Investigator's Responsibilites

True or false: Only the PI is allowed to transcribe the data from the source document to the CRF.

False: a PI must make all associates who are assisting in the study aware of their responsibilities (i.e. transcribing data from the source document to the CRF)

Investigator's Responsibilities: Accountability Records

- doses specified in the protocol were provided to subjects - drug/device was provided only to those within the study - use by study subjects reconciles the amounts received and returned to the sponsor - product was stored as specified by the sponsor and in compliance with regulations - device was used only for its intended purpose

Investigator's Responsibilities: Study Product

- ensure proper storage and handling of study product, accountability, and return or destruction of unused study drug - ensure the study product is only being used by those who have agreed to participate in clinical tries (i.e. signed ICF)

Investigator's Responsibilities: Informed Consent

- must ensure that all requirements relating to obtaining informed consent (21 CFR 50) and IRB review/approval (21 CFR 56) are met - obtain informed consent PRIOR to entry into the study

By signing the FDA 1572, the investigator agrees specifically to:

- obtain IRB approval prior to starting any study related activities - ensure that an IRB the complies with requirement s of 21 CFR 56 will be responsible for initial and continuing review - report to the IRB all changes in the research activity and any unanticipated problems - not make changes in the research without sponsor and IRB approval - conduct the study in accordance with the protocol

Investigator's Responsibilities: Adverse Events

- reported during the study (21 CFR 312.64) - maintain adequate and accurate records (21 CFR 312.62) and make them available for inspection (21 CFR 312.68)

Investigator's Responsibilities: Informing Subject

- that drugs are being used for investigational purposes - must explain the proper use of the investigational product to the subjects - assure proper care to be given for study related adverse events

What does FDA 1572 include?

- the name and address of the investigational site(s) - the name and address of the responsible IRB - the name and address of clinical laboratories

What is the value of sponsor payments an investigator must report?

Exceeding 25,000 in value

What is the value of equity interest an investigator must report?

Exceeding 50,000 in value

What FDA document must all investigators sign prior to participating in a drug clinical trial?

FDA 1572

Investigator's Responsibility re: IB

Has read and understood the information within the IB, including potential risks and side effects of the drug

What is the timeline for equity interest reporting?

Interests held during the time the clinical investigator is carrying out the study and one year following completion of the study.

The investigator will...

PERSONALLY conduct or supervise the investigation

Form FDA 1572

Statement of Investigator 1) The agreement between the researcher and the sponsor assuring compliance with FDA regulations. 2) The document that notifies the FDA of relevant changes in researchers conducting clinical trials under the IND * only used in clinical investigations of drugs and biologics, not devices

True or False: According to the FDA guidelines, the financial disclosure form should be completed by all study personnel that have a significant role in the study.

True

An investigator must...

have the adequate time and resources to conduct the study properly