Data Clarification Form Template

Tips For Using the Data Clarification Form Template

Clinical trials rely heavily on the accuracy of the data collected during the trial. Data clarification forms allow you to assess the completeness and accuracy of clinical trial data. 

It also allows you to request additional information or clarification when there are discrepancies in the trial data.

Clinical trials also require discretion, so need a tool to help you securely request data from the investigators. Online data clarification forms allow you to request discrepancies in clinical trial data securely.

Learn more about online data clarification forms, and how to create them:

What Is a Data Clarification Form in Clinical Trials?

Data Clarification Forms  (DCF) are used in clinical trials to clarify and resolve missing data or discrepancies in data collected during the trial. It's a standardized form that the clinical research sponsor or organization uses to request the investigator for additional information or clarification on specific data points.

A clinical trial sponsor sends the data clarification form to the study site or researcher, with a timeframe for completion. The researcher responds to the DCF request by entering the required information and sending it back to the sponsor.

Following that, the sponsor reviews the data to ensure it is correct and complete; if it is, it is entered into the clinical trial database.

What’s the Purpose of Data Clarification Forms?

The main purpose of the data clarification form is to ensure the integrity of clinical research data.  It reviews the accuracy, completeness, and reliability of the data collected during the research.

DCFs also foster collaboration and communication between the clinical research sponsor and the investigator.

The DCF process involves the sponsor informing the investigator about incorrect or missing data. The investigator examines the data, and both parties agree on the next steps to ensure the clinical research is accurate.

What Should be Included in a Data Clarification Form?

A typical data clarification form contains fields that allow the sponsor to collect additional information about specific data points, this includes:

• Participant ID
• Date of Query
• Query number (Field requiring clarification)
• Query description (reason for the clarification)
• Additional information or clarification (link, media, or text)
• Deadline for response.

How to Create a Data Clarification Form

Here’s how to create a secure data clarification with formplus user-friendly builder:

1. Select the Formplus data clarification template.
2. Log in to your Formplus account or create a new account if you don’t have one.
3. Edit the form by dragging and dropping fields from the inputs.
4. Next, save your form.
5. After that, customize the form layout by changing its background, color, and text font.
6. Next, choose your preferred settings such as form privacy, email notifications, and reminders.
7. Share the form with the investigator via email, QR code, or form link.

Conclusion

Using DCFs helps improve the reliability and validity of trial results by ensuring their accuracy.  It helps you identify and correct discrepancies, errors, and missing data.

Creating secure data clarification forms doesn’t have to be a long coding process. With Formplus's customizable data clarification form template, you can collect and provide clinical research data with no coding required.