Question

1. What is one of the most important responsibilities of the Clinical Research Coordinator?

Group of answer choices

The patient comes in for their visits

Every patient has read, understands, and signs the Informed Consent Form

The investigational product is dispensed

Meets enrollment goal or target

2. Who can create Source Documents?

Group of answer choices

Principal Investigator

Clinical Research Coordinators

Nurses

All of the choices

3. What are some common data errors?

Group of answer choices

All of the choices

Providing ambiguous data

Misspelling

Providing incomplete data

Approval of the protocol by the Institutional Review Board is required when?

Group of answer choices

After Initial Protocol Institutional Review Board Approval, Protocol Amendment Institutional Review Board Approval, and Continuing Institutional Review Board Approval

Institutional Review Board approval is never needed

Only Initial protocol needs Institutional Review Board Approval

When there is a change to the Institutional Review Board Approved protocol

How often after the initial Institutional Review Board approval should a protocol be reviewed by the Institutional Review Board?

Group of answer choices

The Institutional Review Board reviews on a monthly basis for greater than minimal risk studies.

The Institutional Review Board reviews after every new patient has been enrolled.

The frequency of reporting varies but should be reviewed at least annually.

A protocol never has to be reviewed after initial approval.

Answer 1

1.Meets enrollment goal or target.

Even enrolment of patient, make them understand clinical trial protocols etc also their important duties. In the provided option by achieving all the three options given ultimate goal is the enrolment of patient for the trials.

2.All of the choices.

Source documents are the group of documents including

• Investigators brochure
• Protocol amendment
• Informed Consent
• Study results etc.
• All these are prepared by PI,nurses,CRC etc

3.All of these.

The errors may come all these way.

4.After Initial Protocol Institutional Review Board Approval, Protocol Amendment Institutional Review Board Approval, and Continuing Institutional Review Board Approval

All this stages needed IRB Approval.

5.The frequency of reporting varies but should be reviewed atleast once in a year.

IRB function is to maintain patient safety.so Review is necessary. But once in a month or after enrolment of every patient is not possible. Once in a year is compulsory.