NIH | National Cancer Institute | NCI Wiki  

Analysis / Development of Formal Requirement Statement:

Item

Description

Information/Response

Date:

(MM/DD/YYYY)


Requirement # 

a unique identifier
e.g <SemConOps Initiative>.<analysts initials><requirement number> 
Init1dbw1
(eventually linked to Use Cases)

---

Originator/Customer's Name:

Originator of the requirement, if submitter is different from originator

Larry Wright

Originator/Customer's Company:

Company Name

---

Stakeholder Community:

Enter appropriate category of stakeholder from Primary Stakeholders:  

  • Software and Application designers and architects
  • Software and Application engineers and developers
  • Scientific and medical researchers
  • Medical research protocol designers
  • Clinical and scientific research data and metadata managers
  • Clinicians
  • Patients
  • Medical research study participants
  • Broader Stakeholders: caBIG® Community WS NIH projects and related commercial COTS vendors (caEHR, SDO's (HL7, CDISC); International Collaborators (e.g NCRI, cancerGrid, China), Government and regulatory bodies (FDA, CDC, ONC)
    (view SemConOps Stakeholders description)

---

Summary/Formal Requirement Statement, by Reviewer:

Be sure to include these 3 elements in your narrative summary: as unambiguously as possible, describe (1) who (List of Actors) is interacting with the system, what the (2) business goal is and (3) how the system might support the actor's ability to achieve their goal.

Terminologists need to develop new content in EVS using the LexEVS services.   Additional contacts are:
Anne Tompkins, RN, MSN
Head, Protocol Information Office
Division of Cancer Prevention
National Cancer Institute
tompkinsa@mail.nih.gov
______________
for CTEP: Jean Zhao
Information Specialist
The EMMES Corporation
401 N. Washington Street, Suite 700
Rockville, MD 20850
E-mail: jzhao@emmes.com
Phone:  301-251-1161 x 246
Fax: 301-251-1355 
_______________
mapping requirements (CTCAE 3 => 4 mappings):
Shanda Finnigan, RN, BSN, CCRC
Operations and Informatics Branch
NCI, DCTD, CTEP
301-435-9105 

Requirement Type (required)

Analyst's assessment of the most appropriate category/type of requirement:

  • Functional: Fundamental or essential to the product - describes what the product has to do or what processing is needed
  • Nonfunctional: properties the functions must have such as performance, usability, training or documentation
    • Project constraint: schedule or budget constraints
    • *Design constraint:*impose restrictions on how the product must be designed, such as conformant to ISO 11179, utilizes 21090 or is able to work on a particular type of device
    • Project driver: business-related forces such as descriptions of stakeholders or purpose of the product/project
    • Project issue: conditions that will contribute to the success or failure of the project

---

Conflicts / Dependencies(required)
Requirements Analyst/ Business Analyst

Are there any conflicts with other requirements / use cases? 
Yes OR No - If yes, what and why?

---


  • No labels