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Business & Decision Life Sciences Handling non-standardized questionnaires Anne-Sophie Bekx 13 October 2014. FDA TA Initiative Project Plan. Scope Include the development and implementation of TA standards to support the regulatory review process for drugs and biologics Objectives - PowerPoint PPT Presentation

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Page 1: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

Business & Decision Life Sciences

Handling non-standardized questionnairesAnne-Sophie Bekx

13 October 2014

Page 2: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

Introduction

CDISC Questionnaire Supplements

SF36: An example

Conclusion

Page 3: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

FDA TA Initiative Project Plan

• Scope– Include the development and

implementation of TA standards to support the regulatory review process for drugs and biologics

• Objectives– Establish and implement FDA’s

requirements– Use an open and transparent process– Express TA requirements in sustainable

standards– Implement in guidance

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm287408.htm

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm287408.htm
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm287408.htm
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm287408.htm
Page 4: FDA TA Initiative Project Plan

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CFAST Therapeutic Area Standards

Page 5: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

CFAST Working Plan – May 2014

20122011 2013

Alzheimerv1.0 Pain

Tuberculosis

Parkinson’sDisease

Virology

201420122013

Polycystic Kidney Disease

AlzheimerV2.0

Asthma

Diabetes

Multiple Sclerosis

v1.0

Cardiovascular Endpoints

QT Studies

Dyslipidemia

Influenza

Hepatitis C

Schizophrenia

Traumatic Brain Injury

Diabetic Nephropathy

Breast Cancer

COPD

Cardiovascular Imaging (Echo)

2015

Rheumatoid Arthritis

Solid Organ Transplant

Post-Menopausal Osteoporosis

Oncology v2.0

Tuberculosis v2.0

Psoriasis

Major Depressive

Disorder

Parkinson’sDisease v2.0

Maintenance Update

Duchenne Muscular

Dystrophy

Oncology v3.0

Irritable Bowel Syndrome

Skin and Skin Structure Infections

Complicated UTIs

HIV

Cardiovascular v3.0

Oncology v4.0

Maintenance Update

2016

Published prior to CFAST

CFAST Project pipeline

Candidates to be scheduled but subject to change

Page 6: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

CFAST Program overview – July 2014

http://www.cdisc.org/therapeutic

http://www.cdisc.org/therapeutic
http://www.cdisc.org/therapeutic
Page 7: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

Enhanced Standards Development Process

Page 8: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

What is CDISC SHARE?

http://www.cdisc.org/cdisc-share

• Shared Health and Research Electronic Library

• SHARE is a global electronic repository for developing, integrating and accessing CDISC standards metadata in electronic format

• Share exists of 4 releases:– R1: Machine-Readable Standards (Q1 2014)– R2: SHARE Concept Model (Q4 2014)– R3: End-to-End Standards Model (Q4 2015)– R4: Multiple Concept Systems (Q4 2016)

http://www.cdisc.org/cdisc-share
http://www.cdisc.org/cdisc-share
Page 9: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

Introduction

CDISC Questionnaire Supplements

SF36: An example

Conclusion

Page 10: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

Therapeutic Area User Guide:1. CDASH domains/variables2. SDTM domains/variables

3. Associated Questionnaires4. Associated CT

CDASHSDTM

Implementation Guide

QuestionnaireControlled

Terminology

Page 11: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

BDLS involvement

• BDLS has 3 members involved in the creation of Questionnaire Supplements to SDTM

• 4 questionnaires have been developed and submitted to the CDISC QS sub-team:

– Generalized Anxiety Disorder (GAD-7)– Fibromyalgia Impact Questionnaire (FIQR)– Hospital Anxiety and Depression Scale (HADS)– Neuropathic Pain Scale (NPS)

Page 12: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

CDISC Questionnaire Supplements

Page 13: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

Questionnaire Naming Rules

Page 14: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

Controlled Terminology

Page 15: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

Introduction

CDISC Questionnaire Supplements

SF36: An example

Conclusion

Page 16: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

SF36: An example

Page 17: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

SF36: An example

Page 18: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

SF36: An example

QSTESTCD: SF360202 QSTEST: SF3602-Gen Health Compared to 1 Year Ago

QSTESTCD: SF360203QSTEST: SF3602-Vigorous Activities

QSTESTCD: SF360204QSTEST: SF3602-Moderate Activities

QSTESTCD: SF360205QSTEST: SF3602-Lifting or Carrying Groceries

QSTESTCD: SF360206QSTEST: SF3602-Climbing Flights of Stairs

Page 19: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

SF36: An example

STUDYID USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN VISITNUM VISIT QSDTC QSDY

XXX-YYY XXXYYY001 1 SF360201 SF3602-General Health SF-36V2 HEALTH SURVEY EXCELLENT 1 1 1 VISIT 1 2014-01-01 1

XXX-YYY XXXYYY001 2 SF360202 SF3602-Gen Health Compared to 1 Year Ago SF-36V2 HEALTH SURVEY ABOUT THE SAME AS ONE

YEAR AGO 3 3 1 VISIT 1 2014-01-01 1

XXX-YYY XXXYYY001 3 SF360203 SF3602-Vigorous Activities SF-36V2 HEALTH SURVEY NO, NOT LIMITED AT ALL 3 3 1 VISIT 1 2014-01-01 1

XXX-YYY XXXYYY001 4 SF360204 SF3602-Moderate Activities SF-36V2 HEALTH SURVEY NO, NOT LIMITED AT ALL 3 3 1 VISIT 1 2014-01-01 1

XXX-YYY XXXYYY001 5 SF360205 SF3602-Lifting or Carrying Groceries SF-36V2 HEALTH SURVEY NO, NOT LIMITED AT ALL 3 3 1 VISIT 1 2014-01-01 1

XXX-YYY XXXYYY001 6 SF360206 SF3602-Climbing Flights of Stairs SF-36V2 HEALTH SURVEY NO, NOT LIMITED AT ALL 3 3 1 VISIT 1 2014-01-01 1

Page 20: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

Introduction

CDISC Questionnaire Supplements

SF36: An example

Conclusion

Page 21: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

Conclusion

• The unavailability of a QS supplement to the SDTMIG complicates standardization

• SDTM philosophy to be applied

• Following the general naming rules published by CDISC will ensure QS data is:

– SDTM-compliant– Of high-quality– As consistent as possible with future QS supplement releases

Page 22: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

Thank you for your attention.Join us for a coffee at our stand.

London, United Kingdom, 13 OCT 2014

Page 23: FDA TA Initiative Project Plan

Restricted © Business & Decision Life Sciences 2014 All rights reserved.

Business & Decision Life SciencesSint-Lambertusstraat - 141 rue Saint-Lambert

B-1200 BrusselsT: +32 2 774 11 00 F: +32 2 774 11 99

[email protected]://www.businessdecision-lifesciences.com/

Anne-Sophie Bekx| Line Manager Data Standards | T. 0032 2.774.11.00 | [email protected]

mailto:[email protected]
http://www.businessdecision-lifesciences.com/
mailto:[email protected]

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