Investigator QC Report |
The purpose of the report is to provide sites with feedback on the quality of the data they collect during a clinical study. The report will display all tests that were graded by ERT QC OverRead during the last reporting period and for the complete study. It will also display an overview over the rated tests for the specific site. |
Non-Proficient User Alert Report |
The purpose of the report is to list all measurements which are performed by a site user who has not performed a passed proficiency test. |
PFT Accounting Report |
The purpose of this internal billing report is to present the number of procedures performed in a clinical trial monthly. The report includes ECGs, Spirometry, BTR, Proficiency and Training tests at each level of overread. This report will be used to determine the amount of OverReads and proficiency tests to bill to a sponsor. |
PFT Alert Results Report |
The purpose of the report is to list all Quality Control (QC) statements for Forced or Slow Spirometry measurement tests performed by site users. |
PFT BTR Report |
The Spirometry BTR Report will include all spirometry tests from study patients for which BTR has been performed and approved. |
PFT QC Findings Detail Report |
The purpose of the report is to list and count all QC statements, by ID, for all Spirometry measurement tests performed by site users. |
PFT QC Findings Summary Report |
The purpose of the report is to aggregate all the QC statements, by ID, for all Spirometry measurement tests performed by site users per site and country. |
PFT QC Grading Report |
The purpose of the Spirometry QC Grading Report is to show an overview of the quality of spirometry tests performed at each site. Therefore, the grade before and after BTR will be counted for all tests with an approved BTR. |
PFT Quality Alert Report |
The purpose of the report is to list all sites where the number of QC findings is more than ten percent of all of the site measurements. |
PFT User Certification Report |
The purpose of the report is to list all users by study site who have performed a study specific number of tests with acceptable quality. |
PHQ-9 Findings Report |
The report provides assessment results for each question contained in the Patient Health Questionnaire (PHQ-9). The report also provides an overall total score and a depression severity evaluation. |
PHQ-9 eC-SSRS 2.0 Combined Findings Report |
The report provides assessment results for each question contained in the Patient Health Questionnaire (PHQ-9) and a summary of the eC-SSRS Findings in one report.
|
Predicted Reversibility Report |
This report displays the predicted values, reversibility values and quality grading of the pre- and post-bronchodilators by patient. The report also displays the quality of the baseline data. |
Proficiency Certificate |
The creation of a Proficiency Certificate for a site user will be triggered by the CDMS UCS. The report will verify proficiency for a user at a site by providing a certificate of achievement. |
QC Frequent Findings Report |
This report will display the three most frequent QC findings for the study, country, and site. |