With the implementation of EDC, which company Standard Operating Procedure (SOP) would require updates for new procedures of handling data?

The implementation of Electronic Data Capture (EDC) fundamentally transforms the process of data review and validation. Unlike paper-based systems which rely on retrospective, batch-based review after data entry, EDC enables real-time, continuous data review. Edit checks fire upon data entry, allowing for immediate identification of discrepancies. This shift necessitates a complete overhaul of the Data Review and Validation SOP to define new workflows for online query generation and resolution, role-based remote data access for monitors and data managers, and procedures for source data verification (SDV) or review (SDR) within the electronic system. This represents the most significant procedural change to daily data handling activities.

A. Handling External Data: While the method of loading external data may change (e.g., direct import vs. manual entry), the core principles of data transfer agreements and reconciliation logic often remain similar.

B. Coding Medical and Clinical Terms: The tool used for coding may be integrated with the EDC system, but the fundamental intellectual process, coding conventions, and query procedures for ambiguous terms are largely unchanged.

C. Data Backup, Recovery, and Contingency Plans: This SOP requires updates, but the responsibility often shifts from the sponsor/CRO to the EDC vendor, making the update focused on vendor oversight rather than internal data handling procedures.

1. Society for Clinical Data Management (SCDM). (2023). Good Clinical Data Management Practices (GCDMP).

Section 8.2, Data Review: "In an EDC study, data review is an ongoing process... The ability to review data in near real-time allows for early identification of trends and potential issues." This highlights the shift from periodic to ongoing review, which is a core procedural change.

Section 8.3, Query Management: This section details the online, real-time nature of query management in EDC systems, which is a stark contrast to paper-based workflows and requires new SOPs.

2. Prokscha, S. (2017). Practical Guide to Clinical Data Management (3rd ed.). CRC Press.

Chapter 11, Data Review, Cleaning, and Validation, p. 189: "With the use of EDC, data review is an ongoing process... The data management plan and the data validation plan must describe the process of data review, including who is responsible for what review and the timing of the review." This directly links EDC implementation to the need for updated data review and validation plans/SOPs.

3. Krishnankutty, B., Bellary, S., Kumar, N. B. R., & Moodahadu, L. S. (2012). Data management in clinical research: An overview. Indian journal of pharmacology, 44(2), 168–172. https://doi.org/10.4103/0253-7613.93842

Page 170, "Data validation": The article contrasts paper and EDC processes, stating, "In EDC, the checks are programmed to be executed at the time of data entry... This reduces the number of post-data-entry queries significantly." This immediate validation is a procedural change requiring a new SOP.