TrialMaster contains a robust Standard Reporting Module. A sample of the extensive list of easy to create reports includes, Summary Reports, Project Status Reports, Subject Enrollment Reports, Subject Status Reports, iCRF Status Reports, Open Query Reports, Comments and Queries by iCRF, Security Permissions by Role, Visit Reports, Data Group Specifications and Code List Reports. The system also renders custom standard reports that include AE Reports, Concomitant Medication Reports, Drug Inventory Reports, SAE Reports and MedWatch Forms.
iCRF Status Report
Show Subject Form Status By Site
SITE NAME: Absecon Medical Research Center
Category |
Subject Count |
Num iCRFs |
No Data |
Comp |
Incomp |
Signed |
Monitored |
Locked |
| Adverse Event |
4 |
6 |
0 |
6 |
0 |
0 |
0 |
0 |
| Concomitant Medication |
4 |
4 |
4 |
0 |
0 |
0 |
0 |
0 |
| CRF |
4 |
408 |
398 |
8 |
1 |
1 |
0 |
0 |
| Screening |
4 |
36 |
24 |
9 |
1 |
2 |
0 |
0 |
SITE NAME: Somerset Medical Center
Category |
Subject Count |
Num iCRFs |
No Data |
Comp |
Incomp |
Signed |
Monitored |
Locked |
| Adverse Event |
24 |
42 |
17 |
3 |
0 |
22 |
0 |
0 |
| Concomitant Medication |
24 |
26 |
23 |
1 |
0 |
1 |
0 |
0 |
| CRF |
27 |
2474 |
2393 |
39 |
11 |
24 |
2 |
5 |
| Screening |
27 |
240 |
187 |
39 |
1 |
10 |
1 |
2 |
Integrated Ad-Hoc reporting is available through LogiXML with Wizard-driven report generation. The system provides support for drill down reports that include interactive charts and graphs. The system also supports aggregating data and advanced calculations. The advanced and easy to use export feature in TrialMaster includes output to client systems in SAS, CDISC, CSV, TAB, XML formats and Oracle Clinical formats. With TrialMaster, you can export data at the Data Groups or Form levels and include an audit trail in data exports. All data exports are automatically encrypted, zipped and password protected.
TrialMaster Archive is a self contained program allowing Sponsors to view all trial data in its originally captured format. Completed CRFs are provided to the Sponsor on a CD sorted by trial, site, subject, visit and form in the same format as originally presented within the TrialMaster system. Trial Sponsors receive a CD that includes data for all sites and final data exports. Investigator sites receive a CD with only their site data presented.
The program is self contained and data is viewed using a standard web browser.
The unique AE adjudication and safety reporting feature in TrialMaster allows you to restrict adjudication function to medical or coding specialists, support searching and browsing the MedDRA dictionary for coding and optionally utilize 3rd party auto-encoding tools (Galt dsNavigator, Oracle TMS). TrialMaster has the ability to generate MedWatch and CIOMS forms from collected and adjudicated AE/SAE forms and generates a Safety pharmacovigilance database.
At the end of your trial TrialMaster creates an FDA Archive Submission ready Casebook containing PDF formatted copies of all Case Report Forms (CRFs) in FDA submission format. The Casebook is fully tabbed and bookmarked to easily find and view particular CRFs. The FDA Title 21 CFR Part 11 compliant solution offers unrivaled freedom to conduct clinical trials your way, with unparalleled flexibility, ease-of-use and complete control over your data. |
