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Web Survey

Online survey and form collection with FDA 21 CFR Part 11 compliance for clinical research and post-marketing studies.

Solution by Dacima Software
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Overview

The Web Survey module is part of the Dacima Clinical Suite and supports building online surveys, forms, polls, quizzes, and questionnaires. Surveys can be completed anonymously, via token, email, or SMS, and are accessible on tablets and smartphones. Unlike general-purpose survey tools, this module is designed for medical and health-related research, complying with FDA 21 CFR Part 11, Good Clinical Practices (GCP), and maintaining a complete audit trail. It supports both cross-sectional (single time point) and follow-up (multi-time point) survey designs.

Survey Access and Entry Options

  • Anonymous surveys
  • URL-based access
  • Username and password access
  • Personalized email invitation with hyperlink-based survey access
  • Customizable invitation and reminder emails and SMS messages
  • Customizable welcome, EULA, login, completion, and timeout pages
  • Customizable non-eligible screen for respondents who do not meet inclusion criteria

Form and Logic Capabilities

  • Conditional dependencies to enable or disable fields, show or hide fields, trigger popup messages, and change colors
  • Eligibility and inclusion checks to determine respondent eligibility before survey entry
  • Ability to create multiple forms that are automatically displayed to the user in sequence
  • Dynamic form logic that triggers specific forms based on response patterns from other forms
  • Simple and complex validation checks

Participant and Mailing List Management

  • Create and manage mailing lists
  • Randomize participants to a study from a mailing list
  • Manage invitations and reminders through the survey manager interface
  • Support for hybrid surveys with automatic tracking of different data collection modes, including email invitations, URL access, and manual entry of paper-based surveys

Data Extraction and Reporting

  • Multiple data extraction options
  • SAS code generator that automatically writes SAS import, format, and label code
  • Query builder for extracting data subsets and generating aggregate and summary statistics reports
  • Built-in reports for summary statistics, data dictionaries, data query reports, and more

Survey Manager Tools

  • Tracking of respondent survey completion and survey status
  • Access to reports and data extraction options
  • Query builder for creating custom reports and outputs
  • Management of invitations, reminders, welcome pages, and other configurable pages

Dacima Software is part of the EvidentIQ Group. A trial version of the software is available, and personalized demos can be arranged to review specific study requirements.

Meta

Domain
Clinical Trial Management
Subdomain
Patient-Reported Outcomes (ePRO/eCOA) & Patient Engagement
Software type(s)
Record-Keeping System
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
Academic / ResearchBiotechCROPharma
Development stage(s)
ClinicalPost-Market & RWE
Target user(s)
Research ScientistQA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11GxP