In accordance with U.S. regulations, THE FDA 1572 form must be collected from all PIs for studies conducted as part of an Investigational New Drug (IND) application, which would include clinical trials of an investigational drug or biologic, with the exception of clinical trials related to the product (which require a similar form called a “review agreement” and must be completed as part of an investigational drug exemption application). 1} In cases where an FDA 1572 form is collected just prior to the release of a new version, sponsors may use the current version to obtain signed agreements from clinicians participating in their clinical trials. The expiration date indicated for the use of the form reflects the publication of the form by the U.S. Office of Management and Budget as it meets the requirements of the Paperwork Reduction Act. Despite the fact that the form has an expiration date, it is not necessary to provide a new form after the publication of the new version with the last expiration date. 2. What is adequate training? The auditor should ensure that all staff involved in conducting the study are properly trained, including all new staff recruited after the study has begun to cope with unforeseen workloads or to replace resigning staff. . .