3 Enter data and dispense kits

  • About collecting adverse event data when integrating with Safety
    Collect adverse event data as you fulfill your data collection tasks, keep track of safety cases, and ensure their transmission to Safety.
  • 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.
  • Edit a safety case
    To ensure the accuracy of data contained in safety cases, you can modify the contents of a safety case, even after its initial submission.
  • Manage safety cases
    Ensure the transmission of your subjects' safety cases to Safety by taking select actions, depending on the cases' statuses.
  • View the details of a safety case
    Monitor, troubleshoot, and gain a more in-depth understanding of a subject's safety case using the Safety Details & Histories panel.
  • About clearing or removing data
    Clearing saved data in a form differs from simply removing data from a field. There are differences in behavior and audit tracking, as well as noticeable differences in specific cases.
  • About deleting, restoring, and viewing deleted form records
    Whenever you restore a form record, its data becomes available to modify in a subject's forms again. Moreover, data is marked as restored in several User Interface (UI) areas, such as the Answer & Visit History sidebar or in any applicable reports.
  • About the Query List
    The Query List allows you to view and work on all of the queries at your site. Obtain an overview of the queries you have permissions to view, apply filters to your list of queries, and answer your queries, all in one place.
  • 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.
  • Answer a query
    You can answer a sponsor's queries at any time.
  • 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.
  • Clear a visit date
    Clear a subject's visit date in order to skip the visit, hide a branch, or hide a dynamic visit added in error.
  • Clear form data
    Clear the data collected in a form in order to remove it.
  • Complete a randomization or dispensation visit
    During a site visit, you collect data as required using the forms associated with the visit. You may also randomize a subject or dispense a kit as part of the visit. To randomize or dispense, the subject must be screened and active. You cannot dispense to a withdrawn subject.
  • Complete a dispensation visit with dose changes
    You must complete all required fields to be able to perform dose changes for a subject during a dispensation visit. To dispense, the subject must be screened and active. You cannot dispense to a withdrawn subject. This procedure applies to rollover studies, as well.
  • Complete an unscheduled dispensation visit
    During an unscheduled visit, you can dispense kits containing an investigational product, Unblinded Pharmacist kits, devices, perform dose changes or confirm the dispensation of kits, but you can't randomize subjects. To dispense, the subject must be screened and active. You cannot dispense to a withdrawn subject.
  • 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.
  • 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.
  • 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.
  • Restore deleted forms
    You can restore deleted rows of a repeating form, deleted rows from the repeating section of a two-section form, as well as instances of two-section forms and lab forms.
  • 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.
  • 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.
  • Work in the Query List
    The tasks you can fulfill in the Query List focus on working with the details of a query, as well as their source form questions.
  • View dispensed kit numbers and dosing instructions
    You can always get a reminder if you've forgotten the kit numbers or need to review the dosing instructions one more time. This procedure also applies to rollover studies.
  • 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.