Quiz 5 Essential documents and records management

1)For products that are FDA approved, according to federal law how long must investigators keep study records

1. 1. 2 years after last marketing action
   2. 3 years after last marketing action
   3. 4 years after last marketing action
   4. 5 years after last marketing action
2. In the US no PI may begin an investigation of a drug (IND) until they complete which of the following:

a. 1571

b. 1572

c. 1573

d. 1574

3. In the US no PI may begin an investigation of a device (IDE) until he/she does the following:
   1. Investigator agreement/statement of investigator
   2. Device research agreement form
   3. FDA form 1571
   4. FDA form 1572

4. PI are 100% responsible for everything that occurs at the investigative site however they may delegate certain tasks to other individuals. Prior to another individual performing a study related task, which of the following most accurately fulfills the requirement as set for the US federal regulations?
   1. Task and individual performing the task must be documented on the delegation of authority log
   2. Individual performing task must complete FDA form 1572
   3. Person performing task must be properly trained
   4. Task and person performing is must be documented on delegation of authority log and person must be properly traine

5. For products that are approved by the FDA according to US federal law, how long must sponsors keep study records
   1. 2 years after last marketing action
   2. 3 years after last marketing action
   3. 4 years after last marketing action
   4. 5 years after last marketing action

6. Is it illegal in the US for investigators in a human clinical research trial to have a financial conflict of interest?
   1. Yes, financial conflict is prohibited
   2. Yes, you can submit to FDA for an exemption

1. 3. No, as long as investigator discloses their financial interest and the sponsor takes steps to minimize bias
   4. No as long as you give up your financial interest

You are working at a medical device sponsor as a project manager. Your company is ready to begin human clinical trials on a brand new device that will be submitted under an IDE. Prior to study start, you are screening and evaluating 10 sites for potential participation in the clinical trial. Each site will receive a brief synopsis of the study protocol and investigational product information.

7. You select 5/10 sites for study. In order to ensure compliance with federal regulations, you notify each site that investigation product will not be shipped and that they should not conduct any subject screening and enrollment activities until the site obtains with of the following?
   1. Delegation of authority log
   2. IRB approval letter
   3. Monitor visit log
   4. Investigators brochure

8. In order to protect your company’s proprietary info, what regulatory document should each site complete prior to you sending the study protocol and any product information?
   1. Confidentiality agreement
   2. FDA form 1572
   3. Financial disclosure
   4. IRB approval letter

9. As project manager you routinely attend company marketing meetings. These meeting review the company’s latest marketing initiative for all products. During a recent meeting you discover one of your investigators has been speaking o behalf of the company at various medical conventions and receiving an honorarium for each speaking engagement. Which regulatory document should you immediately check to see if a conflict of interest has been properly disclosed?
   1. Confidentiality/non disclosure agreement