Investigator Obligations in FDA-Regulated Research Quiz

Form FDA 1572, Statement of Investigator, is legally binding between the Investigator and the:

FDA.

Source Document

The initial documentation of data in a clinical study and includes recorded observations, laboratory reports, medical reports, etc.

Case Report Form (CRF)

The tool that is used to record data during a clinical trial. The CRF is submitted to the sponsor.

When must the investigator update the IRB about the progress of a trial?

During the conduct of the study and at termination

Which of the following is an investigator's commitment to the sponsor?

Submit a new Form FDA 1572 to sponsor as needed

Consent Form (also called Informed Consent Document)

The document that includes the information needed for potential subjects to have sufficient information to provide informed consent to participate in a clinical trial. The FDA regulations and ICH E6 describe the information that must be included in the consent form.

Identify which party is responsible for reporting directly to the FDA the investigator's financial interests with the sponsor:

The sponsor

Protocol

The study plan that describes how a trial will be conducted including information about the investigational product, the criteria for subject selection, the schedule of procedures, and the data analysis product.

In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to:

Conduct or supervise the investigation personally.

The investigator must report adverse events to the:

Sponsor.

Investigator's Brochure (IB)

A compilation of the clinical and nonclinical data on the investigational product and serves as a resource for investigators, institutional review boards/independent ethics committees (IRBs/IECs) during the conduct of a clinical trial.

Source Data

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).

Independent Ethics Committee (IEC)

An independent body (a review board or committee, institutional, regional, national or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of trial subjects.

Institutional Review Board (IRB)

Any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects.