Clinical Trial (CT) Schedule of Activities (SoA)

A Clinical Trial (CT) Schedule of Activities (SoA) is a detailed schedule of clinical trial research activities.

• Context:
  • It can (typically) be represented in a CT Protocol SoA Section (within a CT protocol document) and a CT SoA Configuration File.
  • It can outline the timing of CT Participant Enrollment and Screening.
  • It can detail the administration of Study Treatment.
  • It can specify the collection of Study Data and Study Samples.
  • It can include Follow-up Visits or Follow-up Assessments.
  • It can provide details on Study Procedures, such as frequency and duration of study visits and specific instructions for Study Personnel.
  • …
• Example(s):
  • NCT02975336 SoA (recorded in NCT02975336 SoA Section).
  • …
• Counter-Example(s):
  • …
• See: Schedule, Clinical Outcome Assessment.

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References

2023

• chat
  • A Schedule of Activities (SoA) is a detailed timeline of specific clinical research activities to be conducted during a Clinical Trial.
    • It can outline the timing of Participant Enrollment and Screening.
    • It can detail the administration of Study Treatments or Interventions.
    • It can specify the collection of Study Data and Samples.
    • It can include Follow-up Visits or Assessments.
    • It can provide details on Study Procedures, such as frequency and duration of study visits and specific instructions for Study Personnel.
  • Related terms: Clinical Trial Protocol, Study Design, Trial Methodology, Research Plan.

2021

• https://grants.nih.gov/policy/clinical-trials/protocol-template.htm
  • QUOTE: ... The schedule of activities must capture the procedures that will be accomplished at each study visit, and all contact, with study participants e.g., telephone contacts. This includes any tests that are used for eligibility, participant randomization or stratification, or decisions on study intervention discontinuation. Only include procedures that contribute to participant eligibility and study objectives and endpoints. Other procedures should be done sparingly and with consideration, as they may add unnecessary complexity and detract from recruitment.

    Allowable windows should be stated for all visits. To determine the appropriate windows, consider feasibility and relevance of the visit time points to study endpoints (e.g., pharmacokinetic (PK) studies may allow little or no variation, with required time points measured in minutes or hours, whereas a 6-month follow-up visit might have a window of several weeks). ...

2020

• https://www.a3informatics.com/biomedical-concepts/
  • QUOTE: ... The protocol often contains a tabular overview of the schedule of assessments(SoA). In the SoA, it can be specified that vital signs will be collected at every visit. To understand what vital signs are required, the reader will need to go to a section in the protocol to read that vital signs for this study is defined as heart rate, systolic and diastolic blood pressure and temperature. It typically doesn’t specify which unit (mmHg) and under which condition it is measured: left arm, right arm, standing, sitting, resting for 5 min etc. The protocol isn’t specific enough to allow for data collection. The ‘translation’ from the protocols wording to create the database and EDC setup requires further work. Time and effort is expended by data management and clinical operations. ...

2016

• NCT02975336 Protocol Document [1].
  • Table 1: Table 1 Schedule of Assessments; Screening and Treatment Period (All Subjects), End of Study (Subjects Not

Entering LTE Period)

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