Data queries.

Query management
in eCRF system.

The Data Query module enables study monitors and data managers to communicate with Investigators to ensure the validity of provided data and indicate possible issues with the data. Users receive specific permissions to a particular user level.

Level of accesses.

No access
(default)
"Read only"
option without the possibility
of asking questions and answering for the
query, generating query listings
"Read and write"
option - Creating questions
and answering for the query

Queries creation.

Users (Monitors, Medical Monitor, Data Manager, itd.) can add queries to every questions and pages of the eCRF by clicking in the particular question and/or page.

Creating Queries in the eCRF System
Zrywanie pieczęci
Removal of markers.

Patient data modification due to answers provided to queries results in removal of previous SDV (or compliance) markers, so monitors have a clear indication which pages have to be re-checked.

Monitors can verify and confirm each question, pages, visit, filed. Data verified by a Monitor are marked with a color check mark symbol. Color of marker indicates function of person who is responsible for the verification (e.g. Monitor, Medical Monitor, Data Manager, etc.)

A physicians receives an automatic e-mail notification about new queries containing a link to the queried page. At the same time, the Investigator is temporarily given the option of editing a previously locked (frozen) page. If the physician changes data in eCRF, all markers are removed (broken) for this question, the page and/or the visit in which it occurred. Monitoring persons should verify the data again and approve the form.

All data in eCRF system can be confirmed by an unlimited number of people. This system can be accommodated to the specific monitoring workflow expected by the client’s organization.

Notifications.

New queries
Physicians receive automatic e-mail notifications about new queries generated by the member of monitoring team.
Answer to queries
A monitor receives automatic e-mail notification about any answers to their queries with link to page containing answer.
Notification
Monitors receive automatic e-mail notification about new queries, at the same time when Medical Monitor add queries. This functionality allows Monitors to track process and prevent prolonging the reporting of Adverse Events by Physicians and to stimulate the Investigators to faster query resolving.
E-mail

Other eCRF system functions.

Automatic reports
Comments
Online contracts
Audit trail
Protocol deviation log
MedDRA dictionary
Randomization
Notifications

Frequently asked questions.

What is the Data Query module?
The Data Query module is a tool that ensures the flow of information and communication to confirm the validity of data values. It also allows users to create "data queries."
 
What does "breaking the seal" mean?
After each change to patient data, verification seals are broken, signaling the need for re-verification.
 
What other modules can be provided within the software?
  • Audit trail,
  • Data queries,
  • Randomization,
  • Drug management,
  • Dynamic reports and statistics,
  • Adverse event reporting,
  • Notifications/alerts,
  • Online contract signing.
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