Clinical trial Gantt chart template with site activation waves
An editable clinical trial Gantt chart: ethics and authority approval, site activation in three waves, overlapping enrolment and follow-up, database lock and the study report, with gates and start-to-start links.
What the clinical trial gantt chart template with site activation waves process is
A trial plan is mostly one long wait with two walls in it. Nothing involving patients can begin until the ethics and authority review is finished, and nothing in the analysis can begin until the database is locked. Between those walls the work overlaps heavily: sites open at different times, enrolment runs while later sites are still being trained, and follow-up visits for early patients are under way long before the last one is enrolled. A plan that treats these as one sequential list overstates the length of the study. A plan that ignores the walls understates it.
This template has four groups: Study start-up, Site activation, Enrolment and follow-up, and Close-out and reporting. It has 21 rows, 16 tasks and 5 milestones. "Finalise protocol and consent form" (6 working days) is the only starting task. "Prepare ethics and authority submission" (4) and "Build and test data capture system" (8) follow it, and "Ethics and authority review" (15) is the long wait that ends in the first gate, the milestone "Approvals in place".
Contracts and systems are prepared during the review, not after it. "Negotiate site contracts" (10) starts 2 days after "Prepare ethics and authority submission" starts. "Run wave 1 site initiation" (5) then waits for three things: "Approvals in place", "Build and test data capture system" and "Negotiate site contracts". "First site activated" follows it. "Run wave 2 site initiation" (5) starts 8 days after wave 1 starts, and "Run wave 3 site initiation" (5) starts 8 days after wave 2 starts, so training teams are not idle while earlier sites begin.
Enrolment overlaps activation. "Enrol patients at wave 1 sites" (25) starts when "First site activated" is reached. "Enrol patients at wave 2 and 3 sites" (30) waits for "Run wave 3 site initiation" and "Run wave 2 site initiation" to finish and starts at least 10 days after wave 1 enrolment starts. "Run treatment and follow-up visits" (45) starts 10 days after wave 1 enrolment begins and "Monitor sites and resolve queries" (50) starts 5 days after "First site activated", so data cleaning is not saved for the end. "Enrolment complete" is a milestone, and "Complete last patient follow-up" (30) starts after it, finishing together with the visits.
The second gate is "Database lock". "Clean data and close queries" (8) waits for the last follow-up and for monitoring to finish. After the lock come "Run final analysis" (10), "Write clinical study report" (15) and the milestone "Report signed off". The durations are illustrative: enrolment rate, visit schedules and review times differ for every study. A timeline schedules the work. It does not make a study compliant, approved or valid; those outcomes come from your protocol, your quality system and the reviewers. For the process side, see /templates/clinical-trial-protocol-deviation-process and /templates/regulatory-filing-process. The same gate-and-sign-off logic runs through four neighbouring plans: /templates/medical-device-development-gantt-chart (device development), /templates/regulatory-submission-gantt-chart (a regulatory submission), /templates/method-validation-gantt-chart (analytical method validation) and /templates/computer-system-validation-gantt-chart (computerised system validation).
What this flowchart covers
In this template
- Four groups, Study start-up, Site activation, Enrolment and follow-up and Close-out and reporting, with 21 rows: 16 tasks and five milestones, "Approvals in place", "First site activated", "Enrolment complete", "Database lock" and "Report signed off".
- A hard gate at approval: "Run wave 1 site initiation" follows "Approvals in place", "Build and test data capture system" and "Negotiate site contracts", while "Negotiate site contracts" itself starts 2 days after "Prepare ethics and authority submission" starts.
- Staggered site waves: "Run wave 2 site initiation" starts 8 days after wave 1 starts, and "Run wave 3 site initiation" starts 8 days after wave 2 starts.
- Overlapping enrolment and follow-up: "Enrol patients at wave 2 and 3 sites" starts 10 days after "Enrol patients at wave 1 sites" starts, and "Run treatment and follow-up visits" starts 10 days after wave 1 enrolment starts.
- A second hard gate at "Database lock", which waits for "Clean data and close queries", followed by "Run final analysis" and "Write clinical study report".
When to use this template
- You are planning a study and need to show sponsors, sites and data management when each stage can start and which gate each one waits for.
- You want to see how much opening sites in waves, rather than all at once, moves the date of "Enrolment complete".
- A study lead needs the report by a date and you want to compare the finish date of "Report signed off" with the date you need.
- You want a repeatable skeleton for a phase of a trial that each study team can adapt with its own durations.
The plan, task by task
Every task in the chart with its length in working days and what it waits for. A dependency is a step number; SS is start-to-start, FF is finish-to-finish, and +n is a lag in working days.
| # | Task | Group | Working days | Depends on |
|---|---|---|---|---|
| 1 | Finalise protocol and consent form | Study start-up | 6 | |
| 2 | Prepare ethics and authority submission | Study start-up | 4 | 1 |
| 3 | Ethics and authority review | Study start-up | 15 | 2 |
| 4 | Approvals in place | Study start-up | Milestone | 3 |
| 5 | Build and test data capture system | Study start-up | 8 | 1 |
| 6 | Negotiate site contracts | Site activation | 10 | 2SS+2 |
| 7 | Run wave 1 site initiation | Site activation | 5 | 4, 5, 6 |
| 8 | First site activated | Site activation | Milestone | 7 |
| 9 | Run wave 2 site initiation | Site activation | 5 | 7SS+8 |
| 10 | Run wave 3 site initiation | Site activation | 5 | 9SS+8 |
| 11 | Enrol patients at wave 1 sites | Enrolment and follow-up | 25 | 8 |
| 12 | Enrol patients at wave 2 and 3 sites | Enrolment and follow-up | 30 | 9, 10, 11SS+10 |
| 13 | Enrolment complete | Enrolment and follow-up | Milestone | 11, 12 |
| 14 | Run treatment and follow-up visits | Enrolment and follow-up | 45 | 11SS+10 |
| 15 | Monitor sites and resolve queries | Enrolment and follow-up | 50 | 8SS+5 |
| 16 | Complete last patient follow-up | Enrolment and follow-up | 30 | 13, 14FF |
| 17 | Clean data and close queries | Close-out and reporting | 8 | 15FF, 16 |
| 18 | Database lock | Close-out and reporting | Milestone | 17 |
| 19 | Run final analysis | Close-out and reporting | 10 | 18 |
| 20 | Write clinical study report | Close-out and reporting | 15 | 19 |
| 21 | Report signed off | Close-out and reporting | Milestone | 20 |
How it works
Set the approval wait honestly
Replace the 15 days in "Ethics and authority review" with the time your reviewers take. Everything that involves a patient waits for "Approvals in place", so this one number moves the whole plan.
Keep contracts and systems under way during the review
"Negotiate site contracts" and "Build and test data capture system" run beside the review. Check that your own rules allow site contracts to be negotiated before approval, and move the link if they do not.
Tune the site waves
"Run wave 2 site initiation" is linked start-to-start with a lag of 8 days to wave 1, and wave 3 to wave 2. Change the lag to match how fast your monitors can train and visit sites.
Describe enrolment by wave
Set the lengths of "Enrol patients at wave 1 sites" and "Enrol patients at wave 2 and 3 sites" from your expected enrolment rate. Add rows for further waves or extra sites if you need them.
Make the follow-up fit the protocol
"Complete last patient follow-up" starts after "Enrolment complete" and finishes together with "Run treatment and follow-up visits". Set its length to the follow-up period in your protocol.
Add owners, share and export
Put the responsible person in People, share the chart with the sponsor, site and data teams, and export a PDF or CSV for the study file when you need a copy.
Frequently asked questions
How long does a clinical trial take?
It depends on the disease area, the number of sites, the enrolment rate and the follow-up period. The template uses illustrative working days. Replace them with your own and read the finish date from the chart.
Does the chart make a trial compliant or approved?
No. It schedules the work. Approvals, monitoring, data quality and the study report follow your protocol and your quality system. The chart shows when each part is meant to happen.
Why is database lock a milestone?
Because it is a gate with no duration of its own. "Database lock" is reached when "Clean data and close queries" ends, and "Run final analysis" cannot start before it.
Can I use this for a single-site study?
Yes. Delete the wave 2 and wave 3 rows, merge the two enrolment tasks into one and keep both gates. For corrective actions found during a study, see /templates/capa-gantt-chart.
How do I show an audit or inspection?
Add a task and a milestone after "Database lock", or link a separate plan. For preparation work, see /templates/audit-preparation-gantt-chart. For linking tasks, see /guides/gantt-chart-dependencies.