IMACS Users' Guide – Version 1.0 - The International Society for ...

IMACS Users’ Guide – Version 1.0
12/21/2012
Page 4 of 56
1.2 How do I get started?
Forms
The IMACS patient data entry system is comprised of a series of forms. The data to be
collected are divided into forms that correspond to the clinical time course of the patient.
The Data Dictionary for these forms is found in 2.0 of this manual.
Inclusion/Exclusion Form
Screening Log
Clinical Data Forms
Demographics
Explant
Pre-Implant
AE Infection
Implant
AE Device Malfunction
1 Month Post Implant AE Neurological Dysfunction
3 Month Follow Up AE Major Bleeding
6 Month Follow Up AE Respiratory Failure
Implant Discharge
Death
AE Arterial Non-CNS
Thromboembolism
AE Right Heart Failure
Each form must be addressed in its entirety. Each data element in a form must be
addressed. There is a status bar (ST=) on most questions where “Unknown”, “Not
Done”, or “Not Applicable” may be entered when information is just not available.
Limited usage of this bar is expected. At the bottom of each form there is a ‘Save’ and
a ‘Submit’ button. The ‘Save’ button allows you to leave the form before it is completed
while saving the information you have entered. Once you have completed data entry for
the entire form, the ‘Submit’ button should be selected. Once you select ‘Submit’, the
application will validate the form through a process of range checks and internal
consistency checks. Messages will appear for invalid or incomplete data entered. Even
though a form has been submitted, you may edit information that has already been
entered into the system. When you subsequently select ‘Submit’, the form will go
through the validation process on the edited information.
Once you select “Add a Patient,” then you begin entering the IMACS forms. The first
form is the Demographic form. The specific data elements of this form are described in
Section 2.0 “Data Dictionary”.