10. Enter your Organization Code, Username and Password. These will be provided to you by your iAdvantage Administrator. Note that these entries are case sensitive.

11. Click on Project Manager

12. Make sure that “Add a New Project…” appears in the Find a Project box. Fill in your Project Code and Description. Use the pull down menu to define the Project Contact and Sponsor. If the entries you want do not exist in the pull down menu, click on New and create these - see next screen shots.

13. Make sure that “Add a New Company…” appears in the Find a Company box. Fill in all the fields. Click on Save New Company and wait for the green box indicating that data was saved successfully. Click on the “X” at the top right corner to exit this screen and go back to the main project screen.

14. Make sure that “Add a New Person…” appears in the Find a Company box. Fill in all the fields. Click on Save New Person and wait for the green box indicating that data was saved successfully. Click on the “X” at the top right corner to exit this screen and go back to the main project screen.

15. Once you have completed all the fields to your satisfaction, click on Save New Project.

16. Click on Add a New Study...

17. Make sure “Add a New Study…” appears in the Find a Study box.

18. Fill in all the fields. (You will have to scroll down on this screen.)

19. Click on Save New Study and wait for the green dialogue box to ensure that your data was saved successfully.

20. Next click on the Substances tab. Note - to complete entry of study data you click on the tabs in sequence from left to right I.e. General,Substances, Trials, etc. - see following screen shots.

21. Use the pull down menus to find and add test and other substances. If you do not find your formulation or other substance then add them by clicking on Active Ingredients Manager, Formulations Manager and Other Substance Manager in turn - see next screen shots.

22. From the Substances tab, clicking on Active Ingredients Manager gets you to this screen. To add an active ingredient, make sure that “Add a New Active Ingredient…” appears in the Find an Active Ingredient box.

23. Fill in all the fields. Click on Save New Active Ingredient and wait for the green dialogue box to confirm your data was saved. Then click on Return to Study Study 01 to get back to the Substances tab screen.

24. From the Substances tab, clicking on Formulations Manager gets you to this screen. To add a formulation, make sure that “Add a New Formulation…” appears in the Find a Formulation box.

25. Fill in all the fields. Click on Save New Formulation and wait for the green dialogue box to confirm your data was saved. Then click on the Ingredients tab.

26. Fill in all the fields. Click on Save Ingredients and wait for the green dialogue box to confirm your data was saved. Click on the Lot Numbers tab to fill in lot information, Or click on Return to Study Study 01 to get back to the Substances tab screen.

27. Fill in all the fields. Click on Save Lot Numbers and wait for the green dialogue box to confirm your data was saved. Click on Return to Study Study 01 to get back to the Substances tab screen.

28. From the Substances tab, clicking on Other Substance Manager gets you to this screen. To add an other substance, make sure that “Add a New Substance…” appears in the Find a Substance box.

29. Fill in all the fields. Click on Save New Substance and wait for the green dialogue box to confirm your data was saved. Click on the Lot Numbers tab to fill in lot information, Or click on Return to Study Study 01 to get back to the Substances tab screen.

30. Fill in all the fields. Click on Save Lot Numbers and wait for the green dialogue box to confirm your data was saved. Click on Return to Study Study 01 to get back to the Substances tab screen.

31. Click on the AI Of Interest. Click on Save Test Substances and wait for the green dialogue box to confirm your data was saved. Click on Save Other Substances and wait for the green dialogue box. Then click on the Trials tab.

32. Click on Add a New Trial.

33. Make sure that “Add a New Trial…” appears in the Find a Trial box.

34. Fill in all the fields. Click on Save New Trial and wait for the green dialogue box to confirm your data was saved. (Note - you do not have to go to the other tabs on this screen at this time. Data for the other tabs will be filled in automatically from data entry on other screens.)

35. Click on Add a New Trial for each new trial you wish to add. Next click on the Treatments tab.

36. Click on the Define tab to define your treatments.

37. After you fill in data for each treatment click on Add Treatment. When you have defined all your treatments, click on the Assign tab.

38. Click on the treatments you wish to assign to each trial. Then click on Assign Treatments and you will automatically be brought to the screen for the Summary tab.

39. Verify your treatment information. Next click on the Samples tab.

40. Click on Sample Number Generator.

41. Fill in your subplot. Note - this is a mandatory entry field. See the User Manual for more information. If no subplot definition exists (as in this case), you must add an entry such as “N/A” or “-” or “.” or one of your own choice.

42. Click on Add after you define each subplot. (Only one entry is required if no subplots are defined.) Click on Next>>.

43. Assign your previously defined treatments to each subplot. Click Next>>. (If no subplots are defined, all treatments should be ticked.)

44. Recommended sample types will be automatically defined by iAdvantage. Highlight the sample types you wish to remove and click on Remove. Type in sample types you wish to add and click on Add. Click on Next>>.

45. Assign your previously defined sample types to each subplot. Click Next>>. (If no subplots are defined, all sample types should be ticked.)

46. Click on Add after you define each rep. Click on Next>>.

47. Assign your previously defined sample types to each rep. Click Next>>.

48. Type in sampling events you wish to add and click on Add. Click on Next>>.

49. Assign your previously defined sample types to each sampling event. Click Next>>.

50. Assign your previously defined treatments to each rep. Click Next>>.

51. Assign your previously defined treatments to each sample type. Click Next>>.

52. Each line corresponds to a sample definition and will receive a unique sample number. Verify and edit this list as required. (For illustration, 2 samples are removed - see next screen.)

53. Once you are satisfied with the list (you have the sample definitions you want and they are in the proper order for numbering), click Next>>.

54. Fill in the information to number your samples as you require. Click Finish and you will be automatically brought to the next screen.

55. Verify your sample list. If it is not correct, you can click on Sample Number Generator to start over. Otherwise, click on the Summary tab.

56. Enter any pertinent dates and click on Save Study Dates. Note - Application and Sampling Start and Complete dates will be automatically filled in from your electronic Field Trial Notebooks (eFTN) when you import them. Click on the Labs tab.

57. Define the labs available to this study and click on Save Study Labs. If the appropriate labs do not appear, click on the General tab and then click on New under Test Facility to enter the required labs. Then, click on this tab to define available labs. Click the General tab.

59. To create and generate your eFTNs (electronic Field Trial Notebooks), click on the Notebook Generator in the Study Wizards box.

60. Fill in the required fields. Click on Save General Info and wait for the green confirmation box. Next, click on the Send To tab.

61. Fill in all applicable fields. Click on Save Send To and wait for the green confirmation box. Next, click on the Sampling Forms tab.

62. Click on the type of samples you are collecting in this study. Click on Save Sample Pages and wait for the green confirmation box. Next, click on the Remote Notebooks tab.

63. For each eFTN you wish to generate, click on Generate. This will automatically bring you to the next screen.

64. Make sure Save this file to disk is ticked and click on OK.

65. Choose where you want to save the eFTN on your computer and click Save. Note - the default location is your computer’s Desktop.

66. Once you have saved the eFTN on your computer you may view the eFTN using Advantage FTM (Field Trial Manager). Or you may attach the eFTN in an e-mail to send the eFTN to the PFI corresponding to the eFTN. Note - Advantage FTM will let you view the eFTN in the same manner as the PFI will view the eFTN. Advantage FTM is software provided, at no cost, to the PFI and to you. Since it resides separately on you computer, it will be provided to you on a self-install CD. For a list of Advantage FTM users, please go to our website at www.amagsrv.com.

67. To import an eFTN sent to you from a PFI, first go to the Trials tab of the study that contains the eFTN. Click on Edit corresponding to the eFTN you wish to import.

68. In the Notebooks box, click on Browse.

69. Define the location, on your computer, of the eFTN you wish to import. Click on Open.

70. In the Notebooks box, you will now see the path defining the location on your computer of the eFTN you wish to import. Click on Import.

71. Wait until you receive the above message confirming that your notebook was imported successfully. Click on the word “here” as indicated.

72. Note - In the Notebooks box, you will now see the date and time of the last import of this eFTN.

74. Click on Document Generator

75. Click on First Time Setup

76. Make sure “Save this program to disk” is always ticked. Click OK.

77. The default save location (recommended) for DocGenInstaller.exe is your Desktop. However, you can save it in any location on your computer, as you wish. Click Save.

78. Minimize this screen.

79. Go to where you saved DocGenInstallet.exe on your computer and double click on it

80. Make sure the Installation Folder box reads “C:\Program Files\iAdvantage Document Generator”. Click Finish. If you are asked if it is OK to create the folder iAdvantage Document Generator, click OK.

81. Get back to (maximize) this screen from your task bar. Click on Template/Table Generation.

82. You should now see a Document Generator box with Variables and Tables folders.

83. Tick Keep window on top. This should make it easier for you to use this window. You can search for Project, Study and Trial Variables by typing in Variable names into the Find box or you can just click on the folders to find the Variables. Hint - The (F1), (F2), etc. designations correspond to form numbers in the eFTN.

84. The example in this tutorial shows the creation of a reporting template from an existing word processing document. However, you can create any template you wish, from scratch, by typing your prose into a blank document and clicking and dragging variable or table names as you will see later. However, the file type for the template must always be “.rtf”. In our example, the template file name is “DocGen Example 1.rtf”. So open up an existing document you wish to use as a template. Save it as an “.rtf” file or just create a new blank “.rtf” document.

85. The concept behind creating a template from an existing document is to replace blocks of text with the corresponding variable designation for that text. For example, we wish to replace “Study 01” with the variable “Study No”. The concept for creating a new template is to place variables into your template that will report on the information you want in your document. First define the block of text that you want to replace with a variable. Then find that variable in the Variables list.

86. Next, delete the block of text you want to replace.

87. Left click, hold and drag the variable to the spot in your document where you deleted the corresponding text. Note - The variable will appear in your document with ** at the beginning and end of the variable name.

88. Next we will replace the highlighted block of text with the variable Study Title.

89. As before, delete the text and left click, hold and drag the variable Study Title to the place in your document where your text was.

90. Continue to replace other blocks of text with corresponding variables.

91. Now we will deal with a DocGen feature know as Text Variable. In the case where a variable has multiple values in a study and you wish those values to be reported not as a table but as text within a paragraph, you can create a text variable to do so. Text variables will always report multiple values as “a,b,c,d, and e”. In our case we want to report out Trial Regions as part of a paragraph.

92. First, in your DocGen window, right click on the Tables folder. Then left click on New and choose Folder.

93. Type in your New Folder Name and click OK.

94. Your new folder will now appear under the Tables folder. In this case the folder is DocGen Examples.

95. Now, right click on the new folder you just created. Then left click on New and choose Table.

96. You will now see a Table Properties screen. Even though this is the same screen used to create tables to report table format data in your document, it is also used to create text variables.

97. In the Table Name box, type in the name of your text string variable. In this case it is “Trial Regions”. Drag and drop the variable, (or use the >> button,) you wish to use as a text string expression into the box labeled Used in this table. In this case it is “Trial Region”. Tick the Create as Text String box. Click OK.

98. You will now see your text string variable under the folder you created. In this case you see the variable Trial Regions under the folder DocGen Examples. Highlight and delete the text you wish to replace with your text variable.

99. Insert your text variable where you deleted the corresponding text. In this case, the variable **STRTrial Regions**, has been inserted. Note - When you insert a string variable into your document, the “STR” prefix will always be added to the front of your variable name.

100. Now we wish to create a table to pull data in table format into our document. In this case, we wish to create a table to pull data corresponding to the above table for Test Location information.

101. First, right click on the new folder you just created. Then left click on New and choose Table.

102. In the Table Name box, type in the name of your table. In this case it is “Test Locations”. Drag and drop the variables, (or use the >> button,) you wish to pull information into your corresponding table columns into the box labeled Used in this table. In this case the variables are “Trial No, Trial Region, Trial Location, PFI Name and PFI Company”. Use the Up and Down buttons to order the variables into the column order you desire.

103. Next, click on the Table Format button and you will see the Table Format Properties dialogue box.

104. Adjust the column widths for the table you wish to create by placing your cursor over each line separating the variables, left click and hold and drag the line, left or right, until the desired column width is reached. Click on OK in the Table Format Properties box. Click OK in the Table Properties box.

105. You should now see the table you created under the folder you created. In this case we see the table Test Locations under the folder DocGen Examples. Next, in your document, delete the table you wish to replace.

106. Drag and drop your new table name into your document where you deleted the original table. Note - When your insert a table from DocGen into a document the prefix “TBL” will always be added to the table name. In this case it is **TBLTest Locations**.

107. We have now completed our template. Variables corresponding to blocks of text have been placed into the template. Text string variables and tables have been created in DocGen and inserted into our template. Now save your template on your local computer as an “.rtf” format file. In our case, we have saved our template as “DocGen Example 1.rtf” on the desktop of our local computer.

108. Now we must save the text string variables and tables we created in DocGen and upload them to the iAdvantage server to be used in the query corresponding to our template (which we will also upload later). Click on the X in the upper right corner of the Document Generator window.

109. Click on Copy/Upload Template/Table.

110. Click on Browse next to the New Tables/Text Strings File (.ADZ)

111. Locate the Variables.adz file. It should be on your local computer under your C: drive, under your Program Files folder, in a folder called iAdvantage Document Generator. Click on the file Variables.adz and then click on Open in the Choose file window.

112. You should see the path corresponding to the location of your Variables.adz file in the New Tables/Text Strings File(.ADZ) window. Click on Upload Variables.

113. Wait until the variables are imported successfully and click on the word “here”.

114. Next we have to upload our template to iAdvantage. Click on Copy/Upload Template/Table.

115. Click on Browse next to the Template file(.RTF).

116. Locate your template file. In our case it is on the desktop of our local computer and it is called DocGen Example 1.rtf. Click on your template file and then click on Open in the Choose file window.

117. You should see the path corresponding to the location of your template file in the Template file(.RTF) window. Click on Save Template.

118. Wait until your template is uploaded successfully and click on the word “here”.

119. Now we want to generate a report document on a given study using our template. Click on Document Generation.

120. Choose the corresponding Project, Study and Trial for your report. (Since our template pulls data across all trials for the given study we have chosen Use All Trials...). Click on your template. Click on Generate Document.

121. Make sure Save this file to disk is ticked. Click on OK.

122. Choose the location where you wish to save your document download. In our case, we are going to save to the Desktop of our local computer.

123. Change the document name as you wish. Note - If you add a file extension of “.rtf” the file you save can be easily opened by your word processing software. (Hint - If you have MS Word you can add “.doc” for word to open it easily.) Click on Save.

124. Go to the location where you have saved your document download. Double click on the icon.

125. And voila!. You have your document report with the information in the format you wanted.

126. In the event you wish to download a template from iAdvantage, click on the template you wish to download. Click on Download Template.

127. You will see the template displayed within your Browser window.

128. Save the template from your Browser to your local computer.

129. Note - It is recommended that you save the template with a name different than the original name of the template. There are two reasons for this; - It will prevent the accidental overwriting of the original template that you may have on your local computer. - If you make changes to the template and upload it to iAdvantage, it will be treated by iAdvantage as a new template and iAdvantage will ask for a different filename. In this case DocGen Example 1.rtf has been changed to DocGen Example 2.rtf.

130. Note - One final caution is that the template is displayed in your Browser. If you close out of this screen using the X in the upper right corner, you will be closing your Browser and will find yourself completely out of iAdvantage. You will then be required to login again. To exit this screen use the Back arrow on your Browser.

131. Using the Back arrow on your Browser will get you back to this screen. You can now continue to work in iAdvantage as you wish. Thank You for following this tutorial! If you have questions or comments, please contact us at www.amagsrv.com using the Contact Us facility.