Clinical Trial Best Practices

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The best practices for clinical trial operations are difficult to define/describe due to clinical trials being diverse in nature. Yet there are certain requisites that are universally relevant to all clinical trials and best practices can be adopted within these requisites for a clinical trial. The following is a list of such requisites.
• Pre-clinical trial provisions
• Defining a protocol for the clinical trial
• Adhering to standards in protection of trial subject
• Defining investigator and sponsor responsibilities
• Site selection
• Patient recruitment
• Regular monitoring of observations and events
Preclinical trial requisites:
Before launching a trial, the sponsor of the trial in consultation with clinical investigators needs to justify and establish a study protocol for conducting the clinical trial. An …show more content…
This will involve conversations with clinical investigators and sponsors primarily who will design a standard protocol. Sponsors will then need to develop standardized procedures to oversee operations in concordance with local regulations and costs. Case report forms are an example of a document required by all clinical trials. Hence developing one and updating it regularly is considered a best practice.
Adherence to protection of trial subject:
This is a core principle of pharmacovigilance where the safety of the volunteer/patient is of paramount importance. The Declaration of Helsinki provides a template and standard on which the sponsor can lay out ground rules for implementing adequate safety measures to protect volunteers/patients. This is useful in conducting a trial in an ethically justified manner and hence this will always be considered a best practice. Setting up an ethics committee to monitor the ethical aspects of a trial is also another best practice.
Investigator and sponsor

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