Validation & Submission Overview

 

The Submission page is where the submitter runs the application review process and submits the application to workflow.  The application review process ensures that the application has been fully completed by performing a check of the accuracy of the application against pre-defined business rules, such as the following:

 

The submitter is able to validate or check the application at any point during the application process, even if all forms have not been completed.  Click the ‘Run Application Review’ button on the Submission page to initiate the validation check.  The first time application review is executed, the page will return a message that the application is ready for submission or, if errors have been identified, a list of issues is returned.  During any subsequent validation checks, while the application review is in progress, the screen will display the message:  “Application validation is running. Please wait…”

 

Any validation errors encountered by the system will be displayed in a list with a short description of the problem and the error type.  When the error is in a form, the name of the form is indicated and the error description is a link that will open that particular form in a separate browser window where the error can be fixed.  When there is a staffing error, the error description is a link that will open the Staff & Access page in a separate browser window where the error can be addressed. 

 

When there is an attachments error, the error description is link that will open the Attachments page in a separate browser window where a missing document can be uploaded.  The errors will remain in the list until the application review is re-run.  A check mark will indicate when the submitter has viewed a particular error.  The validation design allows the submitter to address a partial list of the errors and resume fixing errors at a later time if desired.

 

The system will indicate once the application is considered ready for submission.  The submitter can submit at the time of validation or wait until a later date.  If the user waits to submit and navigates away from the page, upon returning to the Submission page, the application must be reviewed again to ensure no changes have been made.  When the application is complete and ready for submission, click the ‘Submit’ button.  This will start the workflow sign-off process.

 

A PDF view of the entire application is available from this page by clicking the ‘View Full Application’ button.  The PDF version of the application includes all the questions and answers from the application forms, the list of study staff and the list of any attachments that were uploaded as part of the application process.  Also included are any electronic attachments, with the exception of attachment types ‘Response to Review’ and ‘Staff Certification Form’.  This PDF form can be saved and/or printed.

 

Here is a list of some validation errors that may be encountered and how they should be corrected:

Error

Resolution

Form / Type: Study Site: BWH

 

Description:  Please check your study staff list. Each performance site must have a staffed Principal Investigator.

When the Performance Site form is filled out, the performance site is selected.  For each site selected on this form, there must be an assigned study staff with a role of “Principal Investigator” or “Site Principal Investigator”.

 

Click into the error to make changes on the Staff & Access page or return to the Forms page and click into the Performance Site form, if necessary.

Form / Type: Study Site

 

Description: Each staff person must be assigned with a role.

All staff must have an assigned ‘Role’.  A staff member can be saved without a role because the user entering the application online might need to consult someone for the correct role designations, but if the protocol is submitted with any staff with a role omitted, an error will be displayed.

 

Click into the error to make changes on the Staff & Access page.

Form / Type: Staff

 

Description: Protocol must have a staffed Principle Investigator

This indicates that there has been no Principal Investigator (PI) staffed to the protocol. 

 

Click into the error to make changes on the Staff & Access page; add a study staff with a role of Principal Investigator.

Form / Type: Sponsor Funding

 

Description: The protocol must have a Primary Sponsor.  You must indicate this by answering Yes to the Primary sponsor question.

There must be at least one primary sponsor, unless sponsor type selected was “None”.

 

Click into the error to open the Forms page.  Select the appropriate Sponsor form to make the change indicating ‘primary sponsor’ (the last question on the Sponsor / Funding form).

Form / Type: Attachments

 

Description: (example) Protocol Summary must be attached.

All required attachments must be added or indicated as ‘hardcopy’.

 

Click into the error to open the Attachments page to add the information for any required attachments.

 

Steps to Validate & Submit

 

  1. Click the ‘Submission’ tab

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  3. Click the “Run Application Review” button to validate that all required fields contain data.

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  5. If there are no errors, click the "Submit” button.  If there are errors, click the error description to be brought to the form to correct the error.

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  7. Once you click the “Submit” button, the submission (new protocol or process) is automatically routed for electronic sign off using the defined rules for workflow.  You can track the progress of the sign off process by going to the Pending Applications page and clicking on the Workflow History icon in the row where the transaction appears.