CERTAS - Researcher Configurable Palm-Based Self-Monitoring System
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FEATURES & BENEFITS

Researcher Configurable Palm-Based Self-Monitoring System

CERTAS TARGET AUDIENCE:

CERTAS addresses the needs of clinical trial sponsors, researchers, and clinicians by facilitating the cost-effective means of designing and administering research protocols, collecting data at the source and analyzing and managing the resulting data. CERTAS’ researcher-configurable questionnaire module eliminates the need for programmers, resulting in time and cost savings. The use of EDC and eDiaries results in improved data accuracy and integrity by reducing the transcription errors and retrospective reporting associated with paper-based diaries. The ease of real-time recording of eDiaries improves participant adherence. The data is available for real-time online use by sites and sponsors through wireless web synchronization to manage research trials and to monitor the progress of a trial.

KEY BENEFITS:

CERTAS is a fully integrated electronic data capture (EDC) system that collects data directly from patients and study participants, utilizing electronic patient diaries (eDiaries), wireless technology and interactive voice response (IVR). The EDC is part of a complete study management system that makes real-time data available both at the desktop and on the web. Components of the system include researcher-configurable questionnaires, wireless data collection and retrieval, device alerting capabilities and participant data management.

  • CERTAS was designed primarily for delivering self-monitoring logs and diaries to subjects using hand-held devices such as a Palm or a Cell Phone. The flexibility of the CERTAS system, however, allows for many other possible uses.
  • CERTAS can record any subject report.
  • CERTAS can record responses from individual patients.
  • CERTAS can record data from field interviewers and observers, not just subjects.
  • CERTAS can be used anywhere.
  • CERTAS can intervene as well as assess.

The CERTAS system allows you to create and administer studies through the use of Field Protocols, which give you full control over the creation of Questionnaires which are administered through several Delivery Modes for your study Participants. Once participants complete the questionnaires, the Results are immediately available for your review and can be exported into most statistical analysis programs using the Comma Separated Value (CSV) format. With the use of CERTAS, participants can choose from one of three delivery Modes to complete their questionnaires. Delivery modes include Palm, Cell phone, and IVR administration with configurable alerting functionality. All Results collected from hand-held devices are stored within the CERTAS Desktop application for easy viewing. CERTAS contains a Results List Screen and a Results View Screen that allow you to view collected data. The CERTAS results view screen also allows you to perform simple data manipulation , including filtering and sorting. CERTAS Online is a service provided by CERTAS that allows you to store a copy of your Field Protocols and all data they contain securely in centralized servers. With our Multi-Site Studies Program, you are able to share protocol data with other sites in your research study. Results, Questionnaires, and Participant Summaries can all be transferred between sites to ensure the most accurate and up-to-date information is collected. CERTAS Library is a web site containing field protocols that have been put into the public domain. It provides a starting point for the design of your own field protocols and allows importation of the template protocols into your CERTAS Desktop program.

KEY FEATURES:

FIELD PROTOCOLS:

Questionnaires - Questionnaires are groups of questions (or Items) that will be administered to study participants. Items within a Questionnaire are ordered by the responses that a subject may give. They can be created in a linear order, where only one set of questions are asked to all participants, or in more complex fashion, where different questions are asked depending on answers to prior questions. CERTAS supports this complex ordering through the use of branching where a particular question can branch to subsequent questions depending on subject responses.

Participants - The second major group of information contained in a Field Protocol is the list of study participants that will use hand-held devices to enter data and take Questionnaires. You define all of the participants who will have the Questionnaires within a Field Protocol administered to them. Participants are defined by two key pieces of information: a Participant Code, or numeric ID for each participant, and by the type of device that the participant will use to complete Questionnaires (either a Palm or Cell Phone).

Results - Field Protocols also group all results collected from study participants into a common pool of data that can be exported at any time to another system for data analysis. CERTAS exports data in CSV (Comma Separated Value) format, which can be read by data-analysis tools. You can export collected data from CERTAS to another tool at any time. Results are categorized within CERTAS by the source questionnaire to which they are related. CERTAS contains a Result Viewer window that allows you to perform preliminary data analysis, including sorting and grouping of the data in complex ways.

QUESTIONNAIRES:

CERTAS allows you to construct Questionnaires using two methods: The Questionnaire Wizard or The Visual Designer.

The Questionnaire Wizard - CERTAS contains a wizard that walks you through the process of creating a new Questionnaire from scratch. The Wizard prompts you to fill out all of the information necessary to create a working Field Protocol, and allows you to use all of the available question or item types within your new Questionnaire. The Wizard is limited to creating "linear" questionnaires, presenting the same set of items to a study participant regardless of answer type.

The Visual Designer - The CERTAS Visual Designer allows you to drag and drop one of nine Item types from a Palette onto a Design Surface, as shown in the figure below. Using this drag-and-drop approach, you can create complex Questionnaires that describe different sets of questions to administer based on participant's responses to previous items. For example, the Binary item type allows you to ask Yes/No type questions. If the subject answers "Yes" to the question, then one set of subsequent questions can be asked. If the subject answers "No" to the question, then the user will be prompted with a different set of questions. Questionnaires support nine different Item types, including:

  • Instructions - This item presents a Participant with instructions for answering questions in the questionnaire.
  • Binary – It gives the Participant the option to answer Yes/No, True/False, Present/Absent, and other kinds of questions with this Item type.
  • Multiple Choice - Allows you to create multiple choice answers
  • Text - Allows you to ask questions that are answered with text-based responses, such as "What is your name?"
  • Numeric - Allows study participants the ability to enter free-form numeric answers, such as a response between 1 and 1,000.
  • Integer Scale - Presents a study participant with a numeric scale to choose a numeric response. You can set the scale limits anywhere between 0 and 10.
  • Time/Date - Allows you to ask questions requiring a time, date, or time and date response.
  • Visual Analog - Presents the study participant with a Visual Analog Scale, which allows the participant to mark visually a numeric response using limits that you design.
  • End Items - Ends the questionnaire. These item types allow you to record where a participant ended his or her questionnaire. You may also designate that each of these items can be answered as "I don't know" by the subject.

ALERTS:

The CERTAS Palm application supports Alerts, a feature where the user is prompted to complete a Questionnaire at a specific time of the day. At times that you specify, the subject’s device (e.g. Palm) will produce an auditory alert, launch the CERTAS Palm application, and display the first item of the Questionnaire on the device. CERTAS supports a number of different Alerts types, including: Scheduled Alerts, Custom Schedule per Device Alerts, Fixed Interval Alerts, Random Interval Alerts, and Conditional Alerts.

Scheduled Alerts will prompt the subject to complete the questionnaire at specified times each day. You create a schedule with the specific times during the day and days of the week that the prompt should occur.

Custom Schedule per Device Alerts are similar to Scheduled Alerts, but allow you to customize the schedule for each device. You define a default schedule that applies to all devices, and then tailor the schedule on each device as needed.

Fixed Interval Alerts will prompt the subject to complete the questionnaire at a specified interval of time between each alert (e.g. every 2 hours). You set a start and end time during the day for Fixed Interval Alerts, as well as the interval between alerts.

Random Interval Alerts will prompt the subject to complete the questionnaire at a random time point within a specified interval. For example, if the random interval is set between 2 and 4 hrs., then the subject will receive an alert every 2 to 4 hrs., the exact time of which is randomly selected from all possible times within that interval. Although not purely random (e.g. the alerts are constrained by the random interval), the alerts are sufficiently random and unexpected for sampling purposes while also providing some control over the number of samples obtained each day.

Conditional Alerts allow you to make an alert for a questionnaire conditional on the subject completing another Questionnaire (the Trigger Questionnaire), or a specified branch of the Trigger Questionnaire.

PARTICIPANTS:

CERTAS supports subject confidentiality (no names, just IDs) and allows you to define each of the Participants who will have a particular Field Protocol administered to them. Each Participant in CERTAS has two key pieces of information associated with them: A Participant Code and a Device Type.

A Participant Code uniquely identifies each participant within a Field Protocol. You create this numeric code when adding each new Participant to the Field Protocol, so that it is recorded within the CERTAS Desktop application. You also enter the numeric code onto Palm and cell phone devices to identify the Participant who is using the device. The Participant Code allows you to correlate results collected from devices, such as a Palm, with the Participant who entered the data.

You also specify a Device Type for each Participant associated with a Field Protocol, such as a Palm or cell phone. Specifying the device type allows CERTAS to synchronize both the Field Protocol that should be placed on the device as well as collecting data from the device after users have completed Questionnaires.

RESULTS AND DATA EXPORT:

All data collected from hand-held devices is stored within the CERTAS Desktop application for easy reference. CERTAS contains a Results List Screen and Results View Screen that allows you to preview collected data. The CERTAS Results View Screen also allows you to perform simple data analysis, including filtering and sorting.

CERTAS allows collected data to be exported at any time into Comma Separated Value (CSV) format. CSV formatted data can be imported by most statistical analysis applications.

CERTAS is also capable of importing and exporting Field Protocols, including all Questionnaire definitions, Participant definitions, and collected Results. The import and export files can be emailed to colleagues, saved to a disk, or transferred in the same way that a word-processor document might be shared.

When importing a file into CERTAS that has been exported from CERTAS previously, you may add the imported data as a new Field Protocol, or merge the file into an existing Field Protocol. During the merge process, CERTAS will ensure that no data is lost and will prompt you if a conflict is detected. You can choose to keep both existing and newly imported data, or to keep the new or existing data only.

INPUT MODES:

CERTAS allows data to be collected electronically from study participants using one of three device types: Palm devices, Cell Phones, and Interactive Voice Response System. Collected data need not be transcribed manually, but rather the entire process of running a study in CERTAS is done electronically.

CERTAS supports data collection from Palm devices with the latest OS software installed. Data is communicated back and forth between the CERTAS Palm application and the CERTAS Desktop application residing on your computer by the HotSync process. The HotSync process works by connecting a Palm device (or Palm "cradle" that houses the Palm device) to your desktop computer using a data cable. When the Palm is connected to your computer, you press the HotSync Button on the Palm cradle or the data cable, which starts the synchronization process. During the synchronization process, CERTAS will transfer the latest set of Questionnaires onto the devices, as well as retrieve the latest set of data the subject has entered. Data collected from the device is available within the CERTAS Desktop program for viewing or export to other systems.

CERTAS supports data collection from a limited set of cell phone models and carriers. Cell phone data collection in CERTAS works by transferring collected data securely from a participant's cell phone to CERTAS Online servers. Once the data has been uploaded from cell phones on to the central CERTAS Online servers, you can download the collected results automatically using the CERTAS Desktop application. The CERTAS Mobile application does not support Alerts. Subjects must start the process for completing a questionnaire manually.

CERTAS IVR allows you to collect data from study participants who complete questionnaires by using a touch-tone telephone. Using IVR (Interactive Voice Response), study participants enter data at any time by dialing the CERTAS IVR phone number. After dialing the CERTAS IVR phone number, participants are prompted to log into the IVR system by entering a numeric user name and password that you have provided. After logging in, participants then complete questionnaires over the phone. You can then view or export the collected data for analysis.

CERTAS MULTI-SITE STUDIES:

A multi-site study in CERTAS is a study in which two or more distinct groups of researchers collect data as part of one study. Each group of researchers may be located in different geographic areas and be part of different organizations. Using CERTAS, each group of researchers establishes a CERTAS Online account, one account per research group. After CERTAS Online accounts have been established for each research group, CERTAS automates the process of sharing Field Protocols and their associated Questionnaires between groups. CERTAS also automates the process of collecting and combining data across all groups.

CERTAS LIBRARY:

CERTAS Library is a web site containing Field Protocols that have been put into the public domain. CERTAS Library provides a starting point for the design of your own Field Protocols. You can use each of the Field Protocols from CERTAS Library as you see fit. Each Field Protocol available at CERTAS Library contains at least one Questionnaire that can be used as an example or even a basis for your own work.

CERTAS Library contains Field Protocol files that are designed to be imported into CERTAS Desktop. Once you have downloaded a Field Protocol from CERTAS Library, select the Import Protocol option from the main File menu. Importing the Field Protocols downloaded from CERTAS Library stores them within CERTAS Desktop for future use.

SYSTEM REQUIREMENTS:

PC

  • Windows 98/ME/2000/XP (Home or Professional)
  • 64 MB RAM
  • 100 MB available hard disk space
  • Video resolution 800 x 600 and 256 colors

Palm

  • Tungsten E or Tungsten E2 (Recommended)
  • Palm OS 5X or above software
  • 500 KB of memory