Interactive GCP Workshop 9-19-07

7/26/2019 Interactive GCP Workshop 9-19-07

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An InteractiveApproach to

Good Clinical

Practices (GCPs)Brandi N. Ring, M.A.

Boston University School of Medicine


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Good Clinical Practices

(GCPs) ICH E6 DefinitionA standard for the design, conduct,

performance, monitoring, auditing, recording,analyses, and reporting of clinical trials thatprovides assurance that the data and reportedresults are credible and accurate, and that therights, integrity, and confidentiality of trial

subjects is protected!


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Good Clinical Practices

(GCP) "he term #C$! %as coined by industry

&DA has specific regulations governing conduct ofclinical trials

"he International Conference on Harmoni'ation(ICH) has developed guidelines for conduct andreporting of clinical trials (ICH E6)

Industry practices such as electronic datacollection and monitoring practices ensure #C$and integrity of trials


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Legal Regulatory

Framework* +tatutes (a%s)- eg, &D.C Act of */012 3egulations- eg, 2* C&3 $arts 45, 4, 46, 0*2

7 implement the provisions of the &D.C Act

0 #uidelines- informal guidance provided toindustry by &DA 8ot binding on &DA or

industry

Case la% (court decisions)- provide precedents

on the 9real %orld: interpretation of the la%


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U.S. Regulations Cover obligations of +ponsors, ;onitors,

Investigators, and I3


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Principles o GCP "he benefits of the trial must justify the ris>s

The rights, safety and well-being of thesubject must be the priority throughout the

study.

8on7clinical data support the clinical proposal

"he trial is conducted under a scientifically soundprotocol


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Principles o GCP "he I3


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Fundamentals o GCP "he +ponsor and Investigator must assure

patients: rights and have evidence of appropriateinformed consent

Investigators must have all essential studydocuments at initiation, including the approvedprotocol, IC&, C3&s, +AE reporting forms, etc

+tudy sites must follo% the I3< approvedprotocol, without deviation.


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Fundamentals o GCP All +ponsor responsibilities, such as monitoring,

safety oversight and reporting, data collection,etc must be met

Investigator and site personnel must understandresponsibilities of conducting a trial that e@tendbeyond routine clinical practice


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!nteracti"e #orks$op


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Goals o %$e #orks$op

"o familiari'e everyone %ith studydocuments and provide good and bad

e@amples of documentation

+ A+B E+"I8+

$lease feel free to interrupt


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!&F'R* C'&S&%

HF D I


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!normed Consent ;+"


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!normed Consent If a ne% informed consent is issued

!llpatients must be re7consented %ith thene% Informed Consent &orm at their "E#Tvisit E@plain the changes

BEE$ A 3I#I8A+ IC&s must be retained as a legal record of the

patients consent to participate in the study

$rovide the subject %ith a copy of the ne% IC&

"he most recent IC& must be used and alloriginal copies must be retained


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!normed Consent Form HF D I B8F I& I:; +I8# "HE 3I#H"

&3; I3< Approval +tamp

Date Issued = Approved

Gou should record some%here visible thedate of the latest approved consent anddouble7chec> before every ne% subject


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!normedConsentForm

Must be

signed anddated at thetime ofconsent byBOTH thesubject andthe person

conducting


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#ork +reak

$A#E *


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F*, !nspection Common Deficiencies

$nade%uate consent &'(

$rotocol 8on7adherence 0*

3ecords Inade?uate=Inaccurate 26

Drug Accountability Inade?uate 25

I3< deficiencies **

Investigator &ailure to report Adverse Events

$ttp-www.ir/orum.orgdocumentsdocumentsodule
http://www.irbforum.org/documents/documents/Module4.pdfhttp://www.irbforum.org/documents/documents/Module4.pdfhttp://www.irbforum.org/documents/documents/Module4.pdf


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!CF 1elpul 1ints "he subject must sign and date their o%n signature J study staff

may 8" fill in the date for the subject

Double chec> the IC& before you and the patient leave the room Jcorrect any mista>es immediately

If the time the IC& %as signed needs to be recorded in the sourcedocuments J ma>e sure your cloc>s are synchroni'ed and %ritethe e@act time do%n (8 38DI8#)

"he IC& process should be documented for each patient J betterto document at the beginning than to %ait

;ay be in a note to file 8eeds to be subject specific

;ay %ant to create a sample sheet=binder to remind you of pagesneeding signature, initials etc


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Procedures

FHA" D I D

8EK"


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Inade?uate consent 4*

)rotocol "on-adherence *'(


Drug Accountability Inade?uate 25

I3< deficiencies **




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Protocol &on2ad$erence Enrolling subjects that do not meet

eligibility re?uirements

8ot completing visits according to theprotocol

8ot performing procedures


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#ork +reak

$A#E 2


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F*, Perspecti"ePatricia 1olo/aug$

C$ie o +!' +ranc$ o *!S o 'C+3

+OT $"$F$!"T /E0$!T$O" Enrollment of ineligible subjects Liolations of protocol affecting safety

E@tensive data corrections and?uestionable changes

Inade?uate oversight of study personnel Inappropriate delegation of authority $oor oversight of satellite sites

8o informed consent &ailure to communicate %ith I3 all Inclusion=E@clusion Criteria

;a>e sure you have documentation

;a>e sure you have as>ed the subject about all points

If a subject avoids a ?uestion or gives you aambiguous response J re7address

&ollo% the protocols numerical limits %ith labresults J even if they can be e@plained or are notclinically significant A Hematocrit of does not fit the ?ualification if the

inclusion criteria states-

;ust have hematocrit greater then 4


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1elpul 1ints Frite a note to file on your screening

procedures, follo% the same procedure foreach patient

se 8otes to &ile to e@plain anything thatneeds to be e@plained


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Inade?uate consent 4*


ecords $nade%uate1$naccurate 23(

/rug !ccountability $nade%uate 24(

I3< deficiencies **




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Source Documents Fhat is a source document

"he first place things are %ritten do%n "raditionally Chart notes

E@amples Chart 8otes Clinic Charts ab 3eports $hone ogs $hysician etter K7rays, C"s, ;3I etc


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Source *ocuments &or some studies (traditionally industry)

$re7templated +ource documents could be

provided for you

"his %ill ma>e your life easier

"he source documents %al> you through all the?uestions you need to as> and the proceduresyou need to perform


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Case Report Forms (CRF8s) Fhat is a case report form

Collects the trial re?uired data


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Case Report Forms (CRF8s) "he data that is collected by the sponsor

3

"he data used for analysis

sually separate from your sourcedocuments (but not al%ays)

+ome ;i@ing +ome studies do not have 9official: source docs

to capture study information


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*ocumentation in Source *ocs CRFs Complete in blac> in> only

Cross out error %ith a single blac> line

Frite correct information in as close as

possible Date and initial the change


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Source *ocument 1elpul

1ints btain as much information on medicalhistory and concomitant medications as isavailable J if the patient does not >no%(e@- dosage) as> them to find out and tocall you

If patient has been diagnosed %ithdepression the Investigator should indicatethat subject is stable or the depression %illnot interfere %ith the study

Document


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Source *ocument 1elpul

1ints ;a>e sure all cloc>s are synchroni'ed andif possible, use 2-55 digital cloc>s

Include e@planations of mista>es

(E@- $atient accidentally %rote the incorrectyear)

Initial and Date ;ista>es

Document reason for late entries

Document all attempts to contact subjectand schedule visits


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CRF 1elpul 1ints 3emember on 8C3 pages J use the cardboard

divider so you have clean records It may help to put some plain %hite paper bet%een the

source docs and C3&s as %ell

+E e your time %hen transcribing ;a>e sure you are using the right patient binders

Copy neatly and correctly

Correct mista>es immediately


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1elpul 1ints Double chec> everything beforethe

patient leaves

Document everything

se 8otes to &ile 3e7chec> documents e sure

you initial J date J e@plain the addition


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F*, !nspection

Common Deficiencies Inade?uate consent 4*



Drug Accountability Inade?uate 25 $B deficiencies ''(




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F*, !nspection

Common Deficiencies Inade?uate consent 4*



Drug Accountability Inade?uate 25 I3< deficiencies **

$nvestigator Failure to report !dverse Events



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Adverse Events

An adverse event (AE) is any unto%ardmedical event that occurs in a subjectreceiving a pharmaceutical product- it

does not necessarily have a causalrelationship to the treatment

uic> 3eference #uide


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, 'R &'% ,9(%$at is t$e :uestion) $atient goes to dentist for a scheduled cleaning "O $atient goes to dentist for toothache, has root canal

procedure 5E 6Toothache is the !E, oot anal is the

treatment 7 recorded on the con meds page8 $atient goes to gynecologist for scheduled annual e@am, is

prescribed H3" as a prophylactic "O 6but it is a change in con meds8 $atient has a cosmetic procedure scheduled before start of

study "O 6but record treatment as a con med8 $atient has a cosmetic procedure scheduled after start of

study that is performed during the study "O 6but record treatment as a con med8


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,d"erse "ent Recording If a procedure is planned and scheduled before a

patient enters a clinical trial then that procedureand associated underlying condition are notconsidered as (+)AEs "he underlying condition

should be recorded as medical history

If a procedure is scheduled after the patiententers a clinical trial and the procedure occursduring the trial %ithout aggravation of the

underlying condition then the procedure isrecorded as an (+)AE and the underlyingcondition is medical history


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,d"erse "ent Recording If a procedure is scheduled after the

patient enters the clinical trial due toaggravation of the underlying condition

then the underlying condition is recordedunder medical history the aggravation isrecorded as an (+)AE, the procedures istreatment of the (+)AE


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AdverseEvents

,LL untoward medicale"ents need to /erecorded as ,s;including e


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,d"erse "ent &arrati"e +ubject //754 (Initials Ae migraine medicine every timethey %o>e up to relieve the pain Fhen as>ed thepatient indicates treatment as E@cedrin ;igraineappro@imately every 1 hours

8o% fill out the AE document


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Let8s >ll out t$e , Page +ubject- //754 Event- ;igraine nset Date-0*7;AG72554

3esolution Date-*7M872554 +everity- 3elation to +tudy Drug- Action "a>en- ;edication (E@cedrin ;igraine) utcome- 3ecovered +erious- 8


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, Page


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Concomitant

edications

,ll medicationsneed to /e recorded(including;supplements;

"itamins and topicalmedications)

Get as muc$inormation (dose;

route; re:uencyetc) as you can t$e>rst time

ake sure t$at ,

orm is completed i


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Let8s >ll out t$e Con edsSource Page ;edication- E@cedrin ;igraine

Dosage- 2 "ablets

Administration

3oute- ral &re?uency- Every 1 hours

Indication- ;igraine

Date +tarted- ;ay 0*st

, 2554 Date +topped- Mune *st, 2554


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Con ed Source *ocumentPage


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1elpul 1ints If a medication changes, as> %hy, the

underlying cause may need to be recordedas an adverse event

Document 3easons for all missed visits orout of %indo% visits "hese may be due to an AE that may need to

be recorded


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'"erall Some 1elpul 1ints BEE$ A +"DG 3EA"ED DC;E8"+

Even if they seem outdated J file in the regulatorybinder or in patient binders

Frite ELE3G"HI8# do%n, before you forget

$ut subject numbers on every piece of paper +o you >no% %hich subject it belongs to

Address all issues in your monitor follo% upletters A+A$

Initial and date everything Fhen in doubt initial and date any%ay


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1elpul 1ints

FHE8 I8 D


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3uestions

Interactive GCP Workshop 9-19-07

Documents

Transcript of Interactive GCP Workshop 9-19-07