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.
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:
For in-home patient assessment:
- Identify lab supply needs, provisioning partners
- Assess equipment needs and ID provisioning
- Assess in home nursing needs and ID providers
- ID eSource requirements and in-home data collection plan
- Develop training strategy and content
For remote or virtual patient assessment:
- Assess equipment needs and ID provisioning
- Assess in home assessment needs and telemedicine requirements with site staff
- Identify lab supply needs, provisioning partners
- ID eSource requirements and virtual / remote site data collection plan
- Develop training strategy and content
Tools
Regulatory Documents
FDA/U.S.
Europe/EMA
Reference Documents
TransCelerate Modernizing Study Conduct: Home Health Visits Process Flow
ViewMRCT IRB/EC Considerations - Full Document
ViewMRCT IRB/EC Considerations - Helpdesk
ViewMRCT IRB/EC Considerations - Notifications & Reminders
ViewMRCT IRB/EC Considerations - Devices
ViewMRCT IRB/EC Considerations - Connected Sensors
ViewMRCT IRB/EC Considerations - Remote Visits
ViewTranscelerate Modernizing Clinical Trials Direct-to-Patient Shipment Process Framework
ViewTranscelerate Modernizing Clinical Trials Local Community-Based Facilities Process Framework
ViewTranscelerate Modernizing Clinical Trials Telemedicine Process Framework
ViewNIH - Informed Consent for Research Using Digital Health Technologies
View