1 / 23

FDA TA Initiative Project Plan

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

maryam-ryan
Download Presentation

FDA TA Initiative Project Plan

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Business & Decision Life SciencesHandling non-standardized questionnairesAnne-Sophie Bekx13 October 2014

  2. 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

  3. CFAST Therapeutic Area Standards

  4. CFAST Working Plan – May 2014 2012 2011 Virology Parkinson’s Disease Tuberculosis 20122013 2015 2014 2016 2013 Pain Maintenance Update Published prior to CFAST CFAST Project pipeline Oncology v4.0 Maintenance Update Candidates to be scheduled but subject to change Cardiovascular Imaging (Echo) Cardiovascular v3.0 Parkinson’s Disease v2.0 COPD HIV Major Depressive Disorder Breast Cancer Complicated UTIs Psoriasis Diabetic Nephropathy QT Studies Skin and Skin Structure Infections Tuberculosis v2.0 Cardiovascular Endpoints Traumatic Brain Injury Oncology v2.0 Irritable Bowel Syndrome Multiple Sclerosis v1.0 Schizophrenia Post-Menopausal Osteoporosis Hepatitis C Oncology v3.0 Solid Organ Transplant Diabetes Influenza Polycystic Kidney Disease Duchenne Muscular Dystrophy Alzheimer v1.0 Dyslipidemia Rheumatoid Arthritis Asthma Alzheimer V2.0

  5. CFAST Program overview – July 2014 http://www.cdisc.org/therapeutic

  6. Enhanced Standards Development Process

  7. Whatis CDISC SHARE? • Shared Health and Research ElectronicLibrary • 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

  8. CDASH ControlledTerminology SDTM Implementation Guide Questionnaire Therapeutic Area User Guide: CDASH domains/variables SDTM domains/variables Associated Questionnaires Associated CT

  9. BDLS involvement • BDLS has 3 membersinvolved in the creationof Questionnaire Supplementsto 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)

  10. CDISC Questionnaire Supplements

  11. Questionnaire Naming Rules

  12. Controlled Terminology

  13. SF36: An example

  14. SF36: An example

  15. SF36: An example QSTESTCD: SF360202 QSTEST: SF3602-Gen Health Compared to 1 Year Ago QSTESTCD: SF360203 QSTEST: SF3602-Vigorous Activities QSTESTCD: SF360204 QSTEST: SF3602-Moderate Activities QSTESTCD: SF360205 QSTEST: SF3602-Lifting or Carrying Groceries QSTESTCD: SF360206 QSTEST: SF3602-Climbing Flights of Stairs

  16. SF36: An example

  17. Conclusion • The unavailability of a QS supplement to the SDTMIG complicatesstandardization • SDTM philosophyto beapplied • Following the generalnamingrulespublished by CDISC willensure QS data is: • SDTM-compliant • Of high-quality • As consistent as possible with future QS supplement releases

  18. Thank you for your attention. Join us for a coffee at our stand.London, United Kingdom, 13 OCT 2014

  19. Anne-Sophie Bekx| Line Manager Data Standards | T. 0032 2.774.11.00 | anne-sophie.bekx@businessdecision.com Business & Decision Life Sciences Sint-Lambertusstraat - 141 rue Saint-Lambert B-1200 Brussels T: +32 2 774 11 00 F: +32 2 774 11 99 lifesciences@businessdecision.com http://www.businessdecision-lifesciences.com/

More Related