New Role Models for the EDC Study Team

Training, workflow and service provision

DTI Conference Centre

1st November 2005

Emma BanksDatatrial Limited

Aims

To discuss the potential evolution of roles

Examine workflow

Discuss the need for front end standards

So what’s new?

Roles

Service Quality

Process

People

EDC system

Conventional Roles

Clinical Project Manager

Clinical Trial Administration

Clinical monitoring

Clinical data management

Statistics

EDC Roles

Clinical monitoring

Clinical Monitoring / clinical data management

Clinical Trial Administration / Clinical data management /

Clinical Project Management

Helpdesk

Software and process trainers

Statistics

Do roles need to change?

Clinical monitoring

Clinical monitoring / Clinical data management

Clinical Trial Administration / Study operations manager / Clinical

data management

Will a merging of these roles help?

Helpdesk – who does this?

Software and process trainers – how and when, by who?

Statistics – has it changed?

New EDC Roles

Clinical trial administration and clinical data management

and / or Clinical monitoring and clinical data management:

Is this viable as a standard?

How are companies structured?

What are the training needs?

What happens to the technical skills that reside within CDM?

Clinical Research Associate

Key skills

Specific clinical knowledge, assisting sites in applying for

ethical approval, negotiating, liaison with the investigator and

site staff, ensuring adherence to the protocol, source data

verification, query management, some data management,

planning and time management

Clinical Research Associate and Clinical Data Manager

Key skills

Specific clinical knowledge, assisting sites in applying for

ethical approval, negotiating, liaison with the investigator and

site staff, ensuring adherence to the protocol, source data

verification, query management, significant data management,

planning and time management

Clinical Trial Administrator and Clinical Data Manager

Key skills

Understanding and training in the clinical trial process,

protocol development, recruitment and reporting, drug

supplies and logistics, data capture process, data reporting

requirements, project management

Management of the study requirements rather than ‘doing’ the

job

Technical Data Manager

Key skills

eCRF design, database development, validation check

programming, data import and export

Helpdesk

Key skills

Technical software knowledge, study understanding and

ability to assist with software and clinical issues

Assume helpdesk is more than one tier and comes through

Technical and goes onto Operations eg CDM, CRA, CTA

Training

Key skills

Technical and end user understanding of software, good

delivery methods, cost effective refresher training, real

hands on experience of the system in use and the issues

a site may have

Statistics

Key skills

Trial and protocol understanding, control over data

access and data mining during the course of the study,

protocol deviation review, improved data quality, fraud

detection, reduced patient numbers?

Do we need standard roles for EDC?

Are the conventional skill divisions enough?

Or are they too much?

Redundancy

Re-aligning

Are we being objective when ‘re-structuring’ for EDC?

What about training needs?

Role Overlap

Clinical Data Management

Training

HelpdeskClinical monitor

Clinical Trial management

Workflow

Roles

Service Quality

Process

People

EDC system

Workflow and Process System independent?

Simple?

Complex?

Standards across systems?

Standard functionality?

Standard terminology?

We expect sites to be experts on many systems however, we would

rarely expect this of a data manager!

Common workflow elementsSet-Up

2UAT

(end user)

3Feedback

1eCRF designValidation check specification and programming

Common workflow elementsProcessing

1Data

capture and

preliminary

cleaning

5Data

amendment/updateAddition of new data

4CDM stepQueriesCoding

SAE handling

2Source Data Verification

CRA queries

3Investigator sign

off

6No further changes requiredDatabase

lock

Training

Roles

Service Quality

Process

People

EDC system

Training

Which people require training?

Delivery?

Buy in?

Who does it?

When?

Refresher training required?

Support

Helpdesk provision?

Technical and operational support?

Data

Clinical

Data managers / CTAs / CRAs?

Service and Quality

Roles

Service Quality

Process

People

EDC system

Service and Quality Who are your customers?

Can standards affect service provision?

Efficiency

Cost

Quality improved?

Data reporting efficiency?

Clinical team e.g. metrics, recruitment

Statistics e.g. protocol deviations, safety summaries

What is the ideal? Increased efficiency across all functions

High standard of service and quality

Clear objectives for training and support

Expedited reporting and efficient use of trial numbers

Are these all equal?

Which is most important?

How do we achieve this?

EDC Standards

Role evolution

Standard workflow

Standard terminology

High quality training and support

The reality………………

emma.banks@datatrial.com