Transcript Study Data Standardization Plan

Study Data Standardization Plan
Kick0ff Meeting
23 July 2014
Agenda
• Introductions
• PhUSE Team Best Practice Guideline
• Overall objective – development of template
for Study Data Standardization Plan
• Relationship to Study Data Reviewers Guide?
• Development of work plan – Can we break
down the work elements?
• Next Actions/Plan for follow-up meetings
Team Members
Name
Organization
Bezek, Cathy
Blauwet, Mary Beth
Brennan, Michael
Chang, Tony
Dwyer, Kate
Fenaughty, Christine C
Hientzsch, Beate
Johnson, James
Kaufman, Laura
Kelly, Kristin
Kenny, Susan
Lozano, Jane
Naro, Nick
Russotto, Anne
Ryley, Pam
Simonsson, Linda
Astellas Pharma
Astellas Pharma
Janssen
Amgen
FDA
Pfizer
Accovion GmbH
Summit Analytical
PDS, Inc.
Accenture
Maximum Likelihood, Inc.
Lilly
Pfizer
Celgene
Takeda
I-MInd
STUDY DATA TECHNICAL CONFORMANCE GUIDE
(February 2014)
• For clinical and nonclinical studies, sponsors should include a plan (e.g., in
the IND) describing the submission of standardized study data to FDA. The
Study Data Standardization Plan (Standardization Plan) assists FDA in
identifying potential data standardization issues early in the development
program. Sponsors may also initiate discussions at the pre-IND stage. For
INDs, the Standardization Plan should be located in the general
investigational plan. The Standardization Plan should include, but is not
limited to the following:
1. List of the planned studies
2. Type of studies (e.g., phase I, II or III)
3. Study designs (e.g., parallel, cross-over, open-label extension)
4. Planned data standards, formats, and terminologies and their versions
5. List of and justification for studies that may not conform to the
standards
STUDY DATA TECHNICAL CONFORMANCE GUIDE
(February 2014)
• The Standardization Plan should be updated in
subsequent communications with FDA as the
development program expands and additional
studies are planned. The cover letter
accompanying a study data submission should
describe the extent to which the
Standardization Plan was executed.
Additional Topics
– Plan for managing pooled analyses
– Plan for conversion of legacy study datasets
– Relevant controlled terminologies (e.g., MedDRA)
and version – by study
– Any need for a controlled terminology not
addressed by current standards
– Targeted questions for FDA
– Running summary of discussions and resolutions,
meeting minutes
Study Data Reviewer’s Guide(SDRG)
• “The SDRG is intended to describe SDTM data
submitted for an individual study in Module 5
clinical section of eCTD.”
• “The SDRG purposefully duplicates
information found in other submission
documentation (e.g., protocol, clinical study
report, define.xml) in order to provide FDA
Reviewers with a single point of orientation.”
Study Data Reviewer’s Guide(SDRG)
• Introduction provides an overview and inventory of standards
used on the study.
• Protocol Description provides a brief orientation to the study
and, if necessary, additional context for trial design datasets.
• Subject Data Descriptions section provides additional context
for subject-level SDTM domains that are not adequately
documented in define.xml or the SDTM implementation guide
• The Subject Data Descriptions also describes sponsor-specific
annotated CRF conventions as needed
• Data Conformance Summary documents the validation inputs
used to evaluate SDTM conformance and summarizes
conformance findings.
Example: SDRG Descriptions of
Standards and Controlled Terminology
Version
SDTM
SDTM v1.2/SDTM IG v3.1.2 including
Amendment 1. Oncology Domains, TU,
TR, and RS, have been submitted
according to the version released for
public comment dated 30-Jan-2011
Controlled Terminology
CDISC Controlled Terminology dated 22Jul-2011 has been used for all domains
except for LB. LBTESTCD and LBTEST use
terminology from the 29-Jun-2012 CDISC
Controlled Terminology package.
Data Definitions
define.xml v1.0
Medications Dictionary
Proprietary sponsor medication dictionary
Medical Events Dictionary
MedDRA v14.1
Proposed Sub-Teams
• List of studies
– Non-clinical
– Clinical
• Plan for managing pooled analyses
• Relevant controlled terminologies (e.g., Medra) and version – by
study
• Any need for a controlled terminology not addressed by current
standards
• Targeted questions for FDA
• Running summary of discussions and resolutions, meeting minutes
• Completion Guidelines?
• Samples
Some Points to Consider
• When should the Study Data Standardization Plan
be drafted (review/approval)
• Who should coordinate and manage the Study
Data Standardization Plan
• When should the Study Data Standardization Plan
be submitted
• What triggers an updated submission of the
Study Data Standardization Plan?
• How does the Study Data Standardization Plan
relate to the drafting/approval of Study Data
Reviewers Guide?
List of the planned studies
• Can this list be created/updated once and
anticipate use in other contexts
– List of studies in IB/Annual Reports
– List of studies in NDA/BLA
• Word Template versus structured content?
Next Steps
• Draft Project Description
– Review by PhUSE Steering Committee
– Post to Wiki
• Meeting Frequency?
– Propose once a month
– Checking (call/email) every two weeks with sub-teams
• Communication within team?
• Target deadline?
– Sub-team commitement
– Project Plan – next month
Backup
eCTD Module 5 Table of Studies
Sample Non-Clinical Table Formats (IB)