Subject and data entry FAQs

• About clearing dynamic questions
  Consider these points when it comes to clearing dynamic questions.
• Can a subject who screen failed be rescreened?
  Yes, a subject can be rescreened based on how your study's settings are configured.
• How does clearing data impact my study?
  Clearing saved data on a form differs from simply deleting data in a question. Clearing data has different effects on the different study areas.
• How is data impacted when a site user undoes a subject's event?
  Whenever a site user or any other user undoes a subject's withdrawal, screen failure, or study completion, your study's data is impacted in several places.
• What is a change for encoding?
  In Clinical One Cloud Service, Change for encoding represents a predefined reason included in your organization's default system code list. You can typically select this option for justifying an update to data that was already collected and saved for a subject.
• What is the difference between an XPORT and CPORT file format?
  The SAS Transport file format (XPORT) is an openly documented file specification maintained by SAS, a commercial company with a variety of software products for statistics and business analytics. The CPORT file format is not openly documented. In Clinical One Cloud Service, SAS Transport File Formats are currently running on Version 8.
• What are my options for defining a subject's number format?
  If you allow site users to enter subject numbers, you must define the subject number format. This ensures consistency for all subject numbers assigned in a study. When defining this format, you have several options.
• What does a site user do when a subject moves?
  The study team can transfer the subject to a site that is closer to home, as long as the new site uses the same or a newer study version as the subject's original site.
• What happens if a site user enters invalid data?
  A message explains why the answer does not meet the required criteria, but if the question isn't marked as required, then screening, randomization, and dispensation can still occur.
• What happens if a site user doesn't answer a required question?
  The site user can save the form, but the subject can't be screened or randomized, and kits cannot be dispensed.
• What time zone is subject data in?
  If the time zone is specified for the site, all values on the Subjects page are in the site's local time zone except the date and time values in Answer & Visit History, which is on the right when you open a visit.
• What can't be done after a subject completes a study?
  Forms that weren't started prior to study completion can't be started. Additionally, other subject actions, such as screening, randomizing, withdrawing, dispensing, and skipping a visit, can't be done.
• Workflow for updating a subject number during the study conduct period
  A site user is only allowed to update a subject number when assigned with the appropriate permission.