Innovative Clinical Trials SOP Quiz V1 30jun12

Each visit from a Clinical Research Associate (CRA, or 'Monitor') must be recorded on a Monitor Visit Log and maintained in the Regulatory Files.

• True

• False

One of the most important things to ensure when reviewing a potential protocol is that the study is safe.

• True

• False

The first person who finds a person in a medical emergency does what?

• Calls for help

• Does her nails while the person turns blue

• Transport the person to the roof for medivac pickup

An Adverse Event that causes death, prolongs hospitalization, causes a birth defect, or causes a life-threatening event is called a:

Regulatory Documents, although the PI's responsibiltiy, are often delegated to the Coordinator. The Coordinator knows that ___ _______ relating to clinical studies will be kept in the regulatory binder, and that ___ ________is required before any study activities can commence.

• All medications, monitor documentation

• Lab certification, clia waiver

• Source data, IRB closeout letter

• All documents, IRB approval

It is not necessary to check the ID of an FDA Auditor when they present themselves to the research office, even if they say they are an FDA Auditor.

• True

• False

To be trained on Innovative Clinical Trials' SOPs, you may read the SOPs individually, or the SOPs may be reviewed as a group during a staff meeting.

• True

• False

An IRB must have at least 5 members, be composed of men and women, and have at least one member with non-scientific expertise, among other criteria.

• True

• False

Two original copies of a Clinical Trial Agreement (Investigator Agreement) are prepared and signed prior to starting any study procedures.

• True

• False

If a subject pre-qualifies for more than one study at the same time, he or she:

• May decide to participate in both at the same time

• May be persuaded by the PI to do one rather than the other

• Must be given the choice to choose one for him/herself without coercion

• May participate in both, but only if he/she agrees not to take drug on both studies

One of the criteria used to evaluate a site for the appropriateness of a clinical trial is:

• That all site personnel wear navy blue scrubs

• That the site has qualified study personnel without sufficient time, knowledge, and experience to conduct the study

• That the site has access to an adequate number of potential study subjects that would meet study criteria

• That all site personnel have had experience with FDA audits

One of the most important things to think about when conducting internal QA/QC of source documents is

• The color of the ink used to record entries

• The presence of the most current ICF, sign appropriately by all required parties

• The date in which the visit was done

• The data written on a sticky note, but attached to a memo-to-file explanation

Choose the best answer for the following definition: Any adverse experience, the specificity or severity of which is not consistent with the current investigator brochure; or, if an investigator brochure is not required or available, the specificity or severity of which is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended. [21CFR312.32(a)]

• Adverse Event

• Side Effect

• Unexpected Adverse Event

• Serious Adverse Event

At study close-out, which of the following is not appropriate for the coordinator to do?

• Ensure all CRFs are complete, all source is complete

• Prepare the study closure report for the IRB

• Pack the unused & returned drug for long-term storage with the source documents

• Ensure the safety & data reports are complete with the help of the CRA

Patient ABC has consented to have her medical record reviewed for clinical research purposes. This means that any research team member can peruse her chart at any time for any reason.

• True

• False

Before a study can be started, name a document that the site must have:

The reporter of misconduct on a clinical trial will be protected as a 'Whistle Blower' and no retaliatory actions will be tolerated.

• True

• False

A blinded rater is one who:

• Is blind and has to use one of those red-tipped white canes

• A study personnel who performs study assessments, but is prohibited from seeing other certain study information or performing other certain study assessments

• Is completely blind to who the subject is

• A rater who cannot see the assessments he/she is giving

In order to ensure accuracy and quality is at its best,  all _____ ______ _____ are complete during the study visit or as soon as possible after the visit. The Clinical Trial Agreement often dictates how much time a site has to complete these after a visit occurs.  

Who of the following might be ideal to coordinate a study at Innovative Clinical Trials:

• Someone who has been a nurse for 20 years, but no research experience

• Someone who is not a nurse, but has 3 years experience coordinating studies in phase I-IV

• A newly hired recruiter with no coordinating experience

• A medically trained person who says they can coordinate clinical trials

Who may conduct the revised informed consent process?

• PI, CCRC, RN, SUBI, LVN, CCRP

• PI, CCRC, LVN, Recruiter, CCRP

• CCRC, RN, Research Assistant, PI

• CCRC, Subject, LVN, SubI

One element contained within Informed Consent is:

• The subject's responsibilities

• The clinical trial is non-invasive

• A statement of indemnification of the physician investigator

• The guarantee that the subject will receive active drug

BONUS: When the PI assesses Adverse Events, he shouldn't indicate 'CS or NCS', but rather indicate 'related or not-related' to study drug or procedure.

• True

• False

Standard Operating Procedures may be signed by any of the Principal Investigators.

• True

• False

The purpose of sponsor interactions may include which of the following (select all that apply)

• Site initiation visit

• Ongoing study visit

• Close-out visit

• Holiday lunch

• Telephone conversations

If a tornado warning is issued by the appropriate officials, the central internal safe room designated for the office is the:

• Research bathroom

• Record room behind the front desk

• The recruiter's office

• Dr. McCarroll's office

The following are examples of different types of fraud as it relates to clinical trial conduct: (select all that apply)

• Not taking a subject's blood pressure, but writing a blood pressure in the source

• Not taking a subject's blood pressure, but writing a note in the source that it was 'inadvertantly missed'

• Signing someone else's name on a delegation log

• Taking a subject's study drug upon return, but keeping it for oneself and documenting it was taken by the subject

• Retaking an EKG repeatedly until measurements 'fit' the criteria

• Retaking an EKG once to 'verify' the reading, but calling the sponsor for guidance

From the following recruitment methods, choose the ones that ARE NOT appropriate for Innovative Clinical Trials staff to do: (choose all that apply)

• Advertisements

• Enticing a reluctant student into participation with promises of 'Big Cash'

• Posters

• Leading a homeless person to the office with offers of 'free medicine'

• Use of EMR for patients who've agreed to be contacted

The Investigator is responsible for: (check all that apply)

• Maintaining SOPs that meet or exceed FDA regulations and GCP Guidelines

• Maintains all test articles, including investigational product and subject records

• Ensuring all study activites are performed correctly

• Ensuring every staff member has had training on taking blood presssures

• Ensuring that each coordinator has been trained on research SOPs

• Ensuring source documents are signed in a timely manner

The usual and customary temperature for an investigational drug storage area is:

• 66F-78F

• 68F-77F

• 65F-80F

• 66F-76F

In case of a nature disaster, who is responsible for ensuring security and recovery of all financial and information technology systems?

• Tim, the IT Guy

• Office Manager

• PI

• Coordinator

The appropriate people who may co-sign a non-licensed coordinator to dispense, maintain, or receive a Controlled Substance Investigational Product (CSIP) can be which of the following:

• Principal Investigator, if he's an MD or DO

• RN

• PharmD

• Principal Investigator, if he's a Doctor of Chiropractic

• LVN

• SubInvestigator, if he's an MD or DO

• UAP (Unlicensed Assistive Personnel)