3 Manage subject data

  • About required questions for Randomization and Trial Supply Management (RTSM) events
    Learn more about specified data points required for Randomization and Trial Supply Management (RTSM) events.
  • Best practices for collecting data
    You must pay attention to certain details during your process of filling out forms in the application.
  • Enter data in a form with two sections
    The first part in a two section form represent the flat part of the form, which creates the overall form instance, and contains the leading questions. The second part contains the repeating table where multiple rows of data can be added as it relates to the applicable form instance.
  • Enter data in a repeating form
    Repeating forms allow you to collect multiple instances of the same type of data.
  • Enter data for an adverse event
    To continuously collect a subject's data on adverse events, and possibly concomitant medication, hospitalizations, and many more, then depending on how your study has been designed you can access and complete the forms within the Adverse Events visit, at any time during the course of the study.
  • Apply a data flag to a question
    Mark questions in a form as Not Applicable, Unknown or Not Done if you don't have an answer for these questions.
  • Update a value on a completed form
    Go back and update a question on a form, such as when you discover a data-entry error. This procedure also applies to rollover studies.
  • About updates to a dynamic question
    When you update or clear the answer of a determining (parent) question or a dynamically-displayed (child) question, you must keep in mind the specifics of this update according to each use case.
  • Update the answer to a dynamic question
    You can update the answer to a determining question (parent question) and automatically clear or hide the answers to its dynamically-displayed questions (children questions), too.
  • Upload or delete documents from forms
    You can upload or delete documents in forms to provide additional information for subjects in a study.
  • Link forms
    You link forms in order to connect related data within your study. If form associations are designed in your study, you can link data from one or more forms (repeating, two-section or one-section forms) to the source form (repeating or two-section). And keep in mind that only data that has been previously entered appears in the launched form.
  • Import Electronic Health Record (EHR) data
    Learn how to import EHR data for a linked subject. This includes demographics, medical history, medications, labs, vitals, and procedures.
  • Sign data
    Some studies require you to sign subject data. Signatures may be applied at different levels.
  • Clear or delete data
    There may be situations in which you need to eliminate subject data. You must know there is a difference between clearing and removing data, specially in terms of data audit and the possibility of restoring deleted elements. Browse the topics in this section and learn more about these two actions.
  • Manage queries
    During data review, sponsor users may raise queries on specific questions that may need revision or some sort of clarification. Learn how to answer and manage queries that are assigned to you.
  • Work with Safety Cases
    Depending on the study design, subject adverse event data may be integrated with Safety. This integration streamlines Serious Adverse Event data collection.