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| | AppliedClinicalTrials - A Closer Look at the 1572: Interpreting the FDA's Statement of Investigator Form |
 | | Through this seemingly mundane form, a clinical investigator must provide a study sponsor with information on the education, training, and experience that qualifies him/her to conduct a particular study as well as his/her commitment to conduct the proposed study in accordance with the protocol and federal regulations. |
 | | Over the years, several factors have contributed to industry uncertainty regarding the 1572 and its use, among them the fact that, today, the 1572 has both mandatory and practical, nonmandatory uses. |
 | | That is, there is no FDA regulatory requirement for completion of a 1572 when a sponsor has designated the non-U.S. study or sites as 'non-IND' (although a sponsor may still request completion of the 1572 as part of an internal SOP-and FDA, of course, expects SOPs to be followed). |
| www.actmagazine.com /appliedclinicaltrials/article/articleDetail.jsp?id=125562 (1830 words) |
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