What it contains

A schedule of activities (SoA) is usually a table in the study protocol. Visits run across the top, procedures run down the side, and a mark shows which procedure happens at which visit. It typically includes:

  • Each visit's name or code, and its target day
  • The allowed window around each visit
  • Consent, eligibility checks and medical history
  • Exams, vital signs, labs, ECGs and other procedures
  • Dosing and investigational product steps
  • Footnotes with conditions, which often change what's required

A sample layout

Sample schedule
Template
Visit
Target and window
Procedures
Screening
Up to 28 days before Day 1
Consent, history, labs
Baseline
Day 1
Vitals, labs, dosing
Visit 3
Day 29, plus or minus 3 days
Vitals, labs, ECG
End of study
Day 85, plus or minus 7 days
Exam, labs, ECG

Illustration only. Always work from your study's approved protocol.

How sites use it

  • Scheduling: working out visit windows for each subject
  • Source documents: building worksheets so nothing is missed at a visit
  • Supplies: planning the kits and staff each visit needs
  • Budgeting: pricing each procedure and visit before you sign
  • Billing:invoicing for what was completed

Check it before you rely on it

Read every footnote, and compare the schedule with the rest of the protocol. When an amendment changes it, update your worksheets, staff training and budget too.

Build it once

In PAS OneCore, you enter the schedule of activities once. It then drives calculated visit windows, eSource templates and invoice pricing.