Investigators, Principal Investigator, Coordinating Investigator — Who is actually doing what here?

Investigators, Examining Doctors, Principal Investigator, Coordinating Investigator: Who are they and who is actually doing what here?

Clinical research is a complex field that comprises various key roles that are essential for the success of a clinical investigation (medical device trial). When planning and carrying out a clinical investigation or study, coordinating investigators for the clinical investigation or "other clinical investigation" or performance study, prinicpal investigators and investigators are important players at the interface with participants of clinical investigations so that the study can be successful at all. The tasks/ duties and necessary requirements for these positions are described in accordance with the relevant regulations and ethical guidelines.

The coordinating investigator, principal investigators, and investigators play critical roles in planning, executing and monitoring clinical trials, carrying out specific tasks in accordance with relevant regulations and ethical guidelines to ensure the safety of participants and the integrity of data.

What does the Coordinating Investigator do? Tasks and requirements

The medical head of the clinical investigation, also known as coordinating investigator (MDR), is sometimes referred to colloquially as "Principal Investigator" (PI) a term deducted from clinical trials of medicinal products. He or she plays a central role in conducting clinical trials, including other clinical investigations and performance studies. In accordance with ISO 14155, the Regulation (EU) 2017/745 on Medical Devices (MDR), and the Medical Device Law Implementation Act (§30 and §62 MPDG), the coordinating investigator must fulfill specific responsibilities and requirements. Regulation (EU) 2017/746 barely specifies the duties, tasks and requirements. It is important to note that also the term "Chief Investigator" is being used, which can lead to further confusion. With the entry into force of EU Regulation 536/2014, the role of the Head of Clinical Trial (for clinical trials of medicinal products) will no longer exist.

Note from ISO14155 on the term coordinating investigator: The terms “national investigator” or “global investigator” are used synonymously.

Tasks/duties of the Coordinating Investigator:

• Patient safety and rights: The coordinating investigator ensures the safety and well-being of study participants. This includes compliance with ethical principles and ensuring that participants are fully informed about the study and that their consent is obtained.
• Coordination: The coordinating investigator is responsible for the clinical investigation plan and the clinical trial report together with other parties. He or she coordinates the activities of all investigators involved in multicenter trials and ensures that the clinical investigation is carried out in accordance with applicable regulations and the protocol.
• Monitoring: The monitors compliance with ethical and legal standards, including the Helsinki Declaration, which sets out ethical principles for medical research involving humans.
• ‍Reporting: LKP is responsible for submitting reports to the relevant authorities and ethics committees.

Requirements of the Coordinating Investigator:

• Qualification: In Germany, the coordinating investigator must have appropriate qualifications and at least two years of experience in carrying out clinical trials, other clinical trials or, in the case of performance studies, in carrying out interventional clinical performance studies using in vitro diagnostics (§30 MPDG).
• Knowledge: The coordinating investigator must have comprehensive knowledge of the legal and ethical bases for clinical trials, including regulations (EU) 2017/745 and 2017/746 as well as ISO 14155 and any further applicable national laws.
• Ethics: The coordinating investigator must comply with the ethical principles of the Helsinki Declaration, the European Code of Medical Ethics and the respective national professional code for physicians.

The role of Principal Investigators in clinical investigations explained

Principal Investigators are responsible heads of the team at an investigation site (synonymous with “investigation centre”). This role is particularly important when a clinical investigation is being conducted at multiple sites.

Duties/duties of the Principal Investigator:

• Leadership: Principal investigators lead the team of investigators at a investigation site and ensures that the clinical investigation meets the requirements of Regulation (EU) 2017/745.
• Safety: He or she ensures that the safety of exam participants is ensured and that the reliability and security of the data obtained is not compromised.
• Assignment of tasks: Principal Investigators assign tasks to members of the study team and supervises their implementation.

Principal Investigator Requirements:

• Qualification: Principal investigators must be qualified doctors or, in exceptional cases, another qualified person who has sufficient experience in clinical research.
• Experience: He or she must be able to demonstrate at least two years of experience in conducting clinical investigations.

The role of the Investigator: medical care and more

The Investigator, is responsible for carrying out the clinical investigation at an investigation site.

Tasks/duties of the Investigator:

• Implementation: The Investigator shall conduct the clinical investigation in accordance with the protocol and applicable regulations.
• Patient care: He or she is responsible for the medical care of subjects enrolled and ensures that their rights and safety are maintained.
• Documentation: The investigator documents all relevant data and events during the clinical investigation and reports them to the Coordinating Investigator or Principal Investigator.

Requirements for the Investigator:

• Qualification: Investigators are qualified doctors or, in exceptions, other persons with sufficient (also “suitable”) qualifications and experience in patient care. In German legislation (MPDG) in exceptional cases, persons from other professional groups with sufficient qualifications may also take on the role of Investigator (§30 and § 62 MPDG). Investigators are responsible for the subjects enrolled in the investigation and provide the necessary resources (including rooms, number of suitable patients, own time, staff) and the continued care of patients. Investigators also ensure the uninterrupted flow and processes of clinical investigations and, above all, that investigational subjects are informed.
  They also ensure the uninterrupted flow and processes of clinical investigations and, above all, provide information for study subjects, obtain consent and consent to the privacy policy and are available to study participants on an ongoing basis for further questions. Examiners must promptly, correctly and completely document the necessary information in the patient master data or in the case report form (CRF) and be available for inquiries.
• Knowledge: Investigators must know and comply with the principles of Good Clinical Practice (GCP) and relevant medical, legal, and ethical requirements.

Compliance with these requirements and tasks is crucial for the successful and ethically justifiable conduct of clinical studies.

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