The regulations at 42 CFR 11.4(c) outline procedures for determining the responsible party for an applicable clinical trial (ACT) or a clinical trial voluntarily submitted under 42 CFR 11.60. The regulations specify that the sponsor of the trial will be considered the responsible party unless and until a principal investigator has been designated the responsible party in accordance with 42 CFR 11.4(c)(2).
For purposes of the regulation, if an ACT or clinical trial is being conducted under an investigational new drug application (IND) or investigational device exemption (IDE), the IND/IDE holder is considered to be the individual or entity who initiated the ACT or clinical trial and, therefore, the sponsor as defined in 42 CFR 11.10(a), regardless of how the clinical trial is being funded. For clinical trials not conducted under an IND or IDE, the sponsor is considered to be the person or entity who initiated the trial and would be identified as follows:
Where the clinical trial is being conducted by an entity under a research assistance funding agreement such as a grant or sponsored research agreement, the funding recipient generally is considered to be the initiator of the clinical trial, and therefore, the sponsor. This is because, as a general rule, when a clinical trial is funded in this manner, the funding recipient “initiates” the clinical trial process by, for example, submitting a funding proposal and designing the clinical trial.
Where the clinical trial is being conducted by an entity under a procurement funding agreement such as a contract, the party obtaining the goods or services for its direct benefit or use (the funder) generally is considered to be the initiator of the trial, and therefore, the sponsor. This is because, as a general rule, when a clinical trial is funded in this manner, it is the funder of the clinical trial that initiates the clinical trial process by, for example, contracting with another entity for that entity to conduct a clinical trial meeting the specifications of the funder.
Where there is no funding agreement supporting the clinical trial, the person or entity who initiated the clinical trial by preparing and/or planning the clinical trial, and who has appropriate authority and control over the clinical trial to carry out the responsibilities under section 402(j) of the Public Health Service Act (including this part) is the sponsor. [81 FR 65003-04].
