non-eCRF

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 Non-eCRF Data: A Guide for Clinical Data Managers

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Clinical trial data collection primarily relied on electronic case report forms (eCRFs), relegating non-eCRF data to a small portion of the study. However, the landscape is rapidly evolving, with recent studies showcasing a remarkable transformation. Non-eCRF data now plays a substantial role, contributing more than 30 to 40% of data in some clinical trials

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𝗡𝗼𝗻-𝗲𝗖𝗥𝗙 𝗗𝗮𝘁𝗮?

Non-eCRF data referred to any data collected in a format other than electronic forms. 𝗧𝗵𝗶𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗲𝗱 𝗽𝗮𝗽𝗲𝗿-𝗯𝗮𝘀𝗲𝗱 𝗰𝗮𝘀𝗲 𝗿𝗲𝗽𝗼𝗿𝘁 𝗳𝗼𝗿𝗺𝘀, 𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝘆 𝗿𝗲𝘀𝘂𝗹𝘁𝘀, 𝗶𝗺𝗮𝗴𝗶𝗻𝗴 𝗱𝗮𝘁𝗮, 𝘀𝗲𝗻𝘀𝗼𝗿 𝗱𝗮𝘁𝗮, 𝗽𝗮𝘁𝗶𝗲𝗻𝘁 𝗱𝗶𝗮𝗿𝗶𝗲𝘀, 𝗮𝗻𝗱 𝗼𝘁𝗵𝗲𝗿 𝗻𝗼𝗻-𝗱𝗶𝗴𝗶𝘁𝗮𝗹 𝘀𝗼𝘂𝗿𝗰𝗲𝘀

𝗠𝗮𝗷𝗼𝗿 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗼𝗳 𝗠𝗮𝗻𝗮𝗴𝗶𝗻𝗴 𝗡𝗼𝗻-𝗲𝗖𝗥𝗙 𝗗𝗮𝘁𝗮?

⭐ 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝗶𝘇𝗮𝘁𝗶𝗼𝗻 : One of the critical aspects of managing non-eCRF data is ensuring that it is standardized.

⭐ 𝗧𝗶𝗺𝗲𝗹𝘆 𝗮𝗻𝗱 𝗔𝗰𝗰𝘂𝗿𝗮𝘁𝗲 𝗖𝗼𝗹𝗹𝗲𝗰𝘁𝗶𝗼𝗻: Another challenge with non-eCRF data is ensuring that it is collected in a timely and accurate manner.

⭐ 𝗜𝗻𝘁𝗲𝗴𝗿𝗮𝘁𝗶𝗻𝗴 𝗻𝗼𝗻-𝗲𝗖𝗥𝗙 𝗱𝗮𝘁𝗮 into the overall clinical trial dataset can be a complex process.

⭐ 𝗗𝗮𝘁𝗮 𝗾𝘂𝗮𝗹𝗶𝘁𝘆: Non-eCRF data can be of lower quality than eCRF data due to a number of factors, such as human error, incomplete data, and inconsistent formatting.

⭐ 𝗗𝗮𝘁𝗮 𝘀𝗲𝗰𝘂𝗿𝗶𝘁𝘆: Non-eCRF data can be more difficult to protect from unauthorized access than eCRF data.

𝗘𝘃𝗼𝗹𝘂𝘁𝗶𝗼𝗻 𝗼𝗳 𝗡𝗼𝗻-𝗲𝗖𝗥𝗙 𝗱𝗮𝘁𝗮

🔯 𝗧𝗵𝗲 𝗥𝗶𝘀𝗲 𝗼𝗳 𝗲𝗦𝗼𝘂𝗿𝗰𝗲 Data Capturing information directly from electronic medical records (EMRs), digital diaries, wearable devices, and other digital health technologies.

🔯 𝗜𝗺𝗮𝗴𝗶𝗻𝗴 𝗗𝗮𝘁𝗮 The emergence of Picture Archiving and Communication Systems (PACS) revolutionized the collection, storage, and analysis of imaging data.

🔯 𝗖𝗲𝗻𝘁𝗿𝗮𝗹 𝗟𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝘆 𝗗𝗮𝘁𝗮 𝗧𝗿𝗮𝗻𝘀𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻𝘀 Laboratory information management systems (LIMS) enable the direct transmission of lab results into EDC systems, streamlining processes and minimizing errors.

🔯 𝗣𝗮𝘁𝗶𝗲𝗻𝘁 𝗥𝗲𝗽𝗼𝗿𝘁𝗲𝗱 𝗢𝘂𝘁𝗰𝗼𝗺𝗲𝘀 : Traditional paper-based questionnaires have given way to electronic patient-reported outcome (ePRO) systems.

🔯 𝗛𝗮𝗿𝗻𝗲𝘀𝘀𝗶𝗻𝗴 𝗪𝗲𝗮𝗿𝗮𝗯𝗹𝗲 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝗮𝗻𝗱 𝗦𝗲𝗻𝘀𝗼𝗿𝘀 The integration of wearable devices & sensors has opened new horizons in clinical trials. Real-time data collection of physiological parameters, such as heart rate, blood pressure, & activity levels, allows for continuous monitoring and analysis.

Despite these challenges, the use of non-eCRF data in clinical trials is a valuable tool that can help to improve the safety and efficacy of new drugs and treatments.


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