Difference between revisions of "Nonclinical Study Data Reviewers Guide"

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[https://www.phuse.eu/css-deliverables '''Click here to access the current Nonclinical SDRG Package''']   
 
[https://www.phuse.eu/css-deliverables '''Click here to access the current Nonclinical SDRG Package''']   
  
The Nonclinical SDRG package has been developed to comply with the FDA's [http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf Study Data Technical Conformance Guide]<br />
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The Nonclinical SDRG package has been developed to comply with the FDA's Study Data Technical Conformance Guide.  The current version of this document can be found at the website: [https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources FDA Data Standards Resources]
  
 
Learn more about Nonclinical Topics Working Group of the PhUSE Computational Sciences Symposium, and its other projects @[[Nonclinical Topics Working Group]].  
 
Learn more about Nonclinical Topics Working Group of the PhUSE Computational Sciences Symposium, and its other projects @[[Nonclinical Topics Working Group]].  
 
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<br />
  
=Current Work - Spring 2019=
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=Current Work - Summer 2019=
The team is exploring ways to improve Section 5, for reporting validation issues.  FDA Reviewers have agreed to help us by giving their feedback on several questions developed by our group.  The questions are:<br />
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===Improving Section 5. Data Standards Validation Rules, Versions, and Conformance Issues===
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FDA Reviewers have given feedback on questions from the nSDRG team. Click Here to read the questions and answers: [[nSDRG Section 5 Q&A with FDA]]<br />
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===Identifying Location of Study Endpoints in SEND Datasets===
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FDA has asked the nsdrg team about ways to help reviewers identify the location of the endpoints found in the study report in the SEND datasets. The nsdrg team is currently brainstorming for efficient ways to address this need, considering impact on sections 4.1 and 6.2.<br />
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===nsdrg in XML as a future format?===
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The Optimizing the Use of Data Standards working group has a project developing the csdrg and adrg in .xml format: [https://www.phusewiki.org/wiki/index.php?title=Data_Reviewer%27s_Guide_in_XML Data Reviewer Guide in XML].  Mike Hamidi, a co-lead on this project presented their work and the possibility to do same for nsdrg in mid 2020.  The nsdrg team is considering the opportunities, impacts and benefits of developing a nonclinical deliverable.<br />
  
'nsdrg Questions for FDA regarding Section 5 - Data Standards Validation Rules, Versions, and Conformance Issues<br />
 
 
# What kinds of information do Reviewers find useful in this section?
 
# Do you expect that explanations of issues in section 5, when impacting data content are referenced or further explained in the dataset explanations  (section 4.2) ?
 
# Are there some examples of what has been seen in nsdrg and considered “too technical”? (in messages or explanations of validation issues.) 
 
# Should all validation issues be described in this section, including those determined to be “false”? (false = errors or warnings that result from bugs in Pinnacle 21 Community or other validators that may be used.  Some examples of common rule breaks that are false in nature:  Errors:  DD0059, DD0028, DD0024, DD0064. Warnings:  FDAN037, FDAN169, FDAN212, FDAN218, FDAN341, DD0029, PCO497.)
 
# Are there particular domains which need special consideration regarding the handling of conformance issues (such as MI and Tumor data – where there are a lot (14) of business rules)?
 
# Do people who do “data loading” use the nsdrg?
 
# Is the FDA tracking validation rule violations by quantity and/or rule ID? Are trends emerging to suggest certain rules could be either A) impractical for companies to adhere to, or B) too vague in meaning. For example, high variety of explanations could indicate wide misunderstanding of the rule or its application.
 
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Stay tuned for information on what we learn!
 
  
 
=Purpose=
 
=Purpose=
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== Conference Calls and Minutes ==
 
== Conference Calls and Minutes ==
[[Nonclinical SDRG pilot project meeting minutes]]
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nsdrg team meeting minutes are maintained in the PhUSE Project Team Space open to team members.
  
 
=Presentations=  
 
=Presentations=  

Latest revision as of 14:34, 15 August 2019


Welcome the Nonclinical Study Data Reviewers Guide project Wiki!
The nSDRG package has been developed by this team and is available for public use:

  • Nonclinical Study Data Reviewers Guide - TEMPLATE
  • Nonclinical SDRG Guide with recommendations on how to use the template
  • Sample Nonclinical SDRG's developed by team members

Click here to access the current Nonclinical SDRG Package

The Nonclinical SDRG package has been developed to comply with the FDA's Study Data Technical Conformance Guide. The current version of this document can be found at the website: FDA Data Standards Resources

Learn more about Nonclinical Topics Working Group of the PhUSE Computational Sciences Symposium, and its other projects @Nonclinical Topics Working Group.

Current Work - Summer 2019

Improving Section 5. Data Standards Validation Rules, Versions, and Conformance Issues


FDA Reviewers have given feedback on questions from the nSDRG team. Click Here to read the questions and answers: nSDRG Section 5 Q&A with FDA

Identifying Location of Study Endpoints in SEND Datasets

FDA has asked the nsdrg team about ways to help reviewers identify the location of the endpoints found in the study report in the SEND datasets. The nsdrg team is currently brainstorming for efficient ways to address this need, considering impact on sections 4.1 and 6.2.

nsdrg in XML as a future format?

The Optimizing the Use of Data Standards working group has a project developing the csdrg and adrg in .xml format: Data Reviewer Guide in XML. Mike Hamidi, a co-lead on this project presented their work and the possibility to do same for nsdrg in mid 2020. The nsdrg team is considering the opportunities, impacts and benefits of developing a nonclinical deliverable.


Purpose

Our team continues to work to:

  • maintain the Nonclinical Study Data Reviewers Guide (nSDRG), based on FDA's Technical Conformance Guide and any public feedback
  • provide guidance on "best practices" for creating nSDRG
  • compare with anticipated potential requirements from other regulatory authorities
  • maintain alignment with the cSDRG, maintained by Optimizing the Use of Data Standards Working Group for Clinical Studies


Got a question?

The SEND Implementation Forum is a great place to ask questions and get answers! If you have a question on nSDRG, feel free to post it HERE on the FORUM, and your question will be answered by SEND experienced folks in the PhUSE community.

Overview and Scope

Preparation of a Study Data Reviewer’s Guide (SDRG) is recommended as an integral part of a CDISC standards-compliant study data submission. The challenge is to operationalize this new documentation requirement efficiently and effectively.
Challenges we seek to answer with this project:

  • Provide a practical template for easy access and use
  • Provide guidance document which describes expected content and options to guide nonclinical SDRG authors.
  • Provide authors with examples, describing how to handle different data situations with SDRG content.

Things we expect to learn along the way:

  • Exploration of ways to generate the nonclinical SDRG and who should do the job.
  • The SDRG is expected to be useful by FDA reviewers. Can it also be useful for other nonclinical study stakeholders?
  • Will the SDRG evolve as systems and processes gain expertise in the new SEND requirements for submission of nonclinical data?


Current Published nSDRG Package

The current package is available here, for public use.

This link will bring you to the PhUSE Deliverables page for PhUSE documents referenced by Regulatory guidances. Scroll to mid-page to see the Nonclinical Study Data Reviewers' Guide guideline and template.

The nSDRG team continues to monitor FDA's Technical Conformance Guide updates (which occur 2X per year, expected in MAR and OCT) and also public comments received from users of nSDRG. As these new inputs are evaluated, we will post answers in the SEND Implementation Forum, and update the published documents as needed. Stay tuned for update announcements.

Project Team

Name Role Organization E-mail
Susan DeHaven Co-Lead, pharma Sanofi susan.dehaven@sanofi.com
Debra.Oetzman Co-Lead, software vendor Instem debra.oetzman@instem.com
Cathy Roy Team member Merck catherine.roy@merck.com
Daniel Potenta Team member PDS Lifesciences dan.potenta@pdslifesciences.com
Christy Kubin Team member Charles River Laboratories Christy.kubin@crl.com
Haley Wulff Team member Basinc leickhoff@basinc.com
Linda Hunt Team member Merck linda.hunt@merck.com
Lindsy Eickhoff Team member Basinc leickhoff@basinc.com
Nicola Robertson Team member GSK nicola.j.robertson@gsk.com
Jack Baker Team member Covance Jack.Baker@covance.com
Jennifer Feldmann Team member Instem jennifer.feldmann@instem.com
Patricia Brundage Team member FDA patricia.brundage@fda.hhs.gov
Paul Brown Team member US FDA paul.brown@fda.hhs.gov
Rick Thompson Team member J&J RThompso@its.jnj.com
Steve Polley Team member GSK steven.r.polley@gsk.com
Susie Lendal Antvorskov Team member Data Standards Decisions slendal@datastandardsdecisions.com
Tania Smith Team member Covance tania.strimple@Covance.com
William Houser Team member BMS william.houser@bms.com

Plans

Project objectives:

  • Implement the versioning process agreed upon with PhUSE
  • Review and adapt as needed, comments provided by FDA or Public Review
  • Establish ongoing maintenance process
  • Better address Section 6 for Legacy Data Conversion
  • Review, and adapt as needed, to periodic revisions of Technical Conformance Guide
  • Develop new example studies for new types included in SEND 3.1
  • Maintain alignment with Clinical version

Next Meeting

We meet biweekly on Thurs at 11am Eastern time.
To be invited, please contact: Debra Oetzman or Susan DeHaven
You will be welcomed!

Conference Calls and Minutes

nsdrg team meeting minutes are maintained in the PhUSE Project Team Space open to team members.

Presentations

Maintaining the Clinical & Nonclinical Study Data Reviewers Guides CSS 2018 Workshop

Call for Members

People likely interested in our topic: Toxicologists, Data managers preparing SEND data sets, Nonclinical study reviewers (FDA, Sponsor or other), relevant software vendors. What is the commitment?

  • Time will vary with a minimum of 1 hour, every 2 weeks for meeting attendance + 1-2 hours between for authoring, reviewing and assessing outcomes.
  • Attendance to the PHUSE Computational Sciences Symposium conference is not required.

If you would like to participate, please contact one of the Project Co-leads.


Working Documents

Next Version

Nonclinical SDRG Template and Guide - Working documents for next release

Review Comments Tracker

Archive

2015 PhUSE Public Review: Nonclinical SDRG Template and Guide - Drafts for Public PhUSE Review Retired WIKI page for cSDRG and nSDRG - documents now maintained on PhUSE Website for Deliverables