Investigator Responsibilities

Investigator Responsibilities

Investigator responsibilities in clinical research focus on protecting trial participants and ensuring that the clinical trial is conducted appropriately at the investigator site. The investigator is responsible for trial-related activities performed at the site and should conduct the trial in accordance with the approved protocol, Good Clinical Practice (GCP), applicable regulatory requirements and IRB/IEC approval or favourable opinion.

Investigator Qualifications

The investigator should be qualified through education, training and experience to assume responsibility for the proper conduct of the clinical trial.

The investigator should be familiar with the appropriate use of the investigational product, the trial protocol and relevant trial information.

Current international expectations for investigator responsibilities are described in the ICH E6 Good Clinical Practice guideline.

Adequate Resources

The investigator should have adequate resources to conduct the trial appropriately.

This includes sufficient time, qualified personnel, suitable facilities and access to the resources necessary to recruit, treat and follow trial participants according to the protocol.

Delegation and Oversight

Trial-related activities may be delegated to appropriately qualified individuals or service providers.

The investigator should ensure that individuals or parties performing delegated activities are appropriately qualified and adequately informed about the protocol, investigational product and their assigned responsibilities.

The investigator retains responsibility for appropriate oversight of activities delegated under the investigator’s responsibility.

Compliance with the Protocol

The investigator should conduct the trial in accordance with the protocol agreed with the sponsor and approved or given favourable opinion by the IRB/IEC.

Protocol deviations should be appropriately documented.

Changes or deviations should generally not be implemented without appropriate prior approval when required, except where necessary to eliminate an immediate hazard to trial participants or where otherwise permitted by applicable requirements.

Protection and Medical Care of Participants

The rights, safety and well-being of trial participants are fundamental considerations throughout the clinical trial.

A qualified physician, or other qualified healthcare professional where permitted by applicable requirements, should be responsible for trial-related medical care and medical decisions.

The investigator should ensure that appropriate medical care is available for adverse events and other clinically significant conditions related to the trial.

Communication with the IRB/IEC

Before initiating the trial, the investigator should obtain documented IRB/IEC approval or favourable opinion as required.

The investigator should provide the IRB/IEC with relevant documents and information required for initial and continuing ethical review.

Protocol amendments, important new safety information and other reportable matters should be submitted in accordance with applicable requirements.

For more information about independent ethical review and participant protection, see IRB Responsibilities.

Informed Consent

The investigator is responsible for ensuring that informed consent is obtained appropriately before a participant takes part in the clinical trial.

Participants or their legally acceptable representatives should receive relevant information about the trial and have adequate opportunity to ask questions and make an informed decision about participation.

The informed consent process should be appropriately documented.

Investigational Product Management

The investigator or institution is responsible for appropriate management and accountability of investigational products at the trial site.

Responsibilities may include:

• Receipt and inventory
• Appropriate storage
• Dispensing and use
• Documentation
• Reconciliation
• Return or final disposition as applicable

These activities may be assigned to an appropriately qualified individual while remaining under appropriate investigator/institution oversight.

Safety Reporting

The investigator should identify, document and report safety information according to the protocol and applicable regulatory requirements.

Serious adverse events should generally be reported promptly to the sponsor after the investigator becomes reasonably aware of the event, except where the protocol or applicable requirements specify otherwise.

Relevant follow-up information and appropriate medical assessment should also be provided.

Trial Data and Records

The investigator is responsible for ensuring that trial data generated at the site are appropriately recorded and reported.

Data should be attributable, legible, contemporaneous, original, accurate and complete, as applicable, and should support reliable reconstruction and evaluation of trial conduct.

Corrections should be traceable and should not obscure the original information.

Essential Records

The investigator/institution should maintain essential records required for the conduct and evaluation of the clinical trial.

Records should be appropriately managed, protected and retained according to applicable requirements.

The sponsor’s representatives, auditors, IRB/IEC where applicable, and regulatory authorities should have appropriate access to trial records when required.

Recruitment and Trial Conduct

The investigator should assess the site’s ability to recruit the anticipated number of suitable participants within the agreed period.

Recruitment practices should comply with the protocol, ethical requirements and IRB/IEC-approved materials where applicable.

Trial procedures should be performed by appropriately qualified individuals according to the protocol and assigned responsibilities.

Premature Termination or Suspension

If a trial is prematurely terminated or suspended, the investigator/institution should appropriately inform trial participants and ensure appropriate therapy and follow-up where necessary.

The sponsor, IRB/IEC and regulatory authorities should be informed as required by applicable regulations and circumstances.

Importance of Investigator Responsibilities

Investigator responsibilities extend beyond performing clinical procedures. They include participant protection, protocol compliance, informed consent, appropriate delegation and oversight, safety reporting, investigational product management, reliable data and maintenance of essential records.

Effective investigator oversight helps ensure that trial activities conducted at the site protect participants and generate reliable clinical trial results.

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