An Investigator is selected by the sponsor to conduct a clinical trial. An Investigator should be qualified but they don’t necessarily need to be a physician, although a medical professional should be listed as a ‘sub-investigator if that is the case. 

While the day-to-day management of the trial can be delegated, an Investigator has to be responsible for ensuring that the trial is conducted in compliance with the strict guidelines and that recordkeeping is up-to-date. Before a task is delegated, the Investigator needs to ensure that any individual to whom a task is delegated is qualified by education, training, and experience. 

Principal/Primary Investigators 

A clinical trial Primary Investigator is the person responsible for the clinical trial staff and the conduct of the clinical trial at the site. The PI is a model of responsible clinical trial conduct in their field of practice and is responsible for adequately supervising their clinical trial team. 

Protecting Participants 

• The investigators have a duty to protect the rights, safety, and welfare of the participants, and ensure that informed consent is adequately obtained.

•  Controlling drug storage and distribution. 

• Ensuring that the Institutional Review Board (IRB) review, approval, and reporting requirements are met. 

• Maintaining detailed records of the disposition of the drug, histories of previous drug trials, and any other relevant data. 

Reporting 

• Investigators must send progress and safety reports and financial disclosures to the sponsor at least annually during the trial and at the end of the trial. 
• Any serious adverse events must be reported straight away. 
• Any financial disclosures to the sponsor should be updated as necessary during the investigation. 

Maintaining Compliance 

• Keep up-to-date with any communications from the Institutional Review Board (IRB) and ensure that the study team is compliant with IRB requests and determinations. 
• Ensure staff is experienced and verify their credentials.
• Institute regular training and assessments for participant visits, lab testing, data input and handling, drug accountability, and recordkeeping. 
• Ensure that the staff has disclosed any conflicts of interest and understand the importance of doing so. 
• Streamline the protocol, ensuring that it is straightforward with standardized data input, checklists, and minimal amendments. 
• Keep regulatory documents up-to-date with current training certifications and licensure. Ensure that continuing reviews are done annually and submitted to the Institutional Review Board (IRB).
• Hold weekly team meetings and make plans for emergencies, quality assurance, data safety, and data management.
• Implement trial dry runs before participants are involved to ensure that no important factors have been overlooked. 
• Implement regular data input, cleaning, and query answering to keep on top of any systematic problems before they get out of control. 
• Determine if infractions require individual correction of system changes need to be implemented to prevent similar problems from arising in the future. 

Trial Protocol and Accountability 

• The Principal Investigators conduct the clinical trial in accordance with the approved clinical trial protocol. 
• Is accountable to the company that are hosting the clinical trial, and the clinical trial sponsor 
• Provides guidance on responsible clinical trial conduct to other researchers or research trainees under their supervision, encourages education and training in responsible clinical trial conduct, and complies with the relevant laws, regulations, guidelines, and institutional policies related to responsible clinical trial conduct. 

Roles Include: 

• To ensure that appropriate approvals are obtained before the clinical trial begins and that the conditions of any approvals are adhered to during the course of the trial. 
• Ensures that any contractual requirements under a clinical trial agreement are met. 
• Engage with Aboriginal and Torres Strait Islander peoples while respecting their legal rights, local laws, customs and protocols in regards to clinical trials.
• Comply with requirements for consent as approved in the trial protocol. 
• Ensuring participants’ welfare during the clinical trial.
• Provide necessary clinical care to study participants as a result of any adverse events experienced during or immediately following the study.
• Inform the participant’s primary physician about the participant’s involvement in the trial. 
• Provide site info to the sponsor for annual progress reports and final report to HREC and the site. 
• Disclosing and managing actual, potential or perceived conflicts of interest. 
• Responsible for ongoing consent. 
• Retaining the participant on a clinical trial. A participant is not obliged to give their reasons for withdrawing from a study, but a principal investigator should try to ascertain the reason why they want to withdraw from the trial. 
• Keeping clear, accurate, secure and complete records of all clinical trial documents including clinical trial data and primary materials.
• Comply with applicable regulatory requirements related to the reporting of unexpected serious adverse events to the regulatory authority and the sponsor or Coordinating Principal Investigator (CPI) required by the approved clinical trial protocol. 
• Report suspected breaches of the code to the relevant institution and authority. 
• Supervise and work with site Study Coordinators or Clinical Trial Coordinators. 

Sponsor-Investigator 

Fulfils the responsibilities of both the sponsor and investigator as per the Therapeutic Goods Administration (TGA) and Good Clinical Practice (GCP) guidelines. 

Responsibilities 

• Secure the funding for the clinical trial. 
• Creating relevant clinical trial documents (informed consent, protocols, and ethics and regulatory submissions). 
• Ensure that adequate resources are available during the trial such (experienced staff, investigational products, clinical and medical supplies and a central lab). 
• Create appropriate written guidelines like the Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP). 
• Obtaining and maintaining necessary approvals from the relevant ethics committees and regulatory agencies. 
• Managing essential documents using a Trial Master File (TMF) (a collection of documents that can be used by monitors, auditors, investigators and sponsors to prove that a clinical trial has been conducted in compliance with Good Clinical Practice (GCP) guidelines).  
• Participating in peer review in a way that is fair, rigorous and timely and which maintains the confidentiality of the content. 
• Sharing the clinical trial results responsibly, accurately and broadly. 

Coordinating Principal Investigator (CPI) 

A Coordinating Principal Investigator (CPI) is clinically qualified to conduct and oversee a clinical trial that is taking part across multiple sites. 

Roles Include: 

• Submitting trial for scientific and ethical review. 
• Supervision and medical care of participants. 
• Ongoing communication with the HREC office. 
• Secure funding for trial. 
• Has a thorough knowledge of the trial protocol and investigational products. 
• Follow GCP guidelines. 
• Is the Principal Investigator for their own site. 
• For multiple trial sites, ensure collaboration and communication across participating sites in accordance with national guidance and jurisdictional policies.
• For multicentre trials, ensure each participating site is not opened until all regulatory and governance requirements are met. 
• Ensure that a trial sponsor has been identified and knows what their roles are. 
• Register the trial on a publically accessible database (Australian New Zealand Clinical Trials Registry). 
• Ensure that the Investigator’s Brochure is reviewed and updated every year. 

Investigator’s Brochure (IB) 

Every clinical trial must have an up-to-date Investigator’s Brochure (IB), which consists of a compilation of clinical and non-clinical data available on the investigational products to be used in the clinical trial. 

The IB provides the trial sponsors, investigators, and staff with a clear understanding of the meaning of the trial and the protocol requirements. The information allows for an accurate risk/benefit assessment to be made which is crucial to the Human Research Ethics Committee (HREC). 

An IB needs to be reviewed and updated at least annually. 

At Novotech, our clinical trial services have been conducted by our teams of professionals who have years of expertise across all aspects of clinical development. Our teams have established relationships with trial sites, key opinion leaders and Principal Investigators which have resulted in effective clinical trial start-ups, participant recruitment and site selection to deliver results on time.