Session Title:OpenClinica’s New Form Engine
Time:10:00 – 10:55Location:Breakout 1

Cal Collins | Co-founder & CEO, OpenClinica

Summary:OpenClinica is moving towards a new, more powerful form engine that will be used for capturing and reviewing data. This session will introduce the new form engine and review some of it’s exciting key features. We will discuss how a form will be built, showcase the more sophisticated form design, and exhibit how some of the new features will make data entry more effective.


Session Title:OpenClinica’s New Architecture & Web Services API
Time:11:00 – 11:55Location:Breakout 1
Presenter:Krikor Krumlian | CTO, OpenClinica
Summary:Build a comprehensive architecture & API offering that positions OpenClinica to be a powerful platform that enables friction-less systems integrations & spurs the development of innovative web and mobile applications.


Session Title:The eSource Enigma
Time:1:00 – 1:55Location:Breakout 1
Presenter:Laura Keita | Director of Compliance & Training, OpenClinica

There are many questions in the industry regarding eSource: Who’s the originator? What’s the source? Who has control of the records? How does my EDC integrate with an EHR? With a CTMS? With …? In this session we’ll discuss these questions as well as present updates from OpenClinica and the industry regarding approaches to decoding and solving the eSource enigma.


Session Title:Building Modules in OC4
Time:2:00 – 2:55Location:Breakout 1
Presenter:OpenClinica Engineering Team
Summary:OpenClinica wants to empower engineers to build modules that solve real world problems.We will talk about the different types of modules you will be able to build & the tooling that OpenClinica will provide to get you started.


Session Title:Use of OpenSource Tools for a Patient-Facing Safety Reporting Tool: MySafeCare
Time:3:15 – 4:10Location:Breakout 1

Brittany Couture | Research Assistant, Brigham & Women’s Hospital

Summary:MySafeCare provides hospitalized patients and their families with a quick, electronic, and real time way to submit safety concerns to appropriate hospital staff. These submissions are view-able by clinical staff via a secure dashboard, which provides space to document follow up actions. The use of OpenClinica and other open source software for this application allowed for extensive usability testing with end users while rapidly iterating and refining versions to optimize usability and functionality of the tool. These iterative user-centered design methods are crucial for patient and clinician facing tools in a fast paced hospital environment.


Session Title:Table Data Collection with ODK Collect
Time:4:15 – 5:10Location:Breakout 1
Presenters:Lindsay Stevens | Clinical Trials Database Developer, The Kirby Institute, UNSW

Following a successful pilot project, the Kirby Institute at the University of New South Wales, Australia has been rolling out a tablet based data collection system. This system uses Android tablets, the ODK Collect app, XForms and XLSForm to deliver a high quality, secure and primarily offline electronic data capture process for patient reported outcomes. This session will cover practical aspects of the system including:

  • A brief overview of the XForms universe
  • Android deployment environment (including Google Apps for Education)
  • Data flow from participant to OpenClinica
  • Study development process and tools for XForms
  • Challenges and future plans for online data submission
Session Title:Using OpenClinica in a prospective multi-center cohort study in Latin America
Time:10:00 – 10:55Location:Breakout 2

Morgan Hess-Holtz, MBA, MPH, Victor R. Garcia T., Computer Engineer | Gorgas Memorial Institute for Health Studies


OpenClinica was used in for electronic data collection, transformation, cleaning, and quality control in a prospective cohort study in Panama and El Salvador. Variables evolved throughout this study and best practices developed based on the field team’s and research interests resulting in effective, flexible strategies that maintain quality control standards including:

  • Automatic migration of data changes in CRFs, with default specifications
  • Identification, evaluation and diagnostics of data quality
  • Defined, standardized formats for variables
  • Spanish platform with training materials for different user roles.

This session aims to demonstrate the process testing and implementation of procedures to mitigate challenges in a resource limited setting.


Session Title:Community Datamart
Time:11:00 – 11:55Location:Breakout 2
Presenter:Lindsay Stevens | Clinical Trials Database Developer, The Kirby Institute, UNSW
Summary:The Community Datamart provides a multi-purpose way of accessing your study data for various types of reporting and analysis. This session will provide an overview of the project and update on its latest developments. Frequently asked questions will (hopefully) be addressed by a step by step demonstration of the “basic” setup procedure, discussion of the advanced setup, and discussion of study design parameters that affect the datamart build process.


Session Title:Case Studies of OpenClinica Participate
Time:1:00 – 1:55Location:Breakout 2
Presenter:Ben Baumann | COO & Co-Founder, OpenClinica

Since its release just over a year ago, OpenClinica Participate has been used in a wide variety of clinical studies, including different eCOA modalities and device provisioning models, for both industry and academic research. This session will examine a set of actual Participate studies, both completed and in progress. We’ll discuss challenges and implementation strategies related to usability, patient engagement, logistics, and incorporation of standardized instruments, while articulating best practices.


Session Title:Lessons Learned: Naming Conventions, Rules, and Data Cleaning in Grids
Time:2:00 – 2:55Location:Breakout 2
Presenter:Patrick Murphy | Senior Director, Data Management, RTI Health Solutions

This session will detail practical “lessons learned” from a recent study set-up with OpenClinica. Topics will include:

  • version control of CRF templates and the effect of specifying versions to sites and the effect of INSERT actions on the selection of CRF versions
  • naming conventions for variables
  • modifying variable names when response text (e.g., yes, no) are changed (e.g., yes, no, not applicable)
  • using the INSERT action to populate variables on one CRF based on another CRF to: remind users of previous answers, to perform skips/hide-show of variables
  • data cleaning programs on variables in grids
  • programmatically adding subjects to sites using a tool on Trial Data Solutions website
  • writing rules comparing data from two different CRFs within the same event; focus on problems with syntax, OIDs
  • implementing ‘time of day’ data collection and comparing times between different variables

The session will be interactive with attendees being able to offer their insights and ask questions during the presentation.


Session Title:Streamlining OpenClinica Data Uploads
Time:3:15 – 4:10Location:Breakout 2

Jacob Rousseau | Senior Clinical Director, Netherlands Cancer Institute

Summary:The CTMM-TraIT project performs a large number of uploads of data to OpenClinica for clinical-studies. To facilitate this, a web-based application for data upload to OpenClinica has been developed in close cooperation with the department of Hematology of the University of Cambridge and the Hyve. The application supports an interactive channel and an unattended channel for automated uploads for example from EHR-systems. Uploads are performed using the OpenClinica SOAP-Web Services API. The application performs standalone validations prior to the actual upload to OpenClinica. Any errors are reported back immediately to the human-operator or logged to file for the unattended upload.


Session Title:Best Practices for Increasing Accuracy and Efficiency of Database Build in Complex Scenarios
Time:4:15 – 5:10Location:Breakout 2

Tiantian Zhao| Database Designer II, FMD K&L


This session will share best practices and lessons learned in a case study presentation highlighting a Phase 2 Randomized, Double-Masked Placebo-Controlled Cross-Over Safety and Tolerability Study of the Active Drug for Drug-resistant Epilepsy. We will showcase that when being faced with various complexities and challenges, utilizing the appropriate tools and techniques will help increase the efficiency and accuracy of the database build. Topics will include:

  • Demand from sponsor’s programming team to have raw data sets to be compliant with CDASH and SDTM
  • Tight timeline and limited resource to perform database build, QC and UAT
  • Best practice of using OpenClinica to design local lab CRFs with different normal ranges