E2B Documentation

Appearance

WF-002: Data Processing Workflow ​

DOCUMENT CONTROL

FieldValue
WF IDWF-002
Version1.0
StatusActive

Data Processing Workflow ​

Document Control ​

Document TitleData Processing Workflow
Document Version1.0
Effective Date2023-04-24
OwnerE2B Data Processing Team

Workflow Diagram ​

┌───────────────┐   ┌───────────────┐   ┌───────────────┐   ┌───────────────┐
│   Data Input  │   │  Data Intake  │   │  Data Validation│   │  Data Output  │
└───────────────┘   └───────────────┘   └───────────────┘   └───────────────┘
        │                    │                    │                    │
        ▼                    ▼                    ▼                    ▼
┌───────────────┐   ┌───────────────┐   ┌───────────────┐   ┌───────────────┐
│  Receive data │   │ Ingest data into│   │  Validate data│   │  Export data  │
│    sources    │   │    E2B system  │   │  integrity    │   │   from E2B    │
└───────────────┘   └───────────────┘   └───────────────┘   └───────────────┘
        │                    │                    │                    │
        ▼                    ▼                    ▼                    ▼
┌───────────────┐   ┌───────────────┐   ┌───────────────┐   ┌───────────────┐
│  Categorize   │   │  Process data │   │  Resolve data │   │   Distribute  │
│   data types  │   │   as per SOPs │   │  discrepancies│   │   processed   │
└───────────────┘   └───────────────┘   └───────────────┘   │     data      │
        │                    │                    │         └───────────────┘
        ▼                    ▼                    ▼
┌───────────────┐   ┌───────────────┐   ┌───────────────┐
│   Set up data │   │   Perform QA  │   │   Finalize    │
│ transformation│   │     checks   │   │   processed   │
│    workflows  │   └───────────────┘   │     data      │
└───────────────┘                       └───────────────┘

Workflow Phases ​

Data Input ​

Objectives:

  • Receive data from various sources (e.g., regulatory authorities, clinical trial sites, etc.)
  • Categorize the received data based on data types (e.g., case reports, safety reports, regulatory documents, etc.)

Steps:

  1. Establish and maintain secure channels for data collection from different sources.
  2. Develop a data categorization schema to classify the incoming data based on its type and source.
  3. Implement automated or manual processes to route the received data to the appropriate data processing teams.

Exit Criteria:

  • All incoming data is received and categorized according to the defined schema.
  • Data routing mechanisms are in place and functioning correctly.

Data Intake ​

Objectives:

  • Ingest the received data into the E2B system.
  • Perform initial data processing and transformation as per standard operating procedures (SOPs).

Steps:

  1. Develop and maintain data intake workflows to onboard new data sources.
  2. Implement data transformation and enrichment processes to ensure data integrity and consistency.
  3. Establish quality control checks to validate the correctness of the ingested data.

Exit Criteria:

  • All received data is ingested into the E2B system.
  • Initial data processing and transformation are completed as per defined SOPs.
  • Data quality checks are performed, and any issues are identified and addressed.

Data Validation ​

Objectives:

  • Validate the data integrity and completeness within the E2B system.
  • Resolve any data discrepancies or issues identified during the validation process.

Steps:

  1. Implement comprehensive data validation rules and checks to ensure data accuracy and consistency.
  2. Develop automated or manual processes to identify and flag data discrepancies or issues.
  3. Establish a data discrepancy resolution workflow to address and remediate identified issues.

Exit Criteria:

  • All ingested data is validated and meets the defined quality standards.
  • Any data discrepancies or issues are identified and resolved.

Data Output ​

Objectives:

  • Export the processed and validated data from the E2B system.
  • Distribute the processed data to the appropriate stakeholders or downstream systems.

Steps:

  1. Develop data export workflows to extract the processed data from the E2B system.
  2. Implement data distribution mechanisms to securely deliver the processed data to the relevant stakeholders or systems.
  3. Establish notification and reporting processes to communicate the completion of the data processing workflow.

Exit Criteria:

  • Processed data is successfully exported from the E2B system.
  • Processed data is distributed to the appropriate stakeholders or downstream systems.
  • Relevant stakeholders are notified of the completion of the data processing workflow.

Success Criteria Checklist ​

  • [ ] All incoming data sources are properly integrated and connected to the E2B system.
  • [ ] Data categorization and routing processes are implemented and functioning as expected.
  • [ ] Data ingestion workflows are established, and all received data is successfully onboarded into the E2B system.
  • [ ] Data transformation and enrichment processes are in place and performing as per defined SOPs.
  • [ ] Data quality checks are implemented, and any identified issues are resolved.
  • [ ] Comprehensive data validation rules and checks are defined and applied to the ingested data.
  • [ ] Data discrepancy resolution workflows are in place, and all identified issues are addressed.
  • [ ] Data export workflows are established, and processed data is successfully extracted from the E2B system.
  • [ ] Data distribution mechanisms are implemented, and processed data is securely delivered to the relevant stakeholders or downstream systems.
  • [ ] Notification and reporting processes are in place to communicate the completion of the data processing workflow.