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19th Annual DIA CDM Symposium & Exhibition 200419th Annual DIA CDM Symposium & Exhibition 2004

Clinical Data Management Personnel:The Evolution of Roles and Skills in a Small CRO

Clinical Data Management Personnel:The Evolution of Roles and Skills in a Small CRO

C. Michael BaileyProject Manager

Department of Clinical Data Management and Statistical ServicesBiotechnical Services, Inc.

C. Michael BaileyProject Manager

Department of Clinical Data Management and Statistical ServicesBiotechnical Services, Inc.


ObjectivesObjectives

The Evolution of Roles and Skills ofClinical Data Management PersonnelThe Evolution of Roles and Skills of

Clinical Data Management Personnel

Assembling A Clinical Data ManagementDepartment from Scratch

Assembling A Clinical Data ManagementDepartment from Scratch



• A “Subatomic” Structure of a Clinical DataManagement Department

• Exegeses That Stimulated Staff Expansion

• Value ( neé Necessity ) of Cross-training ClinicalData Management Personnel

• Potential New Functions for Clinical DataManagement and its Personnel

• A “Subatomic” Structure of a Clinical DataManagement Department

• Exegeses That Stimulated Staff Expansion

• Value ( neé Necessity ) of Cross-training ClinicalData Management Personnel

• Potential New Functions for Clinical DataManagement and its Personnel

From our experiences we should beable to recognize:From our experiences we should beable to recognize:



• Beginning

• Evolution

• Adaptation

• Beginning

• Evolution

• Adaptation

These Objectives Will be Framed by OurExperiences Over the Past Ten Years…These Objectives Will be Framed by OurExperiences Over the Past Ten Years…


BeginningBeginning

How Does A Pharmaceutical CRO find aHome in Little Rock, Arkansas?How Does A Pharmaceutical CRO find aHome in Little Rock, Arkansas?

By Importing theTalent, of CourseBy Importing theTalent, of Course


• Established by a Biochemist / Toxicologistwith Pharma Experience

• Originally Specialized in RegulatoryDocumentation

• Eventually expanded into QualityAssurance and Clinical Data Management

• Established by a Biochemist / Toxicologistwith Pharma Experience

• Originally Specialized in RegulatoryDocumentation

• Eventually expanded into QualityAssurance and Clinical Data Management

Company BeginningsCompany Beginnings

BeginningBeginning


• Core Personnel Came From Existing Staff

— Biologist / Medical Writer— Statistician

• A Senior Manager was Hired

• First Projects were Salvage, RetrospectiveEfforts…Which led to…

• Prospective Studies

• Core Personnel Came From Existing Staff

— Biologist / Medical Writer— Statistician

• A Senior Manager was Hired

• First Projects were Salvage, RetrospectiveEfforts…Which led to…

• Prospective Studies

Clinical Data Management DepartmentClinical Data Management Department

BeginningBeginning


• Original Hard Copy and Working Photocopy

• Basic Data Review (no specifications)

• Manual Data Clarification Forms

• Medical & Data Review Performed bySponsor

• Organizational Free-for-All

• Original Hard Copy and Working Photocopy

• Basic Data Review (no specifications)

• Manual Data Clarification Forms

• Medical & Data Review Performed bySponsor

• Organizational Free-for-All

Process…Process…

BeginningBeginning


• SAS Database Platform

• Pre - 21 CRF Part 11 Specifications

• Data Entry Through SAS FS Edit

• Medical and Therapy Vocabularies in HardCopy

• SAS Database Platform

• Pre - 21 CRF Part 11 Specifications

• Data Entry Through SAS FS Edit

• Medical and Therapy Vocabularies in HardCopy

Technology…Technology…

BeginningBeginning


It is not necessary to change. Survival is notmandatory…—W. Edwards Deming

It is not necessary to change. Survival is notmandatory…—W. Edwards Deming

Evolution Evolution


Evolution Evolution

Clinical Data Management EvolutionClinical Data Management Evolution

Clinical Data Management Staff Expanded

— Non-Statistician Programmers— Medical Personnel— Data Personnel

Clinical Data Management Staff Expanded

— Non-Statistician Programmers— Medical Personnel— Data Personnel


Clinical Data Management EvolutionClinical Data Management Evolution

Duties Defined and Expanded

— Project Managers— Data Managers— Medical Managers— Programming

Duties Defined and Expanded

— Project Managers— Data Managers— Medical Managers— Programming

CrossTrainingCross

Training

Evolution Evolution


Process …Process …

• In-House Medical and Data ReviewGuidelines Implemented

• 21 CFR Part 11 Documentation Implemented

• Data Edit Catalog Developed

• Data Clarification System Implemented

• In-House Medical and Data ReviewGuidelines Implemented

• 21 CFR Part 11 Documentation Implemented

• Data Edit Catalog Developed

• Data Clarification System Implemented

Evolution Evolution


Technology…Technology…

• Streamlined Programming Processes

─ CRF Tracking

─ Entry Screens

─ DCF System

• Automated Vocabulary Systems

• 21 CFR Part 11 / Validation

• Streamlined Programming Processes

─ CRF Tracking

─ Entry Screens

─ DCF System

• Automated Vocabulary Systems

• 21 CFR Part 11 / Validation

IntegratedIntegrated

Evolution Evolution


Progress has not followed a straightascending line, but a spiral with rhythms ofprogress and retrogression, of evolution anddissolution.—Johannn Wolfgang Von Goethe

Progress has not followed a straightascending line, but a spiral with rhythms ofprogress and retrogression, of evolution anddissolution.—Johannn Wolfgang Von Goethe

AdaptationAdaptation


• Is Needs-based

• Uses Newly Developed Skills Efficiently

• Benefits from Cross-Trained Personnel

• Provides additional professionalopportunities and Department Expansion

• Is Needs-based

• Uses Newly Developed Skills Efficiently

• Benefits from Cross-Trained Personnel

• Provides additional professionalopportunities and Department Expansion

Clinical Data Management AdaptationClinical Data Management Adaptation




• QC/QA-related Services

• Ancillary Services

• QC/QA-related Services

• Ancillary Services

Clinical Data Management AdaptationClinical Data Management Adaptation


• Software and Process Validation

• Quality Assurance Services

• Monitoring

• AE Surveillance Services

• Software and Process Validation

• Quality Assurance Services

• Monitoring

• AE Surveillance Services

QC/QA Services Derived from ClinicalData Management Include:

QC/QA Services Derived from ClinicalData Management Include:




• Medical Vocabulary Application

• Data Screening Paradigms

• Stand Alone Statistical Services

• Clinical Study Report Preparation

• Medical Vocabulary Application

• Data Screening Paradigms

• Stand Alone Statistical Services

• Clinical Study Report Preparation

Ancillary Services Derived from ClinicalData Management Include:

Ancillary Services Derived from ClinicalData Management Include:


Lately it occurs to me what a long, strangetrip it’s been.—Jerry Garcia

Lately it occurs to me what a long, strangetrip it’s been.—Jerry Garcia


• Cross-train Staff

• Keep Staff Small

• Motivation for Innovation

• Cultivate Alternate Services

• Anticipate More Evolution

• Cross-train Staff

• Keep Staff Small

• Motivation for Innovation

• Cultivate Alternate Services

• Anticipate More Evolution

Final Thoughts...Final Thoughts...

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Clinical Data Management Personnel: The Evolution of …biotechnicalservices.com/downloads/downloads/BSI - Clinical Data... · Clinical Data Management Personnel: The Evolution of