21 CFR 312.50 - General Responsibilities of Sponsors

What it says

Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation, ensuring that the investigation is conducted in accordance with the general investigational plan and protocols in the IND, maintaining an effective IND, and ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Sponsors can transfer duties to a contract research organization, but responsibility for the study remains with the sponsor unless transferred in writing.
• Monitoring is how the sponsor confirms that the study is run to the protocol and that data are reliable.
• Investigator qualifications should be checked and documented before they are selected.

What FDA inspectors look for

• Whether monitoring was adequate and followed a plan.
• Whether obligations transferred to a CRO are documented in writing.
• Whether noncompliant investigators were dealt with promptly.

Related regulations