When Should 1572 be submitted?

When Should 1572 be submitted?

In cases when a new site is added or of replacement of an investigator at an existing site, a 1572 must be submitted to the FDA within a 30-day window of the site’s/investigator’s addition/replacement.

Who must be added to 1572?

A new 1572 is required when an investigator is participating in a new protocol that is added to an active IND and when the Principal Investigator of an ongoing study changes, when a Sub-Investigator is added, and when there is a change of location in which the study is being conducted.

What is the purpose of 1572?

A form that must be filed by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial.

Should study coordinators be on the 1572?

For example, a research coordinator often recruits subjects, collects and evaluates studydata, and maintains study records. Therefore, the research coordinator should usually be listed in Section #6 of the 1572.”

Which party submits the Form FDA 1572 to the FDA?

When new investigators are assigned to a clinical investigation under an investigational new drug application (IND), the sponsor completes and signs a Form 1572 before allowing the investigator to get involved in the clinical investigation.

Can a nurse be a sub investigator?

Nurses can also serve as investigators or sub-investigators on research studies. Such is the case with Radica Palmer, RN, a nurse practitioner at Northwell Health. Her role as a clinic nurse has evolved over the years, and has excelled in a leadership role in research for her department.

When completing an investigator agreement What does the investigator agree to?

In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to: Conduct or supervise the investigation personally.

What is an FDA 1572 form?

According to U.S. regulations, the Form FDA 1572 is required to be collected from all PIs for studies being conducted under an Investigational New Drug (IND) application, which would include clinical studies of an investigational product or biologic, excluding device-related clinical trials (which require a similar form called an “investigator

Is there a guide for filling out and maintaining the 1572?

Many common mistakes are made when filling out and maintaining the 1572 form, so the hope is that this guide will be useful to new sites, clinical research coordinators (CRCs), clinical research associates (CRAs), and other clinical research professionals.

Can a co-investigator fill out a separate 1572 form?

In cases when a co-investigator is assigned, then under 21 CFR 312.3 (b) the co-investigator must fill out and sign a separate 1572 form. The address to provide in Section 1 of the 1572 is for the PI’s office, study site, or other business place where he/she can be reached by mail or in person.

What is the purpose of the Pi form 1572?

Through this form, the PI provides specific information to the sponsor, including his/her qualifications and information about the clinical site, in aim of assuring conduct of the clinical trial according to FDA regulations and guidelines. {1} By signing the 1572 form, the PI is making a legal commitment to adhere to FDA expectations by: