JMP® Clinical: Generating Semi-Automated Patient Narratives for Regulatory Submission
See how to:
- Understand benefits of using JMP Clinical to generate patient narratives
- Customize Narratives Using Templates
- Register a study
- Explore and select subjects for narratives
- Select Adverse Event narrative template
- Specify information to include in narratives (event types, exposures, concomitant medications and medical history)
- Select findings to include in narratives
- Examine narratives
- Save narratives as MS Word files
- Generate Graphical Patient Profiles
- Examine and interpret graphical and tabular patient results
- Copy graphs and tables to narratives
- Export tables to MS Word
- Customize, select and reorder graphical information
- Save customized graphical format to Patient Profile template for reuse
NOTE: Q&A included at 28:40.
Resources
- JMP Partners who might provide JMP Clinical services, including generating templates
OtherRe: JMP® Clinical: Generating Semi-Automated Patient Narratives for Regulatory Submission@PatrickGiuliano ,
There is not a specific capability within JMP or JMP Pro that can replicate what JMP Clinical does for creating Patient Narratives except for exporting a Journal or Report in RTF which can be opened in Word.
JMP Clinical uses a combination of Velocity Template Language (VTL), Rich Text Format (RTF), JSL, SAS and Java to be able to generate the tables need to feed into a template that is a combination of VTL and RTF that is then invoked by Java. The SAS part could be completely replaced by JSL and I supposed it could also replace the VTL component. RTF files can be read by Microsoft Word and JSL would need to be written to use the formatting language to export a document/file so it could be read in programs like Microsoft Word.. There are other formats as well like OpenDocument (ODT/ODT) and I see that Office 365 can read ODT files. JSL would have to be written to create these XML based files.
With that said, I am sure one could find a way (with heavy scripting in JSL), to extract content from JMP reports, insert it into a template like framework (which could be its own file, much like what JMP Clinical does), incorporate user input, and then export as an RTF file. It would be a lot of work.
Re: JMP® Clinical: Generating Semi-Automated Patient Narratives for Regulatory Submission@ron_horne Here is a page with some resources. I noticed that one is a broken link to some stability analysis info., and I am looking into that
https://www.jmp.com/en_us/support/jmp-resources-for-pharma-biotech-industries.html
Also, this book by Rob Lievense might be of interest:
https://support.sas.com/content/dam/SAS/support/en/books/pharmaceutical-quality-by-design-using-jmp/70178_excerpt.pdf
Re: JMP® Clinical: Generating Semi-Automated Patient Narratives for Regulatory Submission@Chris_Kirchberg and @Byron_JMP , @ron_horne had a question you may be able to answer:
I am looking for a drug synergism analysis in JMP but couldn't fine any. would you be able to point me to anything on the topic? otherwise, an example in sas may also be useful.
I did see the dose response analysis example in the following link which is part of the topic: More choices for modeling nonlinear responses
Re: JMP® Clinical: Generating Semi-Automated Patient Narratives for Regulatory Submission@Chris_Kirchberg This was my first exposure to JMP Clinical, I noticed a LOT of integration and "extensibility" (for lack of a better word) with Microsoft Word (Office 365) which makes me ask the Question: Does JMP Standard (or Pro) today offer a similar capability in the context of any currently available platforms (or available add-ins)? The context for my question - this type of menu-driven specification of information and resultant compilation of that information in MS Word would be useful for example, when generating design verification/validation reports in a medical device product-development environment. In my view, generation of statistical information seamlessly into static MS Word reports is highly favored in this environment, as it is in the Clinical Life Sciences (Clinical Trials) environment. I can scrub the community myself and do some research but mainly curious from your perspective and deeper experience with the JMP Clinical product. Thanks! @PatrickGiuliano
