Request for a meeting by Regulated Industry



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Date conversion04.09.2017
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Regulated Product Submissions R2 Test Case


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

  • Contact Information, To;

    • Contact Type = ‘Regulatory’

    • Contact Name = Sally Wilson

    • Contact Address = 1011 New Drug Ave

    • Contact Phone = 312-889-0798

    • Contact Email = sally.wilson@feelwell.com

    • Contact Fax = 312-555-1122

  • FDA Information

    • Agency = FDA

    • Center = CDER

    • Office = OND

    • Division = ODEIV


  • Contact Information, From;

    • Contact Type = ‘RPM’

    • Contact Name = Mark Gray

    • Contact Address = 10903 New Hampshire Ave Silver Spring MD 20905

    • Contact Phone = 301-796-0698

    • Contact Email = mark.gray@regulator.gov

    • Contact Fax = 301-796-1122

  • Submission information

    • Application = ??

    • Sequence Number = ??

    • Category / Subcategory = Meeting Confirmation / Protocol Design




Data elements

RPS Standard

Applicant




Application Identifier

Application.Id = 123456

Submission Identifier

Submission.Id = 0A0A

Submission Unit Identifier

SubmissionUnit.Id = ABCD

Context of use Identifier


ContextOfUse.Id=C123

Contact Type

ContactParty.Code=’Regulatory’

Contact Name

Person.name=‘Sally Wilson’

Contact Address

Person.addr =‘1011 New Drug Ave’

Contact Phone

Person.telecom[start-with,’tel’] = 312-889-0798

Contact Email

Person.telecom[start-with,’mailto’] = sally.wilson@feelwell.com

Contact Fax

Person.telecom[start-with,’fax’] = 312-555-1122

Agency




Application Identifier

Application.Id = 123456

Submission Identifier

Submission.Id = 0A0A

Submission Unit Identifier

SubmissionUnit.Id = EFGH

Context of Use


Context of Use Identifier


ContextOfUse.Id=C987

Link to Correspondance

ContextOfUse.Links.RelatedContextOfUse.Id = C123

Contact Type

ContactParty.Code=’ RPM’

Contact Name

Person.name=‘ Mark Gray’

Contact Address

Person.addr =‘10903 New Hampshire Ave Silver Spring MD 20905’

Contact Phone

Person.telecom[start-with,’tel’] = 301-796-0698

Contact Email

Person.telecom[start-with,’mailto’] = mark.gray@regulator.gov

Contact Fax

Person.telecom[start-with,’fax’] = 301-796-1122

Category

Category.code = Meeting Confirmation

Sub category

Category.Category.Code = Protocol Design


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.)




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