Introduction of new standards and Governance Structurearchive.opengroup.org/public/member/proceedings/q411b/... · Increased IVRS use (Project 2) C Forecasting & inventory mngmt concept

- an OCM exercise

Introduction of new standards and Governance Structure

Author: BHSQ • Approved by: HNR • Version 1.0 The Open Group Sweden Conference , November 2011 Slide 2

Agenda

Short Introduction to NNIT

The Pharmaceutical Business Segment

Architectures in Clinical Development

NNIT Process Vision

Case Story – Introducing New Standards & Governance

The Approach

Governance & OCM

Conclusion

Questions


Short Introduction to NNIT


How does NNIT fit into the IT world?

LOCAL

INTERNATIONAL

CONSULTANCY SUPPLIER

Large international producers of software and/or hardware

Traditional large international IT consultancies

Local, Danish or Scandinavian niche producers of software and/or hardware

Local, Danish or Scandinavian IT consultancies


TOGAF9 is the foundation - relation to NNIT‟s offerings

Enterprise business processes

Map processes to systems

Enterprise business processes

Workflow architecture

Organisational strategy

Middleware & scheduling architecture

Gap analysis

Application principles Transition architecture

Capability assessment

Implementation governance model

Scoping

Compliance assessment

Risk management

Development and deployment guidance

Project estimation and planning


The Pharmaceutical Business Segment


The pharmaceutical segment

The Financial Crisis poses great challenges for all industries. Further pharma specific issues include:

Declining productivity of research & development

Long Development Timelines

Regulatory Compliance

General Risk Adverseness

Generic competition – as patents run out on Blockbusters

Uncertain future reimbursement for new products and technologies

Poor public opinion towards the industry

“Global pharmaceutical sales are expected to reach $1.1 trillion in 2014” (Reuters)


Architectures in Clinical Development


Is Clinical Development Special??

Methods for Determining Vaccine Efficacy and Effectiveness and the Main Barriers to Developing a Fully Deployable Malaria Vaccine Caterina Guinovart* and Pedro L. Alonso, NCBI

http://www.ncbi.nlm.nih.gov/books/NBK1693/


Business Architecture (Level 2)

SITE INVENTORY MANAGEMENT

Res. MgtDBRLPLV

PROTOCOL DEVELOPMENT

Final CDP Final Protocol

RECRUITMENT STRATEGY

STATISTICAL DATA HANDLING & ANALYSIS

MONITORING

DATA ADMINISTRATION

CDP DEVELOPMENT

SITE SELECTION &INITIATION

Initiate site

selection *3

TRIAL PRODUCT DESIGN

Final Site

Selection

Technology

Provisioning

HA/EC

submission /

approval

Investigator /

monitor

meeting

EDC Training

3* Assessment of:a. Investigator & Staffb. Resources at sitec. Of patient pop. and recruit. strategyd. Of laboratory facilities Assessment ofe. EDCf. Infrastructureg. Payment / budgeth. Regulatory requirements & ethics

5*a. Trial site & staff assessmentb. Review subject status & recruitmentc. Adverse Event review & follow-upd. Review protocol adherence / Review entered CRF Datae. Review informed consent proceduref. Disc. review, correction & handlingg. Assess supplies & storage conditionh. Perform drug accountabilityi. Review laboratory proceduresj. Check investigator trial filek. Perform SDV

1*Update IMPACT databaseInput to EudraCT databasePrepare in-house agreement

4*Revied Entered CRF dataReview Subject status & recruitmentDiscrepency Review

2*StudygroupInt. Study GroupInvestigators

IVRS Training

Site Initiation

REPORTING

Initiate

programming

and validation

Stat. analysis

(Simulated)

Stat. analysis

(blinded)

Initiate SAP

Evaluate and

provide feed-back

to SAP (EOT)

EOT based on

simulated data

Stat. analysis

(un-blinded)

Results

MeetingICTR

Publication

EOT (Tables,

Figures, Listings)

Submission

datasets

Exploratory

results

Explore, visualize and drill down in

data

SUBJECT & DRUG MANAGEMENT

Drug

DispensingDrug Returns

Screen Failure

RandomizationDrug

Reconciliation

NO

PATIENT RECRUITMENT

Subject

Screening

Manage / modify

recruitment strategy

Action

required ?

Monitor

Recruitment

No Action

VALIDATION PLAN & TRIAL SET-UP

Define TVP review

process and

validation strategyCreate TVP

Create

Database/

eCRF

Prioritize all

checks

Approve TVP

TVP

Setup Standard

& Trial specific

validation

Annotation

reviewProduce

Annotation

User

Acceptance

test

Annotations

Generate

simulated data

(optional)

Transfer

blinded data

Transfer un-

blinded data

Prepare statistical

analysis instance

for final run

IVRS SET-UP

Draft IVRS

URS

Vendor

specifications

Vendor Build

& Validates

System Test

System Go

Live

Protocol

Design

Research

1st draft of

protocol *1

Peer Review

(checklist) &

SG review *2

Second draft

of protocolISG Review

Final Draft

Identify CROs QC Check

Prepere,

Review and

Finalise CDP

Final Dose

Form

Final Pack

Design

Label

Approval

INVESTIGATIONAL PRODUCT PRODUCTION

Calculate Bulk

Forecast

Optain CDP /

Protocol

Calculate

Packaged

forecast

Manufacture

Packaged

Product

Manufacture

Bulk

Source

Comparators

Label product

WAREHOUSE / DEPOT INVENTORY MGMTRaise Drug

Shipment

Request

Check

Warehouse

Inventory

stock level

below

trigger?

Packaged

stock

available?

No

Yes Pick, Pack

and Ship

Raise Drug

Shipment

Request

Check Site

Inventory

Pick, Pack

and Ship

Is stock

level below

trigger ?

Yes

CDP Design

Research

Define

Milestones

TRIAL & RESOURCE MANAGEMENT

Demand

setting

Ressource

Supply

Project

Review

Portfolio

review

Time

Reporting

FTE & Cost

follow-up

Adjustment of

templates

EOT based on

”fake” randomized

data

Evaluate and

provide feed-back

to SAP (EOT)

Write, review and

approve ICTR or

publication

Request

eCRFs for

D&D cases

Generate

eCRF for D&D

Include

eCRFs in

Submission

Define and

Enter Trial

Meta data

No

Yes

Yes

NO

DATA ENTRY & VALIDATION

Contact Site

CRF Ddata

Lock

Evaluate +

Plan Visit *4

Conduct Site

Visit *5

Protocol

deviation form

Corrective

action

required?

Site Visit

Required

Document Site

Visit &

Deviations

Follow up after

site visitNO

NO

Yes

Yes

SITE CLOSURE

Send to Ethics

Committees

Final Protocol

Enter eCRF

data

Enter SAE

data

Load External

Data

Manage online

edit checks

Manage off-line

validations

Execute /

Manage Manual

checks

Medical coding

C

Stock / Site

inventory

Create

electronic

CRF Archives

Close Study

Site

PRC

Send to Local

Health

Authorities

Send Protocol

to affiliates

Revise Trial

Data Set-upA

Green Light

A&BA A

DATABASE RELEASE

Sign Database

release

DBR

Meeting

SAE

Reconsiliation

DATA REVIEWConduct data

review (ITM,

DM, Stats,

MW) Alert Data

ManagementUnlock data

Plan Data

Review

Data Issues

Review

Protocol

deviationsNO

YesC

Plan DBR

Assign

Subjects to trial

populations

Database/

eCRF

Map to CDW

Prepare pCRF for

AE and pregnancy

follow-up

If applicable. Provide

pCRFs for AE and

pregnancy follow-up

Un-blinding

Review eCRF

1st request for

essential documents

for ICTR

2nd request for

essential documents

for ICTR

Trial Set-up

(Impact)

Initiate statistical

data handling &

decisions

Transfer Data

B

Close IVRS

Finalise

programming

and validation

Finalise statistical

data handling &

decisions

Final

SAP

Protocol / Planning (456 & 589) Forecasting / Ordering (456) Packaging Packaging Synopsis Distribution Specifications Distribution Shipping Order Trial Master File

Trial Management

Ongoing Resource allocation

Global

recruitment

strategy

Country

recruitment

strategy

Regional

recruitment

strategy

Site

recruitment

strategy

Final ICTR

Withdrawels

FPFV


Segmentation across the entire landscape

= GxP-validated systems

= Non-GxP systems


Organisational Architecture (Roles & Depts) Tasks

1. Prepare CDP

2. Prepare Investigators Brochure

3. Prepare protocols

5. Site Initiation

6. Patient Recruit-ment

7. Treatment period

8. Conduct data manage-ment

9. Conduct Statistical Analysis

10. Prepare ICTR

11. Prepare reports and publica-tions

Draft CDP available

Final CDP available Draft protocol available

Final protocol available First subject in

Last subject in

Last subject out Database release

Analysis complete

Reports complete

Project plan, resource demand and supply

Time reporting, analysis and reporting

4. Prepare data management / statistical analysis

People & Skills

Culture and Behaviour

CSO /

CSCo /

IVRS

Designer

LTM /

Monitor /

Site support

Investigator

/ Site personnel

DM

Stat

Medical

Writer

Key changes in Department interfaces

Forecasting (Project 2)

Formal clinical supply strategy

IVRS decision tree / mngt process (Project 2)

IVRS design standards (Project 2

Forecasting guidelines and inventory models to ooptimize inventory levels (Project 2

Standardization (Project 2)

More structure in planning and management activities (Project 2

Efficiency and quality of service provided (Project 2)

N

C

N

N

C

PVP /

GPT /

ITM

Standardization (All) Front-loading of tasks

(Project 3 + Project 1) Early decision making

(Project 3 + Project 1) Compliance / lead-

times (All) Visibility of demand

(Project 4) Feed-back loop /

continues learning (Project 4)

Project 4 Concept Project 1 concept IVRS concept Mngt reporting

(Project 3 + Project 4 BW)

Demand setting (Project 4)

Project and portfolio review process (Project 4)

Availability of CDP in timely manner for supplies planning & Project 1 frontloading (Project 2 + Project 1)

Project 1 usage decision (Project 1)

Resource allocation (Types and timing for Project 1 trials (Project 1)

Changed process for CDP design research (Project 3)

N C Time reporting Resource analysis /

continues learning (Project 4)

N Availability of protocol in timely manner for supplies planning (Project 2)

IVRS decision tree / mngt process (Project 2)

Changed process for protocol design research (Project 3)

Early update of plans with key dates for Project 1 (Project 1)

C

N

N

C

Changed process for IB design research (Project 3)

C Optimal subject recruitment levels (Project 2)

Enhanced possibilities in monitoring enrolment display of patient levels at different sites (Project 2, Project 1, CSW)

C

Changed process for inventory management and drug accountability on IVRS trials (Project 2)

C


Front loading of tasks (Project 1)

Investigator / Site interaction (Project 1)

Ongoing tasks (Project 1)

Split of remote vs. onsite tasks (Project 1)

Potential change of the monitor role (Project 1)

Project 1 concept and tool (Project 1)

Increased IVRS use (Project 2)

Forecasting & inventory mngmt concept (Project 2)

IVRS Tool (Project 2)

C

C

C

Site Project 1 feasibility check (Project 1)

Set-up and training of site users (Project 1)

N

N

Enhanced possibilities in monitoring enrolment status (Project 2, Project 1, CSW)

C

C Remote data monitoring / review (Project 1)

Change in archiving process (Project 1)

Changed process for CRF tracking (Project 1)

N

C

C

• Use of Project 1 tool and frontloading of tasks; early data and ongoing review/cleaning (Project 1)

• Stop of paper CRF collection, resupplies, scanning to eSubmission (Project 1)

• Reduce day-to-day site inventory mgmt (Project 2)

C

From paper to more electronic tools (IVRS, Project 1)

IVRS concept and tool (Project 2)

Project 1 Concept and tool (Project 1)

Site Project 1 feasibility check (Project 1)

Set-up and training of site users (Project 1)

Formalised use of IVRS to manage subject recruitment levels (Project 2)

Use of Project 1 tool for data capture & query resolution (Project 1)

Dispensing calls to manage site inventory (IVRS) Safety data collection possible through Project 1

rather than faxing (Project 1)

N

N

N

N

N

C

S

Earlier timing of trial set-up components, and decision making; eg. quality excp, how to handle and act on deviations etc.(Project 1)

N

C


Front loading of tasks (Project 1)

Ongoing tasks (Project 1)

Project and portfolio review process - managers (Project 4)

C




C


C

Earlier and ongoing data cleaning and validation (Project 1)

Changed process for CRF tracking (Project 1) Changed process for medical coding (Project

1) Changed process for SAE Reconciliation

(Project 3)

Changed process and deliverables for DBR incl. shortened time span from LPLV to DBR (Project 3+Project 1)

DW Adm. Standardization Bridging DM and Stat

New role

N

C

C

C

Earlier timing of trial / DB set-up components, and decision making (Project 1) N C

Enter design trial data before FPFV (Project 3)

Administration of Project 3 and availability of data (simulated data, blinded data, un-blinded data, frozen data snap-shots)

N N

Standardization (Project 1+Project 3)

More analysis / interpretation (Project 3)

Front loading of tasks (Project 1+Project 3)



Early creation of SAP (Project 1 + Project 3) Earlier and ongoing data review and analysis. Earlier

confirmation of data quality (Project 1 + Project 3)

N N

Earlier and ongoing data review. Earlier confirmation of data quality (Project 1+Project 3)

N

Less programming, table look-up and validations (Project 3)

Fewer request for programming (Project 3) Use of new standard tables and standard

reports (Project 3) More time for analysis and interpretations

(Project 3)

C

C

N

N

Trial management, review groups, Project 1 set-up resp. unit, CSO/CSCo: Alignment of CDP, Protocol to ensure Supply planning (Project 2) and Project 1 frontloading (Project 1)


C


C

Trail mngmt, DM, Stat: Interaction and work pattern in trial and DB set-up (Project 1)

LTM/Monitor, Investigator: Site interaction and work-pattern (Project 1, Project 2)

Monitor, DM, DW adm, Stat, MW: Interaction and work pattern in data cleaning, review, confirmation of quality, access and analysis (Project 3+Project 1)

N

Time reporting N

Time reporting N

Time reporting N

Time reporting N

Time reporting N

Time reporting N

Mindset & Skills

C

Electronic archiving (Project 1)

N

Earlier completion of final ITCR (Project 1 + Project 3)

C Standardization

(Project 1) Front loading of tasks

(Project 1) Ongoing tasks (Project

1)


= New task

= Changed task C

N

Earlier process for site selection (Project 1)

Early update of plans with key dates for Project 1 (Project 1)

Set-up mapping to Project 3 before FPFV (Project 3)

IVRS data standards

N

N


NNIT – EA and Pharma

Pharmaceutical Companies are also starting to embrace Enterprise Architecture However, traditionally a strong segmentation of the organisations have meant that smaller and often isolated architectures have been developed An internal push for Pharma Companies to start initiatives covering the entire business vertical as well as horizontal is observed A desire to spend an ever-decreasing IT budget on value-adding initiatives instead of maintenance supports the push


Gartner – Enterprise Architecture Focus


Setting the direction

Photo: Glassmerchant, UK, blog.TravelPod.com


NNIT Process Vision


The three levels that should be perfected

Ease Cost

Business benefits

Technology

Processes

Definitions


Definitions

The basic things, that must be in order

Culture (Governance , Project, Compliance, etc)

Standards

Meta and master data

Data models

Data exchange formats

Naming conventions

Ownership

Authoring – what application owns what data

Processes

Strategies (IT, business)

Technology

Processes

Definitions


Processes

Departmental collaboration and sharing of data

Access to data (global), enabling fastest possible actions

Local and global operating procedures – fit to each other

Governance model

Process descriptions and reporting

Streamlining, optimisation, procedural flexibility

Technology

Processes

Definitions


Technology (vision)

Plug and play applications

SOA environment

Clinical Portals for internal and external people

Real-time reporting of trial status and progress

Efficient and feedback based simulations of trial situations

Technology

Processes

Definitions


In

ho

use

Ou

tso

urced

Present clinical application architecture

CTMS• Generate and maintain non-subject trial

data e.g. trials, countries, sites,

investigators,

• Generate subject visit schedules

• Generate enrolment forecasts, milestones

and monitoring & treatment progress

reports

• Verify source data (pCRF)

• Track CRF pages (pCRF)

• Report screen failure/reason

• Track and report site activation

• Generate enrolment report

• Report withdrawal/reason

• Green light, Supplies strategy

• Site Activation

EDC• Design electronic CRFs

• Design database for clinical data

• Manage eCRF data entry and review

• Manage and track data discrepancies

• Verify source data

• Record investigator approval of eCRF data

• Capture screen failure & withdrawals

• Collect key efficacy data for interim

analysis

• Capture SAEs

• Track eCRF pages

Clinical Supply

Chain• Manage product data and bills of

materials

• Manage inventory and raw materials

• Generate randomisation schedule codes

• Manage clinical packaging orders

IVRS• Unblinding – (IPS via IVRS)

• Randomize subjects

• Calculate dose for dispensing

• Maintain drug inventory

• Maintain drug status

• Capture screen failure & withdrawals

• Productive – site visit dates

(investigator)

CDMS• Design database for clinical data

• Manage pCRF data entry and review

• Track missing pCRF pages (pCRF)

• Edit check data and resolve queries

• Load and range check external data

• Code AEs, SAEs, concomitant

medications & medical history

• Investigate Information-amended CRF

pages

• Check range and consistency in patient

identifiers/visit dates

External Data• Laboratory data

• ECG data

• Electronic patient diary data

• CRO Patient Load

Safety• Capture SAEs (eCRF)

• Enter SAE data from CIOMS (pCRF)

• Code SAEs

• Record and track safety cases

• Query and analyse safety data

• Report pharmacovigilence information to

regulatory authorities

CIOMS Data• SAE information from

pCRF studies

External

Packaging

Facility/local

depots

• Fax

Resource Portfolio

Management

Project tool• Maintain project plans

• Define time budgeting structure

ERP system• Highlight supply/demand

resource gaps to support review

process

• Record actual time & resource utilisation.

• Allocate costs

• Project &

building blocks

• Resources

EDMS• Store, retrieve and track regulatory

documents

• Manage document versioning and

change control

• Support publishing and electronic submissions to authorities

• Provide document search capabilities

• Initial shipment request (manual)

• Re-supply requests (manual)

• Shipment details

Clinical Data

Warehouse

Data Warehouse• Handle Clinical and Operational data

• Handle study metadata

• Reconcile SAEs

SCE• Handle and analyse statistical data

• Calculate statistically derived

parameters

• Define study populations

• Conduct statistical analysis and

reporting

• Maintain std. program library

• Patient Demographic data (eCRF)

• Clinical Data (eCRF)

• Site Number (eCRF)

• Box/lot dispensed*

• End of trial enrolment

notification (pCRF + eCRF)

• Screen failures (pCRF + eCRF)

* Subject to drug + batch accountability

discussion

• Trial identification data

• Site monitor and investigator details

• Site activation notification

• Shipping Address

• Green Light Date

• Supplies Strategy per clinic

• End of trial enrolment notification

(screening)

• End of trial randomization notification

(LPFV)

• Screen failures, codes + dates (pCRF)

• Withdrawals, codes + dates (pCRF)

• Patient Identifiers, visit dates, DoB, Gender

(+ other data recorded today)


• Site address details

• Initial shipment request (manual)

• Re-supply requests (manual)

• Randomization

schedule & codes

• Shipment

details


• Site & investigator details

• KPI data

• Protocol deviations (NTF &

analyses)

• Study data tabulation model

(manual)

• SAEs for reconciliation

• Database annotation Doc

• Data handling plan

• DM SAEs for reconciliation

• Patient Demographic Data

• Cleaned Clinical Data

• Captured SAEs

(eCRF, from EDC)

•Trial data


• Site & investigator details

• Subject Information

• Box #, Lot #, RAN #

• Treatment group

• DoB

• Straticification

• Withdrawals (pCRF + eCRF)

• New subject enrolment (eCRF)

• Subject Completion


• KPI Data

Clinical Trial

Disclosure

Clinical Portal


Protocol

Design•Clinical and Study metadata

•Study design standards

•Study

design

standards

•Study

design

•Study

design

•Study

design

standards


Future application architecture


Case Story – Introducing New Standards & Governance


The Approach


(Preliminary Phase) Identified and prioritised

pains and opportunities Issues and root causes Critical success factors and

enablers Benefits Specific business case areas

to develop in the planning phase

Architecture vision

Specific Roadmap and priorities

Architectures – 1st round Business case for each

opportunity for Exec Phase Relative business value,

Priorities, Dependencies Implementation plan,

Technology enablement, Risk Assessment Program management plan Standards and templates

Planning

Architectures – 2nd round Programme office Specification Vendor selection Implementation Roll-out Benefit realization OCM (change

management)

Execution

Project delivery approach (example)

The NNIT approach follows a gate-model, to ensure objectives and sponsorship for each phase are met, before starting the next


Case Story

A medium-sized pharmaceutical company initiated a pre-project together with NNIT with the scope of defining a change program for the optimisation of their clinical development by introducing a Clinical Data Warehouse (CDW) and a Statistical Computing Environment (SCE):

A preliminary phase was conducted

Overall vision for the program was formulated

High-level architectures were constructed

Business cases were developed


Data Collection Process Today

Analysis & Long List

Business Cases

Business Cases Data Collection

80 Questionnaires

45 Interviewees

383 Statements: •Duplicate •OCM •Other

Prioritisation

Mapped against: Focus Area Process Project Candidate

224 Findings

607 Statements

10 Impr. Areas

Priority Meeting

Workshop

50 Statements: •OCM


Programme Vision

Current State

HIP Vision

Short Term

Year 0-2

Long Term

Year 6… Medium Term

Year 3-5

Based on our analysis, it was at this point clear that a CDW and a SCE could only be introduced after a foundation project with the scope of introducing CDISC standards for CRF and clinical databases had been performed.

Vision


Foundation

Programme

Simplified working processes

Optimised use of clinical data

Easy sharing of data and

best practices

Clinical Data Warehouse

Standardisation

Coding Data Acquisition and Management

Statistical Computing

Environment & Data Visualisation


Standardisation Project

The project had two main tracks:

1) the actual, hands-on mapping of existing standards to the new standards (SDTM, ADaM) including the development of methods and procedures

2) the handling of the related procedural and organisational changes, ensuring the transition, and the development and introduction of standards governance, maintaining the standards.

The presentation will focus on the latter part, namely the OCM exercise, with emphasis on the implementation of a standards governance organisation.


Solution overview - Standardisation start point

Protocol CRF

Design Data

Capture

Clinical Data Base

Securing SDTM format

Implementing SDTM format

Start and end point is SDTM format

definition

Clinical Data

Warehouse

Analysis &

Reporting

Clinical Data Base

Clinical Data Base

Clinical Data Base

Clinical Data Base

Clinical Data Base

ADAM for the trials

Author: xxxx • Approved by: xxxx • Version xx INTERNAL USE ONLY Slide 32

Governance & OCM


Organisational Change Management Goals

During the project, it must be ensured that all employees and

stakeholders that either have influence on, or are impacted by,

the project, will:

Understand the impact of the project

Understand their role in the implementation of the changes to processes and structures

Support the project goals

Have commitment to help with the success of the project

Have the ability to follow the new and changed processes and procedures

Accept the changes and understand related benefits

If this is successful, there is a high chance that the desired

change in behaviour is realised after the project


Main perceived barriers - expected from stakeholders

Reduction of creativity – it‟s like working in a factory, you

take away my innovation power

Loss of power

It‟s not my problem!

Habits and „we do not have time‟


OCM Approach

Content included the following:

Scoping & Planning

Mandate from Management

Stakeholder management

Communication Principles

Procedural change mapping

Line of Business buy-in

Standards Governance

Organisational Change Mapping – Obstacles

Training setup

Learning points & Conclusion

Planning for the unexpected


Standardisation Project

Operational Performance

QA

OR

HR

Data Mgt. & Coding

Clinical DB

Medical Writing

Med Directors

Project CTMs and Directors

Med resp

Strategic Planning

Clinical Data

Division

Medical Department

XXX

Other Areas

IS/IT

Areas with impact

Pharmaco-vigilance

Clinical Operations

XXX

CRO Negotiation

Finance

Methodologies

and Clinical Data

Analysis Division

Clinical BI

Safety

Statistics

Impact Map


Governance = Clear Responsibility/Authority

Patient Data

Supply

Safety

Statistical Analysis

Trial Meta Data

Registration

Submission Data

Resource Management

Management Reporting

Non-clinical Trial Data

Clinical Trial

Manager


Governance and Standards

Governance

Continuous Improvement

Implement

Standards

Involvement in definition of standards

Strong ownership and governance of standards

Processes for maintaining and improving the standards


Principles for Standards Governance Governance Organisation must be involved right from the first draft of protocol

for all studies

Using the current version of the Standards is obligatory

Approved exceptions are allowed

Exceptions will be facilitated by the governance and appropriate tools

CDISC nomenclature and terminology (data structure and code lists) cannot be changed

All exceptions and changes have an impact and must be motivated by the requester

Processes for Exception and Change Requests must be followed, leading to „Accepted‟ or

„Rejected‟ status, ensuring minimal delay to the progress of the study


Standards Governance Organisation

SGM: Standards Governance Manager SDM: Standards Domain Manager

SDM

CRF & DB Standards

Group

SDM

Statistical Standards

Group

SDM

Protocol Standards

Group

Protocol Standards

Group

SGM

Standards Governance

Manager

SDM

Coding & PV Standards

Group

Standards Governance Committee


Resource Impact analysis

5 SGM + SDMs +

SDG

SGM Ensure

Implementation

15

Relevance / Completeness

3

SGM

Exception Request Process

Ensure exception list and

documentation is updated

17

Exception request (ER) completion

2

No

Ensure Exception list and

documentation is updated

19

Exception Needed

1

Requester

Categorization

6

Complete and document ER for further analysis

4

Yes SGM

+ SDMs

Perform Implementation

16

LoB

Approval SGM

8

No Escalation by Requester

9

SGM

Minor/ Medium

Impact analysis

7

SGC

ER handling by SGC

11 Yes

Yes ER Approval Transmission

13

Yes

No

No ER Reject transmission

14

Approval

12

To Change Request

18

Major Impact analysis

10


Conclusion


Results

Governance Processes

Protocol CRF Database Analysis Report

Standards Library

Project/Trial

Phase

Therapeutic Area

Global

Governance Reporting

Governance Organisation

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Industry maturity assessment

Basic Advanced Industry Average

AS-IS TO-BE

Vision & Strategy

Governance

Compliance

Standards

System landscape

IT Strategy

Governance Model


Observed project challenges

Implementation of a new architecture is a major task, which requires:

Strong management buy-in from the very top of the company

Shared vision and goal

Decision power

Long term plan and funding

Organisational visibility and linkage

Strong planning and governance capabilities


Its about being in control!

Definitions

Have high attention on Company Vision, Culture, Standards, Ownership of responsibilities – Clear Strategies for Change

Processes

Well defined & efficient, that produce reliable results without requiring superhuman effort!

Technology

Tools to facilitate, automate, integrate the processes, leverage the standards and allow us to use our ”human” resources to best advantage


Questions


Bjørn Hjorth-Sørensen D.Phil, MSc Principal Consultant

NNIT A/S Buddingevej 197 DK-2860 Soeborg Denmark

+45 3075 9668

[email protected] www.nnit.com

Special thanks to Henrik Nørgaard Rasmussen & Birgitte Agergaard


Always be open and honest

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Documents

Introduction of new standards and Governance Structurearchive.opengroup.org/public/member/proceedings/q411b/... · Increased IVRS use (Project 2) C Forecasting & inventory mngmt concept