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Paper TT02Digitalization of Clinical Study Report (CSR) Tables and Listings for CrossReport Verification Iraq Mohebalian, Bayer, Whipping, NJ Michael Badlands, Bayer, Whipping, ABSTRACT Large scale
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01
Begin by gathering all necessary information and documents related to the clinical study, such as the study protocol, consent forms, and patient data.
02
Choose a digital platform or software that will support the digitalization process. Ensure that the software complies with regulatory requirements and provides necessary security features.
03
Input the study protocol and other relevant information into the digital platform, making sure to follow any required templates or guidelines.
04
Upload consent forms and other necessary documents, ensuring that they are properly organized and easily accessible.
05
Use appropriate security measures to protect patient data and ensure compliance with privacy regulations.
06
Implement features within the digital platform that allow for data collection, storage, and analysis. This may include electronic case report forms (eCRFs), data entry forms, and data visualization tools.
07
Train study personnel on how to properly use the digital platform, including entering and accessing data, generating reports, and conducting data analysis.
08
Conduct a thorough testing phase to ensure that the digital platform is functioning correctly and capturing data accurately.
09
Monitor the digitalization process throughout the clinical study, addressing any issues or concerns that arise.
10
After the study is completed, ensure that all data is properly archived and securely stored in compliance with regulatory requirements.

Who needs digitalization of clinical study?

01
Pharmaceutical companies conducting clinical trials or studies
02
Academic research institutions conducting clinical research
03
Contract research organizations (CROs) managing multiple clinical studies
04
Regulatory authorities overseeing clinical trials
05
Healthcare organizations and providers involved in clinical research
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Digitalization of clinical study is the process of converting traditional paper-based clinical study documents and processes into electronic format.
All organizations conducting clinical studies are required to file digitalization of clinical study.
To fill out digitalization of clinical study, organizations need to convert their paper documents into electronic format and submit them through the designated online platform.
The purpose of digitalization of clinical study is to improve efficiency, accuracy, and accessibility of clinical study data and documents.
All relevant data and documents related to the clinical study must be reported on digitalization of clinical study.
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