A Guide to Effective Protocol Training With an Electronic Data Capture (EDC)

By Editorial Team on May 13, 2024

When kicking off a new trial, comprehensive protocol and Electronic Data Capture (EDC) system training for sites is necessary. The study build within the EDC encapsulates many of the elements of the protocol, including what data is collected, who can access what (which forms, form sections, and data points), how fields are populated, and what calculations and automations are performed. Proper training ensures sites fully understand their roles, responsibilities, and workflow within the EDC.

Who to Train

Firstly, it is essential to determine who (which roles) should be trained. That is actually pretty easy. Comprehensive EDC training should be provided to all staff with an assigned role, including clinical investigators, data entry personnel, treatment administrators, etc.

Providing extra focused training time may be beneficial for specific roles. Treatment administrators, for example, often require additional guidance on drug dispensation, inventory management, and associated electronic case report forms (eCRFs).

Separate training tracks can also be created for distinct roles like invoicing managers or others who may only need to access and enter data in specific sections of the EDC.

Protocol training should be conducted jointly by a trainer and a protocol expert. They can speak to how the EDC study build and protocol are used together.

Key EDC Training Areas

Study Forms and Access Rights

The eCRFs built within the EDC should map to protocol-specified data collection requirements. During training, review:

  • How forms are organized, which forms exist, and their purposes
  • Repeat visits and how forms for these visits may differ
  • Edit checks configured on the forms to ensure accurate recording of the data as specified by the protocol
  • Who can enter data on each form based on roles (e.g., investigator, monitor, etc.)
  • Blinding requirements and how they are enforced, which should include any forms or fields that are restricted from view for specific roles
  • When to create groups of forms (e.g., when a patient comes in for an unscheduled visit) or a single form (e.g., to track more information regarding a serious adverse event) as needed
  • Any site-level forms, including documents regarding amendments
  • Any forms at the project/study level if they relate to the protocol

Data Entry Responsibility

Make clear who is responsible for completing each form. This might be at the form, form section, or field level. For example:

  • The investigator conducts the physical exam and enters the findings.
  • The treatment administrator tracks investigational product dispensation and administration.
  • The data entry personnel enters measurements on behalf of the clinician examining the patient.

Automations and Calculations

Explain where data is pulled for derived fields due to some automation or calculation. For example:

  • Forms that will appear and possibly disappear based on some criteria (e.g., patient eligibility)
  • Eligibility criteria calculations, which could be based on demographic and screening inputs
  • Visit window calculations to determine the following allowable visit date range
  • Data populating between forms based on previous entries

By understanding the origin of such data points or automation, staff will better understand how the system functions per the protocol requirements.

Protocol <> EDC Comprehension

Build comprehension checks into training:

  • Review the protocol and explicitly map sections to the corresponding EDC forms/fields.
  • Allow ample time for questions to identify areas requiring clarification, particularly around topics that might not be intuitive.
  • Provide protocol documents and training materials for reference – and make them easily accessible!
  • Stress the importance of the protocol as the source document the EDC is built around.

Hands-On Practice

By conducting practical hands-on exercises in a training database, sites get experience using the EDC. This allows sites to get direct experience before going live, become familiar with edit checks and process flows, and have a safe space to make mistakes.

Go through a mock test case – from start to finish – for a comprehensive hands-on exercise:

  • Add a subject and enter subject details. Walk through all forms for the initial screening/baseline visit.
  • Complete any consent forms and sign up for ePRO to collect electronic patient reported outcomes.
  • Practice randomization and confirm proper subject assignment.
  • Move on to the treatment forms and inventory management.
  • Continue through all remaining scheduled study visits. Perhaps walk through an unscheduled visit as well.

By rehearsing a study journey for a hypothetical subject, including randomization and inventory tracking, sites gain vital experience using the full breadth of EDC capabilities under different scenarios. Other hands-on practice ideas include:

  • Clarify expectations from the start, detail study visit procedures, and outline actions for each visit.
  • Enter mock screening data and observe inclusion/exclusion criteria calculations.
  • Enter vital signs to see real-time edit checks firing – warnings and errors.
  • Practice medical coding with mock adverse events and concomitant medications.
  • Schedule an upcoming visit and review calculated allowable next visit date windows.

The hands-on approach enables sites to build essential muscle memory with the system before actual study use, and trainers can identify any areas requiring more clarification.

Training Tips

Some additional best practices for effective EDC and protocol training:

  • Invite your protocol expert to be a part of the training.
  • Provide training materials to staff in advance so they may focus on filling gaps in their understanding by paying more attention during training and asking questions.
  • Record sessions for those unable to attend or for future reference.
  • Use real-world, study-specific examples over generic ones.
  • Move beyond presentations to interactive, hands-on activities.

Then, after training, sit back and relax. Well…not exactly! After the site’s first patient visit, review completed forms to assess protocol comprehension and continue to do so as patients move along from visit to visit. By thoroughly covering protocol alignment with the electronic data capture (EDC) system from data entry to queries to approvals, you equip sites with a clearer perspective on the protocol requirements to promote high data quality and compliance and accelerate the study timeline.

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