Work Instruction for Biostatistics Support Request Process

Title: Biostatistics Support Request Process
Document ID: WI-BSRP-001
Effective Date: [Insert Date]
Version: 1.0
Owner: Biostatistics Department
Approval: [Insert Approver Name/Title]

Purpose

To provide a standardized and FDA-compliant procedure for managing biostatistics support requests, ensuring quality, efficiency, and traceability throughout the workflow.

Scope

This work instruction applies to all biostatistics support requests submitted to the Biostatistics Department. It covers the process from request submission to post-evaluation feedback.

Responsibilities

  • Requester: Provide complete and accurate information on the support request form.
  • Biostatistics Coordinator: Oversee the intake, triage, and assignment stages.
  • Biostatistician: Conduct consultation, analysis, and deliverables preparation.
  • Biostatistics Supervisor: Ensure adherence to timelines and quality standards.

Definitions

  • Triage: The process of reviewing and categorizing requests based on feasibility and priority.
  • Deliverables: Outputs provided to the requester, including statistical reports, datasets, or visualizations.
  • Post-Evaluation: Feedback collected from the requester to assess the process and outcomes.

Procedure

1. Request Submission

  1. The requester submits a detailed support request form via the designated platform.
  2. Required Fields:
    • Study objectives and hypotheses.
    • Description of the data (e.g., “2024 survey data of 500 participants”) and statistical needs (e.g., “logistic regression analysis”).
    • Deadlines and specific deliverables requested (e.g., “results by MM/DD/YYYY, graphs for presentation”).
  3. Example:
    • A researcher submits a form requesting statistical analysis for a randomized controlled trial to test intervention efficacy.

Records Generated: Request form (electronic), tracking ID.

2. Triage and Review

  1. The Biostatistics Coordinator reviews the request within 2 business days.
  2. Checklist for Review:
    • Completeness of the request (e.g., missing information about sample size).
    • Feasibility based on provided data and requested analysis.
  3. Example:
    • If the data description is vague, the coordinator requests clarification, such as asking for the variable names and formats.

Records Generated: Triage checklist, clarification emails.

3. Prioritization

  1. Requests are ranked based on urgency, complexity, and scope.
  2. Criteria for Prioritization:
    • High priority: Deadline within 2 weeks.
    • Medium priority: Deadline within 1 month.
    • Low priority: Exploratory analyses with no specific deadline.
  3. Example:
    • A grant application requiring statistical analysis for submission next week is given high priority.

Records Generated: Prioritization matrix, request tracking log.

4. Assignment

  1. The request is assigned to a biostatistician based on expertise and availability.
  2. Notify the requester of the assignment and provide the biostatistician’s contact information.
  3. Example:
    • A request involving survival analysis is assigned to a biostatistician with expertise in survival methods.

Records Generated: Assignment record, notification email.

5. Consultation

  1. The biostatistician schedules an initial consultation with the requester.
  2. Agenda for Consultation:
    • Clarify study goals (e.g., confirm variables to include in regression models).
    • Discuss data cleaning needs (e.g., handle missing data).
    • Agree on deliverables and timelines.
  3. Example:
    • The biostatistician and requester decide to use logistic regression instead of linear regression after reviewing data distribution.

Records Generated: Consultation report, meeting notes.

6. Analysis and Execution

  1. The biostatistician performs the analysis according to the agreed plan.
  2. Steps in Analysis:
    • Data cleaning (e.g., remove outliers or impute missing values).
    • Statistical modeling (e.g., conduct a mixed-effects model).
    • Generate graphs and tables.
  3. Example:
    • The biostatistician creates survival curves and estimates hazard ratios for a study on patient outcomes.

Records Generated: Analysis plan, statistical code, QC log.

7. Results Delivery

  1. Deliver completed work in the requested format (e.g., PDF report, PowerPoint slides).
  2. Conduct a results walkthrough with the requester to address any questions.
  3. Obtain acknowledgment of receipt from the requester.
  4. Example:
    • A final report includes a regression table, a diagnostic plot, and an executive summary of the results.

Records Generated: Deliverables, acknowledgment form.

8. Feedback and Post-Evaluation

  1. Requester completes a post-evaluation survey within 10 business days.
  2. Review feedback to identify areas for improvement.
  3. Example:
    • A requester suggests simplifying the language in reports for non-statistical audiences.
  4. Implement corrective actions as needed.

Records Generated: Feedback survey, corrective action report.

Quality Assurance and Auditing

  • Conduct quarterly audits of the biostatistics support process to ensure compliance with this work instruction.
  • Maintain all records for a minimum of 5 years for FDA review.

Records Reviewed: Audit log, process documentation.

References

  • SOP-BSRP-002: Biostatistics Analysis Standards.
  • FDA Guidance for Industry: Statistical Principles for Clinical Trials.
  • ISO 9001:2015 Quality Management Systems.

Revision History

| Version | Date | Description | Approved By |
|————-|—————-|——————————–|—————-|
| 1.0 | [Insert Date] | Initial version | [Insert Name] |