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Based on my experiences, I have worked as a Clinical Research Associate (CRA) in the clinical vaccine trial field for a pharmaceutical company. I have participated in steps of the workflow in Protocol Discussion and Data Design (Variables and Data Work Flow). The pharmaceutical company I work for serves as the “sponsor” for the research. So, I assisted the clinical team in all activities related to clinical trial preparation, including protocol discussion and implementation.
After that, I joined the Data Management Service company, and I work as a Data Manager (DM). The Data Management Service is responsible for all steps in the data management process workflow. In my role, I participated in project initiation and during study conduct as follows:
– Data Collection/Case Report Form (CRF) Development: I created and maintained the Case Report Form (CRF).
– Development of a Data Management Plan (DMP): My task involved providing input and reviewing the data management plan.
– Database Access Control: I am responsible for managing the database’s access control.
– Database Setup and Edit Checks Programming/Data Entry Screen Test: My task involved setting up the database and conducting programming and data entry screen tests. The process also includes performing database testing, specifically data entry screen tests, and preparing an edit check specification for the programmer team to test before the database launches.
– Investigator Meeting/CRF Completion Training: My task involved providing training to the study team and coordinating with the study team or sponsor for overall project management aspects.
– Data Validation/Data Quality Control (QC): Validate study data in the clinical data management system and ensure database accuracy during the course of clinical studies as well as coordinate with the study team and sponsor to address study data-related issues.
– Data entry and processing: Prepared CRF completion guidelines and sent them to the study site.
I would like to improve the edit check program so that it can be used in full function to support the process of data validation if the research uses an EDC system. Currently, edit-check programs are a feature that can help with data cleaning, data validation, and QA processes. However, it still takes DM staff a significant amount of time to complete this specific step, which ensures the data is clean and ready for analysis. Therefore, developing an edit-check program for full function or creating another tool could potentially reduce the time staff spends performing these steps, while also ensuring high-quality data for the data analysis process.