What are the Key Components of a Clinical Trial Application?
The application includes several critical components such as:
Study Protocol: A detailed plan that outlines the trialâs objectives, design, methodology, statistical considerations, and organization. Investigatorâs Brochure: A comprehensive document that provides clinical and non-clinical data on the investigational product. Informed Consent Form: Ensures that trial participants are fully aware of the studyâs risks and benefits before participating. Ethics Approval: Approval from an independent ethics committee to ensure the study is conducted ethically. Manufacturing Information: Details about the production and quality control of the investigational product.
