Clinical trial timeline template

This clinical trial timeline template is an editable Gantt chart for a sample investigator-led study, from protocol and approvals through recruitment, follow-up, analysis and reporting. The stages are standard; replace the example durations with your study's timings.

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A clinical trial timeline in Ganttile by quarter: protocol, sponsor sign-off, ethics review and approvals, then database build, site set-up and the start of recruitment
  • 6 groups
  • 35 tasks
  • 6 milestones
  • 41 dependencies
  • About 33 months
  • Updated November 2, 2026

Ganttile publishes this planning template. Its durations describe an invented study, not regulatory or medical guidance. Approvals and timing depend on the study, country and institutions.

What does a clinical trial timeline include?

The sample has six overlapping groups, from protocol development to publication:

GroupMonthsWhat happens
Protocol and approvals1 to 6Protocol, statistical sections, sponsor sign-off, registration, ethics review and other approvals.
Site set-up3 to 7Database, case report forms, agreements, budgets, training and initiation visits.
Recruitment7 to 19Screening, consent, enrolment, recruitment review and steering committee meeting.
Intervention and follow-up8 to 25Intervention, follow-up, monitoring and adverse event recording.
Data management and analysis8 to 29Entry, queries, analysis plan, cleaning, database lock, analysis and interpretation.
Reporting and publication29 to 33Final report, registry results, participant summary, paper and close-out.

Task names start with the leading role because Ganttile has no assignment field.

Which clinical study timeline milestones are included?

The sample tracks six milestones:

  • All approvals in place: month 6, before site training.
  • First participant in: month 8, after initiation visits.
  • Last participant in: month 19, after twelve months of recruitment.
  • Last participant out: month 25, after six months of follow-up.
  • Database lock: month 27, after cleaning, data entry and the analysis plan.
  • Final report submitted: month 31, with the paper and close-out after it.

Why does site set-up overlap ethics review?

The sample runs database work and site agreements during review to avoid waiting until approval to start set-up. They need the signed-off protocol, not approval; site training and initiation visits wait for the approvals milestone.

How can you plan for slow recruitment?

Add review points to recruitment, the bar most likely to run long. The sample reviews recruitment three months after the first participant, then holds a steering committee meeting three months later.

Turn on Auto schedule under Settings and extend recruitment by three months. Last participant in, last participant out, database lock and the final report move with it.

What comes before database lock?

The sample finishes the analysis plan during follow-up. Lock also waits for final cleaning after the last participant leaves and for data entry.

How do you adapt the chart?

  1. Approvals: replace placeholders with your committees' timetables.
  2. Recruitment: use participant targets and expected site rates.
  3. Follow-up: replace the sample's six months with your protocol's schedule.
  4. Critical path: it is off by default and highlights correctly only with Hide weekends on. Enable both under Settings.
  5. Export: send a PDF, or an Excel task table with names, dates and durations but no bars.

Use template copies the dependencies into a free account starting on the coming Monday. For funding, use a funder work plan; for doctoral writing, a 12-week thesis plan. Choose a smaller study schedule for research without sites or follow-up visits.

Common questions

How long does a clinical trial take?

There is no standard length. It depends on the design, how fast participants can be recruited and how long each one is followed up. The sample runs about 33 months from the first protocol draft to close-out, with twelve months of recruitment and six months of follow-up, as an example only.

Does it fit a phase 1, 2 or 3 trial?

The stages are common to most interventional studies, but the template does not model the requirements or durations of any trial phase. Add the stages your protocol and sponsor require and set their lengths from your own approvals and sites.

Can the whole study team see the timeline?

Ganttile has no public share link. Invite colleagues through the linked Breeze account, free, to view and edit the chart, or export a PDF for the steering committee or the funder.