Free guide
Protocol-to-study-plan checklist
Before you build a timeline, task list or budget, pull these details out of the protocol and note the page each one came from.
01Study basics
- Protocol number, version and date
- Phase, design, number of arms and planned sample size
- Number of sites and countries
02Schedule of activities
- Every visit, with its timing and allowed window
- Procedures and assessments at each visit
- Screening, treatment and follow-up periods
03People and roles
- Sponsor, CRO, site and vendor responsibilities
- Who reviews and approves the plan
- Safety reporting contacts and timelines
04Milestones
- Site activation, first participant in and last participant out
- Interim analyses and data review points
- Database lock and study report
05Budget drivers
- Procedures and visits that drive per-participant cost
- Vendor services such as labs, imaging and drug supply
- Monitoring visits and their frequency
06Risks and changes
- Eligibility points likely to slow enrollment
- Known risks and how they will be watched
- A process for updating the plan after each amendment
Always confirm details against the current approved protocol version. This checklist is general guidance.
See your own protocol turned into a plan
Bring a protocol, or use our sample study. In 30 minutes you will see the extracted schedule, the generated plan and what your team reviews before anything goes live.
Prefer email? Write to jmodi@manakiki.net. A person replies, usually within one business day.