Our Clinical Research 101 series takes an in-depth look at key steps and tips for navigating the clinical research process. The fourth installment in our Clinical Research 101 series is by Salima Jutha, Project Manager at CHÉOS, on the responsibilities of an investigator in a clinical trial.
Salima is a clinical trial specialist with over 14 years of experience in coordinating and managing clinical trials. Her expertise is in ensuring GCP compliance at the site and sponsor level, Health Canada regulatory submissions, and safety and project management. Salima’s recent projects include the North American Opiate Medication Initiative (NAOMI) study, for which she had a dual role as both trial coordinator and clinical project manager. She is currently the Clinical Trial Manager for the Study to Assess Long-Term Opioid Maintenance Effectiveness (SALOME) and also coordinates other CHÉOS-delegated studies. The Centre’s project managers are experts in the regulatory, policy, budgeting, and implementation requirements for clinical research studies. If you would like to inquire about our services, please submit your request here.
What is an investigator in a clinical trial?
An investigator is the person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a site, the investigator is the responsible leader of the team and may be called the principal investigator.
For clinical trials that are regulated by Health Canada, there must be a Qualified Investigator (QI). The QI is the person responsible to the sponsor for the conduct of the clinical trial at the trial site. The QI must be able to provide health care under the laws of the province where that trial site is located. This means the QI must be a physician or dentist and a member in good standing of a professional medical or dental association.
An investigator must be qualified by education, training, and experience to fulfill the role. The investigator can delegate duties required to conduct a study to other team members but NOT the responsibility.
What are the responsibilities of an investigator?
Be qualified by education, training, and experience to conduct the clinical trial, including:
- Be thoroughly familiar with the appropriate use of the investigational product (study drug) as described in the protocol and Investigator’s brochure/product monograph and other documents provided by the sponsor.
- Be aware and comply with ICH GCP (International Conference on Harmonization – Good Clinical Practice) and all applicable regulatory requirements.
- Allow monitoring and auditing by sponsors and inspection by appropriate regulatory authorities.
Provide adequate resources at the trial site to conduct the clinical trial:
- Including: qualified, trained and informed staff, adequate facilities-space and equipment, suitable patient population, enough time to conduct the study.
Provide medical care:
- Make medical decisions, ensure medical care for adverse events and new illnesses discovered during study participation, determine reasons for early withdrawal.
Communication with Research Ethics Boards (REB):
- Ensure that the study, consent, and other documents provided to the subject are approved by the REB and comply with GCP and other regulatory requirements
- Prior to starting the study, obtain ethical approval for protocol, informed consent form, recruitment materials, and other documents given to the patients.
- Provide the REB with a copy of the Investigator’s brochure, product monograph, or information about the product or intervention to be studied so the REB can fully assess the risks involved.
- During the study, inform the REB of any changes to the protocol, Investigator’s brochure (or other safety information about the product/intervention), protocol deviations, or unanticipated problems.
Compliance with protocol:
- Follow all procedures as described in the protocol unless to avoid an immediate harm to study participants.
- Report any deviations to the protocol to the sponsor and the REB
Investigational product:
- Maintain adequate records of receipt to the study site, inventory, dispensation to subjects, and return of unused product.
- Provide proper storage of the investigational product as required; maintain and make available, if requested, records of storage including temperature logs and equipment records.
- Ensure study product is prescribed as specified in the protocol and subjects understand how to take and store the study products dispensed to them.
- **This responsibility may be appropriately delegated to a pharmacist.**
Randomization procedures and unblinding:
- To unblind only if medically necessary, as described in the protocol and, if possible, to try to contact the study medical monitor prior to unblinding.
Informed consent of trial participants:
- Obtain and document the process of informed consent of participants in the study at the site. The Investigator is responsible for ensuring that the study and consent and other documents are approved by the REB and comply with GCP and other regulatory requirements.
- Communicate new information, in a timely manner, to subjects in an updated, REB-approved consent form.
Records and reports:
- Ensure accuracy, completeness, legibility, and timeliness of data reported on the CRF (case report form) and be consistent with source documents.
- Date, initial, and explain any changes or a correction to the CRF.
- Maintain trial documents specified by the Essential Documents section of the ICH guidelines and as required by applicable regulatory requirements.
- Retain essential documents until at least two years after the last approval of a marketing application or at least two years since formal discontinuation of the investigational product; Health Canada requires essential documents to be kept for 25 years.
- Provide access to research-related records to monitors, auditors, representatives of the REB, and regulatory authorities.
Progress reports:
- At least once a year, provide a written summary of the trial to the REB
- As requested, and as required by regulatory requirements, provide written reports to the sponsor, REB, and/or institution on any significant changes to the study and any increased risks to the participants.
Safety reporting:
- Immediately report Serious Adverse Events (SAEs)—or any abnormalities affecting participants’ safety—to sponsors and to the REB as per specific reporting guidelines.
Premature termination or suspension of trial participants:
- Ensure participants are informed and receive appropriate therapy and follow-up if the trial is prematurely terminated or suspended for any reason.
- Inform and provide a detailed written explanation of the termination/suspension of the trial to the REB and, if the investigator terminates the trial without prior agreement, to the study sponsor
- Promptly inform the institution and sponsor if the REB terminates or suspends approval of the trial, and provide the sponsor with a detailed explanation of the termination/suspension.
Final report:
- Upon completion of the trial, provide a summary of the trial’s outcome to the REB and any required reports to the sponsor and regulatory authorities, as requested.
Why are the responsibilities of the investigator important?
- To ensure that the safety and well-being of all participants in the study at the trial site are protected.
- To ensure data collected at the study site is credible and accurate.
- To ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected.
Additional resources:
GCP consolidated guidelines
