Jack Hoselton is an experienced monitor, having reviewed data forms at nearly 200 animal hospitals for more than 50 clinical trials. Jack always looks forward to the training meeting for each new trial because he gets to finetune his understanding of the protocol and meet his assigned investigators before the study starts. Last February, Jack was thrilled that the meeting for his latest trial would be in Florida, giving him a break from the harsh winter in Massachusetts.
By mid- March, Jack had conducted initiation visits at all of his sites. He was impressed by one which seemed enthusiastic and well-organized. During his initiation visit, Jack learned that they had prescreened several potential subjects and already had appointments for three Day 0 visits. So, before leaving, Jack scheduled his first monitoring visit for two weeks later.
Upon arriving for that visit, Jack met with the site staff, provided a quick review of the study protocol and GCPs, reconciled test article, and then asked if there were any problems during the first two weeks. Mary Kessler, the treatment administrator, said that the only problem was that enrollment had been much faster than expected.
Jack asked Mary to describe how they kept from falling behind. She noted that Dr. Kelsey, the site’s principal investigator, ran “a pretty tight ship.” At that moment, Dr. Kelsey, who happened to be walking by on her way to surgery, stuck her head through the open door and said to Jack, “The captain of this ship has a good crew, and everyone has been working very hard on your study!” “On that note,” Jack said, “let’s look at some data forms.” Mary pointed to the stack of case binders on the credenza.
Jack grabbed the first binder and began to check every form for completeness, accuracy, and consistency. He was pleased to confirm medical history with each subject’s medical record and especially impressed by this site’s documentation skills. When Jack was almost through, Dr. Kelsey stopped by to see if he had any questions. He did, but he first wanted to understand how Dr. Kelsey conducted her study visits.
“I’m quite proud of our process,” beamed Dr. Kelsey. “First, my study coordinator brings the pet into the exam room and weighs it. Then, she records the weight on the form. I examine the pet and dictate my findings, which the study coordinator records on the form. I then ask the pet’s owner if there have been any problems. The study coordinator records the owner’s comments while we speak.”
“As we finish each visit, the receptionist brings the next subject into an open exam room. Once I finish with the first animal, the study coordinator and I move into the next room and repeat the process. We keep going from room to room until we’ve completed all study visits scheduled for that day. Then I return to my regular appointments.”
“Wow,” Jack said. “Almost like an assembly line!” Jack thought about that for a minute and then asked, “When do you review and sign the study forms?”
“Most of the time,” Dr. Kelsey answered, “I do it over the weekend, usually while watching TV with my husband. The joint downtime is nice but, after awhile, I get bored with sports,” she chuckled. “If I see study data that looks questionable, I put that form aside to discuss with the study coordinator. Otherwise, I sign and date the rest of the forms.”
“I see. So, you date your signature on each form to match the date of the corresponding visit?” Jack wondered. “Of course,” responded Dr. Kelsey. “I follow GCPs and make sure that all study data is recorded contemporaneously, just like we were taught during training. Am I doing something wrong?”
“Sort of.” Jack realized that Dr. Kelsey needed a better understanding of the term “contemporaneous.” “You’re doing a fantastic job of recording your observations during the visit. However, you’re not reviewing and signing the forms until several days later. Then, you’re dating your signature as if you had signed the form on the day when the visit occurred.
That causes two problems, one practical and the other ethical.” Jack suggested that, by not reviewing each data form right after the data was recorded, Dr. Kelsey might not catch errors until several days later. By then, more cases could be affected. He also explained that, by back-dating her signature, Dr. Kelsey was misrepresenting when the review actually occurred. That could be much more serious because it could call into question the integrity of some or all of Dr. Kelsey’s data. “Oh, dear,” Dr. Kelsey sighed, “I didn’t think of it that way.”
This and similar situations occur more often than most of us would care to admit. It highlights the need for greater care in selecting investigators, more rigorous and detailed training before each study begins, and diligent oversight once things get going. In the end, though, we are forced to trust that each investigator understands and follows GCPs.