CRM CRM Budget & Contract Management

Question 1

What is the primary purpose of a Clinical Trial Agreement (CTA) budget?

Accepted Answer

To define payment terms and reimbursable costs between sponsor and investigative site

Answer

To outline the scientific objectives of the study

Answer

To document adverse events reported during the trial

Answer

To establish the randomization schedule for study participants

Question 2

Which cost category typically represents the largest portion of a clinical trial budget?

Accepted Answer

Site and patient-related costs including procedures and staff

Answer

Investigational product manufacturing and distribution

Answer

Regulatory submission fees

Answer

Insurance and indemnification premiums

Question 3

What is a 'pass-through' cost in clinical trial budgeting?

Accepted Answer

An expense incurred by the CRO that is billed directly to the sponsor at cost

Answer

A cost the sponsor absorbs without reimbursing the site

Answer

A penalty fee charged when a site misses an enrollment milestone

Answer

A recurring monthly retainer paid to the investigator

Question 4

How should a Clinical Research Manager handle a budget deviation identified mid-trial?

Accepted Answer

Document the deviation, notify the sponsor, and initiate a budget amendment if needed

Answer

Ignore it if the overall study budget remains within 10%

Answer

Reallocate funds from another site without sponsor approval

Answer

Wait until study close-out to reconcile the discrepancy

Question 5

What is the purpose of a milestone payment structure in a clinical trial agreement?

Accepted Answer

To tie sponsor payments to the achievement of specific study deliverables

Answer

To pay investigators a flat fee regardless of work performed

Answer

To reimburse patients for travel expenses at fixed intervals

Answer

To fund regulatory authority inspections at predefined time points

Question 6

Which document formally establishes the payment terms between a sponsor and an investigative site?

Accepted Answer

The Clinical Trial Agreement

Answer

The Investigator's Brochure

Answer

The Protocol Synopsis

Answer

The Monitoring Plan