As a young nursing student, I was taught that, unless an activity was documented, it did not happen. Nursing notes had to be signed, dated, and time-referenced. Once I graduated and started working in a hospital, I saw other nurses get reprimanded for not satisfying this rule. Those receiving multiple reprimands were enrolled in remedial training.
Later in my career, I became involved in human clinical trials and found a similar documentation standard. If an investigator forgot to document a patient’s weight, height, or other important information during a study visit, the corresponding data field remained empty for the duration of the study…even if the oversight was discovered later. Data cannot be created after the point at which it should have been recorded. Instead, such uncaptured data was categorized as “missing.”
I carried this knowledge with me as I migrated to veterinary clinical trials. In most trials involving client-owned pets, the investigator is responsible for instructing each owner to document their observations in their diary or on a data form. Often, this training is effective, especially if the investigator selects the more responsible owners from their clinic’s client roster. However, not all owners pay attention, understand the importance of proper documentation to the success of the study, or follow the investigator’s instructions.
To avoid these documentation challenges, sponsors spend a large portion of every study’s investigator training meeting discussing the standards for documentation and the importance of training each study subject’s owner in protocol adherence and proper documentation.
Everyone involved must fully understand that, without complete and accurate recording of owner activities and observations, the study may be delayed…or fail.
These efforts notwithstanding, we occasionally encounter owner “issues”. Here are some of our more “interesting” experiences:-
A New Enrollment Strategy?
During owner training, it is important to show the test article to the owner and then instruct them exactly how to give it to their pet. In one study, the test article, a rather slippery caplet, was dispensed in a blister pack. As Mr. Smithers* pushed a caplet out of the blister pack for Tubby*, the larger of his two dogs, it flew onto the kitchen floor. His other dog, Rascal*, quickly licked it up and scurried out of the kitchen. Mr. Smitherswrote the following on his test article administration form: “Study product given to Tubby. Rascal ate it. Will enroll Rascal in study.”
A “Nopeful” Situation
Shortly after assuming monitoring responsibilities from another monitor, Shirley* soon discovered that none of the owners understood their responsibilities. Diaries were incomplete and no one was using the proper date field format. One owner wasn’t recording the test article administration time, as required. What she was recording were only the instances when she forgot to give the test article to her pet! Under the “Comments” section of her owner diary, there were many entries of “Nope” and “Forgot” but no indication whatsoever of when she remembered to give the test article.
Mrs. Wheatley* had enrolled her dog, Sophie,* in a trial to evaluate a new genitourinary product. One day, she offered the test article to Sophie. Sophie snapped it up…but then promptly spat it out. Thinking fast, Mrs. Wheatley picked up the rejected test article, wrapped it in a piece of cheese, and gave it back to Sophie. Sophie loves cheese, so she took it. But, as soon as she realized that there was test article inside, she spat it out. Undeterred, Mrs. Wheatley picked up the twice-rejected test article and put it directly in Sophie’s mouth. Equally determined, Sophie spat it out a third time and, just to make her opinion abundantly clear, urinated on it! Mrs. Wheatley made the following entry in her diary: “Test article offered three times. Sophie eliminated.”
‘Stamp’ of Approval
The project leader of a study decided to train each investigator at their clinic.
At one of those training meetings, Dahlia* (a potential study subject’s owner) was in the waiting room when the rather handsome project leader arrived. At the end of the study, all of the owners brought in their diaries for the monitor to review. When the monitor came to Dahlia’s diary, she didn’t quite know what to do. So, she overnighted it to her supervisor.
What did the supervisor find? On every single page of Dahlia’s diary, in bright red, was her very special “signature” … presumably as a message to the study’s project leader.
Needless to say, all of the forms had to be returned to Dahlia for a more customary signature. There also was a note to file to explain the late entry signatures.