Clinflash EDC Study Build Training Q&A Session Recap | All the Study Build Challenges You Care About, Answered Here!

Last week, the Clinflash EDC Study Build Training live series officially concluded. From protocol interpretation to CRF design, and from study build workflow to go-live validation, we broke down "how to build a study" into three comprehensive sessions. However, when it comes to hands-on practice, users often find that the problems encountered in real operations are never the standard cases from textbooks, but rather countless details that seem minor yet become genuinely frustrating when they get in the way: Is data still there after dynamic hiding? Will frozen field values change with associated modifications? How many reuse times should be set when CF loops infinitely?

In response to these practical pain points, we addressed them one by one in the Q&A session. To make it easy for everyone to refer to at any time, this article compiles the highlights of the Q&A from the live session. We hope this "Q&A Handbook" can help you clear blind spots and improve efficiency in your study build work.

Q: In MRCT studies, does the system support multi-language display?

The system supports multi-language configuration. During study build, the native language can be set to Chinese. After study build is completed, export the multi-language SDS, translate offline, and import it back into the system. Then you can switch languages on the entry side, and the interface content will display in the corresponding language. At the same time, reports can also be exported in the corresponding language version based on the current page language.

Q: If a large number of external hospitals are involved, which laboratory configuration mode is recommended? Does it need to be entered by CRC themselves?

The specific mode should be chosen based on the actual project situation. Clinflash EDC provides the "External Hospital LNR" mode, and also supports the "Local Hospital + External Hospital" combined mode, as well as opening all indicator ranges, allowing entry personnel to directly enter ranges on the page.

Q: When setting up dynamic dropdown, if "Field Description" is checked and associated with the AE "End Date," will this "End Date" appear in the exported dataset, or only display on the system page?

This field will only display on the page and will not be stored as a data point, so it will not appear in the exported dataset.

Q: Is multi-language setting done at the project level or node level?

Multi-language settings are translated at the project level through SDS and then imported.

Q: When creating a new field, how should "Manual Review Required" in field permissions be set to display only DM Review?

This location by default captures all review groups that have been enabled in "Node Configuration" – "Review Type." When adding new fields, the system defaults to checking all review groups. If batch changes are needed, you can export the SDS after eCRF design is completed, modify it uniformly offline, and then import it back.

Q: In the migration plan, after adding a new migration task and selecting migration data, there are options such as "Custom Function," "Validation," "Validation (Invalid)." What does "Validation (Invalid)" specifically refer to?

Before selecting migration data in a migration task, checking options such as custom functions and validation is intended to perform batch processing on migration data after this database modification. Among them, "Validation (Invalid)" means: some validations were in valid status before this database modification, and after the modification they are set to invalid. For such validations that change from valid to invalid, you can choose the corresponding query handling strategy, such as unconditionally closing previously issued queries, closing unanswered queries, or not closing queries.

Q: The dynamic display settings for fields are converted into code after saving. If modifications are needed later, you need to go into "Custom Function" to adjust the code. Will direct modification in "Form" without going through code be supported in the future?

Currently, the system's dynamic display is based on the custom function mechanism. To improve study build convenience, visual settings are already supported for conventional scenarios, but the underlying logic still uses custom functions. If you need to modify dynamic rules after settings are completed, you can set the original custom function to invalid and regenerate it.

Q: Does the system support cross-form dynamic triggering?

Yes. You can set the field to be controlled as hidden by default. When a field in this form (such as a leading field) is triggered, judging the cross-form value can achieve it. This mechanism also applies to scenarios where the same form displays different fields in different visits.

Q: For folder grouping settings, if the three visits CnD1, CnD2, and CnD3 form one cycle group, how should the grouping numbers be set? Should they be uniformly set to 1, or set to 1, 2, 3 respectively?

The grouping for all three visits should be set to the same character (e.g., all set to 1). Visits within the same cycle group should have the same value for the grouping field.

Q: For auto-calculated fields, if "Derived Variable" is checked, when the field is frozen and its associated field changes, will the value of this auto-calculated field change accordingly?

Yes, it will change. After checking "Derived Variable," when the field is not in locked status, if the associated field value changes, this field value will also change accordingly.

Q: For age calculation in laboratory forms (which exist in multiple visits), can it be implemented using templates in validation? Or does it need to be implemented through CF for real-time age calculation?

The system provides two methods: the AGE function in EC and the age calculation template when creating a new EC. For scenarios where laboratory forms appear in multiple visits, it is recommended to use the age calculation template when creating a new EC, as it supports wildcard settings and facilitates cross-visit reuse. Note that the AGE function calculates age by adding one year only after the birth date has passed, while the age calculation template in new EC uses the /365.25 calculation rule.

Q: If a visit is triggered by CF infinite loop, does the folder reuse count need to be set to 999 or left blank?

No, it is recommended to set it to 0. The folder reuse count is used to control whether visits can be manually added on the entry side: leaving it blank means unlimited manual additions per participant, and setting a specific value means the maximum number of additions allowed. This setting only affects manual addition mode; visits generated by CF triggering are not subject to this restriction.

Q: I saw sFTP settings in the report section during the demonstration. What is the specific purpose of this function?

Clinflash EDC provides rich API and sFTP functions. This module is a paid function and is not enabled by default. API provides data input and output interfaces; sFTP, as another method of data output, can configure internal servers and use the report's scheduled export mechanism to output data to a fixed folder on a specified sFTP server at scheduled times.

Q: Can the filling guide in project configuration be exported? Can the uploaded filling guide not directly correspond to specific forms?

The system supports automatically generating filling guides based on field settings in the project configuration menu. After generation, they can be exported in Excel and Word formats. The exported Excel supports offline editing and re-importing for overwriting; the exported Word format template can be customized in node configuration. After online generation, it can be viewed at the "CCI" icon in the upper right corner of the corresponding form page.

Q: After the entire form is frozen or locked, can new Log data still be added?

In frozen status, the system will support adding new Log rows in subsequent versions; after locking, all data is not allowed to be modified by default, and adding new Log rows is also not supported.

Q: If only eCRF is launched initially, and EC is launched later, what are the specific operation steps?

There are two operation methods: 1. Select the corresponding EC in the draft validation, and click "Overwrite to Corresponding Version" in the upper right corner; 2. Re-publish a new version and push the new version to the corresponding environment for it to take effect. Both methods can complete EC launch. Based on considerations of database modification or data migration, the first direct overwrite approach is usually recommended, subject to the actual project situation or company SOP. Note that if you choose the first approach, the overwrite version does not distinguish environments. After the corresponding version takes effect in any environment, that environment is considered to have taken effect.

Q: The system supports multi-window browser operations. Can the timeout lock screen mechanism be cancelled?

Not by default. Timeout lock screen is a security mechanism for data protection. If there is no operation in the current window within 30 minutes, the system will automatically lock the screen, and you need to re-enter the password to continue using it.

Q: Do the questions in eLearning settings need to be prepared by users in advance, or can the system automatically generate them? What is the basis for determining passing?

For standard roles (such as CRC, CRA, DM, MM, PI, etc.), the system has built-in standard courses, and no user customization is required. The criterion for passing the course assessment is reaching 80 points in the exam. After passing, the system automatically generates a certificate. After trainees complete standard course learning in any project, when they encounter a project that requires learning again, the system will ignore it by default, and there is no need to repeat the learning.

Q: For laboratory normal range comparison, if the upper or lower limit is empty, what is the system's default checking logic?

When there is only an upper limit, values below the upper limit are judged to be within the normal range; when there is only a lower limit, values above the lower limit are judged to be within the normal range. All other cases are judged to be outside the normal range.

Q: If the unscheduled visit suffix is automatically updated through the visit date, when encountering the same visit date, does it support adding suffixes such as "-1," "-2" after the date to distinguish them?

Yes, it requires writing CF separately to implement.

Q: After data is entered in dynamically triggered forms or fields, if the conditions for hiding the form or field are met, can they be hidden? If triggered to display again, is the previously entered data still there?

After changing the data so that it no longer meets the display conditions, the form or field can be hidden. If triggered to display again later, the previously entered data will still be retained.

The above is all the content of the Q&A compilation from this Q&A session. We hope it can provide reference for your study build practice. If you have other questions, you can leave a message in the comment section or contact Clinflash technical support personnel. Welcome to follow Clinflash to continuously obtain more EDC system operation tips, study build practical experience, and the latest industry trends!