Presentation eudract euro pres8[1]

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EudraCT Acad Med Sci 0603.ppt

Working with The Clinical Trial

EudraCT Database

Steve Hasler

EFPIA Rapporteur for EudraCT Guideline

VP, European Regulatory Operations, GSK

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Agenda

What is EudraCT?

How is it envisaged that it will be used?

What information is to be included?

Key outstanding issues

How does EudraCT link with EudraVigilance CT?

Progress, Plans and Next steps

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What is EudraCT? Register of all clinical trials being conducted in the EU

Database contains information on each clinical trial– Content

– Commencement

– Termination

– Inspections

Facilitates communication on these clinical trials

Enables authorities’ oversight of clinical trials and IMPs

Provides enhanced protection of clinical trial subjects receiving IMPs

Required by Directive 2001/20/EC

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Detailed Description of EudraCT

Detailed Guidance on the European Clinical Trials Database (EudraCT Database)

– ENTR/6421/01; Draft 5.3, July 2002– ENTR/F2/BL D(2003); Final, April 2003

Content– User Requirements– High level principles governing use of database

identification of the clinical trial identification of the product data entry procedures, etc

– Proposed EudraCT data requirements– Data Flow Diagram (in draft guideline only)

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EudraCT - Clinical Trials Database Draft V02

MS/CASponsor

KEY

Paper/Electronic Submissions

MS/CA interaction with Quarantine Area

MS/CA, EMEA & EC interaction/reporting with EudraCT

RA Secure Network

Internet WEB Registering

MS/CA * 15

EC

EMEA

Qu

arantin

e Area

Internet

EudraCT Data Flow Diagram

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Sponsor Registers with System

SponsorRegisters

with System

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Sponsor Registers with System

Access Control Mechanism– Security from unauthorised access

– Authentication of submitted information

Provides access to Quarantine Area

User Account Management likely to be delegated to Sponsors

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Sponsor Obtains EudraCT Number

SponsorRegisters

with System

SponsorObtains

EudraCTNumber

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Sponsor Obtains EudraCT Number

May be obtained up to one year in advance

Obtained with either– Full set of data, or

– Limited set of information

Limited information set– Trial identification

– Sponsor identification

– Information on the Investigational Medical Product Detail required to be defined

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Sponsor Submits Full EudraCT Data for 1st Member State

SponsorRegisters

with System

SponsorObtains

EudraCTNumber

SponsorSubmits Full

EudraCTData

for 1st MS

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Sponsor Submits Full EudraCT Data for 1st Member State

Subset of data required for Competent Authority (CA) application form

Each CT must be identified in EudraCT before CA assesses application

Submitted data resides in Quarantine Area– Visible to sponsor, CAs, EMEA, Eur Commission

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Information to be included in EudraCT Form (1)

Trial Identification

Sponsor Identification

Applicant Identification

Information on the IMP (test or reference)

Information on Placebo

Site responsible for IMP Release– Manufacturer or Importer

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Information to be included in EudraCT Form (2)

General information on the Trial

Population of Trial Subjects

Proposed Clinical Trial Sites– Investigators

– Central Technical Facilities

Ethics Committee in Member State

Originator of Data

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SponsorRegisters

with System

SponsorObtains

EudraCTNumber

SponsorSubmits Full

EudraCTData

for 1st MS

Sponsor SubmitsFull EudraCT

Data for 2nd MS

EudraCTData Residesin Quarantine

Area

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Sponsor Submits Full EudraCT Data for 2nd Member State

Common data automatically made available by system

Sponsor inputs data which is different for 2nd Member State

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SponsorRegisters

with System

SponsorObtains

EudraCTNumber

SponsorSubmits Full

EudraCTData

for 1st MS

Sponsor SubmitsFull EudraCT

Data for 2nd MS

Sponsor UpdatesData Prior toCompetentAuthority

Submission

EudraCTData Residesin Quarantine

Area

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Sponsor Updates DataPrior to Competent Authority

SubmissionSponsor Completes Ethics

Committee SubmissionForm on Web

Sponsor CompletesCompetent Authority

Submission Form on Web

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Sponsor Completes Submission Forms on Web

EudraCT data is subset of data required for– CA submission form

– EC submission form

System allows completion of submission forms– Full form for Competent Authorities

– Post Form for Ethics Committees

Automated population of forms with data submitted by sponsor

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Sponsor Updates DataPrior to Competent Authority

SubmissionSponsor Completes Ethics

Committee SubmissionForm on Web

Sponsor CompletesCompetent Authority

Submission Form on Web

CAs ValidateSubmitted

Form againstContent inEudraCT

Sponsor Submits Formwith Application toEthics Committee

SponsorPrintsCopy

Sponsor SubmitsForms with

Application toCompetentAuthorities

SponsorPrintsCopy

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CA Validates Submitted Form Administrative check that fields are complete

– Fields are complete

– Fields contain appropriate information

– Information is same on form and in system

Corrections to data may be requested

Incomplete or inaccurate data may invalidate request to conduct a clinical trial

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Form AgainstContent

In EudraCT

1st CA MovesData FromQuarantine

Area toDatabase

Copy of DataVisible to

Sponsor inQuarantine

Area

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Copy of Data Visible to Sponsor inQuarantine Area

Locked file

Viewable by sponsor and CAs/EMEA/Eur Commission

Sponsor may print or download electronic copy

Sponsor can no longer modify data in Quarantine Area

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Form AgainstContent

In EudraCT

1st CA MovesData FromQuarantine

Area toDatabase



Area



Area

2nd CAMoves Data

fromQuarantine

Area toDatabase

CA CompletesData on

Review ofApplicationin Database

SponsorCompletesRequired

Informationin Amendment

Area ofQuarantine

Area

SponsorCompletes

AmendmentForm

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SponsorCompletes

AmendmentForm

CA ValidatesSubmitted

FormAgainst

Content inEudraCT

CA UpdatesData in

Database



Area

CA UpdatesAmendmentsto Protocolor RequestSection ofDatabase

Sponsor InformsCA of End of

Trial

CA UpdatesEnd of

Trial Infoin DatabaseCopy of Data

Visible toSponsor inQuarantine

Area?

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Further Information Required

At or after trial initiation– Dates of initiation, amendment and end of trial

– Inspection details (completed by Member State Inspectorate)

Clinical Trial Sites Manufacturer or Importer of IMP

Unclear whether these details are viewable by sponsors

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Additional Requirements

Staff responsible for data entry to be suitably trained

To have Standard Operating Procedures available to them

Quality Control and Assurance procedures to be in place to verify

– accuracy of data

– integrity of data entry

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Key Outstanding Issues

User Manuals and “How to” Documents

Sponsors to be assured on system usability, confidentiality, user support arrangements, system availability, system stability and system bandwidth

Transitional arrangements

Reports to be generated from EudraCT

Building and piloting of database

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What is EudraVigilance CT? Database of SUSARs on IMPs for trials being carried

out in EU

Facilitates review and safety of use of IMPs in these clinical trials

Facilitates communication between authorities

Enables authorities’ oversight of clinical trials and IMPs

Provides enhanced protection of clinical trial subjects receiving IMPs

Required by Directive 2001/20/EC

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Data Entry to EudraVigilance CT? 2 Options

– web interface minimal IT cost People for data entry

– structured electronic file £££s Automated data entry

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Link between SUSAR Database and EudraCT

EV CT EudraCT

Adverse Events submitted to SUSAR database (EudraVigilance CT) need to be referenced to an investigational product

Information on investigational products is contained in EudraCT

EudraCT and SUSAR database share clinical trial, product and sponsor i.d. as common fields

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EMEA Progress (1)

EMEA have agreed to set up a Joint Working Team for EudraCT

EMEA have established a Joint Working Team for EudraVigilance CT

– First meeting was in mid May

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EudraCT Joint Working GroupProposed Remit from EFPIA Perspective

Business process design and implementation

Ensure needs of clinical trial sponsors are represented

Assess EudraCT design and implementation– confidentiality, security, accessibility, usability,

stability, availability …

Input to “User Guide”

Pilot EudraCT in advance of full implementation, if possible

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EMEA Progress (2)

EudraCT design being progressed by consultants

Design to be finalised and agreed in May 2003

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EudraCT - Current Issues

EMEA have indicated that they have insufficient IT budget to build EudraCT

System design is budgeted and will continue– May 2003 completion

Further progress beyond May unclear

If EudraCT does not exist on 1 May 2004– unclear how EMEA will support CT Directive

requirement for this database

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Questions

[email protected]

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