CDISC Draft Pain Standard for Public Review and Comment
Period - Comments Due Monday, 30 March 2012
This draft Pain Therapeutic Area User Guide supplements the Study Data Tabulation Model
Implementation Guide (SDTMIG) v. 3.1.2 with recommended standards for the submission of data from
Pain-related clinical trials. The user guide was prepared by the Analgesic Clinical Trial Translations
Innovations, Opportunities, and Networks (ACTTION) with participation from volunteer members of
the Submissions Data Standards (SDS) team of the Clinical Data Interchange Standards Consortium
(CDISC). It is intended to guide the organization, structure, and format of standard Pain clinical trial
tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration
(FDA).
The mission of the Pain Data Standards initiative is to create a foundation for future research aligned
with the FDA Critical Path Initiative and supported by the ACTTION public-private partnership. The
User Guide covers the use of Pain instruments (.i.e. Questionnaires) and publically available Pain
concepts mainly specified as efficacy data.
This is the first version of Pain Standards by ACTTION and CDISC, so it is expected that there will be
gaps and areas for further development. To this end the CDISC requests that the clinical research
community review these proposed standards and submit comments for further improvement and
development. Reviewers are encouraged to model these standards with test data and provide detailed
feedback on what did and did not work.
The Pain Standard User Guide references 16 Pain related instruments commonly used in Pain clinical
trials. Each instrument has its own detailed documentation, since it could also be used in other
Therapeutic Areas. These instruments have been modeled on, and work in concert with, existing SDTM
QS domain constructs. To assist the Questionnaire document review, also included are the SDTM
annotated CRF’s. The controlled terminology for the Questionnaires will be included in NCI EVS in
late March.. In addition, there is a new provisional Physiology domain for Nervous System Findings in
which the general pain concepts are populated. This provisional domain will be going out separately for
public review shortly via the CDISC Submission Data Standards team new domain development process
and a broadcast release announcement will be made when comments are addressed.
There is one Comment Form for comments regarding the Pain User Guide and all 16 Pain
Instruments. Please be sure to complete all columns so we can reference your comment. Please do not
add additional columns to the spreadsheet during your review. We will be combining all comments into
one spreadsheet.
Pain Standard User Guide and Questionnaire Review Package 2012-03-03 (zip file)
Pain Questionnaire Annotated CRF Package (zip file)
Pain Standard Comments Spreadsheet (XLS)
Please send all comments to cdiscreviewcomments@cdisc.org by Monday, 30 March 2012. Please
ensure that you put “CDISC Pain Standard Comments” in the subject line of your email. Comments from
many different review packages are all sent to this website. We want to be able to identify the Pain
Standards comments from all others.
List of Pain Standard Questionnaires v1.0
Questionnaire Name
Version Copyright Approved Status
Brief Pain Inventory-Interference Scale (BPI-I)
Brief Pain Inventory-Interference Scale - Short Form (BPI-I)
Clinical Global Inpression (CGI)
Columbia Suicide Severity Rating Scale: Baseline (CSSRS-BSL)
v1.0
v1.0
v1.0
v1.0
Copyright Approved
Copyright Approved
Public Domain
Copyright Approved
Current Opioid Misuse Measure (COMM)
Euroqol (European Quality of Life) Five Dimension three level scale (EQ-5D-3L)
v1.0
v1.0
Copyright Approved
Copyright Not Approved
Faces Pain Scale – Revised (FPS-R)
v1.0
Copyright Approved
Hamilton Depression Rating Scale 17-Item (HAMD 17)
Karnofsky Performance Scale
McGill Pain Questionnaire (Short-Form) MPQ 2
Screener and Opioid Assessment for Patients with Pain (SOAPP-R)
v1.0
v1.0
v1.0
v1.0
v1.0
v1.0
v1.0
Public Domain
Public Domain
Copyright Approved
Public Domain
Copyright Not Approved
Public Domain
Copyright Approved
Short Form 36 health survey standard, US Version 1.0 (SF36 v1.0 Standard)
v1.0
Copyright Not Approved
Michigan Neuropathy Screening Instrument (MNSI)
Mini Mental Scale (MMSE)
Roland-Morris Disability Questionnaire (RDQ)
Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SH) v1.0
Public Domain