SOP Title: SAS Requirements Specifications

SOP #: SAS-SOP #2.1

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Standard Operating Procedure

Title: SAS
Requirements SOP # SAS SOP 2.1
Specifications Issue Date: 24Apr02

Department: Clinical Information Technology Effective Date: 24Apr02

Replaces: n/a

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File name is "371711699.doc"

Document History

Version Effective Approval

Date
1.0 24Apr02 Name #1: Joshua Sharlin, Ph.D.
Title: Director, Clinical IT Dept
Signature:
Signature Date:
Name #2:
Title: Director, Quality Assurance
Signature:
Signature Date:

1. PURPOSE
These procedures describe how to specify the functions SAS programs
are supposed to perform
SOP Title: SAS Requirements Specifications
SOP #: SAS-SOP #2.1
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2. SCOPE
This SOP applies to all SAS program.

3. DEFINITIONS
3.1 SAS -- The primary computer software being used for data
management and analysis.

3.2 Responsible SAS programmer -- The party assigned the task of

writing SAS code to implement a set of requirements.

3.3 SAS co-developer -- A SAS programmer with a skill level equal to

or greater than the responsible SAS programmer.

3.1 requirement -- A characteristic that a program must possess in

order to be acceptable to the user.

3.2 specification -- A brief but detailed unambiguous statement

understandable by a user that describes what a program is to do.

3.3 structured English -- A short hand form of writing that uses

incomplete sentences and simple arithmetic notation (i.e., +, -, /. *)
and simple descriptions of database activity (i.e., combine, match,
common variable).

3.4 walk-through-- A meeting lead by the programmer and attended by

knowledgeable programmers and end-users in which a
specification is reviewed line by line to determine if it is complete
correct and easily understood.

4. RESPONSIBILITIES
4.1 The SAS programmer is responsible for writing and rewriting (as
necessary) the requirements specification.

4.2 The SAS co-developer and the end user are responsible for
reviewing the requirements specification.

5. REQUIREMENTS
5.1 All programming personnel are required to receive training on SAS
development related SOPs.
SOP Title: SAS Requirements Specifications
SOP #: SAS-SOP #2.1
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5.2 Requirements specifications are a prerequisite to program design

and coding activity.

5.3 After final sign-off by the end user, requirements specification for
the program are stored as part of the program documentation.
This documentation will also contain program listings, test results
and output.

6. PROCEDURE STEPS

The responsible SAS programmer is to

6.1 Determine program requirements by interviewing end-users and
examining as many sources of requirements as possible,
including:
1) Protocol and protocol amendments
2) SOPs
3) Notes from meetings and phone calls with FDA
4) Investigator's brochure
5) Annotated case report forms
6) Instructions for completing the CRF
7) Data analysis plans
8) Statistical analysis plans
9) FDA Guidelines

6.2 Create a structured diagram showing sources of data and a

general view of the flow of data within and between SAS data
steps and proc steps.

6.3 Write a statement of requirements using structured English.

6.4 Lead a walk-through explaining the program requirements.

6.5 Make corrections to the requirements specification based on

comments and corrections made during the walk-through.

6.6 Repeat the walk-through and correction process until the

requirements specification accurately and completely describes
the program requirements in a way that is understandable to the
end-user.

6.7 Sign the approval document indicating that the description of

requirements is complete and correct.
SOP Title: SAS Requirements Specifications
SOP #: SAS-SOP #2.1
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The End-User and the SAS Co-developer are to:

6.8 . Participate in the walk-through and, as necessary, correct

and improve the clarity and accuracy of the requirements
specification.

6.9 Sign the approval document indicating that the description of

requirements is complete and correct.

7. ATTACHMENTS
None

8. DELIVERABLES

8.1 Requirements specification.

8.1 Sign-off document signed by the Responsible SAS Programmer,

the SAS Co-Developer, and other parties as required, showing that
the program requirements have been reviewed and are complete
and correct.

9. REFERENCES
None.
SOP Title: SAS Requirements Specifications
SOP #: SAS-SOP #2.1
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10. EXAMPLES OF DELIVERABLES

Example of Requirements (Text)

Title: Requirements for the Calculation of Efficacy

Introduction The purpose of this document is to describe the requirements for
how the SAS analysis programs will calculate clinical and radiological efficacy .
Efficacy was described in version 4.2 of the protocol entitled A Randomized
Study of the Sharlin Device vs. Bone Autograft for the Treatment of Bone
Breaks, study number 81-01. On page 15 and 16 of the above protocol, success
and failure were defined as follows. The exact text from the protocol is reprinted
below in bold italicized type.
7.3 Criteria for Success
The treatment of break will be considered a success only if the
results of the clinical and radiographic evaluations show:
A. Full weight bearing in the affected limb.
B. Patient is not suffering from pain
7.4 Definition of Failure
A procedure will be considered a failure if:
A. if at 36 months, the patient is not full weight bearing in the
affected limb, or if the patient is suffering from severe pain in
the affected limb at 36 months after implantation
SOP Title: SAS Requirements Specifications
SOP #: SAS-SOP #2.1
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Example of Requirements (Table)

Definition of Success, Healing, and Failure

Outcome Healing Cortices
Measured as the sum of four Measured as the
variables in the SAS data set value of OvlCort in
Radio. (ApBrid, LatBrid, ObiBrid, the SAS data set
ObeBrid) Radio.
Success = Yes if 3 to 6 yes's OR 3 to 6
Healing = Yes if 1 or 2 yes's OR 1 or 2
Maybe = 0 () AND 0 ()
Yes if

() All representations of missing

values (i.e., ., -8, -9) count as
zero when calculating a sum.

SAS Variable Possible Values

ApBrid, LatBrid, ObiBrid, ObeBrid ., -9, -8, 1, 2
OvlCort ., -9, -8, 0, 1, 2, 3, 4

Example of Requirements (Table of SAS Datasets)

SAS Data Sets

SAS DS # obs / Unique Each obs represents

Name # vars Identifiers
Radio 4775 / 37 RevNum, A lab tech's evaluation of each
FilmCode film.
Proc 122 / 9 Pat1, Pat2, One treated patient. 122
ProcDate patients were treated.