Tag Archives: Application programming interface

Choosing a Successful Clinical Trial Management System [CTMS]

Steps towards a successful CTMS:

Exploring the benefits of clinical trial management system (CTMS)

The benefits of mapping and developing an enterprise wide solution include6:

  • Centralizing decentralized departments
  • Optimizing institutional review board (IRB) functionality
  • Realizing real-time data available to both investigators and leadership
  • Decreasing bottlenecks in knowledge transfer between various entities involved in research
  • Reducing human errors in reporting that often cause compliance issues
  • Tracking milestones for grants, awards, fellowships, etc.
  • Streamlining the financial structure — billing and invoicing

operational, infrastructure, compliance, and governance issues that can be improved by implementing a CTMS:

  • Staffing: with a better understanding of resources, management will be capable of reallocating staffing assignments to offset excess or inadequate roles.
  • Communication: improved communication will improve patient satisfaction and monitoring of clinical trials.
  • Human error: CTMSs have integrated checking components to limit errors in reporting.
  • Operational flow: improved knowledge flow in various divisions (finance, marketing, administration, training, and recruitment) will help to achieve real-time results and data.
  • Managing clinical data: more accurate and efficient reporting tools will be useful internally and externally for current and future project assessments.

 

Choosing a CTMS that serves your institutional needs

ctmsEven though there is no perfect system, consider the reviewing of some common elements among most of the best systems:

  • Financial reporting tools (coverage analysis, residual and overage reporting)
  • Clinical trial management tools (including applicable clinical trial milestones and reporting dashboards)
  • Searchable clinical trial database
  • Analytical risk-based decisions
  • Reporting dashboards
  • Data warehousing module
  • Recruitment support module
  • Electronic case report form (eCRF)
  • Integrates easily with electronic medical records (EMRs), IRB system(s), etc.

Cost factors and implementation overview

In our experience with the implementation of CTMSs, the following are key aspects of the process:

  • Building a steering committee: the most important aspect of implementing a CTMS is having a committee that is capable of making well-informed decisions for the institution.
  • Forecasting future issues: know the current and future issues of the institution that hope to be resolved with the CTMS.
  • Adapting to change: understand that implementing a CTMS will come with new responsibilities. The institution should be prepared to have individuals fill these new roles. Without this preparation, the CTMS is doomed from the beginning. New hires might not be necessary, but rather a shift in responsibilities. Create a culture of transparency to eliminate conflict and inconsistencies in the future.
  • Training and preparation: design an ongoing tailored training program to meet the short- and long-term needs of staff.  Implement training and train staff on the new technology.

A successful CTMS connects all aspects of clinical trial management and allow administration to focus on making strategic decisions based on analytics and accurate real-time data.

References: Original article can be seen at Applied Clinical Trials with

Comments? Join us at {EDC Developer}

Anayansi Gamboa, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)

As the 3 C’s of life states: Choices, Chances and Changes- you must make a choice to take a chance or your life will never change. I continually seek to implement means of improving processes to reduce cycle time and decrease work effort.

Subscribe to my blog’s RSS feed and email newsletter to get immediate updates on latest news, articles, and tips. I am available on LinkedIn. Connect with me there for technical discussions.

Fair Use Notice: This article/video contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law. If you wish to use this copyrighted material for purposes that go beyond fair use, you must obtain permission from the copyright owner. Fair Use notwithstanding we will immediately comply with any copyright owner who wants their material removed or modified, wants us to link to their website or wants us to add their photo.

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision.

Disclaimer:De inhoud van deze columns weerspiegelen niet per definitie de mening van {EDC Developer}.

iReview in Clinical Data Management

JReview® is the web-enabled version of Integrated Review™ (iReview). It allows users to view, create, print, and interact with their Integrated Review™ objects locally on an Intranet or securely over the Internet. JReview® can be run in two different modes of operation (authoring and non-authoring) in addition to two modes of communication (clear-text and SSL).

iReview Common Development Practice:

  • iReview allows you to saved the library of objects to be deployed at “Global” level in the production environment.
  • Create separate categories (folders for DEV/QC/UAT) before approval (deployment into production)
    – “Development”
    – “QC”
  • Create study specific folders under those categories (e.g. DEV/QC/UAT)
  • Configure UserGroups to manage privileges appropriately at the category level– – “Developers can access – Development”
    – “QR/QT can access QC”

QC/UAT PROCESS

  • You can query iReview metadata
  • Business rule verification by checking

– “Panel names, item names”
– “Object location e.g. Public, private or usergroup”

  • Use of SQL to query iReview objects metadata
  • The information in CONTENTBLOCK is parsed to get
    additional metadata information for a particular iReview
    object
  • Define a detailed QC checklist for each object in the Global Library
  • Maintain a lessons learned document (knowledge base) to improve the development process

  • Continuously improve processes by collecting Metrics

    – Development time

    – QC time

    – Rework time

Advance Functionality

  • Deploy reports with dynamic Filter values
  • Filter values are not static and change during trial conduct
  • Deployment for non-technical end-users
  • Provide easy access to report
  • Create Lookup table(s) in the backend
  • Populate Lookup table(s) with study specific Filter values

  • Using “Filter Output” in IR, add appropriate nested queries to the WHERE clause

  • The use of ImportSQL, more complex dynamic filtering so no need to hardcode values in the front end

  • Saves development time by avoiding the creation of study specific filters and increases re-usability

  • Flexibility to activate/inactivate filter values via backend

Import SQL

  • Modify an Import SQL panel by adding more items will not impact existing reports already using this Import SQL

  • Import SQL has a limitation with max of 2000 characters (will result in the error below)

A workaround would be to create a stored procedure or a view

Patient Selection Criteria

  • Modifying a PSC has no impact on already saved existing reports using this PSC

Object Specifications window

  • Removing Objects (missing folders)
    – When all the objects are removed from a folder in the Object
    Specifications window, the folder with no objects will be hidden but
    not removed
    e.g. Drug Safety ..> All AEs ..> SAE Reports ..>SAE reconciliation
  • Removing all objects under “SAE Reports” folder will result in the “SAE Reports” folder being hidden
  • The workaround would be to use the Category section of Object Management tool to remove these hidden folders

Navigating iReview Windows

  • If you have hundreds of saved objects, typing the first few letters (similar to Windows Explorer) will help with easy scrolling and navigation in the Object Specifications window

Reference: Integrated Clinical Systems, Inc.