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Overview: Subject Data Entry is utilized for various reasons. For practical purposes, it is utilized to collect study information from the subject/patient. However, it has also been utilized as a mechanism to collect in-house study information itself. This can include information that staff may enter from various sites in order to keep up-to-date on study detailsstudy administrative details.
When utilized as a SUBJECT PORTAL...
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Post-Study
1. Utilized for feedback questionarriesquestionnaires, stipend tracking...etc...
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See Examples: (link to examples of layout)
- Branding of portal- Since display space is limited horizontally for institution branded images, visitor instructions and alternative Non-CRF documentation, how much information needs to be included prior to filling out study related forms? What is the technical experience, age of the subject? Are there visual or hearing impairments involved? (Font size, tutorial needed to explain portal environment)
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- Form Design - How many forms need to be filled out by the visitor at each collection interval? Will the visitor be able to modify the form data at any time, or should it be limited to a collection period? Is there a need for supportive multimedia in the forms to be completed? How much time should be spent by the subject at any one visit to the portal?
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- Reports and educational materials - This section can be reserved for static documentation, or, reports specifically designed to make use of the subjects study data. Much like a clinic note or subject level report is customized for the staff, these same reports can be customized to fit the subject as well.
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- Limitations:
- The portal does not include the ability to fill out subject variables that are defined in the system-setup area of a project.
- A data collection interval is unable to hide entire forms based on selections from other forms.
- The portals interval completion status is only reflective of the all forms selected for the entire interval, including those that cannot be filled out by the subject.
- The portal cannot be utilized to directly into the EMR and view their medical information.
- The subject is unable to query identifiable information regarding other subjects.
- Dataset level study data cannot be delivered to the subject as a report.
- The subject is unable to change their username.
- There is not a formal mechanism for the subject to voluntarily dismiss themself from the study. (e.g. provide an immediate way to refuse additional scheduling of study events, subject's inability to enter universal notes regarding study questions, outside of the forms. Perhaps a built in messenger component.
- While unlikely a need, a single patient portal is unable to utilize information from two separate customer installations.
- Subjects are unable to select which forms to complete as an optional method to reach full completion status.