This article serves as a general single-source guide for users at the data entry and review levels. The objectives of this instruction include:
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Opening up a subject's casebook after enrollment is dependent on first completing the subject registration form. Only then can a subject be opened up for further access.
Read more here about accessing subject records and data entry
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Managing Your Queries
As you enter subjects described above, at some point the sponsor may start to conduct monitoring and data management queries of your data entered in the eCRFs. The report called "My Queries Report" is the report to keep you informed on queries to you as a site or your comments back to the sponsor from the query deployed to you. It is one central location to manage all manual and auto queries deployed to your role's web browser:
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Once open, you will see a page similar to the one shown below. Reference the annotations below the image.
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Descriptions for the above image:
Link to the Subject's Records page
Link to the record where the query resides
The user who created the query or "Auto" if it was generated by the system
The number of messages residing on the query. Select this to open the query window and post query messages or close queries.
Text field to search for a specific subject - Must match the subject profile ID exactly.
Display only open or closed queries
Display only Automatic or Manual queries. Automatic queries are generated by the system based on edit checks or missing data.
Further filter the query status by Open-ATTN: Site, Open-ATTN: Monitor Closed, or Re-opened. Queries to the ATTN of the site are those created either by an Admin level role or by the system (e.g. form error). Queries to the ATTN of the Monitor are those to which the site level user has posted a response.
Display only Field, Form, or Interval queries
Display a specific date range of records (Note: this is not the date of the query)
Not visible to all users, depending on permissions - This will display all queries across the entire study regardless of which site(s) you belong to.
Mobile App:
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table like this containing links to view/action queries, or to open up the respective form where the query resides:
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Mobile App:
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Once open, you can choose between the different query types
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Records missing - Visit window has past
Records with open queries or errors needing resolved
Records where data was changed and reasons need to be provided for the data changes
Records awaiting review or signoff eSignature - This is dependent on user permissions and role
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