What's included
A trial timeline is mostly a sequence of approvals with a recruitment period in the middle. The template separates them so the gates are visible rather than buried inside a single "study conduct" bar:
- Protocol development, Concept, scientific review, protocol writing, statistical analysis plan, case report form design and budget. Milestone: protocol final.
- Regulatory & ethics, Regulatory submission, IRB or ethics committee review, response to queries and approval, a fixed dependency for everything downstream. Milestone: ethics approved.
- Site selection & start-up, Feasibility, site contracts and budgets, essential documents, drug supply release and site initiation visits.
- Recruitment & treatment, First participant in, enrolment ramp, treatment and follow-up visits, monitoring visits and safety reporting. Milestone: last participant last visit.
- Data management, Data entry, query resolution, medical coding, reconciliation and database lock. Milestone: database locked.
- Analysis & reporting, Unblinding, statistical analysis, clinical study report, publication and regulatory submission.
Who uses this template
Clinical project managers, CRAs, and academic investigators use this timeline to run a study from protocol and IRB approval through site initiation, enrolment, data lock, and reporting. Enrolment is usually the long pole, so the chart helps sponsors and sites track site activation and recruitment against the milestones that gate analysis and submission.
How to customize it
- Set your ethics submission date first and let site start-up depend on approval, nothing legitimate can precede it.
- Stretch the recruitment bar to match your realistic accrual rate per site per month, not the target rate.
- Add one row per site if you are running multi-centre and need activation tracked individually.
- Insert interim analysis or DSMB review points as milestones where the protocol requires them.
- Mark first participant in, last participant last visit and database lock, these are the dates sponsors ask about.
Scheduling tips
- Treat approvals as hard dependencies. Ethics and regulatory review are third-party durations you cannot compress, so link start-up to them rather than running the two in parallel.
- Plan for a recruitment ramp. Sites activate at different times and accrual builds slowly; a flat enrolment assumption is the most common reason a trial timeline slips by quarters.
- Leave real time between last visit and database lock. Query resolution and coding routinely take longer than the data entry itself.
- Keep monitoring visits on the chart. They consume coordinator time that would otherwise be assumed available for recruitment.
- Baseline at first participant in. Pre-activation dates are estimates; once the study is live, track variance against a fixed baseline.
Related templates
- Gantt Chart Template for Research & Thesis
- Grant Proposal Gantt Chart Template
- PhD Research Gantt Chart Template
- Browse all Gantt chart templates
Frequently asked questions
How long does a clinical trial take?
It varies enormously by phase and indication, a small Phase I study may run about a year, while a Phase III programme commonly runs three to five. This template uses a roughly two-year schedule you can compress or extend by moving the end date.
What should a clinical trial Gantt chart include?
Protocol development, regulatory and ethics approval, site selection and initiation, recruitment and treatment, data management through database lock, and analysis and reporting. All six phases are pre-loaded with milestones on the gates.
Can I use this in a grant application?
Yes, that is one of the most common uses. Export to PDF or PNG from the free editor and drop it into the proposal, or download the PowerPoint version for a slide.
Is the clinical trial template free?
Yes. Free Excel, PowerPoint and CSV downloads, and free online editing with no account and no watermark.