Standard Operating Procedure for the Data Update Process. June 5, 2014 Version 2.0

Transcription

1 Standard Operating Procedure for the Update Process June 5, 2014 Version 2.0

2 Table of Contents I. INTRODUCTION...1 II. PURPOSE AND SCOPE...1 III. ROLES AND RESPONSIBILITIES...1 IV. PROCESS ENABLERS...2 V. DATA UPDATE PROCESS...3 A. DATA UPDATE PROCESS FLOW... 3 B. DATA UPDATE PROCESS DESCRIPTION Verify Source Availability Verify/Modify ETL Process Extract from Source Systems Transform and Load into MSCDM Test and Validate ETL; Consult with the MSOC as Needed Answer Quality Analyst Questions as Needed Perform Quality Review and Characterization Update the Update Schedule and Update Tracker... 5 SOP for Update Process v2.0 - i - June 5, 2014

3 I. INTRODUCTION Mini-Sentinel is a pilot project sponsored by the U.S. Food and Drug Administration (FDA) to inform and facilitate development of a fully operational active surveillance system, the Sentinel System, for monitoring the safety of FDA-regulated medical products. Mini-Sentinel is one piece of the Sentinel Initiative, a multi-faceted effort by the FDA to develop a national electronic system that will complement existing methods of safety surveillance. Mini-Sentinel Collaborators include and Academic Partners that provide access to healthcare data and ongoing scientific, technical, methodological, and organizational expertise. The Mini-Sentinel Coordinating Center is funded by the FDA through the Department of Health and Human Services (HHS) Contract number HHSF I. Given Mini-Sentinel s large number of participating organizations and scale of activity, Standard Operating Procedures (SOPs) are needed to support the project. SOPs are detailed instructions written and followed to achieve uniform performance of specific functions. They provide a basis for evaluation and improvement of processes. II. PURPOSE AND SCOPE The purpose of this document is to define the SOP for the Update process the loading of data into the Mini-Sentinel Common Model (MSCDM) format by the Partners and management of data update schedules at the Mini-Sentinel Operations Center (MSOC). This SOP adheres to the current Mini-Sentinel Statement of Principles and Policies. To review other Mini-Sentinel SOPs, please see Standard Operating Procedures on the Mini-Sentinel website. III. ROLES AND RESPONSIBILITIES Table 1 describes the roles associated with the Update process. SOP for Update Process v2.0 - i - June 5, 2014

4 Table 1: Update Roles and Responsibilities Role Name Location Description Responsibilities Technical Analyst Quality Analyst Manager Partners Partners MSOC Performs technical activities in support of data update process Tests and validates ETL Manages Update process for each Partner Verify use of the most current MSCDM specification Review updates to the MSCDM and implement required revisions Review the MSOC data review report from prior extraction, transformation, and loading (ETL) and implement required revisions Review internal system changes to modify ETL process as needed Extract, transform, and load data into MSCDM format Perform Quality Review and Characterization process Update MS Query Tool system to incorporate updated summary files Confirm that loaded data is valid and consistent with source data Monitor and report progress for data update Manage the Update Schedule Manage and resolve issues during data update process Maintain and distribute process enablers IV. PROCESS ENABLERS Process enablers are templates, forms, requirements, guidelines, and other documentation, separate from the SOP, which enable efficient management of the process. The following enablers support this SOP: Update Schedule - Document used to track Partner update schedules Update Tracker - Document used to track the Update and the Quality Review and Characterization process (i.e., tracks the completion of required process steps and who completes them) The Update Process section details how the listed Enablers will be used in this SOP. SOP for Update Process v June 5, 2014

5 V. DATA UPDATE PROCESS The Update process provides procedures for the loading of data into the Mini-Sentinel Distributed base, following the MSCDM, by the Partners and managing data update schedules at the MSOC. The processes for data extraction, transformation, and loading, review, and management are described in this document. A. DATA UPDATE PROCESS FLOW Figure 1 depicts the Update Process Flow. There are three roles in the process. Roles at the MSOC are in green and those at the Partner sites are in blue. The process is performed according to the numerical order of the process steps. Figure 1: Update Process Flow B. DATA UPDATE PROCESS DESCRIPTION The steps required for the Update process are detailed below. The participating roles for each process step are also indicated. 1. Verify Source Availability Participating Roles: Technical Analyst (at Partner) The Technical Analyst will initiate the Update process based on the Update Schedule. The Technical Analyst will verify that the original source data required for the Update is ready for the Update process. SOP for Update Process v June 5, 2014

6 2. Verify/Modify ETL Process Participating Roles: Technical Analyst (at Partner) The Technical Analyst will verify that the most current Mini-Sentinel CDM version is in place at the Partner. The Technical Analyst will review the data quality report from the prior ETL and implement changes as needed. Additionally, the Technical Analyst will review changes to source systems to determine if ETL process changes are needed prior to implementation. 3. Extract from Source Systems Participating Roles: Technical Analyst (at Partner) The Technical Analyst will extract the original source data required for the Update, from the data source system(s) at the Partner. 4. Transform and Load into MSCDM Participating Roles: Technical Analyst (at Partner) The Technical Analyst will transform and load the extracted source data into the Mini-Sentinel CDM. 5. Test and Validate ETL; Consult with the MSOC as Needed Participating Roles: Quality Analyst (at Partner) The Quality Analyst will confirm that loaded data is valid and consistent with the source data. This is performed by comparing counts and proportion in the Mini-Sentinel Distributed base (MSDD) as compared to Partner source files, visual review of graphs displaying data counts and proportions from within the MSDD, and specific review of known changes within source data to determine that these changes were correctly implemented in the MSDD as well. The Quality Analyst will consult with the MSOC as needed to discuss validation findings. 6. Answer Quality Analyst Questions as Needed Participating Roles: Manager (at MSOC) The Manager will consult with the Quality Analyst at Partners as needed to discuss validation findings. 7. Perform Quality Review and Characterization Participating Roles: Quality Analyst (at Partner) The Partner Quality Analyst will follow the procedures outlined in the Mini-Sentinel SOP for Quality Review and Characterization, which will include sharing Quality and Review output with the MSOC Manager. SOP for Update Process v June 5, 2014

7 8. Update the Update Schedule and Update Tracker Participating Roles: Manager (at MSOC) The Manager will create and maintain the Update schedule and tracker to document data update due dates and completion dates, and relevant information on the Partner s extraction, transformation, and loading process. SOP for Update Process v June 5, 2014