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

The Investigator's Brochure is a comprehensive document prepared by the sponsor of a clinical trial. It provides detailed information about the investigational product being studied in the trial. The purpose of the Investigator's Brochure is to ensure that all investigators involved in the trial have the necessary information to conduct the study safely and effectively.

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

In clinical trials involving Significant Risk Devices, sponsors must comply with specific regulations and obtain appropriate approvals before initiating the investigation. These devices are subject to stringent oversight to ensure the protection and safety of research subjects.

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

This refers to the process where a sponsor (the entity funding or initiating a clinical trial) can delegate some or all of the responsibilities associated with the trial to a Contract Research Organization (CRO).
The transfer of these responsibilities must be documented in writing, usually through a formal agreement or contract between the sponsor and the CRO.
Despite delegating certain tasks to the CRO, the ultimate responsibility for ensuring the quality and integrity of the trial data remains with the sponsor.
The CRO is also obligated to comply with the sponsor's regulatory requirements and standards for the responsibilities that have been transferred.

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 study personnel involves assessing the performance, competence, and compliance of individuals involved in conducting the clinical trial.
This includes evaluating adherence to protocols, ethical standards, and regulatory requirements to ensure the quality and integrity of the research.

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

These steps and considerations are crucial for facilities subject to FDA inspections to ensure compliance with regulatory standards and facilitate a smooth and efficient inspection process. Understanding and adhering to FDA inspection procedures contribute to maintaining quality and regulatory compliance within the industry.

ACRP - Association of Clinical Research Professionals Practice Test

ACRP - Association of Clinical Research Professionals Practice Test

FREE ACRP Clinical Study Protocols Question and Answers