Must foreign clinical study sites in a multinational study that includes domestic sites be conducted under an IND?

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No. A multinational study may include domestic sites that are under IND and foreign sites that are not under IND. If an investigational drug and biologics studies is conducted in the U.S. then it must be in compliance with the IND requirements (in 21 CFR 312) and the investigator must sign the 1572 form. If the study involved foreign clinical sites, the sponsor has the option (but not required) to conduct the foreign site studies under an IND. If the sponsor decides to conduct the foreign studies under an IND, the investigator is required to sign the 1572 form. If an investigator (of the foreign site) is not included under an IND, he/she is not required to sign the 1572 form.

If the sponsor decides not to conduct the foreign site studies under the IND, a single protocol to the IND must be submitted by the sponsor and all the sites would need to follow this protocol. Additionally, the sponsor has the option to conduct with one protocol for sites that are under an IND and have other protocol(s) for foreign sites that are not under an IND.  The protocols are usually the same. Any U.S. sites and foreign sites that are included under an IND must follow the protocol that was submitted to the IND. The foreign sites that are not under an IND do not require the protocol to be submitted to the IND. The FDA recommends sponsors that want to submit data in an application for marketing approval, to select the foreign sites that are not under an IND and discuss with the appropriate FDA review division about pooling data from U.S. and foreign sites.

Note:

  • The sponsors are required under 21 CFR 312.32(b) to review any information about the safety of the investigation drug that they have obtained or received from any sources, foreign or domestic.
  • In order to inform the FDA and all the participating investigators about any adverse events (even if occurred in a foreign study), the sponsor is obligated under 21 CFR 312.32(c) to notify the FDA and all other investigators participating in IND safety about any adverse experience related to the use of the drug that is both serious and unexpected.

 

About the Author
Proxima CRO Team
Aryan Abedi
Quality Assurance Intern

Aryan received his B.S. in Biomedical Engineering from Texas A&M University. He has experience in Design and Development, Quality Control, and Quality Assurance and is particularly interested in the use of biomaterials and production of cost-effective medical devices to improve quality of life for patients from various socioeconomics background.  

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