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Do all studies need a 1572?

Under FDA 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.

What is the purpose of the investigator brochure?

The purpose of the IB is to compile data relevant to studies of the investigational product in human subjects gathered during preclinical and other clinical trials to provide the investigator with information necessary for the management of study conduct and study subjects throughout a clinical trial.

What is the difference between trial master file and investigator site file?

PAID MESSAGE \u2013 The Trial Master File (TMF) is held by the sponsor and represents the story of the study of the study. The Investigator Site File (ISF) is held by the site and represents the story of the study at the site.

What is a 1572 in clinical research?

The Statement of Investigator, Form FDA 1572 is an agreement (one-sided contract) signed by a clinical trial investigator to provide certain information to the clinical trial sponsor, and to assure the sponsor that he/she will comply with US FDA regulations related to the conduct of a clinical investigation of an ...

What is an CTSI form?

The Clinical Trial Site Information (CTSI) form is required to be submitted by clinical trial sponsors prior to initiating a protocol or implementing subsequent amendment(s) at the clinical trial site for trials that are subject to Division 5 of Part C of the Food and Drug Regulations or the Clinical Trials for Medical ...

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