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eCRF entry guidelines

 Writing eCRF entry guidelines? Wait!! Don't Forget these critical points!!!

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eCRF Guidelines is one of the important documents & it provides a clear and concise instructions to sites as to how to enter the data into EDC system.

Why eCRF entry guidelines are important? It's important because,

🔹 𝗖𝗼𝗻𝘀𝗶𝘀𝘁𝗲𝗻𝗰𝘆: The guidelines ensure that data is collected and entered consistently across multiple sites, ensuring reliable and accurate results.

🔹 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲: eCRF entry guidelines help ensure compliance with regulatory requirements and industry standards, such as Good Clinical Practice (GCP) guidelines.

🔹 𝗧𝗿𝗮𝗶𝗻𝗶𝗻𝗴: Guidelines serve as a training tool for new study staff, ensuring that all users have a common understanding of the data collection process.

So clear & concise eCRF entry guidelines helpssites & study team members lot of effort & time.
Next time when you write eCRF entry guidelines - ensure to include these critical points

📄 𝗘𝘅𝗽𝗹𝗮𝗻𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗘𝗗𝗖 & 𝗙𝘂𝗻𝗰𝘁𝗶𝗼𝗻𝘀:
Step by step guide to EDC including how to login, reset passwords or log helpdesk case in case of EDC issues, how to navigate eCRF's, to answer queries, different icons in EDC, how to do SDV's , how to sign the eCRF's after data entry

📄 𝗢𝘃𝗲𝗿𝘃𝗶𝗲𝘄 𝗼𝗳 𝗧𝗿𝗶𝗮𝗹 𝗩𝗶𝘀𝗶𝘁𝘀:
This section should explain, how the flow of visits happens in the EDC including Dynamic visits & form triggers & follow-up visits, how to create & enter data into unscheduled visits.

📄 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗳𝗼𝗿 𝗥𝗮𝗻𝗱𝗼𝗺𝗶𝘇𝗮𝘁𝗶𝗼𝗻:
When study has RTSM integrations and randomization happens from external vendors and subject numbers need to be pushed into EDC. Personally I faced a very challenging issue where site created a list of subjectsin EDC ahead of randomization.

📄 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗰𝗼𝗱𝗶𝗻𝗴 𝗱𝗮𝘁𝗮 𝗲𝗻𝘁𝗿𝘆: List down clear instructions about how sites should enter data that will get coded in EDC such as not entering 2 medical events (fever & chills) in to one eCRF, avoid entering acronyms etc.

📄 𝗖𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗗𝗮𝘁𝗮 𝗘𝗻𝘁𝗿𝘆 : Clearly explain sites as to how to enter critical data points including AE, CM, MH, study drug, EOS & EOT. This is where many issues come from.

📄 𝗘𝗻𝘁𝗲𝗿𝗶𝗻𝗴 𝗟𝗮𝗯𝘀 𝗿𝗲𝗹𝗮𝘁𝗲𝗱 𝗱𝗮𝘁𝗮: If sites enter correct lab data including ranges, units etc - it will go long way avoiding lot of issues in the study at later stage.

𝗡𝗼𝘄 𝘄𝗵𝗮𝘁 𝘁𝗼 𝗮𝘃𝗼𝗶𝗱 𝗱𝗼𝗶𝗻𝗴 𝘄𝗵𝗶𝗹𝗲 𝘄𝗿𝗶𝘁𝗶𝗻𝗴 𝗲𝗖𝗥𝗙 𝗲𝗻𝘁𝗿𝘆 𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲𝘀?

1. Do not probe / direct the sites as what data needs to be entered.
2. Avoid Ambiguity & complicating the guidelines
3. Not maintaining consistency with other study documents like protocol etc.
4. Lack of testing before releasing to all sites
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