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Thursday, April 12 • 8:30am - 10:00am
Session II - Special Topics Track

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II-1 - Improving quality to reduce risk through the use of automation

Automated tools can vastly improve the quality of data in clinical trials and registries, thereby increasing the evaluable data, ensuring valid results, and reducing labor. This session will discuss how to leverage advanced automation when using electronic data capture to ensure quality in the data for the project as a whole in the context of 21CRF11 "contemporaneous."
Modern systems can address site, user, and project level data in addition to subject data in an integrated way. These systems enable eSource by use of well-designed forms and navigation.
Systems that enable integrated feedback facilitate appropriate planning of comprehensive edit checks, logic and automated calculations. Automation can go beyond normal edit checks to include an integrated approach to randomization, inventory,  invoicing, laboratory interfaces, AE/ConMed coding, etc. By automatically generating information from other entries and configuration settings, errors can decline precipitously and monitors can focus on clinical issues.
Additional tools can automatically generate deviations, provide a smart look-up from dictionaries, build drop-down options from other entries, show trends to identify outliers, and take advantage of technologies such as bar code readers, RFID wands, specialized apps, etc. It is important to identify the variables and parameters that will be used to track risk and actions associated with each. Identifying these from the beginning allows automation and effective tracking within the system which result in improved quality. By planning for and automating these daily tasks, study management personnel’s time may be freed up to focus on continuous quality improvement initiatives. Learn how in this session.


Level of Content: 

II-2 - Evaluating and validating hosted electronic signature solutions  

Abstract: OECD 17 and 21 CFR Part 11 (including FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application) require that electronic signature solutions meet a host of requirements to ensure that the electronic signature is the equivalent of handwritten signatures. OECD 17 and 21 CFR Part 11 also require these electronic signature solutions be validated. More than fifty electronic signature solutions exist, but not all hosted solutions meet those regulatory requirements. It is the responsibility of users to validate, integrate, and determine if the hosted solution meets regulatory requirements.
The goal of this presentation is to review the following:
  1. Brief overview of the applicable regulations
  2. Points to consider when choosing a hosted signing solution
  3. Integration of a stand-alone hosted electronic signing solution into existing workflows
  4. Lessons learned during validation of a hosted electronic signature vendor
An introduction will provide a brief overview of the OECD 17 and 21 CFR Part 11 documents as they relate to electronic signatures. It will be assumed that attendees are familiar with the current industry best practices for computer system validation.

Category: Other

Level of Content: Intermediate

II-3 – SEND Update (pre-recorded video from Marc Ellison)

Category: SEND

Level of Content: Intermediate


Lelia Scott

Senior Director, Global Quality Systems, Charles River


Marc Ellison

Product Manager, Instem
avatar for Alicia Browner, PhD

Alicia Browner, PhD

Electronic Data Capture and Trial Management, Prelude Dynamics
Our offerings include both do-it-yourself and premium service (for highly complex studies) on a single validated platform. Come talk to us at booth 205!
avatar for Jennifer Siegrist-Skapura

Jennifer Siegrist-Skapura

Global Computer Validation Quality Assurance Specialist, Charles River Laboratories
Ms.Skapura obtained a BS in biology, followed by an MBA from Wright State University. She has been with Charles River for 14 years and is currently a specialist in the global quality assurance computer system validation group. Her responsibilities include providing QA compliance support... Read More →

Thursday April 12, 2018 8:30am - 10:00am PDT
Platinum 9&10