Protocol planning matrix
Schedule of Activities Builder
Draft a protocol-style Schedule of Activities matrix — visits by epoch and timing, activities by category, and which activity occurs at which visit.
Do not enter participant-identifying information
No names, initials, participant/subject IDs, MRNs or dates of birth — anywhere on this page, including in visit or activity names. This builder does not use an actual participant date; it defines relative visits, timing, windows and scheduled activities.
Nothing you enter is uploaded to or stored by this site. “Copy table” writes data to your device’s own clipboard; “Download CSV” and “Download project (.json)” save files to your device; printing can create paper or PDF copies. Once you use any of those actions, that data exists wherever you saved, pasted, printed or shared it — not on this site.
Visits
Activities
| Activity | ||
|---|---|---|
Screening Visit | Baseline Visit | |
| Informed Consent | ||
| Vital Signs | ||
For educational purposes only. This tool does not replace, interpret, amend or override the current approved study protocol, protocol amendments, sponsor instructions or applicable site procedures under any circumstances. Always verify every result against the applicable study documents before use.
This builder is a planning and drafting aid. It does not create an approved protocol, validate a Schedule of Activities, establish clinical permissibility, or produce a conformant regulatory submission. The current approved protocol, Schedule of Activities, amendments, manuals and sponsor instructions take precedence.
Standards context
- ICH E6(R3): the approved protocol’s Schedule of Activities defines the trial visits, interventions and assessments.
- ICH M11/FDA: recommends a tabular Schedule of Activities capturing procedures at each visit, participant contacts, decision-related tests and allowable windows.
- TransCelerate CPT V11: provides a proposed harmonized protocol structure aligned with ICH M11.
These references inform the terminology and structure of this tool. They do not make this builder protocol-compliant or replace the current approved protocol.
How this calculator works
Build a Schedule of Activities (also commonly called a schedule of assessments) as a matrix: customizable visits/contacts/timepoints as columns, customizable activities/assessments/procedures as rows, and a toggle in each cell for whether that activity occurs at that visit.
Every visit can carry an epoch/period, a study-day or free-text timing label, an optional days-before/after-target window (shown as derived ±N or −N/+M notation), and an optional contact-mode note. Every activity can carry an optional category and an optional instruction or footnote. All of these are examples, not a controlled or mandatory list — type any protocol-defined name.
This builder is a structural planning tool, not a date calculator: it does not take an actual participant date and performs no date calculations at all. Every visit is entered independently, with no chained or per-visit-dependent timing.
Add, duplicate, remove and reorder both visits and activities. Visits sharing the same epoch are grouped visually in the matrix header. Removing a visit or an activity also removes only its own cell toggles — every other visit's and activity's own data is unaffected.
Copy the matrix for pasting into a spreadsheet, download it as a CSV file, open a print-friendly view, or download/import a project file (.json) so you can continue editing later — this site has no account or backend, so a project file is the only way to keep your work past this browser session. All of this runs entirely in your browser; nothing is uploaded anywhere.
The tool is arithmetic only. Where legal, payroll, holiday, timezone or jurisdiction-specific rules matter, the page states what is and is not included.
Frequently asked questions
Is this the same as the Clinical Trial Visit Window Calculator?
No. The Visit Window Calculator computes actual target/earliest/latest calendar dates for each visit from one starting event's date. This builder is a structural planning matrix — which activities happen at which visits, grouped by epoch — and does not take a participant date or compute any calendar date at all.
Is this validated for clinical trial or regulatory compliance?
No. This is a planning and drafting aid, not a validated clinical system, source document, protocol-deviation checker, or claim of regulatory compliance, conformance or submission readiness of any kind. For educational purposes only. The current approved protocol, Schedule of Activities, amendments and sponsor instructions always take precedence.
Is any participant information stored or transmitted?
No. This page has no fields for participant name, initials, ID, MRN, date of birth, or any uploaded document, and it never asks for an actual participant date. Nothing you enter is uploaded to or stored by this site. "Copy table" writes data to your device's own clipboard, "Download CSV" and "Download project (.json)" save files to your device, and printing can create paper or PDF copies — once you use any of those actions, the data exists wherever you saved, pasted, printed or shared it, not on this site.
How do I keep my work after I close the page?
Download the project as a .json file before you leave, then use "Import project (.json)" on a later visit to continue exactly where you left off. There is no account or auto-save — the file on your own device is the only copy.
Can I export a structured or regulatory-conformant file?
No. Copy/CSV/print exports and a plain project JSON file are working formats for your own use — none of them claim conformance to any structured data-exchange standard or readiness for regulatory submission.