Compliance Corner: Use clinical trial tools to improve operations
Use clinical trial tools to improve operations
Protocol flow sheets a good start
One way for clinical trial sites to optimize performance, improve compliance, and ensure best practices is to use clinical trial tools to systemize certain operations, including handling the protocol, identifying source documents, and managing risk.
Standardized procedures, outlines, and flow sheets might help to improve quality and efficiency within trials, says John P. Rowell, RN, MSN, CCRC, project coordinator/clinical research educator in the department of medicine, division of research at Louisiana State University Health Sciences Center in Shreveport.
"It saves time in training for coordinators," he notes.
Rowell describes three of the tools, which he calls guidelines, used by his facility:
• Protocol site flow sheet: This tool is a flow sheet used by clinical trial coordinators to carry out the daily aspects of a study, Rowell explains.
"It has a complete contact list in it for all sponsors and on-site contracts, along with the physical, lab, sponsor medical monitors, protocol monitors, and project monitors," Rowell says.
When the trial site receives a protocol from the sponsor, the details of the protocol are put into the protocol site flow sheet, which then provides coordinators and others with a step-by-step guide to everything that will need to be done for that clinical trial, he explains.
Coordinators then can use the flow sheet as a reference, making for more consistent research with fewer protocol deviations and queries, adds Rowell. "We take a copy of it and have source documents, research folders for each individual patient, and we put it in the front of that research folder. So when you see the patient, you have the folder with you."
Some coordinators will set it up in a checklist format, while others might use an outline format, but this is an individual choice, he says.
"Compliance has markedly improved since we’ve done this, because usually the sponsor doesn’t provide any [flow sheet], while this one breaks down the visits to each detail," Rowell notes. "It prevents you from getting the wrong blood code or not doing an eye exam when you should."
Coordinators probably use it most during the first few patients of a study, so it’s as much a training tool as anything else, he adds. "Also, if it’s done at the very beginning of a study, it will help you identify a lot of budget issues. The coordinator creates it and realizes details that will affect the budget in some way or another."
Besides the coordinator, others who will look at the flow sheet are the lab director and principal investigator, as well as some disciplines that might be involved in the study, including respiratory therapy or exercise therapy, Rowell notes.
Typically, the flow sheet runs from two to six pages, and the template is available to all staff, Rowell adds.
It includes the different titles, numbers, protocol versions, principal investigator, coordinator, complete contact list, per-visit activities for the study; and it’s updated and revised if the protocol changes of if something is not working as it should, he says.
• Source document identification tool: This tool lists the first place where any piece of information is written, Rowell explains.
"The first recorded information can be a lot of different things," he adds. "It could be what the doctor wrote in a note in the chart, the lab report, the automatic printout of blood pressure."
Verification of these is extremely important when site monitors arrive to check case report forms against source documents, Rowell says.
"If your source documents are on several different pieces of paper, it’s good to identify that upfront," he notes. "So we devised a sheet that just lists all the different information and where it’s kept."
For example, the source document identification tool may list a wide variety of documents, Rowell says, including the following: hospital records, clinic and office charts; lab notes, memoranda; subjects’ diaries, subjects’ files, and dispensing records; recorded data from automated instruments; X-rays; EKGs; copies of transcriptions certified after verification as accurate and complete; microfiches, photo negatives, microfilm, or magnetic media; records kept at the pharmacy, laboratory, or medico-technical departments; IRB correspondence, sponsor correspondence, and QA records; consent forms, laboratory results, and study visit notes; electronic records, case report forms, and progress notes; physicians’ notes and nurses’ notes; flow sheets and work sheets; telephone logs; information from outside sources; nonstudy clinic visits and nonstudy hospitalizations; or pharmacy records of drug accountability.
The tool includes a document location chart with columns for whether the information has been done, for data, for what the source is, and for the location. For instance, one item under "data" might be the investigator’s agreement, which is identified under the "source" column as "signed form 1572," and its location is listed as the regulatory book.
Having a source document identification tool makes it much simpler to answer both monitors’ and auditors’ questions about documentation, Rowell notes.
Although it took a little time for staff buy-in, now coordinators can see how the tool saves them time during audits and monitor visits, he adds. Also, the tool has helped coordinators catch omissions or mistakes.
"It makes everything more consistent," Rowell says. "For example, if you take the first 50 patients and use the physician office charts, and for the next 50, you go back and use hospital medical records, you may be missing a certain amount of data that you collected on the first 50 patients, so they’re not consistent."
By using the tool, the coordinator identifies from the start, which sources will provide the necessary data, and those sources are the ones used throughout the trial, he says.
• Risk management tool: This tool is used to analyze everything involving a study to assess whether it was a good study for the research site, Rowell adds.
The tool includes budgets and whether the study made or lost money, as well as how the study scored on feasibility and whether the principal investigator did well or poorly on enrollment, he says.
"Did the sponsor respond to your needs? Do they ask for extra things?" Rowell asks. "Did the coordinator spend more time than anticipated?"
Enhancing postmortem
The tool gives research administrators an opportunity to look at every aspect of the study with regard to risk management, and it provides details and data to the typical study postmortem session, he notes.
"Say you did a session on a cardiology study with a certain doctor and sponsor, and the sponsor brings you another cardiology study," Rowell says.
"You can go back to the risk management tool and identify the problem areas, like you may need two coordinators instead of one," he adds.
Or if a principal investigator says he would like to do this study and expects to enroll 20 patients, then the risk management tool completed after his last study in this area would tell the clinical trial office whether it’s likely the PI will enroll that many subjects, Rowell explains.
"You may say to the PI, You only enrolled 10 patients in the original study, so don’t count on 20 for your budget,’" he says.
"As you collect this information over the years, you have data on PIs, including who’s a great enroller and who you have to beep four or five times to get him to see the patient, and you identify all the information for future studies," Rowell notes.
"It’s an electronic tool, and it includes every aspect of information you would use to evaluate a study," he says.
"Each site may do a different version of it, with some not collecting sponsor information, thinking this is not important, and others not collecting physician information because they only work with one doctor," Rowell adds.
One way for clinical trial sites to optimize performance, improve compliance, and ensure best practices is to use clinical trial tools to systemize certain operations, including handling the protocol, identifying source documents, and managing risk.Subscribe Now for Access
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