Investigator Role and Responsibilities in Clinical Trials
Introduction:
When conducting a clinical trial, clinical investigators must meet all research expectations. A clinical investigator’s primary responsibility is to conduct research protecting the rights and welfare of human participants. Investigator is a person who is responsible
for the conduct of the clinical trials at the trial site. If a trial is
conducted by a team of individuals at a trial site, the investigator is the
responsible leader of the team and is called Principal Investigator.
Roles and responsibilities of investigator:
Adequate resources.
Medical care of trial subjects.
Communication with IRB/IEC.
Compliance with Protocol.
Handling of ICF.
Randomization and unblinding procedures.
Records and reports.
Investigator qualifications and agreements:
Investigators should be qualified, educated, trained, and experienced.
Familiar with investigational products and their use.
Should be aware of and follow GCP and Applied Regulatory Requirements.
Permits Monitoring, Auditing, and Inspection.
Make a list of qualified persons to whom he has assigned significant trial-related duties.
Adequate resources:
Ensure that all the persons who assist with the trial are informed about Protocol, IMP & trial-related duties.
To arrange adequate numbers of qualified staff and facilities for the trial.
Having sufficient time to conduct and complete the trial.
He should recruit the required number and suitable subject.
Medical care of trial subjects:
Responsible for all trial-related medical decisions.
Ensure that adequate medical care will be provided for any adverse drug reactions during the trial.
Trial before they join the trial.
If the subject is having a primary physician and wants to inform then the investigator must inform them.
Communication with IRB/IEC:
- Before initiating a trial, the investigator should obtain the approval of the trial protocol, written informed consent form, consent form updates, subject recruitment procedures, and any other information that should be provided to subjects from IRB/IEC.
- As a part of the investigator’s written application to IRB/IEC with a current copy of the Investigator’s Brochure. If the Investigator’s Brochure is updated during the trial, the investigator should provide a copy of the updated Investigator’s Brochure to the IRB/IEC.
- During the trial the investigator/institution should provide the IRB/IEC with all the documents subject to review.
- Investigator should obtain the IRB/IEC approval of the written informed consent form and any other written information that has to be provided to subjects.
Randomization procedures and unblinding:
The investigator should follow the trial’s randomization procedures according to the protocol if any and should ensure that the code is revealed only by the protocol. If the trial is blinded, the investigator should promptly document and explain to the sponsor about the premature unblinding of the investigational product.
Conclusion:
Clinical investigators face many challenges during the conduct of clinical trials that are different from those encountered during the routine practice of medicine. Many of these challenges come from the rigorous nature of clinical trials. When conducting a clinical trial, clinical investigators must meet all research expectations.
References:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3051859/.
https://www.fda.gov/files/drugs/published/E6%28R2%29-Good-Clinical-Practice--Integrated-Addendum-to-ICH-E6%28R1%29.pdf
Written by: Apoorva Madarapu
Qualification: BDS
ID: 131/0722
Email Id: apoorvamadarapu@gmail.com
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