FDA Form 1572 Instructions

The U.S. Department of Food and Drug Administration (FDA) has very specific protocols that a drug company must follow in order for that drug to be allowed into the marketplace. One of those is form FDA-1572, to be completed by an investigator who has the qualifications, experience and training to be considered an expert for the investigation of the drug. According to the FDA-1572 instructions, it could take 100 hours to research the necessary information to properly complete this form.

Instructions

• 1

  Enter the name and address of the investigator into Box 1. There is typically only one investigator per drug test.

• 2

  List all of the qualifications of the investigator on a separate piece of paper, including an overview of the investigators life, education and experience, that would show the investigator is an expert for this particular type of clinical study.

• 3

  List all of the physical locations, in Section 3, where any part of the study will take place including hospitals, medical schools and clinics.

• 4

  Record any of the clinical laboratory locations to be used in the study in section 4.

• 5

  Record the name and address of the institutional review board that will be reviewing and providing approval in box 5.

• 6

  Obtain names of the physicians who will be overseeing the trial’s medical decision for Section 6. Also include in Section 6 anyone who will have direct subject contact or who will be involved in direct contributions to the data. For example, the pharmacist who compounds the drug should be included. Also include anyone who evaluates the data from the study.

• 7

  Enter protocol name and code number, if any, in box 7.

• 8

  Prepare a clinical protocol for section 8, attaching additional pages as necessary.

• 9

  Sign and date the form before participating in the clinical study but after you have received enough information to consider yourself well informed about the study.