Ensuring patient confidentiality during monitoring visits
Monday, May 19, 2014
The Pulse on Study Conduct by Elizabeth Weeks-Rowe
Researchers are ethically bound to preserve the identity and confidentiality of clinical research patients. Patient information must be de-identified to help assure data integrity, prevent bias and achieve an accurate statistical analysis in clinical trials.
Likewise, research patients must be fully informed of this confidentiality, and the extent of the protected health information (PHI) with clinical trial participation. This is why HIPAA language is included with the informed consent form (ICF). Without full disclosure of this information to study patients and their agreement, researchers are prohibited even cursory review of patient information which, in turn, would severely impact data cleaning and data submission.
Patient confidentiality, patient safety and protecting the blind all are key terms that require action and continuous oversight by regional CRAs that is integral to monitoring proficiency.
There are many ways to ensure patient confidentiality, patient safety and blind preservation during monitoring visits. CRAs perpetuate patient confidentiality by confirming patients are identified only by their initials and study number in the case books/documents reviewed. They verify patient information is appropriately redacted before transmission to the sponsor, and that all computer/telephone-generated study drug assignments note the correct patient identifiers and kit/bottle assignment according to the randomized patient arm. CRAs ensure site compliance with patient safety by reviewing the ICF content for required GCP elements, that both the patient and the individual obtaining consent signed and dated all pages correctly and that the ICF process was appropriately witnessed and documented.
Regional CRAs are assigned sites to manage for the duration of a clinical trial, which can be years. Consequently, CRAs become familiar with site staff and with the patient records reviewed. A medical record can tell the tragic or the uplifting, and always tells the detailed story of a patient’s health history. Over an extended period of review with a study patient’s source documents/medical record, CRAs essentially accompany a patient on his or her health journey through a clinical trial, feeling that patient’s sorrow over disease reoccurrence or sharing the triumph of diagnostic results that show progress or recovery. In this way we participate in revolutionary disease treatment that can cure illness and inspire hope—a remarkable gift.
Twelve years ago, I was a CRA on a large oncology trial. I was assigned to manage 10 to 12 U.S. sites, from large academic institutions to small private-practice clinics. I enjoyed visiting one site in particular, a private-practice clinic with a conscientious, involved investigator and a dedicated research nurse. They produced clean and credible study data. As any oncology CRA can attest, a cancer patient’s medical record is expansive and complex. It can take eight or more hours for a CRA to review a screening visit. This investigator had enrolled only three patients in the study, so I had extra time to review data, for which I was thankful, because from my first monitoring visit each patient’s story touched me. I had reviewed each patient’s study data from trial entry. I had learned each diagnosis, treatment, response and disease reoccurrence that had led to our trial. Our study drug targeted a rare cancer, and for some patients, this trial represented their last hope.
One positive aspect of the small cancer center was the specialized treatment patients received. The facility was well funded, with state of the art equipment and treatment. The clinic provided a multi-dimensional focus on all aspects of patient care—both the scientific and the spiritual elements of recovery. The patients were encouraged to involve family members, clergy—whoever they deemed significant in their treatment plan—to ensure full support for recovery. It was an unrestricted atmosphere in which the lines between patient and caregiver were deliberately blurred for optimal patient ease and treatment effect.
The only challenge was the limited physical space for administrative/monitoring work. I worked in either the investigator’s or the study coordinator’s office. I always had desk space and privacy, which was sufficient. And, most importantly, I was secluded from patients during study visits. I saw and heard nothing—that is, until one memorable afternoon.
I had been working in an empty office near the clinic entrance. I was organizing the case books for review and, because the clinic was warm, I had the door slightly open. With my back turned, I did not notice the study nurse and a patient pass by, deep in conversation. I know I was meant to hear their unforgettable words. As I was a relatively new CRA, the experience deeply validated my decision to stay in clinical research.
The two had stopped just beyond my work area. Though I never saw the patient’s face, the message was unforgettable. “I feel so much better! I have not felt this healthy in years! I am so grateful to you, the doctor, the drug company, for giving me this medication.”
I did not hear the rest of their conversation, but I had heard all I needed. It was a randomized, double-blind study. No one knew what treatment the patient was receiving. The only thing that mattered at that pivotal moment was the patient’s state of mind and feelings of improved health and well-being after months of hopelessness.
No matter how small your proverbial role in the drug development process, from data manager to study coordinator, from CRA to CEO, each task is meaningful and has the potential to change the course of a patient’s illness and recovery.
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 business development director. She has written and edited newsletters for several CROs, created training curriculum for CRA/clinical research educational and training programs and is a contributing writer to several research publications. She currently works in relationship development/study startup in the CRO industry.
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