What is an FDA Form 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.
When should I update my 1572?
When Must the Form be Updated or a New One Completed? 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.
Is a 1572 required for an IND submission?
When is the Form FDA 1572 necessary? When filing an Initial IND Submission, a completed Form FDA 1572 must be sent from each site. When adding a new investigator (or new site), or replacing an investigator at an existing site.
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.
What is the purpose of the drug accountability record?
It lists many things about each drug, including the drug name, lot number, expiration date, the amount of drug received, used, returned, or thrown away, and the amount left. Drug Accountability Records help make sure that a clinical trial is done safely and correctly.
When must the investigator update the IRB about the progress of the trial?
During the conduct of the study and at termination.
Do regulations require a CV to be updated every two years?
GCP Investigators: Do Regulations Require a CV to Be Updated Every Two Years? No. FDA regulations do not require a CV or other statement of qualifications to be updated during a clinical study.
What form is used for IND?
FORM 3500A – Used for IND and IDE studies (Also referred to as “Medwatch Form”).
Who can be a sub investigator?
The ICH GCP 1.56 defines sub-investigator as any individual member of the clinical trial designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or make important trial-related decisions (e.g., associates, residents, research fellows).
Can nurse practitioners be principal investigators?
Nurse practitioners (NPs) are ideally suited to assume roles of principal investigators (PIs) in clinical trials. NPs are trained and authorized to perform physical examinations, make clinical assessments, diagnose and treat diseases, and prescribe drugs, either independently or in collaboration with a physician.