CR CASE STUDIES

Left in a lurch: Coping with an untimely exit

Ohio CR coordinator offers case study answer

For most researchers the sudden departure of a study coordinator who leaves months of uncollected data is what might happen in a particularly bad dream.

For one Ohio research site, this exact scenario was a living nightmare. The clinical research (CR) site eventually recovered thanks only to the pluck and determination of one research coordinator.

"What happened was their study coordinator called in sick one day and never came back," says Anne Looney, RN, CCRC, a research coordinator for Mid-Ohio Heart Clinic Inc. of Mansfield, OH.

When the coordinator disappeared, she left a mess that no one at the site knew how to handle. So the CR site hired Looney, who had no research experience, but proved to be the right person for the job.

"She didn't do a lot of data entry, so even though a lot of patients were enrolled, there was not a lot of data," Looney recalls. "For example, we had one trial with 62 patients and data for only five patients."

Looney's job was to organize the chaos.

"I came in not knowing a lot about research, but had to devise a plan to look at all of the open studies and find the contact person for each," Looney says. "The sponsors gave me lists of patients who had signed informed consent (IC) forms, and then I checked on updates with the IRB."

Once Looney could find IC forms for all patients, she went through the clinic's records and called patients, asking them when they last visited the clinic and whether they are using a study medication.

The next step was to obtain data from study subjects' primary care physicians and hospital visits.

"Some data points were missing," Looney notes. "So if I didn't have records at my clinic, I'd ask the patient if they saw a primary care physician or maybe they went to a rapid response clinic."

From these providers, she could collect vital signs and medications.

"If the patient had been in Florida, then I contacted hospitals in Florida, putting all data together," Looney says. "Then I collected source documents for the trial."

Looney brought her findings to investigators, and they decided that some trials would have to be closed because they had never been properly initiated.

"We were involved in a couple of trials where the site had been opened for a year or more with no patients entered," she says.

But if the study had enrolled patients and had informed consent documents for them, then Mid-Ohio Heart Clinic chose to continue the trial, filling in the data holes wherever possible.

Sponsors were very helpful, she notes.

"They were willing to come out and help us make sense of data," Looney says. "For one trial with no follow-up, they brought in a data manager and two monitors who helped me work through data and get everything organized."

Sponsors also sent Looney source documents from another research coordinator. And the data manager showed her how to use the electronic case report form system for entering data and assisted with regulatory documents.

Looney worked weekends to collect data and submit the information by the study monitors' deadlines. She also began to educate herself about clinical trial research, using online research education and learning from sponsors.

"I went to a lot of beginning research seminars, good clinical practice (GCP) seminars, and protecting research subjects seminars," she adds. "I joined the Association of Clinical Research Professionals (ACRP) and obtained information from ACRP."

Communications breakdown

Looney learned that her predecessor had not responded to follow-up letters, citing study deficiencies, from study monitors and had not shared the letters with principal investigators (PIs).

"There was a serious breakdown of communication on a lot of levels," she notes.

PIs could learn a great deal from Mid-Ohio Heart Clinic's experience about how to reduce the risk of a data collection disaster.

"One thing researchers and coordinators should do with each trial is chart the research activities on the day of the activities, so if someone leaves today and is hit by a bus, then someone else will know where they are with study visits and data collection," Looney suggests.

Research coordinators should take CR training courses and work closely with sponsors and monitors to get up to speed on studies. They also need to keep communication lines open, perhaps by using electronic spreadsheets and white boards in the office, she says.

"We keep boards in our office with the name of the trial, IRB data, IRB deadline, and other items posted so we know exactly what's going on," she adds. "Originally, I was the only coordinator, but now we have two other ones and a research assistant."

Also, coordinators should be trained to speak with the PI if they have any problems or concerns.

"Let them know before we start a new trial if you can do the work, knowing what else you are doing," Looney says. "And if the PI really wants you to do a study, then you have to be open and communicate, saying, 'I'll need more help.'"

The end result of the records fiasco and Looney's clean-up was that three trials were closed, 10 trials remained open and were successfully launched, meeting all data entry deadlines, Looney says.

"It was a matter of going through everything and setting aside time when the monitors visited," she adds.

"We had no FDA audits during this time, but even if we were audited, we'd be okay at this point," she says. "It was a matter of getting the regulatory documents together and filling in the holes."