Report Card: Methods for Managing Lab Norms within your EDC System

Shannon Roznoski
Director, Product Management, Forte
May 16th, 2019

In addition to information collected directly at the study site, most protocols include laboratory tests and other assessments that are conducted by centralized or external organizations. As the number of locations and stakeholders involved in collecting and consolidating protocol data increase, so does the likelihood of error.

Laboratory data has unique handling considerations compared to other types of external data. For each data point, laboratory normal ranges are provided and must match the demographics of the participant for the laboratory that completed the testing, on the date the testing was completed. Including normal ranges means there are usually four data points for each laboratory test completed: result, unit, low normal, and high normal. In addition, you may need to capture clinical significance for out of range tests.

There are several methods of handling laboratory data for a protocol. Each method brings opportunities and obstacles to each stakeholder, depending on the traits of the protocol and differences in site operations. We’ll compare the benefits and drawbacks of each method to evaluate the best approach for managing laboratory data based on the specific details of your protocol and organization.

Methods of Managing Laboratory Data

Maintain Lab Data Electronically and External to the EDC System

This method is common within the industry, and works well when a single transfer is received at the end of the study. Using this method, lab data is sent to the sponsor or investigator electronically in a format such as Excel, CSV, XML or SAS datasets in either a cumulative or transactional file. Once received, data are reconciled with the EDC programmatically and discrepancies are resolved via data queries in the EDC or direct communication with the laboratory. Then, laboratory results are incorporated into the datasets by the biostatistician or SAS programmer. This strategy works best when using a central laboratory, as it reduces the number of files and formats caused by multiple sites using their local lab. You may be able to avoid format variability by establishing a standard format for the lab files across all vendors. Noted below are the opportunities and obstacles for different stakeholders implementing this method.

Pros  
Site Staff: Limited entry necessary unless clinical significance tracking is required.
CRA/Monitor: Little to no monitoring because the file from the laboratory is used directly without manual transcription, and lab normal are usually included and not managed separately.
EDC Owner: No IT involvement but the SAS programmer or Database programmer will need to program reconciliation checks and may be called upon to help with interim reports that combine lab data with EDC data.
Cons
Principal Investigator: If interim reports are needed, lab data will need to be merged with the CRF data as part of the reporting process, or the study team will need to view lab data in the transfer format.
Data Manager: Requires reconciliation between the lab file and the EDC system.

 

Upload Electronic Lab Results into the EDC System

While this method is often described as the gold standard, the hurdle of configuring lab imports for different laboratories and file formats across multiple protocols reduces the amount of organizations currently utilizing this method. Using this strategy, laboratory data is received in electronic format and uploaded into the EDC system, with reconciliation between the lab data and CRF data done either programmatically against the lab files or within the EDC. When considering this method, check that your EDC system can support a lab data upload, as not all EDC systems offer this functionality. Secondly, evaluate whether you have the resources to set up and configure the uploads. This method works best when you can work with a small number of laboratories to minimize the number of individual uploads per protocol.

Pros
Site Staff: Limited entry necessary unless clinical significance tracking is required.
Principal Investigator: Lab results can then be viewed within the EDC, and it can be reported and exported along with the CRF data; however, lab data may be in a separate area of the EDC rather than in a CRF.
Data Manager: Upload of data into the EDC allows edit checks to be written within the EDC rather than requiring external reconciliation.
CRA/Monitor: Little to no monitoring necessary because the file from the laboratory is used directly without manual transcription, and lab normal may be included and not managed separately.
Cons
EDC Owner: Setup and configuration of lab data uploads can be complex and time consuming.

 

Require Users to Enter Lab Results into the EDC

While this method requires planning and investment on the front-end, it can bring sustainable benefits to your organization in the long run. By adopting this strategy, protocol admin staff enter lab normal ranges into the EDC at a central location, and lab results are entered into the EDC by the site staff. Units and normal ranges are populated in the CRF by the system based on the laboratory, date of assessment, and demographics of the subject. When evaluating this method, ensure that your EDC system supports this functionality. This system works best when your organization works regularly with the same laboratories or when the number of subjects and assessments on a protocol is very large, making the data entry by the site worth the up-front investment.Lab Normal Managed Centrally within the EDC

Pros
EDC Owner: Configuration of normal ranges is within the application so this method requires little or no technical/IT staff.
Principal Investigator: Lab results can be viewed within the EDC, and it can be reported and exported along with the CRF data.
Data Manager: Some overhead is required in maintaining the reference ranges for each laboratory in a central location; however, all results are in the EDC allowing programmed edit checks within the EDC.
CRA/Monitor: If Source Document Verification (SDV) is being completed for lab data, the results are the only data points manually transcribed, reducing the amount of SDV per lab test.
Cons
Site Staff: Requires more data entry than the methods involving externally managing or uploading results, but sees significant data entry savings over the full lab entry method.

 

Full lab entry within the EDC

While beneficial for some roles, this method increases the data entry burden and potential for transcription errors. Using this method, site staff enters all results, units and ranges into the EDC system. This strategy increases ease for the sponsor or investigator, as all data will be held in the EDC with no configuration or management necessary of the external lab files. However, it greatly increases difficulty for site staff, since there are several data points per lab test, per subject, per time point. Not only is this incredibly time consuming, but volume of data points entered increases the chance for data entry errors.

Pros
EDC Owner: Little to no configuration or IT overhead.
Principal Investigator: Lab results can then be viewed within the EDC, and it can be reported and exported along with the CRF data.
Data Manager: Results are in the EDC, allowing programmed edit checks within the EDC.
Cons
Site Staff: This method requires the most data entry for site staff.
CRA/Monitor: If Source Document Verification (SDV) is being completed for lab data, then lab results and ranges all need review. Highest amount of transcription includes highest chance of data entry errors.

 

Integrate Laboratory into the EDC System

Similar to centrally managing lab normal ranges, this method relies on investment on the front end, but has significant potential for time savings in the long run. This strategy configures the EDC system to automatically load laboratory results into CRFs from an EMR (Electronic Medical Record) source system. This system may not be best for sponsors who work with many sites and laboratories because the integration must be completed for each source, and often involves working with the site IT team to create secure connections through complicated fire walls. This approach is most feasible for large study sites, such as cancer centers or academic research organizations who conduct many trials, using their own local laboratory and can configure a feed from their EMR to the EDC. Both systems are most likely within their own fire wall, which reduces security concerns and the number of protocols that benefit from the integration over time increases ROI (return on investment) for the organization.

Pros
Site Staff: Limited entry required unless clinical significance tracking is required.
Principal Investigator: Lab results can then be viewed within the EDC, and it can be reported and exported along with the CRF data.
Data Manager: Integration of data into the EDC allows edit checks to be written within the EDC rather than requiring external reconciliation.
CRA/Monitor: Little to no monitoring is required because the file from the laboratory is used directly, lab normal may be included and not managed separately.
Cons
EDC Owner: Setup and configuration of lab data integration will require IT and possibly programming staff. It may be more complex than configuring uploads but, once configured, can be utilized across multiple protocols without additional configuration.

 

While each method presents unique benefits and drawbacks, this evaluation framework can provide a strong base for choosing the best method for your team. To learn more about  Forte EDC‘s upcoming lab results integration with EMRs, sign up for our open demo on Wednesday, May 22 at 11AM Central.

Data Management EDC

No Comments

Leave a Reply

Your email address will not be published. Required fields are marked *