Reporting of Test Results, Web Browsing System

Reporting of Test Results, Web Browsing System

Accurate and quick reporting of test results is the cornerstone of our services.
Obtained test results are aggregated into mediford's core system e-MADAM (e-Mediford Corporation Advanced Data Management System) and can be viewed by three means: web browsing system ("e-MADAM plus"), test report, and electronic data.

Service details

Three types of reporting

Test results from the central laboratory service are aggregated into mediford's core system (e-MADAM: e-Mediford Corporation Advanced Data Management System).

The test results at each testing department are transmitted to e-MADAM and they are combined with information (referred to as "demographic information") of each identical participant/patient in the study. "Demographic information" includes gender, age, collection date and time of sample, and whether or not the patient is fasting. Thereafter, along with demographic information, the test results are reported to the sponsor and the medical institution conducting the study, by desired forms.
Three types of reporting methods are available: "Web browsing system (e-MADAM plus)", "test report" (hard copy/fax), and "Electronic data".

Web browsing system, "e-MADAM plus"

Test results can be viewed on the web test data browsing system (service name is "e-MADAM plus").
The status of sample submission, test results, test value alarms, etc. for each participant (or subject/patient) in clinical studies by medical institutions can be viewed on the web. Alarm details will be notified via e-mail, as well.
We also provide electronic data to client's data management department, after consulting regarding the format.

"e-MADAM plus" is a system to view information entered into mediford's core system (e-MADAM: e-Mediford Corporation Advanced Data Management System) using a web browser.
User accounts are issued for all users. Registered users with accounts can browse the site and the accessibility is controlled by users. Registration for the user account can be applied via e-mail.

Two types of service contents

e-MADAM plus provides "basic services" and "optional services".

Basic services
"Basic services" include subject lists, display of details for each subject, download of test reports, notification of critical value alert (alert function in case of data outside reference intervals or abnormal values), etc.
Optional services
As "optional services", it is possible to provide alarm notifications for test values specified by sponsor, progress alarm notifications, graphical display, results list by testing item, progress status for individual subject in studies, etc.

Security measures

For the first log in, you can log in with your user ID and initial password.
When the services are used, a user is required to enter an encryption key issued for each clinical study, and the access will be limited to only users involved in the study.
It is also possible to control accessibility by users. If settings on accessibility need to be changed, you can apply them through the webpage after the study starts.

Test report

Test reports are posted in PDF format on e-MADAM plus. This PDF can be downloaded as needed if you have a user account.

Information viewable

Screening View
In the "Screening View", the progress status of all subjects is displayed in a single list. Contents can be sorted by displayed item.
Test results list
In the "Test results list", test results of all visits for the selected subject are displayed in a list. It is possible to make arrangements such as changing the background color display according to testing schedule, showing results graphically, and calculating variation rate.
Test value alarm
In the "Test value alarm" section, detailed settings for reporting test results are available.
For instance, it is possible to set multiple judging stages in advance by testing items, or to set judgment point based on variation rate from the preset test value at a certain visit as a criteria, and those notifications can be sent, as well.
It is also possible to set notifications with conditions that specific comments are added to the test results, or that multiple judgment conditions are satisfied.
Progress Alarm
In the “Progress Alarm” screen, scheduled visit dates in future are calculated and shown beginning at sample collection date designated as the base line measurement.
An alarm notification is sent when the sample was not submitted on the scheduled visit date, or allowance for the visit schedule can be set in advance as well.
In case of situations requiring an alarm, a notification will be sent via e-mail.

Test report

In addition to reporting via web browsing system (e-MADAM plus) as a standard service, clients can also select receiving reports by hardcopy or fax as an option. "Test report" will be delivered via either media of hardcopy or fax.
The contents of the report and the method of description are defined in consultation with client during the initiation stage of each study, and described in "Study Specification Document (SSD)".

Test report
Test report with amendment track

Subject demographics

The "Subject demographics" column displays demographic information of participants in clinical studies, such as gender, age, date and time of sample collection, and fasting status. The contents of the demographic information are determined for each study according to its characteristics, and such information are shown in test requisition forms.

Matrix name / code / comment

The "Matrix name / code / comment" column displays the type of sample collected, such as blood or urine, and comments regarding the condition of sample (hemolysis, insufficient amount, etc.), if any.

Test Items

In the "Test Items" column, the test items will be described with the names and in the order, as determined in the "Study Specification Document (SSD)" in consultation with the client.
Item names can be written in either Japanese or English.

Measurement values / Matrix / Comments

The "Measurement values/Matrix/Comments" column contains the values measured in laboratories, the matrix code corresponds to sample type used for testing, and auxiliary comments regarding the test results (such as "Reference value due to hemolysis") will be displayed.

Reference ranges / Units

The "Reference ranges/Units" column displays the ranges and the units determined for each testing item at LSI Medience.
In the case that specific reference ranges are to be adopted or tests are performed at an overseas laboratory, please contact your mediford sales representative for consultation. For test items showing abnormal values, it is also possible to set a format including a check box for "clinical significance'' and/or a field for doctor's signature as a remark.

When there are modification in subject's demographic information or test items, etc., a revised test report with revision history will be issued.
The changes will be displayed in red font in the revised report, and the information before and after corrections will be listed in the "Summary of changes" column by each report date.

Electronic data

At Mediford Corporation, data included in test reports reported from our core system e-MADAM is stored in the electronic data output function (DsDL: Dataset DownLoad). Clinical testing results preserved as laboratory data can be provided as electronic data to clients.
Electronic data is primarily provided to the data management department of clients and is used for statistical analysis and approval applications to the pharmaceutical regulatory authorities.
Laboratory data specialists at mediford are the clients’ point of contact and support data management operations and provide high-quality services for every study consistently from initiation, operation stage to its completion.

Basic specifications

The electronic data is basically provided in CSV file format, and names of test item and field design can be customized by DsDL upon consultation.
The data can be also prepared in CDISC (Clinical Data Interchange Standards Consortium) format, such as LAB Model format and SDTM LB Domain format, and can be provided including Controlled Terminology (CT) and SI unit conversion values as well.

Customization service

Building a conversion program enables provision of electronic data with complex data specifications or study designs.
All conversion programs undergo Computerized System Validation (CSV) to verify the validity of electronic data, complying with mediford's SOP (Standard Operating Procedures).

Providing methods

Mediford Corporation can provide electronic data in several ways depending on the sponsor’s request.
The methods include web upload to our test data web viewing system (e-MADAM plus), data transfer to the website and secure FTP server designated by sponsor, optical recording media such as CD-R, and providing data via mediford's Secure FTP server.

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