Get proforma 1572

All GCP training can be accessed through the NIHR. Individuals must register with NIHR Learn prior to accessing the training. Please be aware that the certificate is valid for 3 years from the date of certification.

Under the regulations, a 1572 is only required for studies of investigational drugs and biologics conducted under an IND. It is not required for studies that are not done under an IND, and is not applicable to investigational device studies.

Specifically, the FAQ document states: "Generally, a research coordinator has a greater role in performing critical study functions andmaking direct and significant contributions to the study data. ... Therefore, the research coordinator should usually be listed in Section #6 of the 1572."

As commonly used, the term is meant to indicate that each co-investigator is fully responsible for fulfilling all of the obligations of an investigator as identified in 21 CFR 312.60. Thus under 21 CFR 312.3(b), each co- investigator is an investigator, and as such must sign a separate Form FDA 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.

Investigators are responsible for supervising the proper handling, administration, storage, and destruction of investigational agents (ie, drug accountability). Although these tasks can be delegated to an appropriately qualified individual, the investigator maintains ultimate responsibility.

Generally speaking, Site Investigators complete GCP training within three (3) years of the start of a new study. Investigators are not expected to retake GCP training during the study (unless required by local regulation or at the discretion of the sponsor).

When must I retake the GCP training? GCP training is required every 3 years.

The 1572 has two purposes: 1) to provide the sponsor with information about the investigator's qualifications and the clinical site that will enable the sponsor to establish and document that the investigator is qualified and the site is an appropriate location at which to conduct the clinical investigation, and 2) to ...

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.