FREE ACRP Clinical Study Protocols Question and Answers

Question 1

Profile of the investigational product that includes
Pre‐clinical and clinical trial experience to date
Method of action
ADME properties
Safety profile - what adverse events are expected?
Dosage
Contraindications
PI must be familiar with content

Accepted Answer

Investigator's brochure

Answer

Investigational new drug application

Answer

Case report form

Answer

Essential documents

Question 2

‥ "Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject"
‥ "Is purported or represented to be for use supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject"
‥ "Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject"
‥ "Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject"

Accepted Answer

Significant Risk Device

Answer

Investigational Product

Answer

The Sponsor

Answer

Submit Humanitarian Device Exemption

Question 3

Sponsor can transfer all or some
responsibilities of a trial to a CRO
Must be in writing
Ultimate responsibility for quality and
integrity of the trial data remains with
sponsor
CRO must comply with "sponsor" regulatory
obligations for responsibilities transferred

Accepted Answer

Transfer of obligations

Answer

Purpose of monitoring

Answer

Investigator's brochure

Answer

Publication

Question 4

‥ Education, credentials, training, and experience
- Background in clinical area
- Operational, regulatory, ethical training in conduct of clinical trials
- Certifications
‥ Association of Clinical Research Professionals (ACRP)
- 2 years of experience & passing exam
‥ Study‐specific training
- Investigator meeting
- Initiation visit

Accepted Answer

QA of Study Personnel

Answer

QA of Data

Answer

Termination

Answer

QA of Design

Question 5

‥ FDA Investigations Operational Manual for conducting inspections
‥ When inspector arrives:
- Verify their credentials
- Record inspector's badge #
- Obtain a copy of 482
‥ Inspector's Assignment

Accepted Answer

The Inspection

Answer

Opening Conference

Answer

Introduction

Answer

Closing Conference

Question 6

Promote & protect public health by helping safe & effective drugs reach market
‥ Monitor for continued safety after approved
‥ Enforce regulations regarding:
- Testing of drugs & medical devices in humans
- Manufacturing process of drugs & devices
- Sanitation of foods
- Use of pesticides
- Veterinary medicine C

Accepted Answer

FDA Mission

Answer

The Inspection

Answer

FDA Regulations Enforcement

Answer

The Inspection

Question 7

Should be chosen based on:
- Clinical expertise
- Availability
- Willingness to participate in research
‥ Reimbursement based on usual fee + 10%
‥ May be able to get at reduced rate
- i.e. volume discount
‥ Only enter into budget once rate agreed upon by both parties
- Written agreement of rates/service fees
- Do not estimate!!

Accepted Answer

CRA

Answer

CRO

Answer

Budgeting Ancillary Services

Answer

QA Of Data

Question 8

Ensuring QA of inputs ultimately ensures QA of outputs... the data
‥ Audits should occur to ensure integrity of data
‥ Where does data come from?
‥ When should final QA inspection occur?

Accepted Answer

QA of Data

Answer

In the Beginning....

Answer

Lead Data Manager

Answer

Purpose of Monitoring

Question 9

Standard Operating Procedures (SOPs)

Accepted Answer

‥ Provide consistency & quality in service to customers
‥ Improve efficiency
‥ Facilitates training of new staff
‥ Ensures compliance with regulations

Answer

Guidance documents for conduct of clinical research
- Standards that govern how site operates
‥ FDA requirement
‥ Must be followed exactly

Answer

Commitment & motivation
‥ Clinical trial competencies
‥ Understanding/evaluating clinical trial industry & related affiliations
‥ Recruiting, hiring, & maintaining study personnel
‥ Obtaining proper training & credentialing as researchers
‥ Developing SOPs

Answer

Issues
- Recruitment
- Scheduling
- Ongoing participants
- Adverse events
- Inclusion/exclusion criteria
- Medical opinions or advice
- Documentation

Question 10

Track revenues earned exactly
- Create spreadsheet of study patient activity
‥ Provides view of study progress
‥ Include amount earned, amount invoiced, amount received, & summary
‥ Things that can affect payment:
- Completed case report forms
- Amount of data retrieved by monitor

Accepted Answer

Managing Accounts Receivable

Answer

Line Of Credit

Answer

Managing Cash

Answer

Channel Of Distribution