SOP for Investigator Responsibilities

Purpose

To define the Investigator responsibilities associated with undertaking a clinical trial in accordance with ICH GCP responsibilities for Investigators in clinical trials and XXX.

Scope

This Standard Operating Procedure applies to all relevant employees including, but not limited, to visiting health professionals, contractors, consultants and volunteers who propose to undertake, administrate, review and/or govern human research involving patients/participants, facilities and or staff. The responsibilities described in this SOP are additional to and are to be read in conjunction with Investigator responsibilities defined in all other National and/or NMA SOPs.

All study personnel involved in the clinical study must operate within their scope of practice.

Procedure

Investigator Responsibilities

1. Before the Research Project Commences

The Investigator must:

• At all times, fulfil Roles and Functions as defined in the Clinical Trials Governance Framework.
• Declare in writing any conflicts of interest, or payments they will receive from other parties with any relationship to the study and notify the Sponsor.
• Ensure any payment provided to the participant for undertaking the trial is noted in the Participant Information Sheet and Consent form.
• Demonstrate that adequate participant recruitment is possible.
• Demonstrate adequate staffing levels to ensure success of the study at the site (including any Satellite Site/s).
• Be thoroughly familiar with the appropriate use of the Investigational Product as described in the Protocol, in the current Investigational Brochure (IB) for medicines or Product Information for devices and in other information sources provided by the Sponsor.
• Be provided with evidence of HREC approval, Research Governance authorisation, and the registration number of the trial once it is registered on a publicly accessible World Health Organization compliant clinical trials registry before the first participant is recruited to the study.

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2. During the Course and at the Completion of the Research Project

The Principal Investigator must:

• At all times, fulfil Roles and Functions as defined in the Clinical Trials Governance Framework.
• Perform site evaluation of any Satellite Site deemed to be potentially able to recruit participants to the research project. For each trial, infrastructure and training requirements for Satellite Sites are the same for both the Primary and Satellite Sites, and a Satellite Site should have appropriately contracted, qualified and trained Investigator(s) and delegated staff to undertake delegated trial related activities including obtaining informed consent (if required).
• For XXX, a detailed Supervision Plan is required, in addition to a Delegation Log required by ICH GCP for all Satellite Sites regardless of experience. The conduct of the trial is detailed under the ‘head agreement’, (Clinical Trial Research Agreement/Clinical Trial Agreement between the Sponsor and the Principal Investigator’s Institution) and a Sub-Contract between the Primary Site and the Satellite Site Institutions. Trial participants may have trial visits at both the Primary and Satellite Sites, as determined by the Protocol and Supervision Plan.
• Delegated activities to be performed by a Satellite Site are trial and Satellite Site specific. The Primary Site must consider a Satellite Site’s personnel and facilities in developing a Delegation Log and Supervision Plan suitable for a trial. The proposed delegation of duties and Supervision Plan must be agreed with the team and Sponsor at the time of site selection and must be documented before the study is initiated at each Satellite Site.
• Select and initiate the Satellite Site only when a potentially eligible participant population has been identified.
• Ensure all Primary Site and Satellite Site staff are trained on and adhere to these SOPs.
• Ensure study staff, including those at Satellite Sites, are trained in the Protocol, IB, study procedures, Adverse Event (AE)/Serious Adverse Event (SAE) reporting, and that a system for safety reporting duties is in place for all study staff.
• Promulgate all Protocol variations and ensure adequate training of all trial personnel in the reason for and implications of the new Protocol. Ensure all personnel are suitably trained to undertake the trial and deliver the trial intervention.
• Ensure that study related documentation files and procedures are established and maintained throughout the study at both the Primary and Satellite Sites (as relevant) in accordance with SOP; The Study Master File, including procedures for managing the security of information and trial data and a process for managing data security or privacy breaches.
• Ensure study staff, including those at Satellite Sites, have a clear understanding of the process for securely and suitably storing and ensuring accountability for the Investigational Medicinal Product (IMP).
• Sign all trial related documentation during the course of the research project in a timely manner.
• Ensure audit/inspection readiness throughout the study, have oversight of any audit or inspection of their trial at both Primary and Satellite Sites, and ensure any deficiencies identified through audit or inspection are actively managed to ensure continuous improvement:

1. Procedures must be in place to ensure that the Primary Site is made aware of any findings that arise from a Satellite Site audit or inspection.
2. The PI should follow Sponsor requirements to ensure that appropriate Corrective and Preventative Actions (CAPA) have been implemented and findings reported to the health service organisation and HREC.

• Inform relevant staff when recruitment has been completed and mark the Study Master File as closed to recruitment.
• Sign all trial related documentation at the end of the research project such as documents requiring an end date, indicating the research project is completed including but not limited to: Delegation Log, Training Log, Supervision Plan, agreements, progress reports, eCRF/CRF, SAE reports, etc.
• Ensure all trial related staff and third-party providers have been informed of the research project closure, results and publication plan.
• Inform the participant’s primary care physician (where the participant has consented to do so) of the research project closure, results and, if applicable, the treatment the participant was allocated for notation in the participant’s health and medical record.
• Ensure appropriate ongoing care of participants throughout the trial, if a participant withdraws during the trial and/or if a trial is prematurely terminated.
• Record in the participant’s health and medical record at the appropriate Institution (which may be a Satellite Site) the treatment the participant was allocated (if applicable).
• Ensure a lay summary of the trial results (usually provided by the Sponsor) is disseminated to participants in accordance with the HREC application/trial Protocol, and be prepared to respond to queries from participants in relation to the trial results.
• Document any deviation from the Protocol as per the Sponsor’s guide.
• Notify the Sponsor, HREC and RGO if they leave the Institution, in writing with either their new place of employment and contact details or who their proposed replacement is with contact details for recording on all archiving related documentation.
• Ensure study related documents are archived according to SOP - Site Close Out and Archiving (including at any Satellite Sites as relevant).

Annexure

Nil

Revision History

Nil

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