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8th Summer Institute in Statistics and Modeling in Infectious Diseases

B2ap3 Large Univwa

The 8th Summer Institute in Statistics and Modeling in Infectious Diseases (SISMID 2016) will be held July 11-29, 2015 at the University of Washington in Seattle, Washington USA.

The Institute consists of a series of two-and-a-half day workshops designed to introduce infectious disease researchers to modern methods of statistical analysis and mathematical modeling and to introduce statisticians and mathematical modelers to the statistical and dynamic problems posed by modern infectious disease data. Prerequisites are minimal, and the modular nature of the Institute enables participants to design a program best suited to their backgrounds and interests. Most participants will likely take two or three modules.

Individuals attending the Institute will receive certificates of course completion in recognition of their participation.


  • University of Washington
    1410 NE Campus Parkway
    Seattle WA 98195
  •   Monday, 11 July 2016
  •   Friday, 29 July 2016
  • 8:30 AM PST - 5 PM PST
  • $750 per Member
  • Faculty Staff
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FDA/PhUSE CSS 2016 Highlights

B2ap3 Large FDA PhUSE CSS 2016 Highlights

Clindata Insight is back from attending the FDA PhUSE Computational Science Symposium (CSS) 2016, in Silver Spring, MD and we would like to share the take-home messages from this great conference.

FDA highlighted the importance of Dec 17th 2016, because all studies starting after this date must be submitted as CDISC compliant standard data.   Collen Ratiffe from FDA CDER also emphasized the importance of following the e-Study Guidance andTechnical Conformance Guide.  

 Mary Doi (Office of Computation Science - OCS, CDER) and other FDA members discussed the most common data quality issues in the NDAs received since March 2015:

  • Missing or incorrect define.xml (43%)
  • Trial design domains are missing (15%) – missing TS caused error in loading into Janus
  • EPOCH variables are missing (79%)
  • CT issues (62%)
  • Duplicate records (59%)

FDA was very pleased with what CSS has accomplished in the last 5 years. Helena Sviglin (OCS CDER) emphasized the success of the Reviewer Guide - SDRG in 2012, ADRG in 2014 and most recently NSDRG.   She reminded the audience of how important reviewer guides were in the review process and also mentioned that 38% of the 2015/16 applications were missing reviewer guides. We strongly believe and recommend that reviewer guides should be prepared along with SDTM and ADaM datasets.

Collaboration is the main theme of CSS. Below is the list of working groups, made up by FDA members and industry members. The working groups will continue to meet to work on deliverables such as Study Data Standardization Plan (SDSP), white papers and standard scripts.

  • Optimizing the Use of Data Standards
  • Development of Standard Scripts for Analysis and Programming
  • Semantic Technology
  • Emerging Trends and Technologies
  • Nonclinical Roadmap and Implementation

The CSS conference offered an invaluable opportunity to hear directly from the e-data team, OC team, clinical reviewers and statistical reviewers from CDER and CBER on how they manage and review the submission data. Peng and Kevin’s participation in CSS for the last 5 consecutive years gives us the unique advantage of helping our valued clients prepare better NDA packages and develop CDISC data strategy.

 If you would like to discuss in more details about common NDA data issues, submission readiness, CDISC implementation or CSS, please contact us at. We welcome your inputs and feedback.  

To stay connected, follow us on Twitter @clindata, WeChat @clindata, or like us on Facebook at


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New FDA Guidance on the Use of EHR Data in Prospective Clinical Trials

B2ap3 Large EHR EDC

We are very excited to see that the FDA has just released a draft guidance that consists of non-binding recommendations regarding the Use of Electronic Health Record (EHR) Data in Clinical Investigations. EHR may include patient specific data such as medical history, prior and current diagnoses, treatment plans, immunization records, pharmacy records, and various medical test or lab results.

The guidance document provided recommendations on:

  • whether and how to use EHRs as a source of data in clinical investigations
  • using EHRs that are interoperable with electronic systems supporting clinical investigations,
  • ensuring the quality and the integrity of EHR data that are collected and used as electronic source data in clinical investigations, and
  • ensuring the use of EHR data meets FDA inspection, recordkeeping and record retention requirements.

 Although this description does not establish legally enforceable responsibilities, it indicates that the organizations are preparing for an increase in the usage of EHRs and electronic systems supporting clinical investigations. The guidance document has highlighted some of the potential uses and benefits of integrating EHR into clinical investigations, including “access to real-time and longitudinal health care data for review” and the facilitation of “post-trial follow-up on patients to assess long-term safety and efficacy of medical products.”

The concept of full interoperability between EHR and Electronic Data Capture (EDC) systems is discussed and promoted as having the potential to “reduce errors in data transcription and provide data that is more accurate and complete allowing for improvement in the quality of clinical investigations and the interpretation of data.” The general assessment is that EHRs have the ability to improve multiple facets of the scientific medical process, including improvement in patient safety, data accuracy, and overall clinical trial efficiency.

While EHR systems, in general, are not considered FDA-regulated entities, when utilized as a data source for clinical trials, they should be ready for FDA on-site inspections and audits. The document makes note that EHR data should be “attributable, legible, contemporaneous, original, and accurate” following ALCOApolicy. The guide also provided best practices policy recommendations in regards to use of ONC-Certified health information technology, use of EHRs not certified by ONC, use of EHRs in clinical investigations, data modifications, audit trails, informed consent, privacy and security of data, and inspection, record-keeping, and record retention requirements.

In summary, FDA has provided much needed guidance on the use of EHR in prospective clinical investigations for human drugs, biological products, medical device and combo products for sponsors, clinical investigators and CRO’s. We see great opportunities at the convergence of EHR and EDC systems and the expanded use of rich EHR data in clinical trials to accomplish goals that are otherwise not possible.

For complete details, please read the guidance.

To stay connected, follow us on Twitter @clindata, WeChat @clindata, or like us on Facebook at

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PhUSE Metadata Repositories

B2ap3 Large Phuse


Metadata Repositories – Promises and Realities


The Pharmaceutical industry recognises the value of metadata but has been slow to develop Metadata Repositories (MDRs). The technology has taken time to develop. Fortunately, we now have better tools to automate and manage metadata. Metadata that has historically been saved in excel spreadsheets can now be moved into metadata repository applications. As more MDRs are adopted, the usefulness of metadata is becoming more apparent. This SDE will focus on learning from those that have or are about to implement MDRs.


AstraZeneca – MedImmune,
Gaithersburg, MD


8.30 - 9.00 Presentation Speaker
9.00 - 9.15 Welcome Keynote Speech Frank Senk &
Thejo Annareddy, AstraZeneca &
Alex Batkhan, MedImmuneNevine Zariffa, AstraZeneca VP Biostatistics
9.15 - 9.55 Metadata-driven, Standards-based Clinical Analysis and Reporting Environment Alex Hromcenco &
James Miller, AstraZeneca
9.55 - 10.30 Metadata-driven Analysis – How Users Can Benefit from Metadata Peter Schaefer,
Validated Cloud Applications
10.30 - 10.45 Morning Break  
10.45 - 11.15 How to Find the Best MDR Solution for Your Organisation Kevin Lee,
Clindata Insight
11.15 - 11.45 The Chicken and the Egg Dilemma: Why Metadata Solutions have Struggled Chris Decker &
Scott Bahlavooni,
11.45 - 12.00 PhUSE Future Forum Update Chris Hurley,
PhUSE US Events Director
12.00 - 1.00 Lunch  
1.00 - 1.30 Automating CDISC Deliverables through Processing Metadata Paul Slagle &
Eric Larson,
inVentiv Health
1.30 - 2.00 Moving from Data Collection to Data Visualisation Analytics: Leveraging CDISC SDTM Standards to Support Data Marts Steve Kirby &
Terek Peterson,
2.00 - 2.30 CDER, Regulatory Science Informatics and Metadata: What We've Learnt Salvatore Pepe,
2.30 - 2.45 Afternoon Break  
2.45 - 3.15 Implementing End-to-End Data Standards from a Metadata and Technology Perspective Michael Goedde,
3.15 - 3.45 CDISC Share: The Road Ahead Sam Hume,
3.45 - 4.30          Panel Discussion & Closing Remarks All Speakers

Catering and refreshments will be provided throughout the day.

SDE Chairs:

If you have any questions, or require any information, please contact the SDE Co-Chair.

Frank Senk, AstraZeneca

Thejo Annareddy, AstraZeneca

//">Alex Batkhan, MedImmune

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