Page 135 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-008 SOP Title: Data Dictionary Implementation
4.2 Federal Studies
Federal studies are like Industry studies. The PIs with the grantee group determine the data points to be collected. In the case of a multicentre trial, the primary PI will provide CRFs as well as preliminary definitions. It is the responsibility of the RC to develop the data dictionary for CHST sites, determine the location of the data in the EHR, and meet with the PI to review and get PI approval of the data dictionary.
4.3 PI Initiated Studies
All of the above actions apply; however, it may be helpful to meet with the PI during the development of a PI initiated study to review required data points early on. Questions to consider:
1. What data points are necessary
2. Where in the EHR are the data located
3. Is the information Time Specific?
4.4 Drop Down Menus
Having protected drop down menus for your data collection tools is an easy way to protect your data collection. It provides consistency within the data for statistical analysis and it also helps prevent incorrect data from being entered into the specific fields.
5. SPECIFIC PROCEDURES
5.1 Once consensus has been reached, the RC will create an EXCEL spreadsheet to document the data points, the definition and the location within the EHR. There should be three columns. The name of the data point, how the data is defined and where the data is located within the EHR. Below is an example of a data dictionary.
https://dallaschildrens- my.sharepoint.com/personal/lorrie_burkhalter_childrens_com/Documents/Data%20Di ctionary%20SOP/Data%20Dictionary%20Excel.xlsx
The dictionary should be color coded to provide ease of use.
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