Monitoring in clinical trials
Monitoring in Clinical Trials
Monitoring in clinical trials is a critical activity that ensures the rights, safety, and well-being of trial subjects are protected, and that the trial data are accurate, complete, and verifiable from source documents.
Purpose[edit]
The main purpose of monitoring in clinical trials is to verify that:
- The rights and well-being of human subjects are protected.
- The reported trial data are accurate, complete, and verifiable from source documents.
- The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with Good Clinical Practice (GCP), and with the applicable regulatory requirement(s).
Methods[edit]
Monitoring in clinical trials can be done in various ways:
- On-site monitoring: This is the traditional method of monitoring. It involves the monitor visiting the site where the clinical trial is being conducted.
- Centralized monitoring: This is a remote evaluation of accumulated data, performed in a timely manner, supported by appropriately qualified and trained persons (e.g., data managers, biostatisticians).
- Risk-based monitoring: This is a method that uses a combination of centralized and on-site monitoring practices to oversee a clinical trial effectively.
Responsibilities[edit]
The sponsor is responsible for ensuring proper monitoring of the clinical trial. The sponsor may delegate this task to a Contract Research Organization (CRO), but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.
Regulations[edit]
Monitoring in clinical trials is regulated by various international guidelines and regulations, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) E6(R2).
See also[edit]
Ad. Transform your life with W8MD's
GLP-1 weight loss injections special from $29.99 with insurance
|
WikiMD Medical Encyclopedia |
Medical Disclaimer: WikiMD is for informational purposes only and is not a substitute for professional medical advice. Content may be inaccurate or outdated and should not be used for diagnosis or treatment. Always consult your healthcare provider for medical decisions. Verify information with trusted sources such as CDC.gov and NIH.gov. By using this site, you agree that WikiMD is not liable for any outcomes related to its content. See full disclaimer.
Credits:Most images are courtesy of Wikimedia commons, and templates, categories Wikipedia, licensed under CC BY SA or similar.
Translate this page: - East Asian
中文,
日本,
한국어,
South Asian
हिन्दी,
தமிழ்,
తెలుగు,
Urdu,
ಕನ್ನಡ,
Southeast Asian
Indonesian,
Vietnamese,
Thai,
မြန်မာဘာသာ,
বাংলা
European
español,
Deutsch,
français,
Greek,
português do Brasil,
polski,
română,
русский,
Nederlands,
norsk,
svenska,
suomi,
Italian
Middle Eastern & African
عربى,
Turkish,
Persian,
Hebrew,
Afrikaans,
isiZulu,
Kiswahili,
Other
Bulgarian,
Hungarian,
Czech,
Swedish,
മലയാളം,
मराठी,
ਪੰਜਾਬੀ,
ગુજરાતી,
Portuguese,
Ukrainian
