Becoming a Clinical Research Investigator
The Clinical Research Department of Medtronic Neuromodulation has developed this guidance for physicians who are interested in becoming clinical researchers.
The US Food and Drug Administration (FDA) defines a clinical research investigator as “an individual who actually conducts a clinical investigation, ie, under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.”1
Becoming a clinical research investigator may provide you with opportunities to:
- Be at the cutting edge of medicine.
- Play a critical role in medical product development.
- Help improve the health of patients.
- Increase your professional development and recognition.
About These Guidelines
Medtronic Neuromodulation provides these guidelines for physicians interested in becoming a clinical research investigator. By providing this information, Medtronic makes no offer or commitment to appoint any physician as a future clinical research investigator for Medtronic-sponsored clinical research.
Guidelines and Requirements
The US Food and Drug Administration (FDA) provides the following guidance to physicians interested in becoming clinical research investigators, regardless of the type of study or product. The FDA provides this guidance as suggestions or recommendations unless specific regulatory or statutory requirements are cited.
Understand the Regulations
Clinical research investigators in the United States are required to follow the regulations of the FDA. Failure to follow these regulations can result in legal and financial implications. Studies conducted in other countries have other requirements.
FDA regulations include but are not limited to:
- 21 Code of Federal Regulation (CFR) Part 50—Protection of Human Subjects.
- 21 CFR Part 54—Financial Disclosure by Clinical Investigators.
- 21 CFR Part 56—Institutional Review Boards (IRBs).
- 21 CFR Part 312—Investigational New Drug Application.
- 21 CFR Part 812—Investigational Device Exemptions.
- 21 CFR Part 11—Electronic records; Electronic Signatures.
Train in Good Clinical Practice
"Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible."2 GCP training is available online and in classroom settings.
Actively Employ Physician Oversight
“The investigator should develop a plan for the supervision and oversight of the clinical trial at the site. Supervision and oversight should be provided even for individuals who are highly qualified and experienced.”3
Create an Infrastructure
Clinical research investigators need to ensure they have the necessary staff and facilities to successfully conduct a clinical trial. Research staff should include a dedicated, qualified clinical research coordinator. Facility space may need:
- Waiting room/exam room.
- Medical equipment/facilities (eg, MRI, pharmacy, freezer).
- Drug/device storage (locked space).
- Secure storage for study records.
- Workspace for clinical research staff.
- Lab space/access to labs.
Manage Time Effectively
“The investigator should have sufficient time to properly conduct and supervise the clinical trial.”3 Clinical research can be time consuming. Participation in a study can range in duration from 1 to 10 years. During that time, a clinical research investigator needs to plan and allow time for key study activities, which include but are not limited to:
- Recruiting potential study subjects (including networking with other doctors to request referrals)
- Reviewing and answering informed consent questions with potential subjects
- Meeting regularly with sponsor monitoring representative
- Collection and review of data and data queries
These resources for clinical research investigators are available online.
- FDA Home Page
- FDA Code of Federal Regulations (CFR)
- FDA Guidance for Clinical Investigators
- Center for Drug Evaluation and Research (CDER)
- Center for Devices and Radiological Health (CDRH)
- E6 Good Clinical Practice Guidance for Industry
Clinical research investigators may also need access to the following resources:
- Health Insurance Portability and Accountability Act (HIPAA)/Patient Confidentiality
- ISO 14155
- Declaration of Helsinki
- AdvaMed Code of Ethics
- FDA Code of Federal Regulations, Title 21, Part 812.
- ICH E6 (International Conference on Harmonisation).
- FDA Guidance for Industry Investigator Responsibilities.