CRO (Contract Research Organization)
An organization contracted by the sponsor to perform one or more of a sponsor’s related duties and functions. Duties may be limited to the clinical portion of the trial or may include all regulatory, clinical, contractual and data management duties.
Facilities & Administrative (F&A) Costs
The general support expenses relating to a university function (in this case, research) that cannot be specifically identified to a project. Examples include utilities, the departmental administrator overseeing research, and research support staff in central administration.
Fully-executed agreement
A written agreement, dated and signed by the university, principal investigator and sponsor (or sponsor’s agent) that sets out any arrangements on delegation and distribution of tasks, obligations and financial matters. The protocol serves as the basis of the contract.
Investigator-initiated trial
A trial where the faculty member initiates and conducts a trial whether alone or with others; may have internal or external funding.
Principal Investigator (P.I.)
A person responsible for the conduct of the clinical trial at a trial site. If a team of individuals at a trial site conducts a trial, the investigator is the responsible leader of the team and may be called the principal investigator. (ICH) 21 CFR 50.3 defines an investigator as the individual under whose immediate direction a test article is administered, or dispensed to, or used involving a subject or the responsible leader (principal investigator) of a team of investigators.
Proposal packet
Internal Processing Form, abstract, performance-based budgeting form, and appendix A along with the Institutional Review Board approval/pending letter, ICF, and draft of contract with finalized budget.
Protocol number
The number assigned to the protocol by the sponsor (i.e. HLK-213).
Protocol amendment
A written document that changes the original terms of the contract.
Sponsor
An individual, company, institution or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.