Clinical Trial (CT) Protocol Schedule of Activities (SoA) Section

A Clinical Trial (CT) Protocol Schedule of Activities (SoA) Section is a CT protocol document section that represents a CT SoA.

• Context:
  • It can be input to a Clincal Trial SoA Section to Configuration File Translation Task (into a CT SoA configuration file)
  • It can (typically) include sub-sections, such as:
    • SoA Screening and Enrollment Activities Content: This sub-section outlines identifying and screening potential participants and the procedures for enrolling eligible participants in the study.
    • SoA Study Visits and Procedures Content: This sub-section provides a detailed timeline of all study visits and procedures, including the frequency and timing of data collection, study interventions, and other required procedures.
    • SoA Study Drug Administration Activities Content: This sub-section describes the procedures for administering study drugs, including dosages, administration schedules, and any necessary monitoring or adjustment.
    • SoA Safety Assessments Activities Content: This sub-section outlines the procedures for monitoring and assessing participant safety throughout the study, including identifying and reporting adverse events.
    • SoA Data Collection and Management Activities Content: This sub-section describes the procedures for collecting, managing, and analyzing study data, including the methods for ensuring data quality and integrity.
    • SoA Study Personnel Content: This sub-section specifies the roles and responsibilities of study personnel, including investigators, coordinators, and other staff members, and outlines any required training or qualifications.
    • SoA Study Monitoring Content: This sub-section outlines the procedures for monitoring the study's progress, including the frequency and monitoring methods and any necessary corrective actions.
  • …
• Example(s):
  • NCT02975336 CT Protocol Schedule of Activities (SoA) Section (in a NCT02975336 CT Protocol Document [1]).
  • DS8500-A-U202 CT Protocol Schedule of Activities (SoA) Section (for DS8500-A-U202 CT Protocol Document).
  • NCT04020341 CT Protocol Schedule of Activities (SoA) Section (for NCT04020341 CT Protocol Document).
  • …
• Counter-Example(s):
  • …
• See: CT Statistical Analysis Plan, Informed Consent Form, Case Report Form, Study Monitoring Plan.

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References

2023

• chat
  • Clinical Trial Protocol Schedule of Activities (SoA) section is a critical document in clinical trial research that outlines the activities and procedures that will be conducted during the study.
  • Other terms that the concept might go by include: Study Plan Section, Study Timeline Section, Protocol Schedule Section.
  • Some of the characteristics of the Clinical Trial Protocol Schedule of Activities (SoA) section include:
    • It can provide a detailed timeline of all study activities, including participant recruitment, screening, and follow-up visits.
    • It can include a description of study procedures and interventions, including dosages and administration schedules.
    • It can outline data collection and management procedures, including the frequency and timing of data collection.
    • It can specify the roles and responsibilities of study personnel, including investigators, coordinators, and other staff members.
    • It can identify potential risks and adverse events and outline procedures for monitoring and reporting these events.
  • Associated concepts
  • Clinical Trial Protocol, Informed Consent Form, Case Report Form, Study Monitoring Plan

2023

• chat
  • The Schedule of Activities (SoA) section within a clinical trial protocol document typically consists of several sub-sections that provide a detailed timeline of all study activities and procedures. These sub-sections may include:
    • Screening and Enrollment: This sub-section outlines the process of identifying and screening potential participants, as well as the procedures for enrolling eligible participants in the study.
    • Study Visits and Procedures: This sub-section provides a detailed timeline of all study visits and procedures, including the frequency and timing of data collection, study interventions, and any other required procedures.
    • Study Drug Administration: This sub-section describes the procedures for administering study drugs, including dosages, administration schedules, and any necessary monitoring or adjustments to dosages.
    • Safety Assessments: This sub-section outlines the procedures for monitoring and assessing participant safety throughout the study, including the identification and reporting of adverse events.
    • Data Collection and Management: This sub-section describes the procedures for collecting, managing, and analyzing study data, including the methods for ensuring data quality and integrity.
    • Study Personnel: This sub-section specifies the roles and responsibilities of study personnel, including investigators, coordinators, and other staff members, and outlines any required training or qualifications.
    • Study Monitoring: This sub-section outlines the procedures for monitoring the progress of the study, including the frequency and methods of monitoring and any necessary corrective actions.
  • These sub-sections help to ensure that the study is conducted according to a well-defined plan and that all necessary activities are completed in a timely and efficient manner, while also ensuring participant safety and data quality.

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