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Quality Management System

Overview

The Clinical Research Informatics (CRI) Quality Management System (QMS) is a set of policies, procedures, processes, and integrated applications created and implemented to meet and exceed both customer satisfaction and operational requirements. These mechanisms direct and coordinate CRI’s activities to meet regulatory standards, improve effectiveness, and foster continuous improvement in delivering our products and services.

Policies

CRI.POL-001
Clinical Research Informatics Quality Management System (QMS)

Purpose: This policy establishes the CRI Quality Management System (QMS), i.e., the formal system of structure, processes, procedures, roles, responsibilities, resources and culture deemed necessary by our organization to consistently deliver products and services meeting customer, stakeholder and regulatory requirements. The QMS is comprised of those things, tangible and intangible, necessary to meet the CRI mission.

VIEW POLICY

Effective Date: June 15, 2022
CRI.POL-002
Clinical Research Informatics Human Resources Management Lifecycle (HRMLC)

Purpose: This policy specifies the personnel or Human Resource Management Lifecycle (HRMLC) that we assure that CRI position and personnel management practices are aligned with the University of Texas System and local institutional human resource management policies and procedures and through which we ensure that individuals performing the Clinical Research Informatics (CRI) tasks are qualified by education, training, and experience for the tasks they perform and grow professionally through job training and experience.

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Effective Date: June 15, 2022
CRI.POL-003
Clinical Research Informatics Data Management Lifecycle (DMLC)

Purpose: This policy specifies and establishes the procedural controls for the Data Management Lifecycle (DMLC), i.e., the operations performed on research data from origination to disposal.

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Effective Date: June 15, 2022
CRI.POL-004
Clinical Research Informatics Software Development Life Cycle (SDLC)

Purpose: The mission of Clinical Research Informatics (CRI) at UTHSA is to support knowledge generation toward improvement in human health through provision of data, information systems, and related services to clinical investigators and research teams.

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Effective Date: June 15, 2022
CRI.POL-005
Clinical Research Informatics Project Management Lifecycle (PMLC)

Purpose: This policy is to ensure that projects undertaken by CRI further our mission of supporting knowledge generation toward improvement in human health through provision of data, information systems, and related services to clinical investigators and research teams.

VIEW POLICY

Effective Date: June 15,2022

Standard Operating Procedures

SOP Number : CRI.SOP. DMLC-001
Data Management Plan Creation and Maintenance

Purpose: The purpose of this procedure is to outline the contents of and the process for creating and maintaining Data Management Plans (DMPs) as version-controlled study-specific documentation for data managed by the Clinical Research Informatics Division (CRI) at the University of Texas Health Science Center at San Antonio (UTHSA).

VIEW SOP

Effective Date: DRAFT
SOP Number : CRI.SOP. DMLC-003
Integration of External Data

Purpose: This procedure specifies the process for the acquisition and integration of external data. The purpose of the procedure is to ensure that the acquisition of new data complies with regulations and other requirements and that consistent and appropriate procedures are followed for integrating external data with data managed by CRI.

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Effective Date: DRAFT
SOP Number : CRI.SOP. DMLC-004
Data Collection and Processing

Purpose: This procedure specifies the process for data collection and processing performed by the Clinical Research Informatics (CRI) Division. The purpose of the procedure is to assure that data collection and processing operations comply with regulations and other requirements, are systematically identified and selected, are appropriate for the risk associated with the study, are consistently applied throughout the study, and yield the necessary outgoing quality.

VIEW SOP

Effective Date: DRAFT
SOP Number : CRI.SOP. DMLC-005
Study Surveillance and Operational Reporting

Purpose: The purpose of this procedure is to outline the processes for surveillance and operational reporting for clinical studies managed by Clinical Research Informatics (CRI). Whereas data collection and processing (SOP.DMLC-003) act on and may alter individual data, study surveillance and reporting are read-only operations.

VIEW SOP

Effective Date: DRAFT
SOP Number : CRI.SOP. DMLC-006
Database Lock

Purpose: This procedure specifies the process for interim and final database lock and data snapshots. The purpose of the procedure is to assure that data processing activities are at an agreed stage of completeness and that data quality are within agreed acceptance criteria before data are provided to others or used in analysis.

VIEW SOP

Effective Date: DRAFT
SOP Number : CRI.SOP. DMLC-007
Data Release

Purpose: The purpose of this procedure is to explicitly document alignment of data release by Clinical Research Informatics (CRI) for clinical studies with applicable requirements in the University of Texas System (UT System) and the University of Texas Health Science Center (UTHSA) Handbook of Operating Procedures (HOPs) and to provide operational detail within these requirements for data release by CRI in the context of clinical studies. If a discrepancy between UT system or UTHSA HOPs and this SOP is identified, UTHSA HOPs and UT System HOPs will prevail.

VIEW SOP

Effective Date: DRAFT
SOP Number : CRI.SOP. DMLC-008
Data Archival and Public Data Sharing

Purpose: The purpose of this procedure is to outline the processes for archival and sharing of data for clinical studies managed by Clinical Research Informatics (CRI). Effective archival and sharing facilitates reuse of data by others, often individuals not involved in the original study. It is rarely sufficient to archive or share just the data. Two common reasons for reuse of data from a study are to answer questions about the research and to answer new research questions. Archiving and sharing data necessitates inclusion of additional documentation defining and describing the data in support of reuse.

VIEW SOP

Effective Date: DRAFT
SOP Number : CRI.SOP. SDLC-001
External Software Installation and Verification

Purpose: This Standard Operating Procedure (SOP) establishes the life-cycle to guide the design, procurement, configuration, customization, maintenance, and retirement of both open source and commercial offthe- shelf (COTS) software systems Clinical Research Informatics (CRI) at the UT Health San Antonio (UTHSA).

VIEW SOP

Effective Date: February 21, 2023
SOP Number : CRI.SOP. SDLC-002
Study Database Development

Purpose: This procedure describes the process for designing and developing the Case Report Forms (CRF) and associated data collection forms for data collection operations and clinical trials.

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Effective Date: May 5, 2023
SOP Number : CRI.SOP. SDLC-003
Software Development

Purpose: This Standard Operating Procedure (SOP) establishes the process of writing and deploying software.

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Effective Date: April 18, 2023
SOP Number : CRI.SOP. SDLC-004
Encryption

Purpose: This procedure describes the encryption procedures used by Clinical Research Informatics.

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Effective Date: October 24, 2023
SOP Number : CRI.SOP. SDLC-005
Access Control

Purpose: This Standard Operating Procedure (SOP) establishes processes to manage access control to CRI- managed systems, applications, and data.

VIEW SOP

Effective Date: February 28, 2023
SOP Number : CRI.SOP. SDLC-006
System Backup and Restore

Purpose: This SOP defines the steps and controls necessary to back up and restore data and systems used in CRI administrative, operational, and research operations.

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Effective Date: March 14, 2023
SOP Number : CRI.SOP. SDLC-007
System Downtime

Purpose: This Standard Operating Procedure (SOP) establishes a process to manage planned and unplanned system downtime.

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Effective Date: February 28, 2023
SOP Number : CRI.SOP. SDLC-008
System and Data Decommissioning

Purpose: This Standard Operating Procedure (SOP) establishes a process to decommission computer-based systems (applications) or data managed by CRI technical staff.

VIEW SOP

Effective Date: April 11, 2023
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