Manging and Monitoring Final

Proper safety monitoring of adverse events also involves reviewing the concomitant medications for consistency. A. True B. False

A. True

Which of the following is NOT normally a responsibility of the Regulatory Member of a Clinical Trial Project Team? A. Track and file all correspondence with the FDA B. Answers questions from study sites on eligibility of potential patients for a clinical trial C. Compile INDs and NDAs for submission to the FDA D. Review key regulatory documents from sites prior to shipping study drug E. Call the FDA with minor questions or clarifications

B. Answers questions from study sites on eligibility of potential patients for a clinical trial

All of the following are responsibilities of a Clinical Investigator except... A. Controlling the drugs under Investigation B. Determining which projects require review more than once annually. C. Protecting the rights, safety and welfare of subjects D. Ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan and the applicable regulations

B. Determining which projects require review more than once annually.

In the hierarchy of regulations vs. guidelines vs. SOPs, a company's Standard Operating Procedures (SOPs) always take precedence over applicable regulations. A. True B. False

B. False

Which two vehicles are primarily focused on safety and welfare of study participants? A. PI and CSC B. IRB and ICF C. CRF and CRA D. ICF and PGA

B. IRB and ICF

Which statement is not true regarding the Monitoring Visit Follow-Up Letter? A. Answer any questions the CRA could not answer while on site B. Is filed in the TMF but not in ISF at site C. Details the activities and subjects reviewed at the visit, including any action items D. Should be written in factual statements, not opinionated

B. Is filed in the TMF but not in ISF at site

Which of the following is NOT true about a Clinical Monitoring Plan? A. Helps ensure consistency across CRAs B. Is required by FDA and ICH Guidance C. Describes activities for each type of monitoring visit D. Specifies percent of source data/document verification E. States how frequently drug accountability must be done

B. Is required by FDA and ICH Guidance

Which of the following is NOT one of the purposes of a protocol in a clinical trial? A. Central to conducting any research B. Outlines compensation of subjects and sites for study participation C. Protects patient safety D. Ensures consistency of patient population, drug dosing, and study assessments E. Ensures that data is meaningful

B. Outlines compensation of subjects and sites for study participation

Which statement is more accurate? A. There is no formal FDA approval for an NDA. B. The NDA is filed when the primary safety and efficacy studies are complete C. The sponsor must file an NDA with the FDA prior to beginning a clinical trial. D. Phase II studies are large, comprehensive safety and efficacy studies.

B. The NDA is filed when the primary safety and efficacy studies are complete

All of the following should be included in a protocol EXCEPT: A. A description of the objectives of the study B. The amount of the Investigator's grant per subject C. The study design D. The Inclusion/Exclusion criteria E. Information about treatment groups (drugs, dosages, length of treatment)

B. The amount of the Investigator's grant per subject

All of the following are objectives of a SQV (Site Qualification Visit) EXCEPT: A. To assess the investigator's facilities and equipment B. To collect regulatory documents for the study C. To assess the qualifications, experience and capabilities of the study staff D. To assess the patient population available at the site E. To assess the investigators' interest in the study

B. To collect regulatory documents for the study

After an investigative site begins to enroll patients, a CRA will conduct Interim Monitoring Visits at the site. Which of the following tasks will the CRA do during these visits?

A, B and C only

How frequently do FDA regulations require that Sponsors review and update an Investigator's Brochure? A. At least annually B. At least every two years C. Every time a study is complete D. Every time a serious adverse event is reported E. Whenever the study medical monitor determines that it is necessary

A. At least annually

Which of the following is NOT a responsibility of a CRA on a clinical trial team? A. Develop Case Report Forms (CRFs) B. Visit study sites to verify data captured in CRFs matches data in subject's medical record C. Monitor drug supplies at study sites D. Initiate study sites

A. Develop Case Report Forms (CRFs)

The usual process for recruiting potential investigative sites for a clinical trial is: A. Initial Contact - Site Survey - Confidentiality Agreement - Protocol Synopsis B. Initial Contact - Confidentiality Agreement - Site Survey - Protocol Synopsis C. Initial contact - Confidentiality Agreement - Protocol Synopsis - Schedule SQV D. Initial contact - Confidentiality Agreement - Protocol Synopsis - Draft Investigator Contract

A. Initial Contact - Site Survey - Confidentiality Agreement - Protocol Synopsis

Which of the following statements about the IB (Investigators' Brochure) is true? A. It is used by the sponsor to support its IND application to the FDA B. It is critical to a Lead CRA as she/he prepares a Clinical Monitoring Plan for a study C. It is used by QA to help plan vendor audits before a study begins D. It is included in package inserts by the Sponsor

A. It is used by the sponsor to support its IND application to the FDA

If a pharmaceutical company decides to transfer some Sponsor obligations of a study to a CRO, the transfer: A. Must be explicit and in writing B. Must be approved in advance by the FDA C. Is determined at the end of the project by which group actually performed the activities D. A and B only E. Must follow activities as outlined in the investigator's brochure

A. Must be explicit and in writing

All of the following checks/cross-checks for Regulatory Documents are true EXCEPT: A. Must have CVs for all Sub-Investigators listed on the Form 1572 B. Must have Financial Disclosure Statements for all investigators listed on the Form 1572 C. All Investigator CVs must have been updated and signed within the past five years D. The address on the PI's CV must match the institution address listed on the Form 1572

C. All Investigator CVs must have been updated and signed within the past five years

Aspects of a Case Report Form include all of the following EXCEPT: A. Mechanism for collecting data consistently across all study sites B. Design is primary responsibility of Data Management Department C. Can be easily revised at any time during a study D. Can be either paper or electronic E. Must be signed by the Principal Investigator

C. Can be easily revised at any time during a study

CRF design is the primary responsibility of what department: A. Biostatistics B. Regulatory C. Data Management D. Compliance/ Quality Assurance

C. Data Management

In a typical clinical trial life cycle, in what phase would you most likely find enrollment activity? A. Initiation B. Planning C. Execution D. Closeout

C. Execution

The following document compiles all relevant nonclinical and clinical data on a new drug, with an emphasis on safety data and is shared with all staff working on studies with that drug. A. Protocol B. Informed Consent Form C. Investigator's Brochure D. IND Application

C. Investigator's Brochure

Which of the following statements about IRBs is FALSE? A. Can be local and review research at their institution only B. Are formally designated by an institution to review, to approve and conduct periodic review of biomedical research involving human subjects C. Must have at least five (5) members, none of whom can be formally associated with the institution that they serve D. Can be "Central" and serve multiple sites/ institutions E. Can perform expedited review of research studies

C. Must have at least five (5) members, none of whom can be formally associated with the institution that they serve

Which of the following are legal requirements that must be followed when conducting a clinical trial, and would supersede all other levels of requirement? A. Standard Operating Procedures B. Study Specific Operating Procedures C. Regulations D. Guidance Documents

C. Regulations

Financial disclosure applies to: A. Only the Principal Investigator B. The Principal Investigator and the CRC C. The Principal Investigator and the Sub-Investigators listed on form 1572 D. The Principal Investigator, the CRC and the Pharmacist

C. The Principal Investigator and the Sub-Investigators listed on form 1572

Case Report Forms are USUALLY completed by: A. The CRA B. The Investigator C. The Study Coordinator/Clinical Research Coordinator D. The Project Manager E. None of the above

C. The Study Coordinator/Clinical Research Coordinator

Which of the following is NOT normally a responsibility of the Medical Writing Team Member of a Clinical Trial Project Team? A. Write protocol amendments B. Write clinical study reports C. Write informed consent forms D. Write abstracts and other publications

C. Write informed consent forms

An expedited IRB review process is characterized by: A. Minimal risk study B. Minor protocol changes C. Carried out by IRB Chairperson D. A, B, and C E. B and C only

D. A, B, and C

Which role plays a responsibility in data quality when EDC or electronic devices for PROs are used? A. Study Coordinator B. Data Management C. CRA D. All the above E. A and C

D. All the above

Which of the following is NOT part of an Investigator's brochure? A. Introduction B. Toxicology C. Non-clinical pharmacology D. Financial disclosure statement E. Clinical Safety & Efficacy

D. Financial disclosure statement

Which two vehicles are primarily focused on protection of human subjects? A. FDA and ICH B. IND and NDA C. Principal Investigator and Study Coordinator D. IRB and informed consent

D. IRB and informed consent

All of the following are responsibilities of the Pharmacovigilence (Safety) Member of Clinical Trial Project Team EXCEPT: A. Receive and track all Serious Adverse Event Forms (SAE forms) B. Determine if SAE must be reported to FDA immediately C. Review all SAE forms D. Make corrections to SAE forms

D. Make corrections to SAE forms

Which of the following depicts an appropriate chronological order of events? A. Protocol design, IRB approval, Subject enrollment, Site Selection B. IRB approval, Protocol design, Site Selection, Subject enrollment C. Protocol design, IRB approval, Site Selection, Subject enrollment D. Protocol design, Site Selection, IRB approval, Subject enrollment

D. Protocol design, Site Selection, IRB approval, Subject enrollment

Investigator responsibilities around drug accountability include:

E. A and C

Which of the following types of data are normally used to test the study hypothesis? A.Measurements in the clinic (e.g. Blood Pressure) B. Concomitant medications C. Patient Assessments (e.g. pain, dizziness, other symptoms) D. All of the above E. A and C only

E. A and C only

Which of the following are types of medical practices/facilities that can serve as an Investigative Site? A. Academic Institutions B. Private practice clinics C. Government Institutions D. A and B only E. All of the Above

E. All of the Above

Which of the following would be considered source documentation?

F. A and D

Which of the following are normally included in a Reg Doc (Regulatory Documents) packet from an Investigative Site? A. IRB approval letter that lists protocol and informed consent form B. IRB approved informed consent C. Case Report Form (CRF) D. Completed and signed Financial Disclosure statement from the study coordinator Completed and signed FDA form 1572 E. All of the above F. A, B, and E only

F. A, B, and E only

MATCH UP THESE

J. Protocol - This document fully describes the objectives, design, methodology, statistical considerations, and endpoints of a single clinical trial. E. ICH Guidelines - This document provides a unified international standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. A. IRB - This group's primary purpose is to assure the protection of the rights and welfare of human subjects at the local level. C. PI - This person is responsible for conducting the clinical investigation, (i.e., "under whose immediate direction the drug is administered or dispensed to a subject") G. GCP - This general term is used by the pharmaceutical industry to mean "the ethical and scientific standard for the design, conduct, performance, monitoring, recording, analysis and reporting of clinical trials" F. IB - This living document compiles nonclinical and clinical data about an investigational new drug that is relevant to the study of that drug in human subjects. I. CRA - This team member travels on a regular basis to study sites to monitor the progress of clinical trials D. SC/CRC - The member of the clinical study team who is supervised by the Investigator and who has been given authority to perform critical trial-related procedures and/or to make important trial-related decisions. H. FDA Form 1572 - This document serves as a contract between the Investigator in a clinical trial and the FDA and is formally called the "Statement of Investigator" B. Sponsor - The ICH GCP definition for this term is "an individual, company, institution, or organization which takes responsibility for the initiation, management and/or financing of a clinical trial.

You are a CRA who recently visited 5 different study sites to perform SQVs for an oncology study. Dr. George (a full professor at Johns Hopkins University) was one of the sites included. Dr. George is a very experienced physician, he is well known for his numerous academic publications, he has also worked with Big Pharma Inc., for many years and knows the senior VP of Marketing and the VP for Clinical Research well. He is very interested in the new drug under investigation and has discussed becoming a spokesperson for Big Pharma Inc., if the drug is approved. Dr. George has worked with his study coordinator for many years and relies heavily on her expertise to assess and manage patients on studies. He is too busy to always see patients himself and tells you so during your visit. He plans to "hand pick" several residents to be sub-investigators for this study. He stated that it would be good experience for them to be involved in a clinical study. The coordinator (who is currently working on 5 other studies) will train and supervise the residents. While Dr. George has met enrollment goals on his last 3 studies, there were several significant protocol violations noted in each study. There are also often delays in CRF completion and many the site led by Dr. George typically has the most queries in the studies he has done for Big Pharma Inc. The facilities at Johns Hopkins are excellent. The pharmacy has secure drug storage, constant temperature logs and keeps very good records. IRB approval takes about 3 months after the protocol is reviewed by an independent committee. IRB approval is followed by contract and budget negotiations - total time for startup will be approximately 6 months if all goes smoothly. Johns Hopkins charges a premium for study coordinator and physician time and the standard institutional overhead is currently 40%. Budget negotiations may increase start up time. Provide a list of 5 pros and 5 cons for this site after your SQV. Would you select this site for the study? Yes or No? Provide a clear rationale for your recommendation.

List out 5 pros and 5 cons and then why you would or wouldn't choose this site.

What is considered the primary limiting factor for sites in enrolling subjects into a clinical trial?

Protocol requirements (inclusion/exclusion criteria)

All of the following are involved in Risk-Based Monitoring process EXCEPT:

Reconciliation and accountability of IP

When obtaining consent, the investigator MUST do all the following EXCEPT:

Require subject sign the consent prior to leaving physicians office

Who is ultimately responsible for keeping up with the Delegation of Authority Log?

The Principal Investigator (PI)

Key elements in the source document verification (SDV) process include all of the following EXCEPT:

The site contract

Which of the following is NOT not required as part of the Regulatory Binder per regulations?

The site contract