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GLP Study Protocol Review Checklist

A comprehensive checklist for reviewing and ensuring GLP compliance of study protocols in pharmaceutical research, covering all aspects of protocol design and implementation.

GLP Study Protocol Review Checklist

by: audit-now
4.5

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About This Checklist

Ensuring the quality and compliance of study protocols is a critical aspect of Good Laboratory Practice (GLP) in pharmaceutical research. This GLP Study Protocol Review Checklist is an essential tool for researchers, quality assurance personnel, and study directors to systematically evaluate and improve the design, content, and adherence of study protocols to GLP standards. By implementing this checklist, pharmaceutical organizations can enhance the reliability of their research, minimize protocol deviations, and streamline the regulatory approval process for their studies.

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Industry

Healthcare

Standard

GLP - Good Laboratory Practice

Workspaces

Pharmaceutical Research Facilities

Occupations

Study Director
Principal Investigator
Quality Assurance Specialist
Regulatory Affairs Manager
Research Scientist
1
Does the study protocol adhere to GLP principles?
2
What comments do you have regarding the protocol review?
3
Were there any amendments made to the study protocol?
4
What is the complexity rating of the study design on a scale of 1 to 10?
Min: 1
Target: 5
Max: 10
5
How would you rate the quality assurance measures in place?
6
Is the data integrity maintained throughout the study?
7
What deviations from the protocol were noted during the study?
8
What is the start date of the study?
9
What is the justification for the sample size used in the study?
Min: 1
Target: 30
Max: 100
10
Is the study compliant with relevant regulatory standards?
11
Are the study objectives clearly defined in the protocol?
12
Describe the study design as outlined in the protocol.
13
What is the date when the study protocol was approved?
14
What is the expected completion time for the study in days?
Min: 1
Target: 90
Max: 365
15
Is the study protocol approved by the ethics committee?
16
Are all personnel involved in the study adequately trained?
17
Are there records confirming that all equipment was calibrated prior to the study?
18
What is the projected completion date for the study?
19
How many adverse events were reported during the study?
Min: 0
Target: 0
Max: 100
20
How frequently is the study protocol reviewed for compliance?
21
Is there documentation of the informed consent process for study participants?
22
Summarize the risk assessment conducted prior to the study.
23
What is the date of the latest revision of the study protocol?
24
What is the total volume of samples collected during the study (in mL)?
Min: 1
Target: 100
Max: 1000
25
Are there established data monitoring procedures in place?

FAQs

The checklist covers essential elements such as study objectives, experimental design, test systems, dosing information, sample collection and analysis procedures, data management plans, and quality assurance measures.

This checklist should be used during the protocol development phase, before study initiation, and whenever significant amendments are made to the protocol.

The checklist should be completed collaboratively by the study director, principal investigator, and quality assurance personnel to ensure a comprehensive review.

By ensuring protocols are GLP-compliant and well-documented, this checklist helps create robust study designs that are more likely to meet regulatory requirements and facilitate smoother submissions.

Yes, while maintaining core GLP principles, the checklist can be tailored to specific study types such as toxicology, pharmacokinetics, or stability studies.

Benefits of GLP Study Protocol Review Checklist

Ensures comprehensive coverage of GLP requirements in study protocols

Reduces the risk of protocol deviations and study rejections

Improves consistency and quality across different research studies

Facilitates efficient communication between study personnel and regulatory bodies

Supports the development of high-quality, reproducible research data