RPS R2 Test Case Title: D.1 Send Response to Correspondence. Example 4: Response to a Request for a meeting by Regulated Industry
Storyboard Content: The RA responds to the meeting request received from Vaccines.com to accept one of the proposed meeting times and identifies the originating correspondence identifier.
Note: This storyboard is an example of pre-submission activities, but there are other examples that would happen within a review cycle. Would this storyboard (pre-submission) require any special information?
Test Case Objective:The ability for FDA to respond to a meeting request from Regulated Industry (RI).
Test Case Description: FDA responds to the Sponsor requesting a pre-IND meeting to discuss a protocol design.
Test Case Inputs:
An initial submission unit – meeting request (pre-IND)
Correspondence ID (system generated)
Letter containing FDA acceptance of the meeting request and confirming the meeting date
Test Case Variations:Expected Results:The Sponsor receives a meeting confirmation message from the FDA containing the; submission unit (meeting letter), a relationship to the initial submission unit (meeting request), and a unique correspondence ID.
More than likely, the following fields will contain the same information Domain Area: Human Pharmaceuticals
Region: United States
Software Tools:(List the vendor, product name and version of the software tool being used to input the changes into the actual message. For example Altova, XML Spy, VS 3.0) The following fields will be completed during testing Test Date: Tester’s Name: Tester’s Email: Test Case Deviations:(Describe any unplanned deviations used to continue testing. For example: The test case description instructed you to attach an “approval letter.pdf” to the message but it was not allowed so you attached an “approval letter.doc” to continue testing) Actual Test Results:(Document whether the test passed or failed based on the Expected Results. For example: “Passed. Actual Results matched Expected Results” or “Failed. See Discrepancies and Issue Number 123456”) Test Result Discrepancies:(Document any differences between the Actual Results and the Expected Results. For example: The Expected Results stated the Regulated Industry should receive a correspondence containing submission information but submission information did not display in correspondence.)
Issue Number:(Enter the number provided by the issue-tracking software.)