Gather knowledge. Before becoming involved in clinical research, you should have a thorough understanding of the regulations pertaining to the field. That will help you ensure that your study site is and remains in compliance. In the United States, investigators should be familiar with these regulations:

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

These regulations define what is required by the U.S. FDA and cover the responsibilities of sponsors, investigators and Institutional Review Boards (IRBs). Other countries have their own requirements.

In addition, you must be familiar with good clinical practice (GCP), which refers to the principles and processes you are expected to follow. Compliance with GCP ensures that the rights, well-being and confidentiality of study subjects are protected. It also assures the collection of reliable data for submissions to regulatory agencies.

Establish the necessary infrastructure. You probably need to integrate clinical research space into your existing practice. To accommodate the conduct of clinical trials, you have to think about drug storage, archive space and equipment. You also need to provide workspace for clinical research associates (CRAs).

In addition, someone in your practice will need to assume the role of clinical research coordinator (CRC), or you will need to hire a coordinator. A CRC handles the management and documentation of the trial.

Find a clinical trial. Your therapeutic area, salesmanship, available time and business development budget are likely to play a role in how you search for trials that would fit your and your site’s capabilities. One easy way is to register on this site. You can also browse helpful sites on the Internet, such as CenterWatch.com and Clinicaltrials.gov. Both list thousands of trials. You might also want to visit the websites of drug companies whose products you prescribe and subscribe to industry publications.

Complete essential documents. Once you have been identified by a clinical trial sponsor or clinical research organization (CRO) as a potential investigator, you will be required to complete several forms. These forms are required documentation in order to register you as a clinical trial investigator and to track and evaluate the ethical and procedural conduct of a trial. Your assigned CRA will work with you and your CRC in completing the essential documents required for the clinical trial.

Required documents for an investigational new drug (IND) trial in the United States include:

• Confidential disclosure agreement (CDA)
• Form FDA 1572
• Protocol, amendments and signature page
• Investigational drug brochure (IDB), also called investigator’s brochure
• Curriculum vitae for the principal investigator (PI) and subinvestigators
• Investigational review board, (IRB)/independent ethics committee (IEC) approval letter and roster
• Laboratory certifications and normal ranges
• Investigator’s financial disclosure statement

Have your site inspected. A clinical research associate (CRA) who represents the sponsor or a CRO will conduct a pre-study site visit (PSSV) at your site to evaluate your experience, expertise and interest as well as your staff, facility and potential patient population available for the clinical trial. There are also several other items the CRA will want to discuss with you during the visit, including whether or not you are doing any competing studies within the same time period.

Get IRB approval. An institutional review board (IRB) is a group designated to protect the rights, safety and well-being of patients involved in a clinical trial by reviewing all aspects of the trial and approving its startup. You will be required to obtain IRB approval for the study at your site.

Sign the contract. A contract between you and the sponsor or a CRO needs to be signed before the clinical trial starts. The document usually contains your responsibilities, including the number of subjects you are expected to enroll, timelines for enrollment and the regulatory requirements. It also includes the sponsor’s responsibilities, including financial compensation and how it will be paid. Most sponsors follow a fee-for-service model, meaning they pay for actual work performed, such as subjects enrolled and subject visits.

Prepare for a site initiation visit. A CRA will conduct a site initiation visit (SIV) after the IRB has given its approval and the contract and all essential documents have been completed. The purpose of this visit is to assure that everything is in place for you to begin enrolling patients.

Enroll your first subject. Successful recruitment and enrollment are essential to any clinical trial. Working with study subjects includes recruiting them, scheduling their visits, retaining them and making sure they are compliant with the protocol throughout the study.

Take advantage of your opportunity to learn. Many investigators say that the opportunity to learn new skills and explore new challenges is what makes research so interesting.