Introduction
In the domain of clinical operations concerning the management of clinical trial data and documents, the transition from customized to standardized solutions presents challenges and opportunities.
This article delves into the strategic process of incorporating Veeva's standard Study Archival feature into a clinical operations vault utilized for CTMS, SSU, and eTMF.
Simultaneously, it underscores the decommissioning of the current customer-specific archival solution within the Clinical vault (specifically built for eTMF). The emphasis is placed on various considerations, phased implementation strategies, and ensuring a smooth transition without any adverse impact on data integrity.
Understanding the Landscape
Customized solutions play a pivotal role in clinical operations management, precisely tailored to meet specific operational requirements. Nevertheless, conforming to industry standards becomes crucial, prompting the adoption of standardized solutions such as Veeva's Study Archival feature.
The custom solution primarily focused on electronic trial master file (eTMF) archival. However, the adoption of standard archival expanded the scope, enabling the customer to encompass a solution not only for eTMF documents but also for comprehensive archival of Study clinical trial data from the Clinical Trial Management System (CTMS) module.
Considerations and Planning
The process of transitioning demands meticulous planning to mitigate potential disruptions.
Critical considerations include preserving data integrity, structuring a methodical phased implementation and decommissioning strategy for custom solutions, ensuring compliance and data security, assessing business processes gaps, planning comprehensive end-to-end archival procedures involving both business and IT aspects, and evaluating the impact on existing systems or integrations when adopting Veeva's standardized archival system.
Phased Implementation
Our outlined phased implementation is as follows:
Achievements and Benefits: The successful adoption results in a unified archival process in the Clinical Operations vault with CTMS, eTMF and SSU with enhanced compliance, streamlined workflows, simplified security, scalability, and a seamless shift from custom to standardized archival systems without compromising data integrity.
Conclusion
The strategic transition from custom to standardized solutions in clinical operations is vital. A phased approach mitigates risks and ensures a smooth integration process.
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Supplemental Information #3: Phased Approach to Implementation
The journey of formulating plans into action involves various phases of analysis and assessment and one of them is below:
Evaluation of the Custom Solution Decommission Strategy
Evaluation of the decommissioning process for technical components associated with the customized eTMF archival solution.
• Evaluation of User Role Setup and Study-related objects that have custom archival security configurations.
• Revisions to Object and document lifecycles, including optimization of unnecessary entry criteria, actions, unused lifecycle states, and adjustments to Dynamic Access Control sharing rules.
• Identification and removal of redundant fields and their data dependencies.
• Updates or deactivation of Object and document workflows.
• Adjustments to the Study team role and Role dependencies, incorporating…
Supplemental Information #2: Phased Approach to Implementation
The journey of formulating plans into action involves various phases of analysis and assessment and one of them is below:
Gap Analysis
• Assessing the revised end-to-end archival process for archivists and IT admins and the need for additional configurations specific to customer business process.
• Reviewing the Retention review, Study destruction processes, and other absent business processes encountered during the adoption of standardized archival features.
• Analysing the implications arising from the coexistence of new studies following standard archival procedures alongside old studies archived via custom methods, ensuring continued access for end users to both archived datasets without loss of data access.
Supplemental Information #1: Phased Approach to Implementation
The journey of formulating plans into action involves various phases of analysis and assessment and one of them is below:
Comprehensive Assessment
• Evaluating the comparison between the current custom archival solution and Veeva's standardized archival feature.
• Strategizing the phased implementation encompassing Adoption, Transformation, and Decommissioning.
• Defining security requirements for standardized archival and analysing its implications on existing custom user security.
• Approach for transforming existing custom archived data to align with standardized archival specifications.
• Assessing the decommissioning strategy for the current custom solution, comprehending both prerequisites and subsequent implications without adverse effects