Attachment 1 - SOW_PV Works.pdf

Food and Drug Administration (FDA)

Center for Veterinary

Medicine (CVM)

Consolidate PVWorks Functions With FDA Adverse

Event Monitoring (AEM) Support

Statement of Work (SOW)

Table of Contents

1. BACKGROUND

2. PURPOSE

3. GOALS and OBJECTIVES

4. SCOPE

5. TASKS

5.1 Technical Consultation Support

5.2 Knowledge Transfer Support

5.3 Documentation Support

5.4 Document Repository Migration Support

5.5 Data Analysis Support

SECTION C – STATEMENT OF WORK

1. BACKGROUND

FDA’s Center for Veterinary Medicine (CVM) mission is to protect human and animal health by approving safe and effective products for animals, and by enforcing the applicable provisions of the Federal Food, Drug and Cosmetic Act, and of other authorities.

To achieve this mission, CVM:

A. Ensures animal drug is safe and effective before approving it. The center approves animal drugs for companion (pet) animals, such as dogs, cats, and horses; and for food-producing animals, such as cattle, pigs, chickens, and even honeybees. If the drug is for a food-producing animal, before approving it, the center also makes sure that food products made from treated animals—meat, milk, eggs, and honey—are safe for people to eat.

B. Monitors the safety and effectiveness of animal drugs on the market.

C. Ensures animal food—which includes animal feed, pet food, and pet treats—is safe, made under sanitary conditions, and properly labeled.

D. Ensures a food additive used in animal food is safe and effective before approving it.

E. Conducts research that helps the center ensure the safety of animal drugs, animal food, and food products made from animals.

F. Helps make more animal drugs legally available for minor species, such as fish, hamsters, and parrots; and for minor (infrequent and limited) uses in a major species, such as cattle, turkeys, and dogs.

CVM's Office of Surveillance and Compliance (OSC) is responsible for regulating marketed animal drugs and animal devices for safety and effectiveness. To fulfill the mission, CVM OSC receives and monitors adverse drug event reports for both approved and unapproved animal drugs. Legacy PV Works suite of tools (PV Express, PV Importer, PV Works, PV Admin, and PV Analyser) is the pharmacovigilance system that CVM uses for receipt and evaluation of Animal Drug Adverse Events Reports (ADEs) for both approved and unapproved animal drugs.

2. PURPOSE

The purpose of this contract is to support consolidation of adverse event monitoring functions across the FDA. Support is needed for consultation, data mapping, data validation, data export, data migration, data extraction, data transformation, data load, meetings, inquiries, demonstrations, documentation of custom functions, testing, and other support to meet the FDA objective. FDA requires support and immediate access to all technical details surrounding legacy PVWorks and PV-Admin to gain an in-depth understanding of how PVWorks meets the business needs of the FDA.

3. GOALS and OBJECTIVES CVM requires technical and consultation support for the FDA Adverse Event Monitoring System (AEMS) consolidation initiative. The Contractor shall support all activities requested to consolidate PVWorks functions with the FDA AEM system. Representative activities include, but not limited to:

• Consultations with business and FDA AEM team to support FDA’s objectives of replacing PVWorks with the AEM system.

• Integrate PVWorks data with the FDA AEM system.

• Respond to inquiries, when requested.

• Provide status reporting as requested.

• Extract and export data as requested.

The key objective of this contract is to support the FDA AEMS contractors, government staff, business, and other stakeholders in all activities, especially technical details and deliverables necessary to replace PVWorks functions with the FDA AEMS. Representative objectives include, but not limited to:

• Mapping PVWorks screens to the corresponding database structure such as table names, tag identification, tag name, field name, field type, field operator, and code list.

• Mapping PVWorks reports to database table names, tag identification, tag name, field name, field type, field operator, code list, and Crystal Reports customized for FDA CVM.

• Provide data dictionary.

• Identify and deliver list of data sources and code base.

• Provide datasets as requested.

• Extract, Transform, and Load, data as requested.

• Mapping and other artifacts related to FDA customizations, including, but not limited to, Automatic Follow up Management Process, openFDA extract query and logic, electronic 3-day FAR notifications to district offices, documents and logic behind queries and development of custom crystal reports, PV Admin roles, View Table for IERs validator, how suspect and concomitant products are handled and mapped (XML message does not specify those fields), how PV works manages batch reports from industry, and data extraction or other analytical tool that requires mapping drug event pairs to the latest versions of VeDDRA and CVM Internal Terms.

• Support all testing activities and ensure traceability, verification, and validation.

• Provide and develop scripts as requested.

• Develop test plans and support testing process and activities.

4. SCOPE

The scope of this contract is to support the FDA AEM contractors, government staff, business, and other stakeholders on all activities and deliverables necessary to replace PVWorks with the FDA AEM system.

Scope includes activities such as data mapping, data export, data integration, data migration, data transformation, testing, knowledge transfer, XML, API, Views, and SOP. The Contractor shall also verify and validate the accuracy of all data/deliverables to include supporting the FDA AEMS team in the data verification and validation process.

5. TASKS

5.1 Technical Consultation Support

The Contractor shall provide dedicated technical subject matter expert and resources familiar with the FDA veterinary system's customizations to consult and support on all areas of the contract.

Representative activities include, but are not limited to:

• Support the FDA AEM team and others as necessary to understand current system functionality.

• Support mapping, validation, documentation, consultation, and knowledge transfer of

PVWorks customizations.

• Provide consultation for District Office 3 Day Field Alert Report process.

• Analyze and decompose FDA AEM tasks/requests into system requirements.

• Develop mapping documents to COR/GTL, business, and FDA AEM team for review 5 business days after kick-off meeting.

• Update/Finalize deliverables after 5 business days after receipt of FDA AEM/governments’ comments.

• Work with the FDA AEM team, business and other stakeholders to validate deliverables.

• Consultation services - Support for the new vendor's technical team to understand current system functionality.

• Support comprehensive understanding of application connections and data flow.

• Demonstrate PVWorks, PV-Admin, PV-Agent, PV-Analyser, and other PVWorks modules as requested including, but not limited to, walkthrough system functionality, address questions from technical SME’s, provide diagrams, demonstrations, customizations, etc.

• Support testing activities and artifacts, to include developing automated test scripts.

5.2 Knowledge Transfer Support

The Contractor shall support the transfer of PVWorks knowledge to the FDA AEM contractors and government staff. Representative activities include, but are not limited to:

• Knowledge sharing sessions with Testers to discuss the approach, review test scripts for the “as-is” system, and gain agreement/assistance in running the “as-is” baseline with the selected inputs.

5.3 Documentation Support

The Contractor shall support the delivery of all documentation as tasked. Representative activities include, but not limited to:

• Sample copies of the output from all PVWorks modules and a general business description of what the application does, timing and type of updates, and data pain issues to include in testing.

• The contractor shall document custom functions, to include but not limited to detailed specifications of all custom queries, Crystal Reports, business rules, workflow processes, and data validation logic currently implemented. This would include import of dynamic 1932a forms, automated follow-up managements processes, CVM 3-day FAR, openFDA extract process, integration with IERS and/or DERS or any other FDA CVM customizations.

• The Contractor may be requested to use FDA supplied templates. If an FDA template does not exist, the Contractor may be tasked with drafting a template for approval by the COR. For tasks areas that are governed by the FDA EPLC, the Contractor shall ensure that all system documentation is complete and up-to-date as required. The Contractor shall consult with the COR, or COR designee to clarify the EPLC artifacts, when requested. The required artifacts depend on the task. Furthermore, the Contractor shall ensure that artifacts are updated with the feedback received from the FDA AEM team.

• Document custom field mapping and definitions.

• Document all custom reviewer fields, their data types, validation rules, and relationships to other system components.

• Document query library transfer to provide source code or detailed specifications for all custom reports, searches, and analytical queries used by veterinary reviewers.

• Document database schema’s to include, but not limited to, entity relationship diagrams.

• Document all ETL’s including in-built ETLs, map data, document, and code.

• Document how data is pushed to openFDA including, but not limited to, ETL’s used, etc.

• Provide data dictionary including, but not limited to, data element names, data types, and units.

• Provide automated test scripts.

• SRP XML mappings and information.

• Summaries of regulatory standards, as they apply to data handling.

• Document test plan as requested.

• Document user roles and permissions.

• Document data sources and elements.

5.4 Document Repository Migration Support

The Contractor shall support migration of all attachments and XML messages

5.5 Data Analysis Support

The Contractor shall provide all data analysis and management support including, but not limited to, mapping, extraction, transformation, demonstration. Representative tasks include, but are not limited to:

• Prepare PVWorks data for migration

• Provide gap analysis, as requested

• Ensure data integrity and quality

• Analyze and extract all FDA PVWorks customizations

• Analyze, document, respond to inquiries, provide functions, and map PVAnalyser

5.5.1 Data Cleanup Support

The Contractor shall support data cleanup tasks such as VeDDRA coding population of mandatory fields, code list harmonization, and adherence to existing standards.

The Contractor shall support overall data cleanup activities as requested.

The Contractor shall also provide information, demo, and consultation as requested about the PV-Works analytics platform.

5.5.2 Data Mapping Support

The Contractor shall map all PVWorks data as tasked. Representative activities include, but are not limited to:

• The contractor shall map PVWorks screens and reports to database tables, fields, etc.

• The contractor shall provide data-mapping documents in the file formats XLSX, CSV, PDF, XML, or as requested

• The contractor shall map PVWorks reports to the database table name, tag identifier, tag name, field name, field type, metadata, etc.

• The contractor shall extract and export datasets when requested

• Provide sample XML files

• Excel file that describes the tags, data values, description, and how it is mapped to the current

UI

• Provide list of all fields from the current user interface (UI), limits, if they map from the XML, and if not provide tag name

• Provide UI screenshots

• Provide custom tables, fields, field types, values, limits, etc.

• Map in-built ETL’s to include data, documents, and code

• Contractor shall map 1932A fields in XML format

• Contractor shall clarify existing business rules on source data set

5.5.3 Data Transfer Support

The Contractor shall assist the FDA AEM contractors and government staff with PVWorks data transfer from PVWorks to the receiving system. Representative activities include, but not limited to:

• Provide data dictionaries

• Subject matter expert availability - Dedicated technical resources familiar with the veterinary system's customizations for consultation during the migration period

• Provide system architecture documentation - Database schemas, integration points, user interface specifications, and any APIs or data feeds

• Provide API documentation, including endpoints, formats, authentication methods, error resolution, and rate limits

5.5.4 Data Extraction Support

The Contractor shall extract data to include providing the script or SOP used to scrape 1932A form.

Representative tasks include, but are not limited to:

• Map and extract data to include specifying all adverse event data, including historical records, case narratives, coded terms, reporter information, and associated metadata that must be extracted in standardized formats

• Validate and Verify data integrity - Require the vendor to provide checksums, record counts, and validation reports to ensure complete and accurate data transfer

• Provide deliverables/outputs in the required output formats including, but not limited to, output formats (e.g., XML, CSV, database dumps) and any specific schemas or standards the receiving system requires

5.5.5 Data Import Support

The Contractor shall support all data import activities and data transfer to systems, as requested.

5.5.6 Data Integration Support

The Contractor shall provide data integration support to the FDA AEM team and business.

Representative activities include, but not limited to:

• Perform integration requirements analysis, implementation, and support

• Provide API, Views, and others as requested

• Provide integrations, libraries, and API-interfaces