ESSENTIAL DOCUMENTS I
This document is a written summary of person's career, qualifications, and eligibility to conduct a clinical trial
CV
The CRA signs this form as confirmation of their review of the clinical trial documents during monitoring visits
Monitoring Visit Log
This form is signed by the participant and documents their agreement to participate in a research study
Informed consent
Some of the information documented on this form includes the study product, the lot number, the date product was received and dispensed, the quantity received and dispensed
Investigational Product Accountability Log
This document is an agreement signed by the principal investigator to oversee the conduct of the trial. It also list the local labs, central labs, and any sub-investigators participating on the trial
Form FDA 1572
This form is collected to document the investigators financial information during the course of the study and for 1 year following study completion
Financial Disclosure Questionnaire/Form
This document is an agreement signed by the principal investigator when conducting a device study. The 1572 is not required
Investigator Agreement
This document lists qualified investigators and study staff. The form captures the delegation of significant study-related duties
Delegation of Authority log
This review is conducted at a minimum annually. It is required for continuation of study procedures
Continuing Review
This form is a child's affirmative agreement to participate in research when they are not old enough to give consent
Assent