AdvantageEDC SM Data System Users Guide - The EMMES ...

Production Assistance for Cellular Therapies 

(PACT) 

AdvantageEDC SM 

INTERNET DATA ENTRY SYSTEM 

USER’S GUIDE 

Prepared and Distributed by the 

PACT Coordinating Center (CC) 

The EMMES Corporation 

Rockville, Maryland 

VERSION 5.0 

DECEMBER 29, 2010

PACT 

AdvantageEDC SM (IDES) User’s Guide 

Data Coordinating Center Version 5.0 – December 29, 2010 

Table of Contents 

1 INTRODUCTION .................................................................................................................. 1-1 

1.0 The AdvantageEDC SM User’s Guide ............................................................................ 1-1 

1.1 Additional Background Material ................................................................................... 1-1 

1.1.1 Advantages of Internet Data Entry .................................................................... 1-1 

1.1.2 Functional Requirements .................................................................................. 1-2 

1.1.3 System Architecture ......................................................................................... 1-3 

1.2 Future Directions ......................................................................................................... 1-4 

1.3 Summary ..................................................................................................................... 1-4 

2 GETTING STARTED ............................................................................................................ 2-1 

2.0 Access to the Internet .................................................................................................. 2-1 

2.1 Access to the Internet Data Entry System .................................................................... 2-2 

2.1.1 Internet Data Entry System ............................................................................... 2-2 

2.1.2 User IDs/Passwords ......................................................................................... 2-2 

2.1.3 Suspicious Users .............................................................................................. 2-2 

2.1.4 User Rights ...................................................................................................... 2-2 

2.1.5 User Termination .............................................................................................. 2-3 

2.2 Navigation .................................................................................................................... 2-3 

3 LOGIN AND MAIN MENU .................................................................................................... 3-1 

3.0 Login to AdvantageEDC SM ........................................................................................... 3-1 

3.1 User ID and Password ................................................................................................. 3-2 

3.2 Establishing User ID and Password ............................................................................. 3-2 

3.3 Login ............................................................................................................................ 3-3 

3.3.1 Initial Login ....................................................................................................... 3-4 

3.3.2 Lost or Forgotten Password .............................................................................. 3-5 

3.4 Main Menu ................................................................................................................... 3-6 

3.5 Navigation Features ..................................................................................................... 3-8 

4 GENERAL GUIDELINES ...................................................................................................... 4-1 

4.0 Buttons ........................................................................................................................ 4-1 

4.1.1 Data Entry Formats .......................................................................................... 4-2 

4.1.2 Missing Value Icons .......................................................................................... 4-3 

4.2 System Messages ....................................................................................................... 4-4 

4.2.1 Consistency Checks/Field Validation Error Messages ...................................... 4-4 

4.2.2 Timeout Warnings ............................................................................................ 4-5 

4.2.3 JavaScript Error Messages ............................................................................... 4-5 

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Table of Contents 

4.2.4 Blank Out Value Messages .............................................................................. 4-6 

5 DATA ENTRY PROCEDURES ............................................................................................. 5-1 

5.0 Data Entry Notes ......................................................................................................... 5-1 

6 PRELIMINARY APPLICATION SUBMISSION ...................................................................... 6-1 

6.0 Forms and Instructions ................................................................................................ 6-1 

6.1 Preliminary Application Main Menu .............................................................................. 6-2 

6.1.1 Submitting a Preliminary Application ................................................................ 6-3 

6.1.2 Investigator Information Form ........................................................................... 6-4 

6.1.3 Product Information Form ................................................................................. 6-5 

6.1.4 Manufacturing Information ................................................................................ 6-6 

6.1.5 Regulatory Information ..................................................................................... 6-7 

6.1.6 Funding Information .......................................................................................... 6-8 

6.1.7 Supporting Documents ..................................................................................... 6-9 

6.2 Rejected/Deferred Preliminary Application ................................................................. 6-13 

6.3 Approved Preliminary Application .............................................................................. 6-13 

7 FULL APPLICATION SUBMISSION ..................................................................................... 7-1 

7.1 Clinical Application Data Screens ................................................................................ 7-3 

7.1.1 Full Application Product Information ................................................................. 7-3 

7.1.2 Large Scale Production Methodology ............................................................... 7-4 

7.1.3 Full Application Funding Information ................................................................. 7-5 

7.1.4 Clinical Trial Outline .......................................................................................... 7-6 

7.1.5 Budget Information ........................................................................................... 7-7 

7.1.6 Clinical Application Document Checklist ........................................................... 7-8 

7.2 Translational Application Data Screens ....................................................................... 7-9 

7.2.1 Full Application Product Information ................................................................. 7-9 

7.2.2 Small Scale Production Methodology ............................................................. 7-10 

7.2.3 Full Application Funding Information ............................................................... 7-11 

7.2.4 Translational Application Document Checklist ................................................ 7-12 

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1 INTRODUCTION 

Electronic data capture, using EMMES’ proprietary system AdvantageEDC SM , is a proven webbased 

data collection system that focuses on high quality data and data management efficiency. 

The AdvantageEDC SM Internet Data Entry System can be accessed from any computer connected 

to the Internet. Sites participating in studies sponsored by the Production Assistance for Cellular 

Therapies (PACT) use AdvantageEDC to submit validated data forms and receive immediate 

feedback from the PACT Coordinating Center (CC) using secure transmission technology. If you 

have questions or comments, please contact the CC at pactinfo@pactgroup.net. 

1.0 The AdvantageEDC SM User’s Guide 

This document explains the basic procedures for performing data entry over the Internet using 

AdvantageEDC. This User’s Guide provides information on accessing the software and entering 

data. Illustrations of the data entry screens, navigation buttons, and system-warning messages 

are included throughout the User’s Guide. 

For interested readers, the remainder of the Introduction section includes additional background 

material, describes the advantages of using an Internet data entry system, discusses the functional 

requirements of the software, describes the system architecture briefly and addresses areas of 

future development. 

For instructions regarding access to and use of the AdvantageEDC SM , proceed to Section 2. 

1.1 Additional Background Material 

1.1.1 Advantages of Internet Data Entry 

Advantages of an Internet data entry system include computer platform independence, 

access to current data for both the sites and the CC (read only), immediate data validation 

and real time access to project and software upgrades. 

Platform Independence: Since data entry is done entirely within the user's Web browser, 

any computer with Internet access capable of running Internet Explorer version 6.0 or higher 

can be used for entering data. IBM PCs running Windows, Windows 95, Windows NT, 

UNIX-based computers, or Macintoshes can all be used to enter data. 

Immediate Data Validation: Each field that is entered is checked immediately for format and 

validity. Error messages notify the user of invalid values that are not allowed into the 

system. 

Access to Current Data: Though data entry is done from computers at each site, the data 

reside on a computer at the CC. Each site has immediate access to its data, and the CC is 

able to read and analyze data from all sites. The time lag that occurs in a paper or fax- 

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based system (i.e., sending data forms to the CC, performing data entry at the CC, and 

distributing query reports) is eliminated. 

Upgrades: Internet data entry also facilitates the distribution of software upgrades. After the 

CC has implemented, tested, and approved a new feature, upgrade, and/or fix, any site that 

accesses the software automatically uses the newest version. 

1.1.2 Functional Requirements 

This section discusses the functional requirements of AdvantageEDC, including software 

design issues such as system access, data entry features, reporting features, data integrity 

features, application timeouts, and forms synchronization. Specific issues that relate to the 

overall security of AdvantageEDC are highlighted. 

System Access: System access is restricted by the use of user IDs and passwords. Each 

system user has a unique user ID and password created at the initial registration process 

(See Section 3.2). The only way to access the data entry system is through a login screen. 

A user is allowed into the system only after entering a valid user ID/password combination. 

Other screens do not function if the user has not logged in properly. Accessing the system 

through a single login page is an important security feature of AdvantageEDC. 

Upon successful login, information regarding the user (e.g., full name) is loaded from a user 

information database. The date, time, and IP (Internet Protocol) address of the user's 

computer is captured at login. The user's name is displayed on every screen accessed 

while using the system. This process is helpful to identify who is working on the system 

(e.g., if a user leaves the computer temporarily to obtain information needed for data entry). 

Each user is limited to viewing forms from his/her applications. Specific functions may be 

restricted to certain users. Capturing login information, displaying the user's name, and 

restricting access to certain functions are significant security features of AdvantageEDC. As 

an additional security feature, if necessary, it is possible to restrict specific users to 

accessing the software from specific IP addresses (e.g., ability to access the software only 

from a specific computer). 

Data Entry Features: Several data entry features facilitate finding and entering valid data. 

Users are able to page through data forms for all products entered into AdvantageEDC by 

clicking appropriate buttons located on the data screens. In addition, users are able to 

modify existing data forms, delete forms, reenter data if required to correct information, and 

attach data files to provide supporting information for preliminary applications. As the form 

is saved, other key databases are updated as necessary. 

Reporting Features: Reports generated on data entered in AdvantageEDC reflect the up-tothe-minute 

status of the data. If a form has just been added or modified, the changes are 

reflected in a freshly generated report. 

Data Integrity Features: Each data field entered is validated during the data entry process. 

Some fields are checked for format (proper date, time, or numeric format) and values (in the 

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expected range). Other fields are restricted to a list of valid choices. All data entered also 

have an audit trail (i.e., every time a record is added, modified, or deleted, the current user, 

date, and time is recorded). Upon modifying a record, changes to individual fields are 

tracked. Users are notified if a value entered is out of the defined ranges and are asked to 

confirm that the value is correct. 

Application Timeouts: Every time a user accesses AdvantageEDC, the application server at 

the CC tracks information concerning the user’s session. If AdvantageEDC has been idle 

for a specified period of time (e.g., 20 minutes), the user is logged out of the application 

automatically and is forced to log in again to continue using the system (See Section 4.2.2). 

This feature prevents an unauthorized user from being able to view, add, or modify data in 

the event that the authorized user has left the computer without logging out. Application 

timeouts are another significant security feature of AdvantageEDC. 

1.1.3 System Architecture 

This section discusses the three-tiered nature of the system architecture and server 

configuration issues, such as web server, encryption, application server, and data access. 

Three-tiered Architecture: There are three independent tiers on which AdvantageEDC 

operates: The computer used at the site is referred to as the client; the CC computer that 

contains the data entry web pages is referred to as the server, and the CC computer that 

contains the database files is referred to as the database server. The client can be any 

computer connected to the Internet capable of running Internet Explorer 6.0 or higher. 

Interactive processes, such as prompts about improperly formatted data or out-of-range 

data, occur on the client. When the user clicks a button or a link on a page, an action is 

triggered on the server. The server sends the appropriate pages to the client. The server 

also sends the data entered on the client to the database server. All access to the database 

files is through communication between the server and the database server. The data are 

then sent to the client when the next page is generated dynamically. The server and the 

database server can be located on the same computer or on different computers. The 

server communicates between the client and the database server. The client cannot 

communicate directly with the database server. 

CC Web Server: The web server software allows connection to the server by other 

computers via the Internet. The currently installed web server is the Microsoft Internet 

Information Server. The web server software can be changed or upgraded as system usage 

increases without affecting the functioning of the data entry software. 

Encryption: All data transferred between the client and the servers across the Internet are 

encrypted using Secure Sockets Layer (SSL) technology. Encryption is another important 

security feature of AdvantageEDC. 

CC Application Server: The application server controls all interaction between each client 

and the server. The application server used is Java. The Java application server 

dynamically generates each page the user sees. The application server keeps track of all 

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relevant information during a data entry session and it is the application server that connects 

to the actual data files. The application server enables several of the security features 

mentioned throughout this system discussion. 

Data Access: Access to the database files is through a Java Database Connectivity (JDBC) 

connection. The JDBC connection allows the application server to read and write data in 

the database files. The database files can be accessed only through the application server 

and are not visible directly from the Internet. Connecting to the data files through the 

application server is another important security feature of AdvantageEDC. 

1.2 Future Directions 

Other features that are not part of the current version of AdvantageEDC can be added as the 

system is further developed. 

1.3 Summary 

Implementing data entry processes on the Internet for PACT projects allows the study sites to 

submit validated data forms and receive immediate feedback from the CC in a secure environment. 

Internet data entry is faster and more efficient and gives the applicants greater access to the data 

collected on their products. 

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2 GETTING STARTED 

2.0 Access to the Internet 

For best performance, use Internet Explorer 6.0, Firefox 2.0, or Safari 3.1 or higher. If the user is 

unsure of what browser version he/she is currently using, click HELP from the menu of the browser 

to determine the current version. If no browser is installed on the user’s machine, he/she should 

arrange to have Internet Explorer installed and then proceed. 

For Internet Explorer Users: When using Internet Explorer to access the software, the user should 

verify that his/her machine is storing the newest version of stored pages at every visit to the page 

by selecting Tools then Internet Options from the drop down menu. From the General tab under 

the Temporary Internet Files header, click on Settings. If there is a ◉ next to Every visit to the 

page, the user is ready to begin using AdvantageEDC. If it is not already checked, click on the 

circle then click the OK button on the Settings page and again on the General tab to close the 

window. 

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2.1 Access to the Internet Data Entry System 

2.1.1 Internet Data Entry System 

The AdvantageEDC system is available only to those individuals who have properly 

registered their e-mail address and/or have been granted user rights by the CC. After 

starting the browser program, the user accesses the AdvantageEDC software via its Uniform 

Resource Locator (URL) (i.e., its Web address). Refer to Section 3 for detailed instructions 

for accessing AdvantageEDC and performing data entry functions. 

2.1.2 User IDs/Passwords 

A valid user ID and password is required to access the system (See Section 3.1). The user 

ID identifies who is working in the system and provides a record of who is responsible for 

adding, modifying, or deleting data. This information is linked to the data in the database as 

part of an audit trail. It is very important that the user does not share his/her user 

ID/password for this reason. The user’s name appears in the header of each screen that 

he/she accesses. Users are restricted to only their applications and only to the functions 

associated with the rights the user has been granted. 

2.1.3 Suspicious Users 

If a user attempts to log into AdvantageEDC three consecutive times with the incorrect user 

ID and password, the system will automatically block this user’s access rights. If a user 

becomes locked out of the system, the CC must be notified so that the individual’s user ID 

can be unlocked to permit access to AdvantageEDC. 

2.1.4 User Rights 

Registered users have the following rights in AdvantageEDC: 

Applicant 

• Change user password 

• Enter and modify Investigator information 

• Add a new Preliminary Application 

• Enter and modify information on application data forms 

• Save and delete application data forms 

• Upload supporting documentation data files 

• Submit completed applications 

• Modify and re-submit applications 

SC Voting Member 


• Review submitted applications 

• Vote on submitted applications 

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Peer Review Member 


• View submitted applications 

• Provide reviews on submitted applications 

2.1.5 User Termination 

When the access rights to the AdvantageEDC system for a specified user need to be 

terminated, an e-mail message should be sent promptly to the CC at 

pactinfo@pactgroup.net. This message should contain the name and user ID of the 

individual whose access rights are to be removed, what sites are to be removed, and the 

effective date for this access termination to occur. Upon receipt of this notification, the CC 

will remove the access rights promptly. Prompt removal of access rights is a data security 

and integrity measure. 

2.2 Navigation 

AdvantageEDC has multiple components available to users. Once a user is logged in, he/she 

moves around the system from the Main Menu. The Main Menu is the gateway to the investigator 

information form, product application data entry forms, user administration (Change Password) 

option, and logout of the system. The computer mouse or tab button is used to move from one 

screen to another and between items on a screen. Instructions for use of these functions are 

provided in the remaining sections of this User’s Guide. 

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3 LOGIN AND MAIN MENU 

3.0 Login to AdvantageEDC SM 

To access AdvantageEDC, establish a stable Internet connection and open a browser application. 

Access the application system by navigating to the PACT Coordinating Center website home page 

at www.pactgroup.net (Figure 1). The user can bookmark this page and easily return to this 

location in the future. Click on the Applicant Login link located on the web page and the 

AdvantageEDC Login Screen will be displayed (Figure 2). 

Figure 1 

Figure 2 

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3.1 User ID and Password 

Every applicant will need to register with the PACT Coordinating Center (CC) to establish a user ID 

and password to access the application system. A unique e-mail address provided by the 

applicant serves as the user ID. The steps involved for a new applicant to register and obtain a 

temporary password are outlined in Section 3.2. 

3.2 Establishing User ID and Password 

Click on the Establish your user ID and password (Figure 3) link on the Application Login Screen to 

access the registration page. 

Figure 3 

The New User Registration Screen (Figure 4) will appear and the applicant must complete the 

required fields (listed below) designated by a red asterisk in order to successfully register. Note: 

The information entered will be used throughout the application system so make sure that is it 

accurate before clicking on the Register button. 

Figure 4 

Required Fields: 

• E-mail Address 

• Confirm E-mail Address 

• First Name 

• Last Name 

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Optional Field: 

• Phone Number 

Once all of the required fields are entered, click on the Register button to submit the information. 

If all of the information is entered correctly, an on-screen message directing the applicant to check 

their e-mail for a message from the CC that contains their user ID and temporary password will 

appear (Figure 5): 

Figure 5 

If an error in data entry occurred during the registration process, specific on-screen messages will 

appear to guide the applicant in proper data entry procedures. Once the initial registration process 

is successful, the applicant will not need to register again to submit future applications. 

3.3 Login 

The login screen prompts the user to enter an E-mail address and a Password. The e-mail 

address identifies the user with a particular site and restricts AdvantageEDC access to only that 

user’s data and the functions to which the user has been granted rights. For initial login 

procedures, see Section 3.3.1 of this User’s Guide. 

Instructions: E-mail addresses and passwords are case sensitive (i.e., it makes a difference 

whether the letters are upper case or lower case). 

• Type the E-mail Address/Username. Use the mouse or press Tab to advance to the 

Password field. 

• Type the Password. 

Use the mouse to click on Login to gain access to AdvantageEDC. If the user clicks Cancel, 

he/she will be logged out of the system automatically (Figure 6). 

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3.3.1 Initial Login 

Figure 6 

For the initial login to AdvantageEDC, the applicant will enter the e-mail address used in the 

registration process and the temporary password provided in the CC e-mail response 

following the steps outlined in Section 3.3. Upon successful login, the user will be directed 

to the Maintain User IDs page. 

Click on the Maintain User IDs link (Figure 7) to access the User Administration page 

(Figure 8) where the current password must be entered (Current Password), followed by 

the new user-defined password (New Password) and confirmation of the new user-defined 

password (Confirm New Password). 

Figure 7 

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Figure 8 

Click the Save button on the screen and the new user password will be captured in the 

application system. A link to the Main Menu (Figure 9) will appear in the upper left hand 

corner of the screen once the new user-defined password has been successfully created. 

The user can click on this link to navigate to the Main Menu and initiate the preliminary 

application submission process. 

3.3.2 Lost or Forgotten Password 

Figure 9 

If the user cannot remember or has lost his/her password information, they can obtain their 

current password via e-mail by clicking on the Forgot your password? link (Figure 10) 

located on the login screen. 

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Figure 10 

An entry screen requesting the user’s e-mail address used to initially register with the CC 

will appear (Figure 11). The user enters his/her e-mail address in this screen, clicks on OK, 

and an automated e-mail message containing the current password will be sent to this 

address. If there are any login issues, please contact the CC using the 

pactinfo@pactgroup.net email address. 

3.4 Main Menu 

Figure 11 

Once the user is logged into AdvantageEDC, the first screen he/she sees is the Main Menu, which 

is the gateway to the data entry forms required to submit a PACT application. Use the computer 

mouse and click on the appropriate link to select the desired menu option. The Main Menu is 

shown below (Figure 12). 

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Figure 12 

From the Main Menu, the user may choose the following functions: 

• Investigator Information – The Investigator Information link allows the applicant to move to 

the appropriate screen where the required investigator information is entered. This screen 

needs to be completed before an application can be submitted to the PACT Program. 

• Add New Application – The Add New Application link is used to add a new PACT preliminary 

application. Note: A user only needs to click on this link one time to add a new application. If 

an existing application needs to be finished or modified, see the Existing Applications 

information. 

• Existing Applications – Under the Existing Applications header is where all applications 

initiated by the user are located. Click on the Update button located to the right of the 

application to navigate to an application in process or for making modifications/additions to a 

submitted application ( Figure 13). 

Figure 13 

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3.5 Navigation Features 

• Extend Session 

The Extend Session option allows the user to extend the session timeout clock an additional 

20 minutes. Session time is indicated in the bottom left corner of the data entry screen (Figure 

14). Clicking Extend Session will reset the session clock to 20:00. 

Figure 14 

• Change Password 

The Change Password option allows the user to navigate to the User Administration page 

where a new password can be defined. 

• Logout 

If the user clicks on Logout, the user will exit AdvantageEDC. To reenter the application 

system, the user must log in again. If the user has changed data without saving the information 

and clicks on Logout, a message will be displayed asking the user if they are sure they want to 

leave without saving (Figure 15). Click OK to exit the system without saving the modified data 

or click Cancel to return to the screen to save the data. If no data have been changed, this 

message is not displayed. 

Figure 15 

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4 GENERAL GUIDELINES 

Common guidelines that apply to all AdvantageEDC screens are detailed below. Formspecific 

guidelines are detailed in subsequent sections. 

4.0 Buttons 

Use only AdvantageEDC navigational buttons to navigate throughout the system. Do not 

use the browser navigational buttons or the application system will not function properly. 

Note: The following navigational buttons do not appear on every screen. 

Enter Key 

Throughout AdvantageEDC, buttons are used to direct the action of the user. To direct the 

system to perform a specific function, the user may use the mouse and click on a button, or 

tab to the button and press the ENTER key on the computer keyboard. 

Save 

Once data entry on a screen is completed, the user clicks the SAVE button to save the 

entry. Data are not saved, and thus not entered into the database, unless this button is 

clicked. It is recommended that data be saved frequently in the event the user is called 

away. If the system times out before data are saved (refer to Timeout Warnings, 

Section 4.2.2), any data entered since the last save are lost, and will need to be reentered. 

Delete 

After a record has been saved, the user may delete it by clicking the Delete button. 

Logout 

This button will exit the user from AdvantageEDC. 

As the user navigates between the various pages in AdvantageEDC, navigation links are 

displayed at the top of the different pages. For example, as the user moves from the Main 

Menu page to the Investigator Information page, a link to return to the Main Menu page 

appears (Figure 16). 

Figure 16 

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4.1.1 Data Entry Formats 

Within data entry screens, the data are captured using different formats. 

Check boxes are often used when one of several pre-specified codes or options must be 

chosen (e.g., “No” or “Yes”). Only one choice is allowed (Figure 17). 

Figure 17 

Pick lists (sometimes called “drop down boxes” or “combo lists”) are used when a list of 

possible choices is provided for a data field, but the list is too long to display efficiently 

or clearly on the screen. Depending on where the data field is located on the screen, 

the pick list may display upward or downward. Click on the appropriate option. It is 

then displayed in the box. Only one choice is allowed (Figure 18). 

Figure 18 

Text boxes are used for data that must be typed in, rather than selected from a list. Text 

boxes are most commonly used to capture dates and numeric values, such as 

laboratory values (Figure 19). 

Figure 19 

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Printing Screens 

Printing screens is frequently a convenient mechanism to provide documentation of how the 

AdvantageEDC is functioning (e.g., if the user needs to report a problem with the system to 

the CC) or for internal quality assurance purposes. To print a screen, position the cursor on 

the screen and press CTRL-P (PC) or Command-P (Macintosh). A print menu displays with 

print options for the user’s local printer set-up. If an error message is displayed, the print 

screen command described above will not work. Instead, press the Print Screen button on 

the keyboard, switch to a word processor document (e.g., Word), paste, and then print. The 

user may then send it as an e-mail attachment to the CC to document a problem. 

Individual screens of the preliminary application can be printed for review or to serve as a 

hard copy source document for the applicant. Each screen of the preliminary application 

except for the Supporting Documents screen has a Print button located under the 

Application number at the top of the page. The Investigator Information screen also has 

a Print button located under the Applicant ID information at the top of the page (Figure 20). 

4.1.2 Missing Value Icons 

Figure 20 

The missing values icons are yellow circles appearing next to the questions in order to 

demonstrate which fields must be completed before a data form can be saved to the 

system. A yellow circle means that the field is required and a green check mark means that 

the field has been completed. If data are not entered for all required fields, the applicant will 

receive an error message requesting that all mandatory fields must be completed (Figure 

21). The icons for child fields display accordingly once the parent field requirement has 

been met (See Section 4.2.4). 

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4.2 System Messages 

Figure 21 

4.2.1 Consistency Checks/Field Validation Error Messages 

During data entry, the system performs validation checks on many fields (e.g., dates, times, 

and numeric values) and performs consistency checks between selected fields. If an entry 

in a field fails the validation check or if the data do not meet the specified requirements, the 

user is prompted with a message that indicates the problem. The user must resolve this 

problem by deleting the incorrect data and entering valid data in the space provided on the 

error message or performing some other appropriate action to resolve this issue. An 

example of a date consistency check is provided below (Figure 22). 

Figure 22 

The user can resolve this error by entering the correct date value in the prompt and clicking 

on the OK button. When the Cancel button is selected at this prompt, the form redisplays 

with the field blank (Figure 23). 

Figure 23 

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4.2.2 Timeout Warnings 

The application system logs the user out of AdvantageEDC automatically if there has been a 

period of inactivity lasting 20 minutes. The system displays a warning after 17 minutes of 

inactivity (Figure 24). 

Figure 24 

After 20 minutes of inactivity, the user sees the screen shown below (Figure 25) indicating 

the session has ended due to inactivity. The user must log into the application system 

again. If the user had data present on a screen and did not click Save before the timeout, 

those data are lost and must be reentered. 

4.2.3 JavaScript Error Messages 

Figure 25 

If the system suddenly becomes unresponsive and every time the user clicks the mouse the 

computer beeps, the user has a buried JavaScript error. Press Alt-F4 (PC) or Command-W 

(Macintosh) to close the browser. Then the user will see a JavaScript error box. Write down 

as much of the error message as possible (or capture as a print screen and paste it in a 

Word document, as described in Section 4.1.1) and send it as an e-mail attachment to the 

CC. Then click OK. The user will need to start his/her browser and login again to resume 

data entry. 

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4.2.4 Blank Out Value Messages 

The requirement to complete certain fields on some of the data screens is dependent on 

data entered for a previous field on the screen because of the “parent/child” relationship 

between them (Figure 26). For example, on the Regulatory Information form if a response 

of No is selected for the question “Do you have an IND for the proposed product and/or 

clinical study?”, the following question, “If no IND yet, do you require regulatory assistance 

to file for one?” is now required (Figure 27). 

Figure 26 

Figure 27 

If a “parent” field is modified, data entered in a “child” field may be “blanked out” by the 

system (i.e., deleted) depending on the new data entered for the parent. The following 

message will be displayed (Figure 28). 

Figure 28 

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5 DATA ENTRY PROCEDURES 

5.0 Data Entry Notes 

• Dates are entered as mm/dd/yyyy format on the forms used for data entry. 

• Once data for a form have been saved, the user may choose the Main Menu or the 

Application Main Menu link to select additional forms for data entry. 

• Unless otherwise specified, all data on each form are required. 

• Skip logic is in place on many of the forms that will prevent the user from entering data 

for a field that should be skipped based on the entry of the previous data field (See 

Section 4.2.4 for an example) 

• All aspects of data entry, i.e., addition of new records, modifications of data and/or 

deletion of data, are tracked in administrative databases maintained by the CC. The ID 

of the user who performs data entry and modifications, the date and time of data entry 

and data modifications are also recorded in these databases. 

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6 PRELIMINARY APPLICATION SUBMISSION 

6.0 Forms and Instructions 

This section describes special features for each form and provides specific instructions for 

completion of each form if required (Figure 29). 

Figure 29 

From the Main Menu, the user may choose the following functions: 

• Investigator Information – The Investigator Information link allows the applicant to move to 

the appropriate screen where the required investigator information is entered. This screen 

needs to be completed before an application can be submitted to the PACT Program. 

• Add New Application – The Add New Application link is used to add a new PACT preliminary 

application. Note: A user only needs to click on this link one time to add a new application. If 

an existing application needs to be finished or modified, see the Existing Applications 

information. 

• Existing Applications – Under the Existing Applications header is where all applications 

initiated by the user are located. Click on the Update button located to the right of the 

application to navigate to an application in process or for making modifications/additions to a 

submitted application ( Figure 30). 

Figure 30 

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PACT 



6.1 Preliminary Application Main Menu 

The Preliminary Application Main Menu contains links for each individual data screen that must be 

completed in order to submit a preliminary application to PACT (Figure 31). 

Figure 31 

• Add Product Information – This link allows the user to enter in information used to describe 

the type of product, relevance of this product, source of this product, and other pertinent 

details. 

• Add Manufacturing Information – This link allows the user to enter in the current SOPs 

available, reagents requirements for product manufacturing, and proposed product 

specifications. 

• Add Regulatory Information – This link allows the user to enter in the regulatory information 

required by PACT to accept an application, i.e., who will be the principal investigator, IND 

details, and DSMB status. 

• Add Funding Information – This link allows the user to submit the funding available for 

development/use of this product, product manufacturing, and proposed clinical trial. 

• Add Supporting Documentation – This link allows the user to attach relevant supporting 

documentation required by PACT for application submission. See Section 6.1.7 for detailed 

data upload instructions. 

Note: The “Add” will change to “Modify” once the user saves the data entry form. 

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PACT 



6.1.1 Submitting a Preliminary Application 

Once all six sections of the PACT Preliminary Application have been completed and saved 

into AdvantageEDC, the Submit Application button will become active (Figure 32). The 

applicant can submit his/her application by clicking on the Submit Application button and 

an automated e-mail confirming submission will be sent to the CC and the applicant. If a 

modification is made to a saved data screen and re-saved, the Submit Application button 

will update to Re-Submit Application. 

Figure 32 

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6.1.2 Investigator Information Form 

Database/Keyfields 

• Database: PP1 

• Keyfields: Applicant ID (System generated) 

Special Notes and Data Entry Instructions for Form 

• Missing Value icon appears next to all required information. 

• Form cannot be saved unless all required data fields are completed. 

• Investigator First Name, Investigator Last Name, and E-mail Address fields are readonly 

and pre-populated with data obtained during registration. 

• Ten-digit phone and fax numbers are entered without hyphens. 

Special Instructions - Key Selection: 

• None 

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PACT 



6.1.3 Product Information Form 



• Keyfields: Applicant ID and Application Number (System generated) 




• Date Submitted field is read-only and is populated with the date when the completed 

application is first submitted to the CC. 

• Date format for question “When do you anticipate starting the clinical trial?” is 

mm/dd/yyyy. 

• Skip logic preventing data entry for certain questions is used on this form. 


• None 

6-5

PACT 



6.1.4 Manufacturing Information 









• None 

6-6

PACT 



6.1.5 Regulatory Information 









• None 

6-7

PACT 



6.1.6 Funding Information 









• None 

6-8

PACT 



6.1.7 Supporting Documents 





• This form cannot be saved unless an attachment is uploaded by the user. 


• Attachments for upload need to be in MS Word, Excel, and PowerPoint, or as PDF 

files. The file size for the attachment must not be greater than 10 MB in size. 

File Upload Instructions 

Documents that will be uploaded to AdvantageEDC need to be in one of the formats listed 

above and saved to a location easily accessible on the user’s computer or network. Click 

the Upload Files link on the lower left of the screen to attach the supporting documentation 

( Figure 33). 

Figure 33 

The user is directed to a new screen where he/she can navigate to the location of the 

supporting documentation. Click on the Browse button and navigate to the location where 

the supporting documentation is saved (Figure 34). 

6-9

PACT 



Figure 34 

Click on the name of the file to select the document and then click on the Open button to 

attach this information (Figure 35). 

Figure 35 

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PACT 



The pathway for the location of the file will appear in the File field of the screen. An 

explanation of what supporting documents are attached can be provided in the Description 

field (Figure 36). 

Figure 36 

Click on the Upload button and attach the file to the data entry screen. The following 

screen will appear indicating that the file was successfully uploaded (Figure 37). Click on 

Close Window to return to the Supporting Documentation screen. Contact the CC at 

pactinfo@pactgroup.net with any file upload problems. 

Figure 37 

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The File Name, Upload Date, and File Description will populate the respective fields on 

the Supporting Documents screen. Click on the Save button to add the attached files to 

the data entry screen (Figure 38). The user can navigate back to the Application Main 

Menu and complete additional sections of the preliminary application or submit the 

application if all sections have been completed. 

Figure 38 

The attached file can be viewed by clicking on the file icon under the View option (Figure 

39) or deleted by clicking in the Delete box next to the file and clicking on Save (Figure 40). 

View File 

Figure 39 

Delete File 

Figure 40 

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6.2 Rejected/Deferred Preliminary Application 

If the PACT Steering Committee (SC) does not approve a preliminary application for submission of 

a full application, the word Rejected or Deferred will appear in the Status field for the application. 

The example shown in Figure 41 is for an application that has been rejected by the SC. The PACT 

Coordinating Center (CC) will follow up with the applicant via email with a list of questions or 

requirements that will need to be addressed in the preliminary application before it can be 

approved. 

Figure 41 

The applicant can modify the forms for the preliminary application by clicking on the Update button 

on the Main Menu and updating the corresponding data screens (Figure 42). Once all 

modifications have been completed, the preliminary application can be resubmitted to PACT for 

approval following the steps outlined in Section 6.1.1 of this manual. 

6.3 Approved Preliminary Application 

Figure 42 

If the SC approves a preliminary application for submission of a full application, the applicant will 

be instructed to log into the application system and complete the required forms for the approved 

full application. The preliminary application can be approved for the submission of a translational 

or a clinical application. A link to the appropriate set of forms required for submission of the 

approved application will appear on the Main Menu. The example in the screen capture below is 

from a preliminary application that was approved for the submission of a clinical application (Figure 

43). See Section 7 for the instructions on how to submit a full application. 

Figure 43 

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PACT 



7 FULL APPLICATION SUBMISSION 

Notification via an automated email message will be sent to the applicant when a preliminary 

application has been approved for submission of a full application. The example demonstrated in 

this User’s Guide will be the steps required for submission of a clinical application. The submission 

of a translational application follows these same basic steps. Please contact the CC at 

pactinfo@pactgroup.net with any questions about the application submission process. 

By clicking on the Update button on the Main Menu, the applicant will be directed to the 

Application Main Menu for the clinical application (Figure 44). Individual links to the six screens 

that are required for submission of a clinical application will appear on this screen. The applicant 

will need to click on each link, complete all required questions indicated by the presence of a 

yellow circle, and save each form before exiting the screen. Several of the data fields on these 

screens will be auto-populated with information from the preliminary application and cannot be 

edited by the applicant. A message for documents that need to be attached to a specific form, if 

applicable, will appear at the bottom of the data screen. An applicant should use the Application 

Document Checklist as a reference to make sure that all of the required information for the clinical 

application is being provided to PACT. 

Figure 44 

7-1

PACT 



When the applicant provides all of the required information, the Add on the links will change to 

Modify. When all of the data forms have been completed, the Submit Application button will be 

available. Click on the Submit Application button to send the full application to the PACT 

Program for approval (Figure 45). 

Figure 45 

An automated email message indicating that a clinical application has been submitted will be sent 

to the CC and the applicant. The CC will compile all of the information submitted in the full 

application and present it to the SC for review. Once the SC has reached a consensus on the 

clinical application, the CC will send a follow up email message to the applicant indicating the 

status of the submitted application. If the clinical application needs to be modified for 

resubmission, Click on the Update button located to the right of the application number to access 

the data screens. The appropriate data screens can now be modified and the application resubmitted 

to the CC by clicking on the Submit Application button. 

7-2

PACT 



7.1 Clinical Application Data Screens 

The data screens that comprise the complete clinical application are shown in Sections 7.1.1 – 

7.1.6. 

7.1.1 Full Application Product Information 


• Database: FA2 





• Certain fields are pre-populated with data from the preliminary application and are 

read-only fields that cannot be edited by the applicant. 


• Data files can be attached to this screen. See Section 6.1.7 for file upload 

procedures. 

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7.1.2 Large Scale Production Methodology 










procedures. 

7-4

PACT 



7.1.3 Full Application Funding Information 










procedures. 

7-5

PACT 



7.1.4 Clinical Trial Outline 









procedures. 

7-6

PACT 



7.1.5 Budget Information 









procedures. 

7-7

PACT 



7.1.6 Clinical Application Document Checklist 








• None 

7-8

PACT 



7.2 Translational Application Data Screens 

The data screens that comprise the complete translational application are shown in Sections 

7.2.1 – 7.2.4. 

7.2.1 Full Application Product Information 







• Certain fields are pre-populated with data from the preliminary application and are 

read-only fields that cannot be edited by the applicant. 



procedures. 

7-9

PACT 



7.2.2 Small Scale Production Methodology 









procedures. 

7-10

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7.2.3 Full Application Funding Information 


• Database: FAA 








procedures. 

7-11

PACT 



7.2.4 Translational Application Document Checklist 


• Database: FAB 






• None 

7-12

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