Form FDA 1571 – Used only for IND studies: This form must accompany the initial IND submission. It will contain serial number 0000 for the initial submission. This form is required to accompany all subsequent submissions to the IND. The serial number should be adjusted with each submission, (i.e. 0000, 0001, 0002, etc.)
Key components of the FDA Form 1571
- Contractual agreement between sponsor and FDA
- Name of person responsible for conduct and progress of the study (Item 14)
- Name of person responsible for the review and evaluation of safety information on the drug (Item 15)
- Sponsor agrees to conduct investigation in accordance with all applicable regulatory requirements (Item16)
Form FDA 1572 – Used only for IND studies: This form should accompany the initial IND submission. If multicenter, each site should have its own 1572. NOTE: Anyone performing clinical assessments should go on the 1572. This may include Physician Assistants, Nurse Practitioners, etc.
Key components of the FDA Form 1572
- Contractual agreement between an Investigator and the Sponsor
- Name of person responsible for conduct an investigation and their credentials
- Listing of the facilities and labs that are participating in the investigation
- Listing of the IRB responsible for reviewing/approving study
- Listing of additional Sub-Investigators
- Investigator agrees to conduct investigation in accordance with all applicable regulatory requirements (Item 9 - Commitments)
Form FDA 3500A – Used for IND and IDE studies (Also referred to as “Medwatch Form”). It is for use by user facilities, distributors, importers, applicants, and manufacturers for MANDATORY reporting of adverse events and product problems as designated in the applicable statutes and FDA regulations.
Form FDA 3514 – CDRH Premarket Review Submission Cover Sheet (PDF)
Form FDA 3674 – Used for IND and IDE studies This form must accompany the initial IND or IDE submission as well as the addition of a new protocol to an existing IND or IDE. This is a new requirement as of December 2007. This is a Certification of Compliance that all requirements of the Public Health Service Act (42 USC§ 282(j)) have been met (in essence, compliance with registration in clinicaltrials.gov. Learn more.)
Form FDA 3926 – Used by physicians to request expanded access to investigational drugs for individual patients who suffer from serious or immediately life-threatening diseases and for whom no comparable or satisfactory alternative therapy is available.new form.
VAERS form – Used to report vaccine adverse events.