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Development & Implementation of Serious Adverse Reconciliation Workflow and SOP

This project focuses on the development, implementation, and maintenance of a workflow and standard operating procedures (SOP) for reconciliation of serious adverse events (SAE). The goal is to improve efficiency and ensure regulatory compliance.

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Development & Implementation of Serious Adverse Reconciliation Workflow and SOP

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  1. Development, Implementation and Maintenance of Serious Adverse Reconciliation Workflow and SOP Colleen Cox CareStat, Inc. Company logo here Need to get logo from Carol

  2. Background • Small department • Scope and type of trials changing • Role Definition

  3. Existing SOPs • SOPs newly approved • Minimal forms • Minimal work instructions

  4. Initial Phase • Review of existing SOPs • Gap Analysis • Nomenclature • System Compatibility • Workflow and Procedure Review

  5. SOP Review Findings • Nomenclature • Workflow changes • Gap in SAE Handling and Reconciliation

  6. SOP Development • Review regulations • Review training materials • Colleagues • Industry Research • GCDMP (version 2)

  7. Hurdles • Multiple Forms • Different Content • Different Handling Procedures

  8. Work needs to begin • Documentation in trial specific DMP • Log of SAE discrepancies • Interdepartmental meetings • Provide support and clarification

  9. SOP Development • Standard Sections • Procedure • Who • When • How • With What

  10. SOP Review • Internal review by department • Review by Division management • Review by SOP Committee • Approval by Pres and Exec VP

  11. SOP Implementation • Training • Support • Revisions

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