The introduction to clinical research is thrilling for new investigators and staff. The opportunity to participate in drug discovery and contribute to the development of innovative disease treatment beguiles like a magical elixir—it can obscure the enormity of the commitment required. There is far more involved in starting a clinical research practice or new research position than a patient database, medical license and the ability to obtain vital signs and draw blood. It is a challenging assimilation of establishing infrastructure, negotiating contracts and regulatory approvals and solidifying sponsor relationships to solicit the trials necessary to support cost.
No one realizes exactly what they have gotten themselves into when first starting in clinical research until they are in the thick of it.
Regulatory agency audits of investigative sites find that problems stem from lack of knowledge of the guidelines and regulations that govern study conduct. The International Conference on Harmonization/Good Clinical Practice (ICH/GCP) guidelines are the literal recipe book for the ethical design and execution of clinical trials and (when followed) will help assure the safety of the study patients and credibility of data collection. It is, therefore, imperative that new investigators and staff thoroughly familiarize themselves with GCP guidelines, 21 Code of Federal Regulations (CFR) parts 11, 50, 54, 56 and Section 9 of the 1572. Taking time to learn best research practices will ensure quality research as opposed to deficient data or, in a worst case scenario, investigative negligence and patient injury.
Every clinical researcher has been “the new guy” at some point in his or her career. The breathless enthusiasm felt when new to a role truly expedites learning, motivates workload and drives overall diligence. However, it does not guarantee ability and should never serve in lieu of appropriate training with tasks that influence patient safety and awareness. Inexperienced research staff must maintain oversight and demonstrate absolute proficiency before independently completing critical study procedures, such as ICF and drug dispensation.
Take, for example, the cautionary tale of an investigator in desperate need of a study coordinator. There had been several previous coordinators, seemingly experienced but with deficient training that led to protocol deviations, extensive screen failures and study loss. The investigator had been without a proper study coordinator for several weeks, with several trials starting and no one to manage the process. She finally decided that her best course of action would be to hire a medically trained but research inexperienced nurse and train him or her. The training plan would be rooted in GCP principles and managed personally by the investigator to ensure that best research practice was established.
The investigator hired an enthusiastic nurse for the study coordinator position. She quickly adapted to her role and assisted the investigator in study visits and recovering patients lost to follow-up.
Due to the study coordinator’s strong performance, the investigator decided to train her on the process of obtaining informed consent. The investigator tasked the study coordinator with review of consent guidelines, arranged for her to observe informed consent discussions and planned to supervise the study coordinator during her initial informed consent discussion with a study patient. However, on the day of study patient screening, the investigator’s clinic was overbooked; she barely had time to see patients, let alone supervise the lengthy process of obtaining a study patient’s informed consent. She made the impulsive and unfortunate decision to allow her new study coordinator to consent a study patient without supervision. The coordinator was bright and diligent, and it was a simple skin infection study. What harm could there be?
The study coordinator was thrilled to be delegated such an important task. The study patient was obviously healthy so there was no need for a thorough, page-by-page review of the consent, in the study coordinator’s opinion. The patient reviewed what she considered the important elements of the consent form and then happily signed the document with the study coordinator. The study coordinator drew blood, obtained vitals and processed the patient for her next appointment. Unfortunately, an important consent point was overlooked. The study patient was allergic to a component of the study medication, and returned to the study site several days later with an extensive skin rash. If the study coordinator had observed several consent discussions, and had been appropriately supervised, she would have known to never skimp on a comprehensive review of the consent form with the study patient, even under the most optimal of circumstances.
The investigator was extremely apologetic and discontinued the study medication, but the damage had already been done. The patient’s health was impacted and the patient’s trust impaired, all because the well-intentioned investigator had prematurely delegated the informed consent process to an inexperienced coordinator for the sake of convenience.
Conducting any part of clinical research is a decision that requires deep consideration before proceeding, especially when patient health and safety are potentially impacted.
Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and clinical research writer. She also is author of the novella Clinical Research Trials and Triumphs. Currently she works in relationship development/study startup in the CRO industry. Email firstname.lastname@example.org or tweet @ebwcra.
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