Draft Use Case Titles and Sample Descriptive Text

[averbacj@ls-integration-partners.com]

Colleagues,
Following up on our discussion of May 27 please find below a draft list of possible Use Case titles.  Our objective is to define 2 or 3 Use Cases and to address them in parallel with one group evaluating the set of topics required for the Use Case and another group evaluating the metadata and functionality to manage this set of topics through the Use Case process.

What we need to do:
The proposal is for the group as a whole to agree on the Use Cases to evaluate ( 2 - 3 at most) and begin work in parallel by our next monthly meeting on June 24.

To accomplish this, let's target June 14 as the date for reaching agreement on the Use Cases.  Between now and then please review and respond with your vote by number or provide additional Use Cases that you would like to see.

Draft Use Case Titles as of June 1:
1.	Creating and amending a Clinical Study Protocol Synopsis
2.	Creating and amending an Investigators Brochure
3.	Creating and amending a Periodic Safety Update Report
4.	Creating and amending a Company Core Data Sheet
5.	Creating and amending a Drug Substance Specification
6.	Reviewing and approving IB topics in the context of the entire product topic collection

Sample Use Case Description for the Clinical Study Protocol Synopsis:

A Clinical Study Protocol Synopsis is created including sections for: Sponsor, Product Name, Active Ingredient, Study Title, Number of Planned Study Centers, Phase of Development, Primary Objectives, Secondary Objectives, Brief Study Design, Planned Number of Subjects, Diagnosis and Inclusion Criteria, Exclusion Criteria, Study Drug Description, Brief Dosing and Treatment Regimen, Criteria for Efficacy Evaluation  Primary and Secondary, Brief Pharmacokinetics, Brief Statistical Methods.  Do to slow patient accrual the protocol and synopsis are amended with a change to Inclusion Criteria allowing for subjects from age 18 years or older rather than subject 30 years and older.  In a second amendment, a change is made where subjects in Country A are hospitalized during initial dosing only rather than the first 2 dosing periods.  Experience with the drug has shown this is acceptable and subjects are more willing to participate with less hospitalization required.   Subjects in Country B will continue with the original dosing regimen.