I’m in a presentation right now about managing clinical trials at the department level, and it’s reassuring, and familiar.
Key points to remember:
The contract with the sponsor should be used as an operations document, not put in a drawer. It contains key information to help manage and make key decisions, especially to help guide the PI.
Tracking key metrics against the budget as the trial progresses is vital.
At closeout, if more than 25%-30% of the original project budget remains, there is a problem – expenses have not hit the account, etc.
Working closely with your grants and contracts officer can assist you when facing unusual situations like the early closure of a trial.