The investigator bears primary responsibility for the conduct of a clinical trial at their site, including the protection of the rights, safety, and well-being of all participants enrolled under their supervision. This role demands both scientific expertise in the relevant therapeutic area and thorough understanding of Good Clinical Practice requirements. When a trial is conducted by a team, the individual who serves as the responsible leader of the team is designated as the principal investigator, while other qualified physicians and professionals are termed sub-investigators and work under the principal investigator's oversight.

Investigators must possess qualifications demonstrated through education, training, and experience appropriate to their role, and must be familiar with the appropriate use of the investigational product as described in the protocol, current Investigator's Brochure, product information, and other information sources provided by the sponsor. Before agreeing to participate in a trial, investigators should evaluate whether they have adequate resources to properly conduct the study, including qualified personnel, appropriate facilities and equipment, access to a sufficient patient population, and adequate time to devote to the study given their other clinical and research commitments.

The investigator's responsibilities span the entire trial lifecycle, from site evaluation and preparation through study closeout. Key obligations include obtaining and maintaining ethics committee approval for all study activities, ensuring proper informed consent is obtained from each participant before any trial procedures, providing adequate medical care to participants throughout their involvement, supervising all site personnel involved in the trial, maintaining accurate and complete records in compliance with GCP requirements, and reporting adverse events according to protocol and regulatory requirements. The investigator must also ensure that all data reported are accurate and verifiable from source documents.

The investigator serves as the critical link between the scientific objectives of the sponsor and the clinical reality of participant care. While following the protocol and sponsor instructions, the investigator must maintain independent clinical judgment regarding what is best for each participant. In situations where following the protocol might compromise participant safety, the investigator has the authority and obligation to take appropriate protective action immediately, even if this constitutes a protocol deviation. This independent judgment role cannot be delegated and represents a fundamental protection for research participants.

The investigator bears primary responsibility for the conduct of a clinical trial at their site, including the protection of the rights, safety, and well-being of all participants enrolled under their supervision. This role demands both scientific expertise in the relevant therapeutic area and thorough understanding of Good Clinical Practice requirements. When a trial is conducted by a team, the individual who serves as the responsible leader of the team is designated as the principal investigator, while other qualified physicians and professionals are termed sub-investigators and work under the principal investigator's oversight.

Investigators must possess qualifications demonstrated through education, training, and experience appropriate to their role, and must be familiar with the appropriate use of the investigational product as described in the protocol, current Investigator's Brochure, product information, and other information sources provided by the sponsor. Before agreeing to participate in a trial, investigators should evaluate whether they have adequate resources to properly conduct the study, including qualified personnel, appropriate facilities and equipment, access to a sufficient patient population, and adequate time to devote to the study given their other clinical and research commitments.

The investigator's responsibilities span the entire trial lifecycle, from site evaluation and preparation through study closeout. Key obligations include obtaining and maintaining ethics committee approval for all study activities, ensuring proper informed consent is obtained from each participant before any trial procedures, providing adequate medical care to participants throughout their involvement, supervising all site personnel involved in the trial, maintaining accurate and complete records in compliance with GCP requirements, and reporting adverse events according to protocol and regulatory requirements. The investigator must also ensure that all data reported are accurate and verifiable from source documents.

The investigator serves as the critical link between the scientific objectives of the sponsor and the clinical reality of participant care. While following the protocol and sponsor instructions, the investigator must maintain independent clinical judgment regarding what is best for each participant. In situations where following the protocol might compromise participant safety, the investigator has the authority and obligation to take appropriate protective action immediately, even if this constitutes a protocol deviation. This independent judgment role cannot be delegated and represents a fundamental protection for research participants.