OPERATING
PROCEDURE / Document No.:20-0412_00
Title:
I.PURPOSE/SCOPE
The purpose of this standard operating procedure is to describe the life cycle development of SAS programs within the Biometry group. These programs are used to produce reports and data for regulatory agency submissions, publications, presentations, or other internal use.
This SOP does not cover SAS utilities or external SAS based vendor supplied tools used within Biometry.
II.RESPONSIBILITY
The Manager of Biometry is responsible for ensuring that all programs developed by the Biometry Group are in accordance with these procedures as well as prioritizing the program verification.
The Bioanalysts within Biometry are responsible for planning, designing, developing, implementing, and maintaining programs and documentation in accordance with these procedures.
III.REFERENCES
- Computerized Systems Used in Clinical Trials, Guidance for Industry, April 1999
- SAS Program Specification WPG
- Biometry Analysis Directory Structure WPG
- Blind/Unblinding Procedures WPG
- SAS Program Style and Good Practices Guide WPG
- SOP 20-0413_00 SAS Data Flow
- SOP 20-0410_00 SAS Program Risk Assessment Validation and Verification
- SOP 20-0409_00 SAS Program Change Control
- SOP: 50-0082_00 Data Archival
IV.DEFINITIONS
- SAS - statistical package used by Biometry to perform statistical analysis.
- Program Requester - Person requesting development of a program from Biometry and supplying specifications for the program. Requesters include Biostatisticians, Medical Writers, and members of Clinical Data Operations, Clinical Operations, Quality Assurance and PCDS.
- Program Request –A request for analysis or for data integrity checking; either the creation of analysis files, or some form of output. A program request may be for one or more analysis files, tables, listings, graphs or other output format.
- Task –A set of related programs and outputs usually for a single purpose, see the Biometry Analysis Directory Structure WPG for the definition and use of project tasks.
V.MATERIALS
VI.SAFETY NOTES (N/A)
VII.PROCEDURES
1.0Program Request and User Specifications
1.1The Program Requestor makes a Program Request of the Biometry group. It may be a single program or a task.
1.1.1If the program/task is part of an FDA submission or considered high risk, a Programming Specifications Template is created as detailed in the SAS Program Specification WPG.
1.1.2If the program/task is low risk or an ad hoc request, it does not require a Programming Specification Template but program specifications should be sufficiently detailed in program header to eliminate potential ambiguity in programming.
2.0Initialization
2.1The Manager of Biometry determines whether the request should be setup as a new task or appended to an existing task within the analysis directory structure (see the Biometry Analysis Directory Structure WPG).
2.1.1If a single program, the Manager of Biometry assigns a Bioanalyst to the request.
2.1.2If a new task, the Manager of Biometry assigns one or more Bioanalysts to the request.
2.2If the new task requires the analysis of unblinded data, the Manager of Biometry requests IS to make a Bioanalyst a user in one of the restricted Unblind directories. (see Biometry Analysis Directory Structure WPG and Blind/Unblinding Procedures WPG).
3.0Development and Risk Assessment
3.1If a new task, the Manager of Biometry or an assigned Bioanalyst follows the Biometry Analysis Directory Structure WPG to create the task directory structure and do the initial setup.
3.2The Bioanalyst(s) develops the SAS program(s) in accordance with the SAS Program Style and Good Practices Guide WPG and SOP 20-0413_00 SAS Data Flow and its related WPGs.
3.3The Bioanalyst(s) presents the output of the program(s) to the Program Requester to determine if it meets user requirements.
3.3.1If the Program Requester has changes, the Bioanalyst(s) makes revisions following the directives of the SAS Program Style and Good Practices Guide WPG then resubmits the program(s) to the Program Requester.
3.3.2Data sources may be updated numerous times during the development phase which may lead to further changes.
3.3.3When the Program Requester approves the program(s) as final, the development phase is complete.
3.4After development, a risk assessment is performed by the Manager of Biometry using the guidelines in SOP 20-0410_00 SAS Program Risk Assessment Validation and Verification.
4.0Validation and Verification
4.1The validation requirements for a program/task are determined by its risk assessment.
4.1.1High risk programs/tasks undergo a validation process with formal documentation. (see SOP 20-0410_00 SAS Program Risk Assessment Validation and Verification.)
4.1.2Lower risk programs/tasks undergo a less formal verification process.
4.2The Manager of Biometry assigns a Bioanalyst to perform the validation or verification of the program/task.
4.3The Bioanalyst follows the Verification Checklist WPG in testing the program/task.
4.4If deviations are found during the validation/verification process, the Bioanalyst uses the SAS Program Verification Deviations WPG to report and reconcile all deviations.
4.5When the program/task passes the validation/verification process, the program(s) are released for production.
5.0Change Control
5.1Procedures for changes to production programs are detailed in SOP 20-0409_00 SAS Program Change Control.
6.0Archival
6.1When the Manager of Biometry or designee has determined that the task or antibody of which the program is a part is no longer active or ongoing and is ready for archival, it will be archived according to the data procedures detailed in SOP: 50-0082_00Data Archival.
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