CLINICAL RESEARCH COORDINATOR EXAM QUESTIONS WITH CORRECT ANSWERS

CLINICAL RESEARCH COORDINATOR EXAM QUESTIONS WITH CORRECT ANSWERS

CRC Correct Answer Clinical Research Coordinator

CRA Correct Answer Clinical Research Associate

PI Correct Answer Principal Investigator

CFR Correct Answer Code of Federal Regulations

FDA Correct Answer Food and Drug Administration

GCP Correct Answer Good Clinical Practice

ICH Correct Answer International Conference on Harmonization

SOP Correct Answer Standard Operating Procedure

CRF Correct Answer Case Report Form. Electronic document designed to records all of the protocol required information to be reported to the sponsor on each trial subject and shared with the IRB.

1572 Form Correct Answer Statement of Investigator; signed by the investigator to inform the FDA where the study is being done, who the PI is and who is helping them conduct the study, location of study, and what labs, and which IRB is being used.

IND Safety Report Correct Answer A proposal through which a sponsor obtains FDA approval of its plans to test a new drug in human trials.

Letter of Indemnification Correct Answer Contractual document that guarantees certain provisions will be met between two parties.

IRB Correct Answer Institutional Review Board, To ensure the rights and safety of the research patient; the patient's advocate.

ICF Correct Answer informed consent form- voluntary confirmation of a subject's willingness to participate in a trial and documentation thereof

protocol Correct Answer A document that details who can be included in the study and how the study will be performed from start to finish; to be signed by the PI on the signature page and submitted to the IRB for review and approval.

Amendment Correct Answer An approved change to a clinical protocol which significantly affects the subjects, the scope of the investigation, and quality of the study

Indemnification Correct Answer The process to protect (Indemnify)an investigator, sub-investigator in research against unintentional loss, hurt, or damage to subjects in a clinical trial (insurance)

CDA Correct Answer Confidential Disclosure Agreement

A precursor to a clinical trial; Assuring the sponsor the site will keep any information exchanged will be kept confidential.

IRB Approval Correct Answer The one document that a site must receive before a study drug can be shipped and the study can begin

Study Closure/Final Report Correct Answer The report that has to be completed and submitted to the IRB once a study is finished; after the monitor completes a close out visit.

Changes to advertisements about a study has to Correct Answer Always be reported to the IRB

The documents that are not required to be submitted to the IRB for approval are: Correct Answer Budget, Financial Disclosures, and Clinical Trial Agreement

Feasibility Correct Answer The team/process of how PMG acquires a trial

Investigator's Brochure Correct Answer Contains all of the information on the study medication/device/injection that has been complied up to date, signed by the PI on the acknowledgement of receipt page and submitted to the IRB for review and acknowledgement.

FDF Correct Answer Financial Disclosure Form - FDA requires that anyone involved in a clinical trial complete the financial disclosure agreement. (whether or not they have financial interest in the company and/or drug being studied. (Not submitted to the IRB)

Source Documents Correct Answer Original subject clinical, laboratory, hospital records, office notes, and findings from a trial.

Regulatory Binder Correct Answer Called the "Trial Master File", tracking studies of human trial subjects, maintaining regulatory compliance documents

CRO Correct Answer Contract Research Organization, a commercial organization that conducts all/some of the activities involved in the drug/product development process.

CV Correct Answer Curriculum Vitae; Resume