The role of investigator and its responsibilities in clinical trials
Transforming recent basic scientific knowledge into treatments requires the use of clinical trials. Realizing the seriousness of their duties as investigators is essential for individuals who conduct clinical studies.
Who is an investigator?
Investigator particularly is someone who manages a clinical trial or research study in the scientific field. The investigator is responsible for assisting in the development and execution of the study’s protocol (plan), along with data collection, analysis and reporting. Doctors, scientists, nurses and other research personnel can all be investigators
Qualifications and agreements of the investigator
The investigator must meet certain requirements in terms of education, experience and training. The investigator needs enough time to perform the trial effectively and finish it within the predetermined trial period.
To execute the trial properly and safely, the investigator must have a sufficient number of skilled personnel and adequate facilities available for the anticipated trial period.
The researcher should make sure that everyone helping with the trial is properly informed about the protocol, the investigational products, and their roles and responsibilities in relation to the experiment.
Post and Pre Medical Treatment of Trial Participants
The trial's investigator or sub-investigator, who is a certified doctor or dentist, should be in charge of all trial-related medical decisions.
Both before and after a subject participates in a trial, the investigator and the institution should make sure that the subject receives the necessary medical attention for any adverse events, including abnormal laboratory results that are clinically significant to the trial. If a subject has a primary care physician and consents to having the primary care physician informed about their participation in the research, it is advised that the investigator let the primary care physician know.
Interaction with the IRB (Institutional Review Board)
The written and dated approval or positive opinion of the IRB for the trial protocol, written informed consent form, consent form updates, subject recruitment procedures, such as advertisements, and any other written information to be provided to subjects should be obtained by the investigator and institution before starting a trial.
Compliance with the Protocol
The researcher must carry out the trial in accordance with the regulatory authorities' and sponsors' accepted protocol.
Except when the changes involve only logistical or administrative aspects of the trial, the investigator should not make any modifications to the approved protocol without the sponsor's approval, prior review, and a documented approval opinion from the IRB. The investigator, or a person designated by the investigator, should document and explain any deviation from the approved protocol.
Investigational Product(s)
The investigator or institution is in charge of investigational product accountability at the trial location.
The investigator or institution, a pharmacist, or another suitable person who is employed by the investigator or institution, should keep records of the product's delivery to the trial site, the site's inventory, the use of each subject, and the return of unused products to the sponsor or other appropriate disposition.
The sponsor should specify how the investigational products should be stored, and any relevant regulatory regulations must also be followed.
Informed consent
The investigator must abide by all relevant legal and regulatory standards. The written informed consent form should have the IRB's clearance in writing, according to the investigator.
The trial personnel and the investigator should not improperly persuade a subject to begin or continue participating in a trial. The subject and the impartial witness, if relevant, should be able to understand the language used in the oral and written information, which should be as non-technical as it can be.
The investigator should provide the subject enough time and chance to ask questions regarding the study and make a decision about participating or not. The subject and the person who led the informed consent session should both sign and date the written informed consent form.
Safety Reporting
The SAEs that the protocol or another document, such as the Investigator's Brochure, specifically state that they do not require immediate reporting, all serious adverse events (SAEs) should be reported immediately to the sponsor.
Additionally, the researcher must adhere to all applicable regulatory procedures for notifying regulatory agencies and the IRB of unexpected significant adverse drug responses.
For deaths that have been reported, the investigator should provide the sponsor and the IRB with any further data they have requested, such as autopsy and final medical reports.
Premature Trial Termination or Suspension
If the trial is prematurely stopped or put on hold for any reason, the investigator or institution must notify the participants as soon as possible, ensure that they receive the proper treatment and follow-up, and, where necessary to comply with the relevant regulatory requirements, notify the regulatory authorities.
Investigator's final report(s)
If applicable, the investigator should notify the institution after the trial is finished. The institution or the investigator should then give the IRB a summary of the results of the trial and any reports that are necessary to the regulatory authorities.
In conclusion, it is the responsibility of the investigator to ensure that the investigation is carried out in accordance with the investigational plan, and they are also directly responsible for protecting the trial participants, securing the informed consent of human subjects, and maintaining control over the investigational drug.
References
Submitted by
Isha Kakodker
MSc Medical Biotechnology
Student ID: 217/1222
ishakakodker@gmail.com
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