Trial Assessments

The purpose of the Trial Assessments stop is to conduct the protocol-specified assessments at each trial timepoint or visit, in compliance with the study design.

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Description

Clinical trial assessments are conducted to evaluate the safety and efficacy of a new treatment or intervention.

Here are some additional details about clinical trial assessments:

  • Clinical trial assessments are typically conducted at multiple time points during a clinical trial.
  • The type of assessments conducted will vary depending on the specific clinical trial.
  • Clinical trial assessments may involve collecting data on the participant's health status, side effects, and response to the treatment or intervention.
  • The data collected / results from clinical trial assessments are used to determine whether a new treatment or intervention is safe and effective.

DCT-specific Considerations/Inputs

Clinical trials designed to use DCT methods, technology and services will include options to conduct assessments in settings other than a traditional research site. The options available for assessment conduct at each visit are defined in the protocol, and processes are set up to support these options are part of study start up / site set up. The clinical study staff and the patient determine which options are appropriate for the trial assessments at each visit, based on patient preference and clinical judgement.

For In-clinic patient assessment:

Technology and Data Standards

Data Connectivity

For in-home patient assessment:

  1. Identify lab supply needs, provisioning partners
  2. Assess equipment needs and ID provisioning
  3. Assess in home nursing needs and ID providers
  4. ID eSource requirements and in-home data collection plan
  5. Develop training strategy and content 

For remote or virtual patient assessment:

Best Practices 

Technology and Data Standards 

DCT Curriculum 

  1. Assess equipment needs and ID provisioning
  2. Assess in home assessment needs and telemedicine requirements with site staff
  3. Identify lab supply needs, provisioning partners
  4. ID eSource requirements and virtual / remote site data collection plan
  5. Develop training strategy and content

Tools


Regulatory Documents

FDA/U.S.

Europe/EMA


Reference Documents

TransCelerate Modernizing Study Conduct: Home Health Visits Process Flow

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MRCT IRB/EC Considerations - Full Document

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MRCT IRB/EC Considerations - Helpdesk

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MRCT IRB/EC Considerations - Notifications & Reminders

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MRCT IRB/EC Considerations - Devices

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MRCT IRB/EC Considerations - Connected Sensors

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MRCT IRB/EC Considerations - Remote Visits

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Transcelerate Modernizing Clinical Trials Direct-to-Patient Shipment Process Framework

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Transcelerate Modernizing Clinical Trials Local Community-Based Facilities Process Framework

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Transcelerate Modernizing Clinical Trials Telemedicine Process Framework

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NIH - Informed Consent for Research Using Digital Health Technologies

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