5 Steps to Integrate External Data into Your EDC Platform

posted on November 10th 2014 in Solutions with 0 Comments /

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Frequently clients reach out to us for help with a process to integrate and manage clinical trial data from partners and external sources such as labs. Siobhan Raynard, one of our Clinical Data Managers, and I put together the list below of five key points to consider when putting together a plan to manage the integration of external clinical trial data into your electronic data capture (EDC) platform.

1. Determine what data should be integrated into the EDC platform

It is critical to carefully evaluate the data that should be included in the EDC platform and why this information is important. We work with our clients to begin by asking internal data users what information they need and why this information is needed. Once the data is identified, the next step is to determine if it should be incorporated into the EDC platform. Two key questions to ask, are “what is the intended use of this data”, and “do others need to have access to this information?”

2. Establish a communication process

Communication is key to successfully integrating clinical trial data from external partners. Outline specific details such as key points of contact, how often data is sent, and scheduling on-going “touch points” to communicate status updates and potential issues.

3. Establish guidelines for data transfer

Consult your contract to determine the frequency that has been agreed to for providing updated data. Next, work with your partners to understand their capabilities and limitations in providing data electronically.

4. Agree to common standards

Work with your external partners to agree on specific standards to use in collecting clinical trial data. We strongly recommend our clients and their partners use CDISC standards to collect clinical trial data, which are platform-independent and are becoming the global language for data sharing in clinical research. It is expected that the FDA will require all clinical trial data be submitted according to CDISC standards in the future.

5. “Clean” data from partners

As a part of integrating the external clinical trial data into the EDC platform we often run automatic queries to catch discrepancies, such as date and time and accession number inconsistencies. We can also build in additional reconciliation reports to check for key identifiers, such as date of birth, and identify any discrepancies.

Join the conversation! What are your challenges? How did you overcome them as you integrated external clinical trial data into your EDC platform?

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