Study start hinges on clauses that nobody in the hospital may sign alone.
The sponsor contract arrives as a draft, usually in English, with its own clauses on liability, publication and data use. The clinical trials office reviews the substance, the legal department the legal side, and the research data question is sent off separately on top of that. Meanwhile, the ethics application waits for the signed contract.
1draft contractThe sponsor submits its version, with its own clauses on liability and publication.
3reviewersThe clinical trials office, the legal department and data protection see the same text one after another.
2negotiation roundsEvery comment goes back to the sponsor and comes back changed.
1ethics applicationIt waits for the final contract and adds its own deadline to the lead time.
The 24-month publication period, rather than 12, is already flagged and on the table in the first round, and contract review runs 45% faster.
The 45% is this agent's headline figure. The three reviewers and two negotiation rounds reflect a typical path to study start; they are not measured values.