Overview

Imagine automatically building dynamic multi-media, logic driven content (e.g., charts, graphs, conditional text and formatting, etc.) based entirely on a Subject's OWN data! Learn more and see examples here.

Common Uses

Clinical Trials	Patient Registries	Subject Portal
Serious Adverse Event and Adverse Event reporting Other event reports (e.g., protocol violation, randomization / enrollment, etc.) Invoice creation and reconciliation	Automated clinic notes Data visualization (e.g., charts, graphs, overlay images [i.e., plot tumor locations; see article here]) Case conference notes (e.g., across specialties summaries [i.e., see Clinical Report design article here])	Dynamic newsletter based on preferences, milestones, etc. Outcome goals monitoring and points achievement Delivery of targeted educational materials (e.g., symptom triggered training materials, such as videos - website links - pods casts - etc.)

Examples:

Reports for Subjects	Reports for Investigators

Conditional Formatting	Adverse Event

Visit Summary	Automated Image Overlay (e.g., plot tumor locations)

Invoice	Device Prescription

Video: Introduction To the New Subject Report Features

Watch a video that provides an overview of the new Subject Report features here.

New Features (Studytrax Version 3.47)

Expression Builder
Conditional Formatting
The "Repeater" Control
Charts
Javascript editor

More Information

Key Features
1. Access to ALL data elements
2. Integrated word-processor for layout design, formatting, etc.
3. Design content based on a subject's individual needs using any web-based tool such as:
  1. Example content
    1. Charts
    2. Graphs
    3. Video
    4. Pod casts and other audio
    5. Links to informational websites
    6. Pictures
    7. Conditional text
    8. Anything that can be done on the web!
  2. Organize content, use data to trigger when to present. Examples
    1. Display sleep hygiene materials (e.g., video, websites, podcasts, local treatment providers, etc.) if sleep problems reported)
4. Summarize and visualize progress toward key clinical goals across one or more visits
5. Automate data-driven calculations (e.g., change in BMI over time, raw score to T-scores)
6. Track and list medications
Examples
- Subject Reports
  1. A graphical chart of progress toward clinical goals over time.
  2. Prognostic chart based on the subject's specific clinical characteristics (e.g., a tumor's T, N, M status).
  3. Patient driven requests for information and/or educational materials (e.g., video on upcoming procedure, list of support groups in the area, referral resources, disease overview pdf file, prognostic chart, table of links to recommended websites, etc.).
  4. Report of participation points (e.g., provide total points score based on number of forms completed and the points, in turn, can be redeemed for items of interest).
- Study Event Reports
  1. A report summarizing all adverse events, color-coded with open AEs in red.
  2. A report showing all safety-monitoring variables or clinical intervention triggers (e.g., depression level over time)
  3. A study visit invoice documenting and summarizing all related charges.
What To Consider
- Subject Reports
1. What data-driven information would be helpful for key stakeholders (i.e., research staff, clinicians, subjects)?
  1. What information would help clinical decision making, how is it best conveyed (e.g., graphs, tables, key findings, etc.) and what needs to be documented?
    - Automated clinic notes and reports
  2. What research reports need to be submitted (e.g., adverse event report)
  3. What data and educational materials would be useful for subjects (e.g., a disease overview and recommendations, display of clinical data over time)?
  4. What data-driven clinical events will trigger specific information (e.g., if BMI over 25, show video on weight management)?
2. How can the report content be customized to fit the specific needs of a subject and provide the greatest incentive for participation?
- Study Event Reports
  1. What study events will require reporting?
    1. What template forms need to be completed?
  2. Adverse Events
    1. What are the standardized AE and SAE reporting requirements?
    2. What is the best way to summarize AEs and monitor their status?
  3. What's the best way to visualize safety-related data?
    1. What are the safety monitoring variables and clinical intervention cut-points?

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