Welcome Address & State of the CDISC Union
Dave Evans, CDISC President and CEO
COVID-19 Registry Japan（COVIREGI-JP）
Dr. Norio Ohmagari, Director, Disease Control and Prevention Center, National Center for Global Health and Medicine, Japan
1. What was the biggest obstacle in building the registry?
2. How do you think the registry should be used in the future?
3. What do you think should be the future use of registries, and if you were to create one, what would you keep in mind?
State of CDISC Standards
Bess LeRoy, CDISC Head of Standards Development
CDISC 360 Update
Peter Van Reusel, CDISC Chief Standards Officer
CDISC Library Update
Anthony Chow, CDISC Director of Data Science
1.You mentioned executable conformance rules as a part of the CORE initiative. What do you mean by that?
2. Can you describe the general process for signing up a CDISC Library account?
3. How many more releases do you plan to do this year?
The CDASH eCRF Portal
Alana St. Clair, CDISC Project Manager
Dr. Yuki Ando and Daisuke Iwata, PMDA
2. Is there a timeline for when the PMDA will accept submissions according to SDTM IG 3.3?
3. As of 01-Apr-2020 submissions to the PDMA require submissions in the CDISC Standards. What did PDMA experience after one year of submissions in the CDISC Standards, like efficiency gains etc. What can PMDA recommend to other authorities?
4. Does PMDA still require standard units in SI units (and only SI units)?
5. How does currently authorities/regulators work on cross collaborations/discussions among themselves? Do we see in future such forum where data standards differences will be discussed and resolved to make such vision/dream reality?
6. From when (approx time) ADaM v1.1 data package is recommended to get submitted?
Enhancement of the Role of Clinical Programming in the Age of CDISC
Yasutaka Moriguchi and Natsumi Kawase, GlaxoSmithKline K.K.
2. Presenters explained 7 discussion points in the presentation. Which one does presenter find particularly difficult?
3. In Page 18, presenter explained 6 examples of CDISC data flows. Does presenter still have an experience of such a variety of data flows?
Simplifying the Integration Riddle
Arvind Sri Krishna Mani, Zifo RnD Solutions
Submitting Data with Japanese Characters to PMDA: The UTF-8 and Other Encodings Discussion
Dr. Jozef Aerts, XML4Pharma
2. You mentioned APIs and RESTful web services. How would these be useful to regulatory authorities such as PMDA?
3. Could we also use simple UTF-8 encoded CVS instead of SAS Transport?
The Age Old Problem: A Discussion of Age Derivation and Imputation Techniques
Will Greenway and Joel Clarke, Quanticate International Ltd.
2. On the month and day imputation, you showed data for 3 countries: USA, UK and Japan, did you analyse other countries and did you spot any differences?
3. Would your recommendation of SAS function change for paediatric studies?
Dr. Frank Pétavy, Head of Methodology, European Medicines Agency
2. How can people participate in the Data Strategy Workshop?
3. Recently, we heard the announcement that EMA’s new Clinical Trials Information System passed the audit and will be launched in January next year. Will some of the Data Standards you were mentioning earlier, be already implemented to the CTIS at the moment of launch?
4. If data standards are to be implemented to EMA’s CTIS, will there be a transition period for this implementation? In what degree the changes might affect the submissions as they are done today?
Study Data Standards and COVID-19
Helena Sviglin, FDA CDER
CDER's Experience with ADaM Traceability Assessment and Common Data Quality Issues
Jesse Anderson, FDA CDER
1. So far in your experience with data packages that CDER has received, how often do basic things like keeping the sequence variable for SDTM and ADaM, is this done regularly?
Utilizing CDISC SEND Data to Generate Historical Control Incidence from a Large Database of Toxicology Studies
William Houser, Bristol Myers Squibb / BioCelerate
Create the Define.XML v2.1 with Python
Hengwei Liu, Daiichi Sankyo, Inc.
1.Compared with other programming language, what advantage does Python have in creating the define.xml?
2. This presentation discussed the creation of define.xml for ADaM. Can the same approach be used to create the define.xml for SDTM?
3. If a programming team wants to use the approach in this presentation to create the define.xml, how to design the data specifications for the ADaM datasets?
Yiyuan Ma, Sanofi
Use Cases Report on Integrated Analysis and Legacy Data Conversion
Miu Susuki, JCROA
1.For which group and when were these cases collected?
2. Are there any other cases of clinical pharmacology?
3. Were there any cases related to the version upgrade of Pinnacle21 Community?
Challenges in Submitting CDISC Datasets to Multiple Regulatory Agencies: Toward a New Stage of Standards
Hiroshi Haneji, Sanofi, JPMA
Gap Analysis of CDISC Standards Implementation in Academia and CDISC-Annotated CRF Repository in Japan (AMED project)
Dr. Toshiki I. Saito, NHO Nagoya Medical Center
2. Is academia only user for the aCRF.jp
3. Can pharmaceutical company or CRO can ask to upload their annotated CRF?
2. How would you suggest that someone unfamiliar with CDISC standards start to learn about CDISC standards?
3. Was there a big difference in the way that industry TAUG team members and Academic TAUG team members collected data?
Peter Van Reusal
Questions in PowerPoint