.uestions?.uestions?

blueprint for clinical research sops final

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