Page 134 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-008 SOP Title: Data Dictionary Implementation
1. PURPOSE
The purpose of the current standard operating procedure (SOP) is to outline the purpose and creation of a data dictionary for all research studies.
2. INTRODUCTION
With the implementation of the electronic health record (EHR) the location of the data to be collected in a systematic and concise manner becomes more complex with each technological advance. To ensure the accuracy of the data collected from the EHR for purposes of research is critical. Sponsors will often provide the definition of the data points critical to the device or drug trial, however, the location of the data to be retrieved is determined by the PI and the RC. Data points the EHR are recorded at different times, under different circumstances, either electronically or by a care giver and often on different equipment. Having a thorough understanding of the requirements of the study ensures all team members understand and can collect the data required to complete the study in the same manner. Large research teams including physicians, RCs, RAs and backup personnel need clarity when collecting data. For example, if a blood pressure reading is requested by the sponsor, when, how and by whom that information is collected and where it is recorded becomes vital to data integrity and continuity within the study.
This becomes even more important in an observational or retrospective studies where data points are often set by the PI, who may or may not have thought through the entirety of the data collection plan. Setting definitions for the team, determining the location in the EHR for each data point ensures the accuracy of the data.
3. SCOPE
The development of the data dictionary is the responsibility of the PI and the primary RC. The RC may take a leadership role in the organization of the dictionary; however, the PI must collaborate to develop the definitions of the terms being used as well as offer final approval of the working document.
4. RESPONSIBILITIES
4.1 Industry Studies
Sponsors supply a list of data points to be collected and often a case report form (CRF). This CRF may provide the preliminary list for the RC to begin dictionary development. The RC will ask sponsor for clarification of any ambiguity within the data points. The RC will be responsible for reviewing the data points and definitions and meeting with the PI to reach a consensus on the location of the data within the EHR
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