The Principal Investigator promotes good clinical practices in the conduct of clinical investigations by assuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of data generated at the site, and directing the conduct of the clinical investigation according to federal and state regulations and guidance documents.
Requirements
- Maintaining a current, up-to-date curriculum vitae
- Maintaining current licensure to practice
- Maintaining a current DEA license
- Demonstrating the proper education, training, and experience to conduct the clinical investigation
- Assuming responsibility for the conduct of the clinical investigation
- Execution of Form FDA 1572 for each study, and compliance with Form FDA 1572 requirements for
- Execution of the protocol signature page, as required
- Submission of financial disclosure form(s) before, during, and after study
- Signing sponsor contract(s) as appropriate
- Documenting the financial aspects of the trial in accordance with the Sunshine Act
- Disclosing conflicts of interest as described in the regulations
- Possessing a thorough understanding of the requirements of each protocol
- Determining that inclusion/exclusion criteria apply to the study population
- Assuring recruitment goals are reasonable and attainable
- Assessing overall protocol feasibility
- Following the trial’s randomization procedures
- Not implementing any protocol deviation or changes without agreement by the sponsor and prior review and approval by the IRB (except to eliminate immediate hazards to the subject)
- Reviewing the inclusion/exclusion criteria, schedule of visits, endpoint criteria, and investigational article use with the research team
- Provide the IRB with adequate information to initially review the study (i.e., protocol, investigator’s brochure, informed consent form, recruitment advertisements and any written information to be given to subject(s))
- Provide the IRB with documents for ongoing review (i.e., amendments to the protocol, adverse events, deviations, or new information)
- Securing written IRB approval before initiating the study or instituting any changes to the protocol as approved
- Provide written summaries of the trial status to the IRB annually, or as requested
- Provide written information of premature termination or suspension of a trial
- Provide the IRB with all documents subject to their review
- Having an adequate number of qualified staff to conduct the study
- Having an adequate facility to conduct the study
- Assuring he/she has adequate time to conduct and supervise the study
- Assuring that a qualified physician (PI or sub-investigator) is responsible for all trial-related medical decisions
- Assessing subject compliance with the test article and follow-up visits
- Assessing the subject’s response to therapy
- Evaluating for adverse experiences
- Ensuring that medical care is provided to a subject for any adverse event(s)
- Informing a subject when medical care is needed to treat an intercurrent illness(es)
- Informing the subject’s primary physician about their participation in the trial
- Reporting all serious adverse events immediately to the sponsor and IRB
- Assuring that the informed consent form contains all the elements required by CFR 56 and 45
- Obtaining a signed and dated informed consent from the subject or the subject’s legal representative before initiating any study-related procedures
- Informing the subject or legal representative about all aspects of the clinical trial
- Providing new information about the study or test article(s)
- Ensuring subject confidentiality
- Providing the subject or subject’s legal representative with a copy of the signed and dated informed consent form
- Assuring that the informed consent form is in language that is understandable to the subject
- Securing a witness to the informed consent process when the subject or legal representative is unable to read
- Allowing ample time and opportunity for the consent process and answering questions about the trial to the satisfaction of the subject or legal representative
- Securing consent/assent from minors and mentally impaired subjects as appropriate
- Following emergency use guidelines for waiver of consent in emergencies as directed by the federal regulations and IRB policy and procedures
- Ensuring the accuracy, completeness, legibility, and timeliness of case report forms
- Ensuring that case report forms accurately reflect source documents
- Explaining any discrepancies between source documents and case report forms
- Endorsing changes or corrections to a case report form
- Documenting deviations from the approved protocol
- Documenting and explaining premature unblinding of the investigational product(s)
- Documenting that informed consent has been obtained from the subject or legal representative
- Ascertaining the reason for a patient’s premature study withdrawal
- Documenting adverse events and or medication side effects
- Complying with written procedures to document changes to data and/or case report forms
- Maintaining trial documents as required by the regulations and sponsor for the appropriate timeframe and under secure conditions
- Provide study reports as requested by the sponsor, IRB, and regulatory authorities
- Being thoroughly familiar with the use of the investigational product(s)
- Reading the current investigator’s brochure, product insert, or other source information
- Assuming responsibility for the investigational product at the trial site
- Ensuring the proper use and storage of the investigational product(s) at the trial site
- Reviewing the proper use of the study article(s) by the subject(s)
- Communicating effectively with subjects, research team, IRB, and sponsor
- Meeting regularly with the research team to discuss subject participation and protocol progress
- Assuring that all research staff are informed about the protocol and investigational agents
- Being knowledgeable about regulatory requirements and GCP standards
- Preparing for and attending investigator and start-up meetings
- Participating in monitoring visits and audits as appropriate
- Permitting monitoring and auditing by the sponsor and appropriate regulatory authorities
- Making available to monitors, auditors, IRB, and regulatory authorities all requested trial-related records
- Delegating authority at the site appropriately
- Assuring that all research staff are informed about their trial-related duties and functions
- Maintaining a list of qualified persons and their corresponding trial-related delegated duties
- Attending educational workshops
- Reviewing professional publications
- Participating in professional societies
