CITI Training - CRC Advanced

Job shadowing is when:

A new employee follows an experienced employee while they work

Research misconduct can become regulatory noncompliance when:

A researcher submits false information to the FDA or sponsor in a required report

Goals in project management should be SMART. What does the "A" stand for as a quality of SMART goals?

Attainable

What does ALCOAC stand for:

Attributable, legible, contemporaneous, original, accurate, and complete

For further career options and/or to gain additional knowledge and experience, CRCs may want to consider specializing. This can include:

Becoming more trained and experienced in a specific disease specialty

A qualifying clinical trial is a trial that meets the requirements described in _____________ by CMS.

Clinical trial policy

Factors that have been identified as helping with subject retention include:

Compensation and relationship with the study staff

Use _______________ when developing a clinical study budget to systematically review all the operations planned within a protocol and identify which procedures are billable.

Coverage analysis

Which of the below is one way CRCs as project managers can minimize redundancy, errors, and omissions in clinical trials?

Create a compliance/audit team

When managing multiple trials, it is most helpful to:

Develop standard forms, documents, and source data templates that can be used across multiple trials

In addition to planning and initiating, what are the other phases of project management?

Executing, monitoring, and closing

A paper has been prepared for publication from available study data. A CRC who assisted in data collection and publication preparation submitted the final draft of the paper to the PI for review. One of the tables indicated low study enrollment numbers. In the presence of the CRC, the PI crossed out the numbers on the table and wrote in a series of new numbers to increase the enrollment numbers. The publication was revised for consistency (with the updated enrollment numbers) then submitted, accepted, and published. What type or or types of misconduct occurred?

Fabrication and Falsification

An effective approach to planning an orientation program is to use a four-step process. This includes the following steps:

Identify objectives, identify available resources, plan the orientation activities, review and evaluate progress

CRCs can use internal quality assurance audits to:

Improve quality

Which of the following is a contributing environmental risk factor for misconduct?

Inadequate preparation for a study

The difference between misconduct and honest error is:

Intent

According to the ICH E6 guideline, who is ultimately responsible for supervising and staffing trials with qualified persons and ensuring they are adequately informed about the protocol?

Investigator

Effective self-directed learning involves planning and purposeful activities. This process is one-on-one and typically gets repeated when the next CRC is hired.

Journals, books, and online educational programs

A methodology borrowed from business to improve performance by removing waste and reducing variation, through work standardization and flow with a team-based approach is:

Lean Six Sigma

Typical non-reimbursable items associated with a clinical trial include which of the following?

Legal resources

A CRC writes a goal down as "Recruit more subjects." Is this a SMART goal (Specific, Measurable, Attainable, Relevant, and Time bound)?

No

The three domains of CRC knowledge are:

Organization, principles, and trials

A trainer is assessing the new CRC's experience with study feasibility and start-up, regulatory documents and processes, study visits, and clinical trial billing. This is an example of assessing which of the three domains?

Principles

Creating a culture of compliance is essential to promote quality. The PI and CRC must convey a zero-tolerance policy for research misconduct. As a team leader, the CRC can promote a work environment to keep pace with any challenges that arise. When creating a culture of compliance, a CRC could:

Promote learning and improvement instead of placing blame and finding fault

The CRC should be aware of billing issues when paying subjects in clinical trials. What is the most critical factor related to paying subjects that should be addressed?

Protecting subjects' privacy and confidentiality of data during payment processing.

The purpose of the orientation binder is to:

Provide fundamental information for the new CRC to reference starting on day one.

Corrective action plans are used for:

Respond to noncompliance findings with actions

Which law prohibits a physician from referring Medicare patients for designated health services to an entity with which the physician (or immediate family member) has a financial relationship?

Stark Law

A root cause analysis of the problem can be used to find:

Underlying issues and causes

When would it be best to conduct an analysis of the initial budget against the actual costs to assess the overall costs against projected costs?

When the study is complete