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Electronic Data Capture in Clinical Trials and IVR Study Setup Tips

Electronic data capture in clinical trials tips

While they offer sponsors the ability to run faster, more efficient clinical trials, using an Electronic Data Capture (EDC) or an Interactive Voice/Web Response (IVR/IWR) system can be a challenge for any sponsor. Large pharma, small biotechs, CROs, device companies, and academic research centers all go through the same study startup process of determining which data needs to be collected, and how to assure the data is correct and complete.

Over the years we've helped many companies overcome these challenges and experience the value that Electronic Data Capture and IVR/IWR bring to the clinical trial process. Whether it's insight from the variety of ways sponsors set up pages, visits, and edit checks or learning how to help a study team that has never worked with an eClinical solution, we've seen just about every situation you can imagine.

With that in mind, I've asked some of the BioClinica project teams to contribute their top suggestions and recommendations for launching an Electronic Data Capture in clinical trials or IVR/IWR study. The result is the below list of 11 expert tips.

11 Expert Tips on Electronic Data Capture in Clinical Trials and IVR/IWR Studies

Consistency is King!
Forms and edit specifications need to be consistent throughout a clinical trial. This includes everything from data formatting to form layouts to edit check wording. Don't be afraid if an Electronic Data Capture implementation of your clinical study looks different from a paper implementation. Paper and EDC have very different strengths and optimal paper implementations are not always optimal in an EDC system.

Edit checks should test for only one error. As an example, an edit check such as "Adverse Event Start Date is invalid, please clarify" should be split into several different edit checks to help provide clearer error messages for sites. The following three checks are much clearer for sites to interpret and have the same overall functionality as the original check.

  • Adverse Event Start Date must not be after date of data entry.
  • Adverse Event Start Date must be complete.
  • Adverse Event Start Date must be on or after Date of Informed Consent.

Mark Detweiler – Manager, Study Operations, EDC

Plan Ahead
When setting up a study that is going to be pulling in clinical IVR/IWR data, make sure you know what data is going to be pulled into the forms, the format of the data and that the code lists in each system equal each other. You also want to make sure the data that is pulled in from the IVR/IWR system is read only. This will reduce the amount of data reconciliation.
Ann Marie LaDue – Senior Project Manager, IVR

Take your Time
Incorporate ample time during the development phase to produce a quality database and strive for team input throughout the review phase.
Pete Keller – Senior Project Manager, EDC

Anticipate Closeout
Anticipate the last patient out at each site so that data entry is done in a timely fashion (who else knows that date better?) well in advance of the site closeout visit.
Glenn Schuessler – Senior Clinical Data Manager, Data Management

Training, Training, Training!
Make sure the decision makers responsible for eCRF design and edit checks know and understand the capabilities and limitations of the Electronic Data Capture system before you build the study. This will help avoid disappointment and unreachable expectations.
Bill Primwhere – Manager, Forms and Study Design, EDC

Know the System
It is important to remember that edits can only be triggered when a piece of data is entered and saved on a form. A form where all data is being uploaded will not trigger any edit.
Debbie McGinley – Sr. Clinical Data Manager

Timing is Everything
The site should communicate with the monitor regarding last query answered date so that investigator can plan to be available for e-signatures in time for soft-lock.
Glenn Schuessler – Senior Clinical Data Manager, Data Management

Limit Manual Data Entry
Take advantage of the technology by utilizing choice lists and derivations whenever possible. Less typing by the site means higher quality data.
Bill Primwhere – Manager, Forms and Study Design, EDC

Use Partial Dates Only When Necessary
Partial dates may be needed when collecting adverse events and concomitant medications that may be ongoing, but typically this only applies to the start date. The end date is usually known and should be a calendar date field and not a partial date field.
Jennifer Price – Director, Clinical Solutions

S.D.V. A.S.A.P.
Site monitors should be reminded to Source Data Verify (SDV) site-level data if it is required by the sponsor, ideally before the patient-level data are complete.
Glenn Schuessler - Senior Clinical Data Manager, Data Management

Biostatistics Play a Key Role
Biostatistics are an important part of any clinical trial, and should be involved early and often during the development phase of a study. Make sure they have input into the process and any study changes that will be needed.
Bill Primwhere - Manager, Forms and Study Design, EDC

That was a lot of great information from some true experts in the field. If you found these tips valuable, you may also be interested in my recent on-demand webinar outlining FDA regulations related to Electronic Data Capture in clinical trials.

eClinical tech on-demand webinar

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