Subject and data entry FAQs

• About clearing dynamic questions
  Consider these points when it comes to clearing dynamic questions.
• 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 Oracle Clinical One Platform, 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 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 to coded terms when the answer to a coding question is cleared or updated?
  When a site user modifies or removes a coding question's answer, coding targets are automatically cleared.
• Can a subject who screen failed be rescreened?
  It depends on the reason the subject failed screening.
• 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 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.
• What states can a subject have?
  Depending on the protocol, site users can update a subject's state through multiple actions for a number of times during the study. But have you ever wondered what each state really means for the way you manage subjects' data at a site?
• What actions impact subjects?
  Depending on the protocol, site users can perform multiple actions that have an impact on a subject's state. Most of these updates appear in each subject's history, but do you know what each update means and what's the impact for every subject and the overall user interface?
• What does each icon mean for signing, verifying, or freezing data?
  Each sign, verify, or freezing action has an impact on the study data. Learn more about what each icon means.
• Understanding data clearing
  Clearing saved data in a form differs from simply removing data from a field.
• 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.