Find a Principal Investigator for Your Clinical Trial
Behind every well-conducted clinical trial are skilled principal investigators responsible for regulatory compliance, clinical trial site management, participant safety, and reporting on crucial data. We can source experienced and qualified African principal investigators for your clinical study.
What Is a Principal Investigator in a Clinical Trial?
A principal investigator (PI), sometimes also referred to as a primary investigator, is the person in charge of a clinical trial.
As a part of the clinical research team, they prepare and carry out the clinical trial plan, manage the trial data, and report on the results of the study. Additionally, a PI is responsible for preventing—and reporting on—any instances of clinical trial protocol deviation.
What Does the Principal Investigator Do?
The principal investigator has several roles and responsibilities. For one, the investigator is responsible for ensuring that the investigation is conducted in compliance with FDA regulations, and that study records are up to date.
PI responsibilities also include obtaining informed consent, ensuring patient safety, and reporting on any mild or serious adverse effects of the investigational product or drug.
Principal Investigator Responsibilities
A principal investigator’s main day to day responsibilities are ensuring that research ethics and obligations are followed, and that data is accurately collected, analyzed, and reported. A 2020 article on the specific responsibilities of investigators provides an in-depth review of the three most prominent PI roles:
- Participant safety
- Communication with the IRB/IEC
- Accurate reporting
- Form 1572 compliance (for US trials)
- Communication with IRB/IEC
- Protocol Compliance
Protecting Human Subjects
A PI is a physician or dentist that is responsible for all trial related medical decisions of the clinical research subjects. Protecting the rights, safety, and welfare of study subjects is at the heart of all human subject research. When it comes to subject safety, it is the PI’s responsibility to:
- Obtain informed consent of study participants
- Ensure Institutional Review Board (IRB) approval
- Provide medical care for all adverse events, including significant laboratory values, related to the trial. Protect subjects from harm and report on any serious adverse events immediately
Communication with the IRB/IEC
Prior to the start of the trial, it is the PI’s responsibility to obtain written and dated ethical study approval and favorable opinion from the IRB/IEC for the study protocol, informed consent form, advertisements and any other written material information that is to be provided to subjects.
It’s also the PI’s responsibility to provide a copy of the Investigators Brochure (and any other updates).
During the study, it's the PI’s responsibility to provide all documents subject to review to the IRB/IEC for approval.
The principal investigator is responsible for conducting the study in compliance with the protocol provided by the sponsor, and approved by the regulatory authorities and ethics committees. The protocol or a similar contract should be signed to document the agreement with and responsibility to comply with the protocol.
The PI would not normally implement any deviation from the protocol, without the express permission from the sponsor and prior approval from the IRB/IEC, unless said deviation was for the safety of subjects (to eliminate an immediate hazard) or administrative in nature, in which case, the protocol deviation should be submitted to the IRB/IEC for review and approval or favorable opinion, to the sponsor for agreement and, if required and to the regulatory authorities.
Data Collection and Progress Reporting
When it comes to progress reports and data collection, the principal investigator is responsible for:
- Providing weekly, monthly, and annual reports on the progress and safety of the study
- Updating financial disclosure reports if any circumstances change during the study.
- Supply the study sponsor with a detailed final report once the clinical trial is finished.
The PI is responsible for reporting all Serious Adverse Events (SAEs) immediately to the sponsor, except those SAEs that are specified to not need reporting, by the protocol or any other document (e.g. the Investigator Brochure)
A more detailed written follow-up report should follow the immediate report. Both immediate and follow-up reports should identify patients as unique code numbers or identifiers rather than names, personal identification numbers or addresses.
All Adverse Events (AEs), including laboratory abnormalities, that are deemed critical to the safety evaluation of the study, should be reported in the time frame that is specified in the protocol.
The PI should also comply with the applicable regulatory requirements related to the reporting of unexpected serious adverse drug reactions to the regulatory authorities and the IRB/IEC.
Informed Consent of Trial Subjects
It's the PI’s responsibility to obtain written informed consent from all study participants prior to the start of the study. The informed consent must be uncoerced, voluntary and performed after giving the subject enough time to digest and understand the study details and requirements The PI must adhere to all applicable regulatory requirements, GCP and to the ethical principles that have their origin in the Declaration of Helsinki.
Investigational Product Accountability
The accountability of the investigational product also rests with the PI. He or she may choose to delegate some or all of this responsibility to suitably trained and qualified personnel, for example a pharmacist on site. This includes the delivery to the site, inventory at the site, adequate storage, use by each subject, reconciliation, return to the sponsor or disposal at site.
Randomization Procedure & Unblinding
The PI should comply with the trial's randomization procedures, if any, and should ensure that the code is broken only in accordance with the protocol. If the trial is blinded, the investigator should promptly document and explain to the sponsor any premature unblinding (e.g., accidental unblinding, unblinding due to a serious adverse event) of the investigational product.
Who Can Be a Principal Investigator in a Clinical Trial?
A principal investigator in a clinical trial is usually a healthcare professional. However, you don’t have to be a doctor to become a PI.
Research professionals in various fields can become principal investigators, with the proper education. According to the criteria for principal investigators, all full-time faculty members, and self-supporting research professionals are eligible to be principal investigators, as well as doctoral students seeking funding for fellowships.
What Makes a Good Principal Investigator?
A good principal investigator has to be organized, analytical, empathetic, and have an eye for detail. They interact with trial participants, as well as the study sponsor, convey crucial information, and act as a bridge between stakeholders. Infiuss PI’s are skilled and experienced professionals, well-versed in the world of clinical research.
Records and Reports
Source data should be attributable, legible, contemporaneous, original, accurate, and complete.
The PI is responsible for ensuring that all source data, necessary for the evaluation of the trial, are conducted in adequate and accurate source documents and trial records that include all pertinent observations on each of the site’s trial subjects. In addition, Case Report Form entries must be verified as being identical to the source data.
The PI is also responsible for writing and submitting written summaries of the trial status to the IRB/IEC annually, or more frequently, if required.
Final Report by the PI
Upon completion of the study, the PI is responsible for providing the IRB/IEC with a summary of the outcome, and the regulatory authorities with any required reporting.
Ensuring Compliance with US Food and Drug Administration (FDA) Form 1572
The FDA Form 1572 is a required document for US clinical trials. Though Infiuss operates in Africa, we adhere to equivalent standards.
According to the FDA, “the investigator should ensure that any individual to whom a task is delegated is qualified by education, training, and experience (and state licensure where relevant) to perform the delegated task.”
A principal investigator’s job is to ensure that everyone who participates in a study strictly adheres to the code of federal regulations dictated by the FDA. They do so by:
- Guaranteeing to personally conduct or directly supervise the study.
- Taking responsibility for the research staff.
- Ensuring that all records are prepared and easily accessible for FDA inspections during the trial
Delegation of Authority
Although the PI bears the responsibility for the successful oversight of the study, he or she may delegate any of the varied roles of a principal investigator to a member of site staff. These delegated roles must be specified and signed off by the PI and the staff member in a Delegation of Authority Log, which is filled at the start of the study, and stored in the Investigator Site File.
Africa is a great place to conduct clinical trials if you’re developing a medical device. Think of us as your CRO partner for every aspect of your medical device clinical trial.
Infiuss Health is the preferred CRO in Africa for pharmaceutical companies. With our concierge services and Probe CDMS, we handle everything from site selection to clinical study reporting.
From the biopharmaceutical industry to academia, clinical researchers of all types choose Infiuss Health as their CRO partner to manage clinical trials in Africa.
Principal Investigator FAQ
Everything you need to know about finding a principal investigator and the service we offer. Can’t find the answer you’re looking for? Please chat to our team.
What is the difference between a chief investigator and principal investigator?
A principal investigator (PI) is responsible for conducting the research at a trial site, while a chief investigator (CI) is the overall lead researcher for a research project. Each trial site has to have one PI, whereas the CI doesn’t have to be on location. “Chief investigator” is a term primarily used in the UK, with the US equivalent being “coordinating investigator.”
Can there be two principal investigators?
While it is possible to have more than one principal investigator at the study site, it is discouraged by some trial funding agencies. Large trials usually have a main PI and one or more co-investigators that help with the workload, but the PI is ultimately responsible for the trial running smoothly.
Does a PI have to be a physician?
No, a PI does not have to be a physician. With appropriate training and qualifications, anyone can be a PI. Still, many principal investigators are doctors or educated in a field closely related to healthcare and medicine.
Can a research scientist be a PI?
What is a sub-investigator in a clinical trial?
A contract clinical research organization (CRO) is a company that provides clinical research services to the medical device, pharmaceutical, and biotechnology industries. A clinical research associate (CRA) is a role within a CRO or pharmaceutical company that specializes in trial monitoring.
What should be in a clinical trial monitoring plan?
A sub-investigator is a member of the study staff. They are supervised by the principal investigator and responsible for performing critical procedures and making important decisions related to the study. The FDA refers to sub-investigators as individuals that are authorized to make medical decisions and judgments regarding human research subjects.
What is GCP?
Good clinical practice (GCP) is a standard for conducting clinical trials set by international ethics committees. It serves to ensure standard operating procedures set by regulatory authorities are followed, and all research subject rights are protected throughout the study. GCP guides sponsors and CROs to develop clinical trial innovations that adhere to best practices of safety and efficacy.
Why Conduct Clinical Trials in Africa?
A technology-first approach to research. We are your foot on the ground in Africa.
Traditionally, Africa has not been particularly accessible to American and European researchers. We’re changing that, with the provision of quality clinical research for easy access to African research sites and participants.
Our pharmaceutical & academic partners conduct clinical trials in Africa for a fraction of the cost they would spend in other geographic regions.
The African population exhibits greater genetic diversity than the rest of the world combined. Obtaining safety and efficacy data in clinical trials from populations with broader genetic diversity is essential for data integrity and generalizable results.
If you’re researching rare diseases endemic to the African continent (e.g., malaria, ebola, sickle cell anemia, hantavirus or monkeypox), you’ll want to conduct your clinical trials in Africa.
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