No no. A multinational study may include national sites under the IND and foreign sites that are not under the IND. U.S. drug and biologic studies must be conducted in accordance with the ind requirements of 21 CFR 312, requiring investigators to sign 1572. If a study also includes foreign clinical sites, the sponsor may choose, but is not required to include foreign clinical sites under the NDT. Investigators from U.S. sites and all foreign sites included in the IND would be required to sign 1572. Investigators of foreign sites that are not included in the IND are not required to sign 1572. If the sponsor decides to conduct a multinational study with the United States and certain foreign sites under the IND and other foreign sites that are not subject to the IND, the promoter may send a single protocol to the IND and all websites will follow this protocol. Alternatively, the promoter can conduct a multinational study with a protocol for sites under the IND (US sites and some foreign sites) and another protocol (e) for foreign sites that are not under the IND. If the intention is to aggregate data from U.S.
and foreign sites, the protocols would normally be very similar or identical. U.S. websites and all foreign sites included in the IND must follow the protocol forwarded to the IND. In the case of a foreign website that is not listed in the IND, the protocols should not be forwarded to the IND. In general, when the proponent intends to submit the data in an application for marketing authorization, we recommend that the proponent identify foreign sites that are not performed under the IND and discuss plans to aggregate data from U.S. and foreign sites with the corresponding FDA verification service. However, note that 21 CFR 312.32 (b) requires sponsors to immediately verify the safety information of the test drug that the sponsor receives or receives from a foreign or domestic source. At 21 CFR 312.32 (c), sponsors must also inform the FDA and all participating reviewers, in an IND safety report, of adverse experiences related to the use of the drug, which is both serious and unexpected. This means that the FDA and all examiners involved would be informed of such an adverse experiment under the IND, even if it occurred in a foreign study that was not conducted under the IND. If a researcher sees materials in more than one location, should the examiner list all the sites on the 1572? Yes, I do. The names and addresses of each study site should be identified in the section In this option, the sponsor should perform a single global trial version with some websites under the IND and some not. Some sponsors have created identical protocols, but numbered separately, with only one under the IND, but it is not necessary.
The Statistical Analysis Plan (SAP) must be written using two protocols to include the results of both trials. Essential documents are also used for a number of other important objectives. The timely presentation of essential documents to control centres/institutions and sponsor sites can greatly contribute to the proper management of a process by the auditor, promoter and monitor. These documents are generally verified by the promoter`s independent audit function and verified by the regulator as part of the procedure to confirm the validity of the test behavior and the integrity of the data collected.