If you read FDA warning letters (and you should!), you are aware that the number of citations for failure to correctly complete the required FDA Form 1572 are increasing. An FDA Form 1572 is required for drug or biologic studies conducted under an IND, whether in the U.S. or abroad. Similarly, medical device trials require a signed agreement from each investigator that contains information similar to that requested in the 1572.
There has been long standing confusion and disagreement over who should be listed as a sub-investigator on the 1572. Even experienced clinical investigators continue to struggle with 1572 completion questions and this challenge is further complicated by the growing complexity of clinical trials, which may involve multiple 'satellite sites' or distributing other study functions.
There has been long standing confusion and disagreement over who should be listed as a sub-investigator on the 1572. Even experienced clinical investigators continue to struggle with 1572 completion questions and this challenge is further complicated by the growing complexity of clinical trials, which may involve multiple 'satellite sites' or distributing other study functions.
