The road map to clinical research.
Involvement in clinical trials provides many opportunities for physicians to learn, become exposed to new therapeutic approaches and provide additional options or alternative treatments to their patients. If you are a physician interested in conducting clinical trials, the following steps can help you become a Frenova clinical investigator:
1. Complete the Frenova Site Self-Survey.
2. Ensure you are not listed on any of the following:
- The Office of Inspector General’s List of Excluded Individuals/Entities
- The General Services Administration’s List of Parties Excluded from Federal Programs
- The Office of Foreign Assets and Control’s Specially Designated Nationals List
- The FDA Debarment List of persons debarred pursuant to sections 306(a), (b)(1) and (b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(a), (b)(1), and (b)(2)
3. Complete GCP training and have your study coordinator complete his/her training.
A thorough understanding of the various regulations pertaining to clinical research is essential to becoming a clinical investigator. In the United States, investigators must comply with parts 50, 54, 56 and 312 of the Code of Federal Regulations (CFR) Title 21, which define what the U.S. Food and Drug Administration (FDA) requires of research sites. Other countries have their own requirements. Researchers must also be familiar with the concept of good clinical practice (GCP), which refers to the principles and processes investigators are expected to follow. Compliance with GCP ensures protection of the rights, well-being and confidentiality of study subjects, as well as collection of reliable data for submission to regulatory agencies.
4. Participate in a conference call to discuss your site’s interest in future research trials.
5. Establish a clinical research infrastructure.
Whether you plan to integrate clinical research space into your existing practice or set up a separate research site, you need to think about drug storage, archive space and equipment, and provide workspace for clinical research associates (CRAs). Your site will also need to hire a clinical research coordinator (CRC) to oversee the management and documentation of the trial.
6. Select a study.
Examine the investigator site network newsletters that will be sent to you so that you can find new studies that are looking for sites.
7. Fill out the required forms.
Once you have been identified as a potential investigator, you must complete several forms to register as a clinical trial investigator and to track and evaluate the ethical and procedural conduct of trials.
Required documents for an investigational new drug (IND) trial in the U.S. include:
- Confidential disclosure agreement (CDA)
- Form FDA 1572
- Protocol, amendments and signature page
- Investigational drug brochure (IDB)
- A curriculum vitae for the principal investigator and each sub-investigators
- Institutional review board (IRB)/independent ethics committee (IEC) approval letter and roster
- Laboratory certifications and normal ranges
- Principal investigator’s financial disclosure statement
8. Prepare for a pre-study visit.
As part of the qualification process for a newly awarded study, each potential site will undergo a pre-study site visit (PSSV) by a CRA to evaluate the investigator’s experience, expertise and interest, as well as the site staff, facility and potential patient population available for the trial. The CRA may also discuss several other topics during the PSSV, including whether you are conducting any competing studies at the same time.
9. Receive IRB approval.
Each clinical trial is overseen by an IRB or an IEC to protect the rights, safety and well-being of participating patients. The IRB or IEC reviews all aspects of the trial and must grant its approval before any clinical trial can begin. Once the trial is underway, the IRB/IEC closely monitors the progress of the research.
10. Sign the contract.
Before the clinical trial starts, the principal investigator must sign a contract with the trial sponsor or CRO. The contract typically outlines each party’s responsibilities, including the number of subjects the trial is expected to enroll, timelines for enrollment and the regulatory requirements.
11. Prepare for a site initiation visit.
Once the IRB/IEC has approved the trial startup, and the contract and all essential documents have been signed and processed, a CRA will conduct a site initiation visit to ensure that everything is in place for the investigator to begin enrolling patients.
12. Enroll first patients.
Now that you have become an investigator, you or your staff are responsible for recruiting patients, scheduling their visits, retaining them and ensuring patient compliance with the protocol throughout the trial.