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Requirements For CRO Approval

This document outlines the requirements for approval of a Clinical Research Organization (CRO) or Clinical Trial Centre in Bangladesh. It lists the types of documents that must be submitted including: [1] CRO profile, organizational structure, staff CVs and GCP training records; [2] details on biological sample storage facilities and standard operating procedures; and [3] information on emergency response plans and contractual agreements with hospitals. Approval will ensure the CRO or centre meets international GCP standards for conducting clinical trials.

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Neneng Aini Karuniawan
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70 views3 pages

Requirements For CRO Approval

This document outlines the requirements for approval of a Clinical Research Organization (CRO) or Clinical Trial Centre in Bangladesh. It lists the types of documents that must be submitted including: [1] CRO profile, organizational structure, staff CVs and GCP training records; [2] details on biological sample storage facilities and standard operating procedures; and [3] information on emergency response plans and contractual agreements with hospitals. Approval will ensure the CRO or centre meets international GCP standards for conducting clinical trials.

Uploaded by

Neneng Aini Karuniawan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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(Application has to be submittecl in orgunixation official pacl)

Dated:

To

The Director General

Directorate General of Drug Administration,

Mohakhal i, Dhaka- | 2 I 2.

Srbi..tr Aprli.utio, fo. th. urp.orul of cRO o,Nu-. of th. p.otro..d cRo,,.

Dear Sir

Enclosed: (As per the attached requirements)

Name of the applicant

Designation

Organization.
L"I'ORATE GENqI4L
OF DRUG ADMINISTRATION
BANGLADESH
Authorized
Annexure-l
Title: Requirements for
CRO/Clinical Triat Centre
Revisionffil
NRA-CTO-003/F0
RevietDiG
I _01

Req uirements for CRO/CIinicat T;lrrc*;


Types ofdocument Availabitity of

cRO ProfiG to G;umltiea

organ%
c v o f Res eirc hEEJiIi!ilG[
Job DescriptiG

* u"jlel every person involued.lnlfEJl


got GCp training records, i

Whether rh

a. If not, they have


go1 any contracr with
L'u -ri""Ne"'iii",J*,.,,any Bio-
ffiiligiHiil';1 Sampre
b. Biological Samjest
. ;"o,ffi nffi
lyTtF;
operates lt ;ffi !:lHJ ?c",eoi,ati
und er GCp Com p Ii ance Ai.irrg'rr.*rol
on ;

Whether ,
the CRO or Clinical
Trial Center.

Storage Faciiffi
a. Whether Temperature Sensitive product
Storage Facility
SOP forUanOinffitn
Archive FrciTE
Is the Archive Facility
? has Controlled Access

Does the a
i,;ilE,, contror
house subject area / pool "Ev rrvJprrsl
ofsubjeci,

,Y,:;ffi: tr Hospital or has contract with


gffi;r"ililrt:'g##e.
'croRATE
cEirqI4L or DRuc ADMTNT'TRATT,N
tsrnv or HearrH afi,frai#wpr,ranp,
eaNcLADEsH
:!

Annexure-l T

for CROTC|inicat Trial x


]itle: |eauirements Centre fi
ffi
|1

Emergency@ :.iI
!11

Q"u,,O
.tr

Cortructua
e. g. hospitals, uni vers
iry, unurytiJu i
iril,.,..
""ntro,
vevJ vvr vvr sr!trrsrrr' nandling, compensation,
confrdentialit'
rmrcal clearance. -

Ooes t

Doesrhe%
Yi',"':
estimate@
estima@
Bio-statisticalJoftwil
others if an[
NorejTheau@
requirement of GCp
to meet intemational Theconrenrt@

NAME
WRITTEN BY

or.ersnaSia<iEua-
Md.
CHECKED BY

Salahuilln----
APPROVED BY
;;;;t
Nnanoaker Sagir Ahmed
Majo. cinerai-M[
1 Mustafizur Rahman
DESIGNATION
Tha.'ffiAGC_=-- ,r,,,ii, Dir6ror-- puty utr'ts(:toi.

w
j
SIGN/DAT-
NJ
a&,\o.\Jr-
l

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