SOP for Communication with HREC, RGO, Sponsor and Institution’s Insurer

Purpose

To describe the procedures relating to communication with the Human Research Ethics Committees (HREC), Research Governance Officer (RGO), Sponsor and Insurer.

Scope

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

This SOP takes into consideration the single ethical review processes.

Procedure

The procedure for communication with the HREC and RGO is illustrated in a tabular form in the National Mutual Acceptance Single Ethical Review of Multi-center Human Research Projects - Monitoring and Reporting Tables.

1. Communication with Reviewing HREC

When communication regarding key decision points is verbal, the initiating party should follow up verbal communication with written correspondence/e-mail and send to the call recipient. The title of the letter/e-mail should include the term “FILE NOTE” followed by a text string which should include the decision topic. Such documentation must be filed in the Study Master File (SMF) and where applicable in the Satellite Site Study File (SSSF).

Prior to study commencement, the Investigator (CPI/PI/AI) must:

• Choose a reviewing HREC who’s approval is acceptable to the Institution/s where the clinical study is being undertaken (or ensure the responsible HREC chosen by the CPI is likewise acceptable). Currently acceptable HRECs are documented in jurisdictional policy for public health organisations, and in local Institutional policy for private health organisations.

• Understand the reviewing HREC requirements, submission processes and be aware of their meeting and submission dates to better liaise with Sponsors.
• Be familiar with the relationships between HREC review and approval, governance authorisation and any other processes/approvals that need to be in place (e.g. does the HREC have sub-committees), before any study start up activities can commence. This process and approval flow will be required by Sponsors, auditors and inspectors.
• Submit an ethics application as per the reviewing HREC submission process.
• Include in the relevant section of the ethics application that the trial may be undertaken using telehealth with Satellite Sites, if applicable, and that the informed consent process and/or some or all study assessments will be undertaken using telehealth, face to face consultation or a combination of both.
• Submit any other application as per that process found on the relevant website.
• Ensure all documentation and correspondence pertaining to the submission and approval processes is filed in the SMF e.g. correspondence to and from the HREC, RGO or other bodies.

During the study, the Investigator (CPI/PI/AI) must:

• Comply with all conditions and restrictions applied by the RGO or HREC on the conduct or continuation of the trial.
• Submit all documents/reports/summaries according to the requirements and timelines as stipulated on the respective reviewing HREC approval letter, including but not limited to: Sponsor reports of accumulated safety data outcome analyses; proposed changes to the Protocol; major or Serious Breaches; annual progress reports; and unforeseen events that might affect continued ethical acceptability of the trial.
• Comply with the reporting requirements outlined in SOP "Safety Data Monitoring and Reporting Requirements for Clinical Trials", noting that individual reports of Adverse Events, Serious Adverse Events, Suspected Unexpected Serious Adverse Reactions, Unanticipated Serious Adverse Device Events and six-monthly line listings should NOT be submitted to the reviewing HREC unless otherwise advised.
• Although all deviations must to be reported to the trial Sponsor, only the sub-set of deviations that have a significant impact on the continued safety or rights of participants or the reliability and robustness of the data generated in the clinical trial must be reported to the HREC. These deviations (also known as ‘Serious Breaches’) should also be reported by the Principal Investigator (PI) to their Institution, as they may impact on medico-legal risk, the responsible conduct of research, or adherence to contractual obligations.
• Immediately notify the reviewing HREC of any notification received from a participant in a trial that they intend to initiate a claim for compensation against either the Sponsor and/or the Institution.
• File all documentation in the SMF/SSSF.

At the end of the study, the Investigator (CPI/PI/AI) must:

• Submit a trial termination/closeout report according to the requirements and timelines as required by the respective reviewing HREC. This may be stipulated in the approval letter and/or on their website.
• File all documentation in the SMF/SSSF.

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2. Communication with the Research Governance Office

• For the purpose of this SOP, the Clinical Trial Research Agreement (CTRA), other site specific trial related documentation and the Site Specific Assessment (SSA) Form constitute a research governance application for the Primary Site. Similarly, for the Satellite Site, a Site Specific Assessment/research governance application consists of the Sub-Contract, the SSA Form and other site specific, trial related documentation. This application may be submitted to the RGO in parallel to the HREC submission if all governance related documentation is available and completed correctly.
• In the majority of cases, the final document to be provided to the RGO is the HREC approval. This has the advantage of enabling an RGO review in parallel to the HREC review and allows a more timely RGO authorisation which may lead to expedited study start up. It is important to note, that HREC approval must be obtained and submitted to the RGO, prior to the final RGO authorisation being granted.

Prior to study commencement, the Investigator (CPI/PI/AI) must:

• Submit the Clinical Trial Research Agreement (CTRA), HREC approval, the SSA Form, evidence of any relevant GCP training, and any other required documentation to the RGO.
• Ensure all documentation and correspondence pertaining to the submission and approval processes is filed in the SMF.
• Ensure each Satellite Site in the cluster (whether in a different Hospital and Health Service (HHS) to the PI or the same HHS) completes a Clinical Trial Sub-Contract and a SSA Form, and submits to their RGO.
• Await site specific RGO authorisation before any study related activity can occur at that site.
• Ensure the Satellite Site files all documentation in the SSSF.

During the trial, the Investigator (CPI/PI/AI) must:

Submit all governance related documents/reports/summaries to the relevant RGO according to the requirements and timelines as stipulated by the respective RGO including but not limited to:

1. changes to the CTRA/Sub-Contract;
2. changes to the budget;
3. any change that might affect continued financial acceptability of the trial;
4. any change that may increase Institutional risk.

• Serious Breaches (those deviations that may have a significant impact on the continued safety or rights of participants or the reliability and robustness of the data generated in the clinical trial) should be reported by the PI to their Institution, as they may impact on medico-legal risk, the responsible conduct of research, or adherence to contractual obligations.
• Immediately notify the RGO of any notification received from a participant in a trial that they intend to initiate a claim against either the Sponsor and/or the Institution.
• Ensure all training and accreditation remains current.
• Ensure the Satellite Site files all documentation in the SSSF.

At the end of the trial, the Investigator (CPI/PI/AI) must:

• Notify the RGO the trial has terminated/closed.
• File all documentation in the SMF/SSSF. Poor compliance with the Protocol or Good Clinical Practice (GCP) can lead to data being rejected by regulatory authorities, can compromise participant safety and can nullify a trials insurance/indemnity. ICH GCP requires that the PI (or delegate) document and explain any deviation from the Protocol and requires that non-compliance with the Protocol, SOPs, GCP, and/or applicable regulatory requirement(s) lead to prompt action to secure compliance.

3. Communication with the Sponsor

The Investigator (CPI/PI/AI must):

• Comply with the reporting requirements outlined in SOP "Safety Data Monitoring and Reporting Requirements for Clinical Trials", and should consult and adhere to existing guidance for safety monitoring and reporting published by NHMRC and the TGA.
• Notify the Sponsor within 24 hours of discovery of any Serious Adverse Events (SAE) involving trial participants under the care of the Investigator and where relevant notify the PI in parallel.
• Notify the Sponsor promptly regarding any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants and where relevant notify the CPI/PI/AI.
• Communication must be followed up with written report/email and filed in the SMF/SSSF.
• Notify the Sponsor of any Protocol Deviation or Breach (which may include significant deviation from the Protocol) and where relevant notify the CPI/PI/AI.
• Be available to meet with the Sponsor to discuss study progress, issues and safety.
• Provide the Sponsor with copies of all correspondence from the reviewing HREC and/ or RGO.
• Immediately notify the Sponsor of any notification received from a trial participant that they intend to initiate a claim for compensation against either the Sponsor and/or the Institution.

4. Communication with Institution’s Insurer

If the Institution is notified or becomes aware that a trial participant intends to make a claim for compensation against the Institution or Sponsor for injuries arising as a result of participating in a clinical trial undertaken at the Institution or any of the Satellite Sites under supervision by the Institution, the Institution must promptly notify the Institution’s insurer in writing that such an action is intended.

Communication with Solicitor, Sponsor and CPI/PI/AI

If the Investigator is notified or becomes aware that a trial participant intends to make a claim against the Institution or Sponsor for injuries arising as a result of participating in a clinical trial undertaken at the Institution or any of the Satellite Sites under supervision by the Institution, the Investigator must promptly notify the following in writing that such an action is intended:

• the Institution’s authority
• the CPI/PI/AI as relevant, and
• the Sponsor.

The Sponsor, or the Institution acting as Sponsor, will generally be responsible for reporting to their respective solicitors.

Annexure

Nil

Revision History

Nil

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