Trials Czech Republic

8/11/2019 Trials Czech Republic

http://slidepdf.com/reader/full/trials-czech-republic 1/7

Vladimir Patras: Regulatory Requirements for Clinical Trials Conduct in the Czech Republic

Regulatory Requirements for Clinical Trials Conduct

in the Czech Republic

This document provides applicants for clinical trials approval in the Czech Republic with informationon substantial regulatory requirements. The information provided match requirements as of !!". The

document is published at http:##vpatras.blogspot.com

GENERAL IN!R"ATI!N

REG#LAT!R$ A#T%!RITIE& 'or Competent Authority 'CA((

$tate %nstitute for &rug Control ' Clinical Trials and Pharmacovigilance (ranch)$t*tn+ ,stav pro -ontrolu l/iv0 $e-ce -linic-ho hodnocen+ a farma-ovigilence1

www.su-l.cz

Czech 2inistry of 3ealth

)2inisterstvo zdravotnictv+1

http:##www.mzcr.cz#

Products containing radiopharmaceuticals

$tate 4ffice for 5uclear $afety

)$t*tn+ ,6ad pro 7adernou bezpe/nost1http:##www.su7b.cz#

Products containing 824s2inistry of 9nvironment

)2inisterstvi ivotn+ho prost6ed+1

http:##www.env.cz#

!T%ER RELE)ANT *!+IE&

● Central 9thics (ody: 9thics Committee of 2inistry of 3ealth )9tic-* -omise 2inisterstva

zdravotnictv+1

● %ndustry (odies:

;CR4 Czech Republic );ssociaton of CR4s1 http:##www.acro<cz.cz#inde=.php0;ssociation of %nnovative Pharmaceutical %ndustries http:##www.aifp.cz#cz#inde=.php

LI&T ! RELE)ANT LEGI&LATI!N

>aw 5o. ?@#A@@? on 2edical Products and its amendments0Regulation 5o. "#!!" on 8ood Clinical Pra=is and Clinical Trials

A

http://vpatras.blogspot.com/


http://www.sukl.cz/

http://www.mzcr.cz/

http://www.sujb.cz/

http://www.env.cz/

http://www.acro-cz.cz/index.php

http://www.mafs.cz/

http://www.sukl.cz/

http://www.mzcr.cz/

http://www.sujb.cz/

http://www.env.cz/

http://www.acro-cz.cz/index.php

http://www.mafs.cz/





CTA L!, C%ART

*E!RE T%E &T#+$ 'submissions - all phases(

REG#LAT!R$ A#T%!RITIE&

&ocuments required:Reference: $B> regulations >3 A@ )&ocumentation required for an approval of a

clinical trial on a human pharmaceutical1 and >3 ! );pplication for approval#notification of

a clinical trial1

http:##www.su-l.cz#Ddownload#en!"#-lh#[email protected] )>3 A@1http:##www.su-l.cz#Ddownload#en!"#-lh#-lh!a.rtf )>3 !1

< 9udraCT number < 9lectronic 9udraCT number application

< Cover letter )Czech or 9nglish language1

< Clinical Trial ;pplication )CT;1 ' The 9B standard application form )filled in Czech or

9nglish language1< Protocol

< %nvestigatorEs (rochure

< Case Report Forms )CRF1< %2P&

< $PC for registered medicines

< >ist of authorities where the application has been submitted and their decision< Copy of 9thics Committee decision )if already issued1

< ;pproval of 824 use or release )if applicable1

< Power of attorney if applicant is not sponsor< %nformed consent in Czech language

< Patient information in Czech language< Protocol synopsis in Czech language< >ist of all ongoing trials with the same %2P0

< Viral safety assessment

< ;pprovals for preparations with special substances )such as radiopharmaceuticals0

8241 if applicable< T$9 certificate if applicable

CTA Application Authorisation

EC Application EC approval

60 days – pararrel

Eudra CT number granted

(1 per study)

http://www.sukl.cz/_download/en08/klh/klh19a.rtf










< 82P declaration for substances of biological origin< Copy of manufacturing approval

< &eclaration of certified person of importer from third countries that manufacturing site

comply with 82P requirements )if applicable1

< 2anufacturing permit for importers from third countries )if applicable1< ;nalytical certificate for %2P&0 list of study centers0 information on contact person

Procedure:

G! days approval time0 @! days for gene therapy and products containing 824s0 unlimited approvaltime for =enogenic cell therapy ' cloc-stop if additional documents are required. $ponsor shall report

begining of the trial )start of recruiting1 in G! days to $B>.

ET%IC& C!""ITTEE

CENTRAL ET%IC& C!""ITTEE '"#LTICENTRIC ET%IC& C!""ITTEE(

&ocuments required:

< Clinical Trial ;pplication )CT;1 ' The 9B standard application form )filled in Czech or9nglish language1

< Protocol

< $%$#%C< Recruitment plan including advertising< %nvestigator brochure and available safety data

< %nformation on payments to sub7ects and possible compensation

< %nvestigator CV or other documents confirming his#her e=perience< 9C can require further relevant documents

Procedure:

;ll 9C submissions can be made as pararrel to C; submissions. There is single opinion for

multicentric studies )29C < 2ulticentric 9thics Committees1. $ponsor can address any 9C0 whichshould have relationship toward investigation site0 to act as 29C. 29C review all aspects of the study

e=cept of investigator qualification and site suitability.

2ulticentric 9C decision is issued within HI days after application submission. >ocal 9C stagefollows. 4nly investigator qualifications and site suitability are sub7ect to evaluation of local 9C0

which shall )in multicentric studies1 e=press its position within AI days after multicentric 9C desicion

and report it to $B>0 sponsor and multicentric 9C. Total time for 9C decision )multicentric and local

J




together1 is G! days. This period can be e=tended in case of gene therapy products or products containg824s. The period is unlimited for =enogenic cell therapy. $topcloc- applies if further information is

required. 9thics committee should chec- course of the trial approved at least once a year.

L!CAL ET%IC& C!""ITTEE

&ocuments required:

The same as in case of central ethics committte

Procedure:

Competence of local ethics committees are investigator qualification and site suitability as described

above. ;lso studies with only one site require opinion of ethics committee having multicentricdesignation.

+#RING T%E &T#+$ 'amendments . all phases(

REG#LAT!R$ A#T%!RITIE&

$ponsor have to notify all substantial amandements which include:

• The safety or physical or mental integrity of the sub7ects

• The scientific value of the trial

• The conduct or management of the trial

• The quality )including composition0 manufacturing process1 or safety of any %2P used

in the trial

;nd all changes which include changes in number of enroled sub7ects0 dosage and administation0 trialduration0 inclusion and e=clusion criteria0 methods of data processing0 procedures of samplescollection.

&ocuments required:

< The 9B standard form for notification of amendment )filled in Czech or 9nglish1< 9udraCT number

< ;mended documents

< Proof of payment

Procedure

The sponsor may implement a substantial amendment when the C; has raised no grounds for non<

acceptance. ;mendment may be implemented after JI days from the receipt of a valid notification of

amendment if the C; has not raised grounds for non<acceptance.

H




CENTRAL AN+ L!CAL ET%IC& C!""ITTEE&

$ubstantial amandements have to be submitted for 9C review. Requirements as in the case of R;.

&ocuments required

< ;mended documents

< Covering letter

Procedure:

The sponsor may implement a substantial amendment when the 9C opinion is favourable. 9C should provide opinion within JI days.

T%E EN+ ! T%E &T#+$ 'all phases(

9nd of study reporting

< %n the case of a premature termination0 e=pedited reporting is required to

C;#9C#3ospital and sponsor. ;pplicant is required to present e=planation of premature

termination. Period to report premature termination of the study to C; is AI days.< The sponsor#CR4 reports to C; termination of trial within @! days. Final reports must

be submitted to C; in both premature and planned termination of the study

< Kithin A year after termination0 the sponsor submits a annual study and annual safetyreport to the C; and the 9C.

!T%ER RE/#IRE"ENT&

IN)E&TIGATI!NAL "E+ICINAL 0R!+#CT

>abelling

>abelling must include following information:

< ;ll informations must be presented in Czech language0 information in other languages

can also be included< 5ame0 address0 telephone number of sponsor0 investigation site0 or investigator

< Pharmaceutical form0 administration route0 dose quantity0 name#identificator and

strengh#efficacy in open label studies< (atch number and#or code for identification of content and ad7usting operations

< Reference code enabling study identification0 place of study0 investigator and sponsor if

not stated elsewhere

I






IN&#RANCE 1 IN+E"NIT$

;ccording to the Czech law sponsor is obligated to arrange liability insurance for the sub7ects of

assessment to cover damages to health. ;lso both sponsor and investigator must be insured. There is

no defined amount for insurance coverage.

EE&

Regulatory appro2al

&um in Czech cro3ns &um in Euros

Clinical Trial ;pplication 45677 8547

9=tension of approved clinical trial 9:;77 4:7

Protocol amendment 9:;77 4:7

9thics committee fee )multicentrictrial1

Appro<= >7777 9>77

http:##www.su-l.cz#uploads#Poplat-yDaDsazebni-#[email protected]

Ethics appro2al

9ach 9C has its own fee policy

"I&CELLANE!#&

&ocuments to be submitted in Czech language:

Protocol synopsis0 informed consent0 patient information

$%$#%C requirements

< %nformation on purpose of clinical trial

< The sub7ect is to be informed that the sub7ect may discontinue participation at any time without penalty or loss of benefits

< Potential ris-s and benefits of treatment0 other treatment options

< 8uarantee and e=planation of data protection< %nformation on rights and duties of the patient in regard of the trial

&ata protection

Czech law no. A!A#!!! on personal data protection applies.

?

http://www.sukl.cz/uploads/Poplatky_a_sazebnik/ust29v2_an.doc

http://www.sukl.cz/uploads/Poplatky_a_sazebnik/ust29v2_an.doc

Documents

Trials Czech Republic