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Clinical Trial Risk Assessment & Management Plan

BayBiotech.NET

Before the onset of a trial the study director/sponsor must have a risk assessment and risk management plan to accompany the filing to IRB or FDA for IND or PMA applications.
Hazard is defined as anything that could cause harm and risk is the probability of that harm caused by the hazard.
Risk Assessment Plan for each potential hazard includes mapping and analysis of associated risks, its potential consequences and reasonable steps to reduce the risks.

In a clinical trial hazards are categorized into main four groups:

1.    Hazards for the participants that encompasses protecting participant’s rights.
2.    Hazards for the participant’s safety by assessing the likely risk/ benefit ratio in the study population.
3.    Hazards of the trial with risk associated for recruitment and follow-up.
4.    Hazard to the reliability of the results mainly in terms of study power and adherence to the protocol.

Risk Management Plan includes detailed strategies and considerations to reduce/ minimize the above mentioned hazards customized for a particular study.

It will be Study Director/ Sponsor’s responsibility to educate all the professionals involved in the trial to be aware of the Risk Assessment and Management Plan for a successful trial completion.

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