Schedule of assessments template generator for your protocol

A schedule of assessments (also called a schedule of events or schedule of activities) is a grid in the protocol. Visits or time points run across the top, from screening through treatment to follow-up. Assessments run down the side: consent, eligibility, demographics, medical history, physical examination, vital signs, ECG, laboratory tests, questionnaires, drug administration, concomitant medication review, adverse event assessment and so on. A mark in a cell means the assessment is done at that visit.

The grid looks simple but it carries a lot of weight. It is the checklist a coordinator uses to run a visit; the basis for the site payment per visit in the budget; the source from which data managers decide which forms exist and when they are due; and the reference a monitor uses to spot missing assessments. Protocol guidance such as the SPIRIT checklist for trial protocols asks for a schedule of enrolment, interventions and assessments, often shown as a figure or table.

To build a useful one, decide the visit structure first. List each visit with its nominal timing (Day 1, Week 4) and a window (plus or minus a number of days) so sites know how much flexibility they have. Then list assessments in the order they happen at a visit, group related items, and mark each cell. Add footnotes for anything conditional: "only if the screening result is abnormal", "pre-dose and 2 hours post-dose", "women of childbearing potential only". Finally, count: how many procedures does one visit contain, and how long will it take the participant? Burden is a major driver of dropout, which the dropout-adjusted sample size calculator turns into a larger enrolment target.

Once the grid is stable, it becomes the brief for the study build. Each column becomes a visit in the electronic data capture system; each row becomes a form, or a section in a form, that appears at the visits where it is marked. The vital signs row maps to a vital signs eCRF, the adverse event row to an adverse event form, the laboratory row to a laboratory results template, and so on. A grid that is clear about timing and conditionality makes that mapping quick, and an ambiguous one produces rework.

Capture can do the first draft for you. Its AI study builder reads a protocol (PDF or Word) and drafts the visit schedule and forms; nothing is saved without human review, so the grid you export from this tool is a good way to check what the AI drafted against what you intended. Read about it in protocol to study setup and clinical trial study builder software, and see the CRF builder for the forms themselves. When a study is ready, Capture can export a blank eCRF PDF with a visit-by-form matrix, which is a useful cross-check against the protocol SoA for ethics or IRB submission.

The same grid feeds the budget. Every cross is a procedure someone has to perform and be paid for, so multiply by the number of participants to see the per-visit cost. The clinical trial budget template and the cost-per-patient calculator take it from there, and the timeline calculator shows how follow-up length drives duration.

Once the grid is filled in, count the marks per column. A Day 1 visit with eleven procedures, including blood draws and an ECG, may take half a day; if the same participant is also asked to attend three more such visits in a month, expect missed visits. Look for assessments that appear at every visit without a clear reason, and for visits where several burdensome procedures stack up. Moving a questionnaire to a home diary or dropping a low-value measurement is a cheap protocol change at this stage and an expensive amendment later.

The builder is a simple grid with toggles and CSV export. It does not store your schedule, check that your visit timings are consistent, calculate windows, or model conditional logic such as "only if". It does not produce the formatted table that goes into a protocol document, and it does not know your study, so it cannot tell you which assessments you should include. Footnotes and visit windows are yours to add in the protocol text or in the exported file.

A schedule of assessments is a clinical and scientific document. The assessments, their timing and their relation to endpoints and safety must be decided by the investigators and sponsor, reviewed by the medical monitor and statistician, and approved by the ethics committee or IRB as part of the protocol. If you change the schedule through an amendment, the data capture build must change too; see protocol amendments without change orders. This tool is a demonstration and planning aid, not validated software.