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Public Disclosure AuthorizedImplementation Status & Results Reportage World Bank Second Science & Technology Project (P127308)Second Science & Technology Project (P127308) EUROPE AND CENTRAL ASIA
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How to fill out 21 cfr 312130

01
Obtain the necessary FDA Form 1571 for Investigational New Drug Application (IND)
02
Complete sections including, but not limited to, Investigator's Brochure, Chemistry, Manufacturing, and Controls (CMC) information, and Clinical Protocols
03
Submit the completed Form 1571 to the FDA for review and approval
04
Keep detailed records of the IND application process and any communication with the FDA

Who needs 21 cfr 312130?

01
Any individual or organization planning to conduct clinical trials on investigational drugs in the United States needs to follow the regulations outlined in 21 CFR 312.130
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21 CFR 312.130 is a regulation under the Code of Federal Regulations that pertains to the responsibilities of sponsors of clinical investigations.
Sponsors of clinical investigations are required to file 21 CFR 312.130.
21 CFR 312.130 must be filled out by providing the required information as outlined in the regulation.
The purpose of 21 CFR 312.130 is to ensure that sponsors of clinical investigations fulfill their responsibilities.
Information such as protocol amendments, event reports, and changes in investigator status must be reported on 21 CFR 312.130.
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