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How would you describe the 1572?

The 1572 is more than mere paperwork. Its a binding legal contract between the principal investigator (PI), the trials sponsor and the FDA to conduct a clinical trial. Meaning that if you fail to follow it, it can lead to serious consequences.

What should be listed on a 1572?

List the names and code numbers (if any) of all the protocols under the IND that will be conducted by the investigator signing the Form FDA 1572. A code number is an identifying number assigned by the sponsor. Note: Only one box may be selected. For a combined Phase 1/2 investigation, check only the second box.

Is a 1572 required for an observational study?

Any study operating under an IND requires submission of FDA Form 1572 to the sponser. However, it is NOT required for post-marketing and observational studies.

Is the study coordinator required to be listed on the 1572?

Note: If a research coordinator is performing critical study functions and collecting and evaluating some study data, the coordinator should be listed on the 1572. If the research coordinator is only transcribing data and maintaining study files, the coordinator does not need to be listed.

Who can be a sub investigator in a clinical trial?

If the PI of a clinical trial is not a physician, a qualified dentist or physician must be listed as a Sub-Investigator. Other Sub-Is can include board-certified physicians, fellows, residents, or non-physicians. Those listed as Sub-Is must make direct and docHub contributions to the data.

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