Sr Director Standards Development

Joined April 2009
27 Photos and videos
The CDISC Working Group Meeting (WGM) is underway in Silver Spring, MD! (1st one in 3 years?) The Lab CT team and SEND teams are meeting. @CDISC
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The CDISC Working Group Meeting (WGM) is underway in Silver Spring, MD! (1st one since Covid) It’s a beautiful day for data standards! @CDISC
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Attention Non-clinical data enthusiasts! Next Wednesday, the FDA will host a broadcast of key SEND topics (open to the public). Come see where SEND development is today! Visit the CDISC website for details: lnkd.in/gsHTK3uV #cleardataclearimpact #SEND @CDISC @PHUSETwitta
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Lou Ann Kramer retweeted
The fish were tasked to “drive” the vehicle towards a visual target in the terrestrial environment, which was observable through the walls of the tank. Indeed, the goldfish were able to explore the terrestrial environment, all while avoiding dead-ends and correcting inaccuracies.
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Join the CDISC SEND team in a public meeting hosted by FDA, November 3. Hear about the next major release of SEND, discuss the new SEND Scope section of the Technical Conformance Guide, and hear from our CDISC Japan users! #cleardataclearimpact #CDISC tinyurl.com/SENDF2F

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Lou Ann Kramer retweeted
Was notified last night, that my little brother, Dylan Merola, who was just deployed for over a week, was one of the casualties of the Kabul Airport attack. The news is starting to release his name as the 14th military member to pass away. RIP and say hey to dad & grandma for me
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Lou Ann Kramer retweeted
After the car accident in 2018, one of the things Robin Miller did was send me this Sprint Car and Midget magazine with a note on the front. I had no idea what I’d find when opening to page 52 but he was right. It was good medicine to read about his craziness. Here’s a few pages
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CDISC SEND Team has been so busy! Public Comment for the 4th rules catalog (SEND Rules v4.0), including DART Rules started yesterday: bit.ly/4SENDRulesDRFT. Also, 30-March released: SEND IG v3.1.1 (bit.ly/SENDIGs) and SEND Rules v3.0 (bit.ly/SENDRules). @CDISC

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Are you wondering what is happening with SEND development, CDER/OCS or the FDA OBI/eDATA team? Please join the FDA hosted public meeting during the SEND team's Spring Virtual Meetings this Wednesday! Agenda and connections here: bit.ly/3ebufAn

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Lou Ann Kramer retweeted
12 Apr 2021
fda.gov/media/103587/downloa… FDA Validator Rules v1.5 released

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Inspired by a 16y.o. with Cerebral Palsy - way to do something truly great, @Nike! [from me & my sister who has CP!]
Nike has unveiled their first hands-free shoe: the Nike GO FlyEase.
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In case you didn't see this earlier! FDA Invitation to the Fit for Use Pilot Program - CDISC Standard for Exchange of Nonclinical Data Implementation Guide Developmental and Reproductive Toxicology : Version 1.1 govinfo.gov/app/details/FR-2… #CDISC #ClearDataClearImpact

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Please join us tomorrow, 21-October from 9 - Noon ET to hear FDA updates on the use of SEND in reviews, the use of the define.xml file, updates from OBI/eData and even a SEND update from the PMDA! @CDISC #cleardataclearimpact #SEND #FDA #PMDA cdisc.org/newsletter/iss

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Lou Ann Kramer retweeted
It’s a real privilege to announce @CDISC is partnering with @Microsoft to build the next generation #metadata repository for clinical research #standards. cdisc.org/news/cdisc-and-mic…

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Lou Ann Kramer retweeted
14 May 2020
Reminder! Public Review for SDTMIG v3.4, SDTM v2.0, Conformance Rules v1.2 closes 1 June. CDISC values your input and wants to hear from you! cdisc.org/public-review/sdtm… #cleardataclearimpact.

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Lou Ann Kramer retweeted
30 Apr 2020
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Here are our folks, Ron and Lois Kramer, participating in my dear neighbor, Laurel Hardisty’s, “Root’n Toot’n Honking Happy Birthday Party” this afternoon. Laurel (Sue Nigh’s dad) turned 94 today and his friends… instagram.com/p/B_IcdqqBdmG/…

So many tragedies but they must be shared. #COVID19Pandemic #StopTheSpread
Lou Ann Kramer retweeted
Proud of the @cdisc volunteers and staff working to rapidly build and deploy clinical data standards for #COVID19 #coronavirus #cureforcoronavirus
27 Mar 2020
CDISC Launches Task Force to Rapidly Develop Standards for COVID-19 CDISC Standards Supporting the Research Community during an Unprecedented Time ow.ly/XhiV50yXuVP #cleardataclearimpact
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