2 Processing Dossier Reports

About the Templates Tab

The Dossier Template tab enables you to access report templates used to generate periodic reports (CTPR, ICH PSUR, IND, NDA). The following is an illustration of the Templates tab.

The following table lists and describes the fields and controls on this tab.

To access the template tab:

1. Select Reports -> Periodic Reports -> <Report Type>.

   
   

2. When the system opens the page for the report type you selected:

   • Locate the report and click the row to highlight it.

   • Click Modify.

     OR

     Click New Report.

     
     

3. When the application opens the report dialog box, click the Templates tab.

4. The system opens the Templates tab.

Adding a Template

A template can consist of single or multiple sections. Multiple sections enable you to assign different authors and reviewers for each section.

When it uploads the template, the application does the following:

• Opens a status dialog box to show the executing process.

• Scans the template for scripting instructions, validates the instructions, and extracts the information to be stored for later use.

  To add a template:

  1. Select Reports -> Periodic Reports -><Report Type>.

  2. When the system opens the page for the report type you selected:

     • Locate the report and click the row to highlight it.

     • Click Modify or New.

  3. When the application opens the report dialog box, click the Templates tab.

  4. When the system opens the Templates tab, click Add.

  5. When the application adds a new row in the template section:

     • Enter the section name in the text field in the Section column.

     • Enter a description of the section in the text field in the Description column.

     • Click Attach.

  6. When the system opens the Attachment dialog box:

     
     

     • Type the template file path name OR click Browse to locate and select the template file (DOC or DOCX format) to attach.

     • Click OK.

Modifying an Existing Template

When you modify a template, the application overwrites the old version of the template with the new version.

1. Select Reports -> Periodic Reports -> <Report Type>.

2. When the system opens the page for the report type you selected:

   • Locate the report and click the row to highlight it.

   • Click Modify.

3. When the application opens the report dialog box, click the Templates tab.

4. When the system opens the Templates tab, select the appropriate row you wish to overwrite and click Modify.

5. When the system opens the Attachment message dialog box:

   
   

   • Click Yes to continue modifying the template.

     OR

     Click No to abort the modify operation.

6. When the system opens the Attachment dialog box, enter the attachment name in the File Attachment field and click OK.

The system uploads the new template.

About the Group Assignment Tab

The Group Assignment tab enables you to assign particular roles to users. Any user who is not assigned a user role, cannot modify a template or a report. You can assign any of the following roles:

• Author

• Reviewer

• Author & Reviewer

The following is an illustration of the Group Assignment tab.

About the Notify Tab

The Notify tab enables you select users to receive e-mail notification of new or modified assignments. The following is an illustration of the Notify tab.

About the Owner Tab

The Owner tab enables you to designate one or more groups to own an entire periodic report. Owner groups can do the following:

• Access all authoring and reviewing functions

• Assign user access rights as defined for such roles

• Build and publish reports

The following is an illustration of the Owner tab.

Printing a Dossier Security List

On the Templates tab, you can click Print to print a list of template assignments. This is called a Dossier Security report but may also be called a template assignment list. When you click Print, the application presents the following message:

To print the current Dossier security settings, the system must save the periodic report configuration.

1. Go to the Template tab.

2. Select the appropriate template from the template list and click Print.

3. Click OK when the system displays the following message:

   To print the current Dossier security settings, the system must save the periodic report configuration.

4. The system saves the security settings and prints the Dossier Security report shown in the following illustration.

The following table lists and describes the elements in the Dossier Security report.

About the Author Tab

All the tasks required to generate a Dossier report can be performed from the Author tab in the View <template name> Template. Generating a Dossier report requires you to do the following:

• Provide report content

• Review the report

• Approve the report

• Publish the report

The following is an illustration of the Author tab.

Author Window Fields

The following table lists and describes the fields and controls in the Author window.

Author Window Usage Considerations

When entering content in the Author window, be aware of the following:

The application processes each section and stores it in the database

The Author button is available only to users that have been assigned as authors to the section.

When multiple users are assigned as author to the same section, the application will allow a single section to be "Authored" by a single author at a time.

Clicking Author enables you to navigate through the questions and user prompts from the database.

• If there are no questions for this template, the system displays No Questions Found in the dialog.

• Clicking a question enables you to select or enter the answer in the Answer text box. If the question has been answered during an earlier session, the system displays the previous answer.

The Questions Tree has two sections: Completed Questions and Incompleted Questions.

• Completed Questions - The system displays a list of all answered questions. When you answer a question, the system moves the question from the Incompleted Questions section to this section

• Incompleted Questions - The system displays a list of all unanswered questions. If you fail to answer a previously answered questions, the system moves the questions beck to the incompleted questions category.

The first part of the screen displays all the questions that have been asked in the template section.

• The first question is selected by default.

• You can scroll to view any question in the list.

The second section of the screen enables you to enter any text or select any option value as required.

Click Spell Check to check for spelling errors in a question answered in a text box.

• The system enables the Spell Check button only when you are required to enter the answer in a text box and when focus is on the text box.

• If the question requires you to select an answer from a drop-down list, the system disables the Spell Check button.

Click Close to stop the authoring process.

• If any questions have been answered, the system displays the following messages:

  By closing this window will lose any answers that have not been saved. Are you sure you want to continue?

  If you click Yes (default), the system closes the message and the Author window without saving answers that have not been saved.

  If you click No, the system closes the message box and the Author window remains open.

Click Save to save all answered questions before moving to the next question.

You can continue the authoring process at any time.

The system lists all completed (saved) questions in the Completed Question section.

You can return to a previous question and change its answer.

Select Ignore Question if you wish to skip a question. The unanswered questions remain in raw format in the body of the file itself.

• This check box is active only when a question is selected and unanswered.

Click Final to generate a final.doc/.docx for a template. A final documents replaces the questions and operands with answers from the database.

• If one or more of the questions have not been answered, the system displays the following message:

  There are unanswered questions. Do you wish to generate the final document?

  Click Yes to generate the .doc/.docx file and skip any unanswered questions.

  • If you choose this option, you will have to check out the document and answer the remaining questions manually.

  • If you click No, the Authoring window remains open for further entry.

    Any values derived from the unanswered questions will be left blank.

    Once the final has been generated, click Final to open the generated .doc/.docx file from the database.

Click Draft to generate a .doc/.docx file using the latest data from the database in a read only state. The .doc/.docx will not be saved to the database.

You can move to the next question without answering the current question.

Only one Author can enter report content at a time.

The Author process can be audited.

Entering Report Content

Use the following process to enter report content:

1. Select Reports->Compliance->Periodic to display a list of periodic reports.

2. When the application opens the list of periodic reports, locate the appropriate report and click its associated report icon.

3. Select View Argus Dossier from the pop-up menu.

4. When the system opens the Author tab for the selected report, click Author.

5. When the system opens the Author window, click the expand icon form the Incompleted Questions section to display a list of questions you must answer.

6. Click the question you want to answer to display open the Answer section, then do the following:

   • Select the answer from the drop-down list in the Answer section or enter any text as necessary.

   • Click Save to save the answers to the question.

   • Repeat steps 6a and 6b until you have answered all remaining questions.

   • Click Final to save the completed section of the report in the database.

Setting Ready for Review

Once the final has been generated, the report author can indicate whether the template section is ready for review.

1. Select Reports->Compliance->Periodic to display a list of periodic reports.

2. When the application opens the list of periodic reports, locate the appropriate report and click its associated report icon.

3. Select View Argus Dossier from the pop-up menu.

4. When the system opens the Author tab for the selected report, locate the appropriate template and click the associated check box in the Ready for Review column.

5. When the system opens the Ready for review dialog box, click Yes.

   
   

6. The system places a checkmark in the check box and enables the Check Out button.

Editing a Template Manually

Dossier enables you to use Microsoft Word to manually edit a template. Only one person can check out and edit a document at a time.

1. Select Reports->Compliance->Periodic to display a list of periodic reports.

2. When the application opens the list of periodic reports, locate the appropriate report and click its associated report icon.

3. Select View Argus Dossier from the pop-up menu.

4. When the system opens the Author tab, locate the appropriate template and click Check Out.

5. When the system opens the Check Out dialog box, type a relevant comment in the Comment field and click Download.

   
   

6. When the system opens the File Download dialog box, click Open to download a copy of the template file and open it in Microsoft Word.

   
   

7. Edit the document as required and save it.

   Note:

   You must save the document in one of the standard Microsoft Word file types (.doc or .docx). Otherwise, you will be unable to check the document in.

Undoing a Check Out Operation

Under some circumstances, you may find it necessary to reverse a check out operation. When you check a document out, the system changes the Check Out button to a Check In button as shown in the following illustration.

Note:

To reverse a check out operation

1. Go to the Author tab.

2. Locate and click the appropriate Check In button.

3. When the system opens the Check In dialog box, click Undo Checkout.

   
   
   

4. The system reverses the check out operation without saving changes you may have made to the document.

Retaining Template Versions

The Dossier application provides version control for authored templates. Checking out an authored template initiates the review process and enables you to modify a template as necessary. The Dossier application tracks the template version whether or not has is has a document management system configured for its use. In other words, if a DMS is not configured for Dossier's use, you can check out and modify templates and the system maintains an updated version of the template when you check it in. Once you check in a template, Dossier retains a version of the modified template and makes it available for later viewing by any user who has access to Dossier comments.

The following is an illustration of the Comments window. You can view the checked-in template by clicking the Version Num icon.

When checking templates in and out, be aware of the following:

• An icon identifies a document that is checked in.

• When you place the mouse cursor on the icon, the system provides the following version information:

  • Version Num: x where: x is the incremental version number.

    The system version of the document is considered Version 1 and the version number appears on the Word icon.

    When you check out the system version (version 1) and check it in again, the system updates the version number to 2.

• When you click the Word icon, the system opens the document in the correct application.

  • If you want to replace a version of the document, you must save the file locally and check out the current template and check in the historical version.

• All checked out files retain the document history.

About the Template History and Comments Log

The Comments and History dialog box provides you with information about the whether the document is checked out and who has checked it out, and how the document has been modified and who has modified it.

The following is an illustration of the Comments and History dialog box.

About the Arrange Tab

On the Arrange tab, you can change the order in which sections appear in the final report. You can also delete a section as necessary.

To access the Arrange tab:

1. Select Reports->Compliance->Periodic to display a list of periodic reports.

2. When the application opens the list of periodic reports, locate the appropriate report and click its associated report icon.

3. Select View Argus Dossier from the pop-up menu.

4. When the system opens the Author tab, click Arrange to open the Arrange tab.

5. The system opens the Arrange tab.

Arrange Tab Fields and Controls

The following table lists and describes the sections and fields on the Arrange tab.

Arrange Tab Usage Considerations

When using the Arrange tab, be aware of the following:

• Select the row and click Up or Down to arrange the report sections in the desired order for the final report.

  • If you select the first row, the system disables the Up button.

  • If you select the last row, the system disables the Down button.

• If you move reports or attachments, the system does not save them until you click Save.

  • The system displays the following message:

    The information was saved successfully

  • If you click Close to leave the screen, the system displays the following message:

    You have made changes to the Dossier report order, if you press OK, changes made will be lost.

• You can remove a section to prevent it from being included in the final build.

  • If you remove a section, the system maintains the order.

  • If the Build process is completed, the system disables the Up and Down buttons.

• You must select a row before clicking Remove.

  • If you do not select a row, the system disables the Remove button.

    When you click Remove, the system displays the following message:

    Are you sure you want to remove the highlighted row?

• When you click Remove, the system moves the selected row to the Remove Content section.

  • Click the Minimize/Maximize buttons to collapse and expand the Remove Content section.

  • Collapsing the section provides more space for the Templates / Generated Reports / Additional Content section.

  • When expanded, the Remove Content section displays a minimum of three rows.

• Click Reinstate to put a removed section back in the report.

  • You must select a row before clicking Reinstate.

  • The system disables the Reinstate button until you select the row.

  • When you click Reinstate, the system displays the following message.

    Are you sure you want to reinstate the highlighted row.

  • When you click Reinstate, the system moves the selected row to the bottom of the Templates / Generated Reports / Additional Content section.

• If the Build process has completed, the Remove and Reinstate buttons are disabled

Arranging the Sections of a Report

Use the following procedure to arrange the sections of a report.

To arrange the sections of a report:

1. Select Reports->Compliance->Periodic to display a list of periodic reports.

2. When the application opens the list of periodic reports, locate the appropriate report and click its associated report icon.

3. Select View Argus Dossier from the pop-up menu.

4. When the system opens the Author tab, click Arrange to open the Arrange tab.

5. When the system opens the Arrange tab:

   • Select a row.

   • Click Up to move the row up in the list OR Click Down to move the row down in the list.

   • Click Save.

Removing a Section from a Report

Use the following procedure to remove a section of a report:

1. Select Reports->Compliance->Periodic to display a list of periodic reports.

2. When the application opens the list of periodic reports, locate the appropriate report and click its associated report icon.

3. Select View Argus Dossier from the pop-up menu.

4. When the system opens the Author tab, click Arrange to open the Arrange tab.

5. When the system opens the Arrange tab, select a row and click Remove.

6. When the system removes the section and places it in the Remove Content section of the tab, click Save to save the changes to the report.

Reinstating a Section in a Report

Use the following procedure to reinstate a section in a report:

1. Select Reports->Compliance->Periodic to display a list of periodic reports.

2. When the application opens the list of periodic reports, locate the appropriate report and click its associated report icon.

3. Select View Argus Dossier from the pop-up menu.

4. When the system opens the Author tab, click Arrange to open the Arrange tab.

5. When the system opens the Arrange tab, go to the Remove Content section, select the section to put back in the report, and click Reinstate.

6. When the system displays the following message, click Yes to put the section back in the report.

   
   

7. When the system places the reinstate section at the bottom of the section list:

   Leave the document in its present position OR Select the row and use the Upr and Downs buttons to move the section to its correct position.

Report Generation Usage Considerations

When building a report, consider the following:

• Only the owner of the periodic report can initiate the generate process.

• The owner can initiate the build process only after all sections of the periodic report have been marked Ready for Build.

• The Build button active if the Ready for Build check box on the Author tab is checked.

• When you click Build, the system compiles the report in the order on the Arrange tab.

  • The system converts all files to PDF (if not already PDF) and adds any required header, footers, and page numbers to the report.

  • The system displays a message box with the following message:

    Your Dossier report has been submitted to final build.

  • The system saves the current arrangement before it starts the Build process.

• The Build process does the following:

  Merges all template sections into a single PDF file.

  Ignores instructional comments.

• You cannot modify a periodic report while the Dossier build process is running, and the system disables the Modify and Print buttons until the build process is complete.

• The system prevents you from moving any section on the Arrange tab while the system is building the report. The Arrange section should be grayed out and you cannot move any sections of the report.

• Once the final build is completed, the system disables the Build button.

• If you make any changes on the Arrange tab and click Save after the build is successfully completed, the system displays the following message:

  Your dossier is already built. Saving any changes will require that you rebuild the dossier again. Are you sure you want to save these changes.

  If you click Yes, the system does the following:

  • Dismisses the message.

  • Removes the existing report.

  • Enables the Build button.

  • Disables the View PDF button.

  • Disables the Publish button.

    If you click No, the system retains the existing report.

• Status Button

  • The system activates this button after you start the build process.

  • This button remains active once the build process is completed

  • If you click this button after the build process starts, the system displays the status of the build process in the standard report generation pop.

  • When you click Close on the status window, the system does the following:

    • Closes the status window.

    • Continues to generate the report.

  • The status window displays the progress of the build process.

  
  

• The system displays the following statuses, in order of occurrence:

  Dossier Report Generation Request Received

  • Status is followed by a date and time stamp for when this action kicked off the report in local user GMT offset date/time: "dd mmm yyyy HH:mm" (i.e. "02-FEB-2008 15:43")

  Dossier Report Generation Started

  • The system displays a grayed out check mark until this process starts (picked up by AG Service)

  • Once AG Service picks up the process, the system displays a date and time stamp showing when this action started in local user GMT offset date/time: "dd mmm yyyy HH:mm" (i.e. "02-FEB-2008 15:43")

  Report Converting Templates to PDF

  • The system displays a grayed out checkmark until this process starts.

  • While the process is in progress, the system displays "Processing…"

  • When the process is complete, the system displays the total processing time in minutes and the gray checkmark changes to green.

  • Processing time displays as follows: "(completed in xx min.)"

  Merging Sections before Table of Contents

  • The system displays a grayed out checkmark until this process starts.

  • While the process is in progress, the system displays "Processing…"

  • When the process is complete, the system displays the total processing time in minutes and the gray checkmark changes to green.

  • Processing time displays as follows: "(completed in xx min.)"

  Merging Sections after Table of Contents

  • The system displays a grayed out checkmark until this process starts.

  • While the process is in progress, the system displays "Processing…"

  • When the process is complete, the system displays the total processing time in minutes and the gray checkmark changes to green.

  • Processing time displays as follows: "(completed in xx min.)"

  Creating Table Of Contents and Bookmarks

  • The system displays a grayed out checkmark until this process starts.

  • While the process is in progress, the system displays "Processing…"

  • When the process is complete, the system displays the total processing time in minutes and the gray checkmark changes to green.

  • Processing time displays as follows: "(completed in xx min.)"

  Creating Final Dossier

  • The system displays a grayed out checkmark until this process starts.

  • While the process is in progress, the system displays "Processing…"

  • When the process is complete, the system displays the total processing time in minutes and the gray checkmark changes to green.

  • Processing time displays as follows: "(completed in xx min.)"

  Dossier Report Generation Completed

  • A grayed out checkmark is displayed until this process is started

  • Once the process is complete, the system displays a date and time stamp showing when this action started in local user GMT offset date/time: "dd mmm yyyy HH:mm" (i.e. "02-FEB-2008 15:43"). Errors in the build process are logged into the Safety Error Log.

  • The system displays a grayed out check mark until this process starts (picked up by AG Service)

• If an error occurs during any of the build process, a status box displays the following error message:

  "Failure, please refer to the Argus Safety Error Log for details."

  Any final build error(s) are recorded in the Argus Safety error log.

  When an error occurs, the system destroys any compiled documents. You must restart the process

View PDF Button

• Once the final build process is completed, the system enables the View PDF button.

• Click this button to display the report.

Publish PDF Button

• Once the final build process is completed, the system enables the Publish button.

• If you make changes to the report, the system disables this button until a new build process is completed.

If you make any changes in the Arrange window (i.e., move a report section up or down or add or remove a report section) after the build is completed, the following occurs:

• The system displays the following message:

  "The final dossier has been generated. Making changes now will require the report to be rebuilt. Are you sure you want to make changes?" Options OK or Cancel."

• If you click OK, the system does the following:

  • Disables the View PDF button.

  • Disables the Status button.

  • Disables the Publish button.

  • Enables the Build button.

• If you click Cancel, the system closes the message box and cancels the change action.

When the system opens the Argus Dossier Template window, only the following are enabled. All other buttons, icons, or links are disabled.

Status Button

Author Tab Section Links

• Template Section Links

• Generated Report Links

• Additional Content Links

• Header/Footer Links

Author Tab Comments Icon

• The comments are read-only, and you cannot enter new comments for the Templates Comment icon and the Header and Footer Comments icon.

Arrange Tab

• Arrange Tab Section Links including links to templates, generated reports, and additional content links

• Removed content links.

• View PDF Button

Per the regulation "Guidance for Industry, Providing Regulatory Submissions in Electronic Format - General Considerations" (1999), "the initial page of the paper document should be numbered page 1."

• Set the common profile swith to "Starting from the First Page" so that the first page of the report is page 1, no matter where the table of contents is placed on the Dossier Arrange tab.

• If page numbering is turned off, no page number prints. However, the first page of the report is considered page 1.

Publish Usage Considerations

When publishing a report, be aware of the following:

• The Publish function is available after a report has been successfully generated.

• The system will publish the report only after the report has been built.

• The system displays the status of the Publish process.

  
  

• Users can have access to information used to create the Dossier Report even after Dossier generates the report. Left-click the Status icon to the left of the submitted report and select View Argus Dossier from the menu.