Managing CT offices: delegate and train
Provide strong investigator oversight
Regulatory authorities in both the United States and Canada have been focusing on investigator oversight, an area in which clinical trial sites could have serious issues if their documentation is lacking.
"Investigator oversight is a focus of both the FDA [Food and Drug Administration] and Health Canada," says Jacqueline Busheikin, RN, CCRP, president of JANA Research Corporation in Calgary, Alberta, Canada. JANA Research is an independent clinical research consulting/monitoring organization.
"What I've done is go in and look at the documentation and processes at the site to see if it's possible to assess investigator oversight," Busheikin says. "In some cases, the problem is not that investigators are not overseeing trials, but that documentation is not there to show they're doing so."
Busheikin offers this advice on how clinical trial sites can improve their management and documentation of investigator oversight and other issues:
Delegation and training: "One of the biggest issues is investigator delegation and training," Busheikin says. "Investigators at times delegate too much responsibility to other team members, particularly with their team members not being qualified to conduct those processes."
Also, sites that provide training might not document it clearly.
"That's a major issue, and you have people doing things they do not appear to be qualified to do," Busheikin says.
For example, a study coordinator who has an engineering educational background and who has had no or limited clinical research training might be expected to take a subject's blood pressure.
"That person is collecting medical information without the appropriate qualification or training in how to do it," Busheikin says.
Another example might be a small CR site in which an office manager or assistant is moved into a study coordinator position and is dispensing medications, despite the person's lack of a medical background, she adds.
"Those are the kinds of things that regulators are looking at," she says. "Research sites need to be aware of the requirements, qualifications, and training needed for particular procedures."
Research sites also need to be more familiar with the actual protocol and the procedures that will be required.
"Be cognizant of what qualifications are required for those procedures and be familiar with your staff so you'll know what employees are trained to do and whether they need support training," Busheikin says. "That's a big issue in terms of sending experienced staff to training courses, providing continuing education."
Clinical research sites need to ensure that their staffs are qualified to conduct all necessary procedures, and if they should document all training employees receive, she adds.
Investigator oversight: "Investigators need to be more aware of what the concept of oversight is so they are actually looking at more aspects and details of a research protocol and conduct of a research study," Busheikin says.
The key is to practice and document, she adds.
"Pay more attention to ensuring all patients are eligible in all aspects of a trial and that all procedures are done when they're supposed to be done for a protocol," Busheikin says. "Document what you're doing more robustly and make it clear you're participating more actively in a trial."
One solution might be to use checklists when documenting activity, but Busheikin advises against relying solely on these.
"Good documentation practices include narrative, as well as checklists," she says.
"People have to be cautious because we have a tendency to use checklists without checking them," she says. "They won't meet all the requirements of good documentation, so sites need to develop processes that will ensure that they are aware of all aspects of what needs to be done and then document these more fully."
Another strategy is to develop worksheets for study protocols. These can detail every procedure and the level of oversight necessary for each.
Documentation narrative: A documentation best practice is to provide a narrative.
"Documentation for the conduct of a study needs to tell a story," Busheikin says. "In many cases, just answering 'yes' or 'no' doesn't give us information, just an outline."
There should be some background to support the information that's given, she adds.
"The purpose is not to recreate data that is collected but to recreate the environment and scenario," she explains. "There should be some context, and this sometimes requires a narrative and not just a checkbox."
The investigator or study coordinator should add information about how the procedure was conducted and why it was done a certain way, when it was done, and who did it, Busheikin says.
If a site has electronic documentation, then the electronic form could include a prompt that requests a narrative instead of just listing 'yes' and 'no' questions.
"A lot of times information is provided by pharmaceutical or device sponsors so tools are provided by the sponsor," she says. "This is fine in the sense that the tools should ensure that all information that needs to be collected for the trial is collected."
But investigators should keep in mind that the sponsor is only interested in a portion of data investigators collect for a trial, and sites are interested in broader information, including how well an individual study subject is doing in the holistic sense, Busheikin says.
"So a lot of times the site isn't collecting narrative information because they use the information the sponsor is using, and they document less fully than they need to be doing," she adds. "There's more emphasis now placed on the requirement for documentation to confirm that a procedure was done in the way the protocol described, and that it's in the right order, at the correct time, and all parts of the documentation need to be reported."
Standard operating procedures (SOPs): Documentation issues can be resolved with good preparation, and that includes having an SOP that outlines what research employees do in a particular domain.
The SOPs can also list how a site will document its activities and which data collection tools it will use, Busheikin says.
Staff should be trained how to use the data collection tools properly, and this training also could be documented.
Checks and balances: Clinical research sites can develop their own quality assurance practices by developing tools and systems for assessing quality and identifying errors or inconsistencies, Busheikin suggests.
"Have some quality checks during the study," she adds. "Periodically, someone should ensure everyone is doing what they need to do."
Quality checks can be based on regulatory requirements and good clinical practice guidelines. The person conducting the quality check should understand what exactly is required in terms of documentation, she says.
Studies with pharmaceutical sponsors will have a monitor conducting this quality check, and most monitors do a good job of this, Busheikin says.
Adverse events: Some studies still collect everything that would meet the criteria of an adverse event, even if the AE is not related to the study product.
"We have to have more clear definitions in the protocol about what will and will not be collected," Busheikin says. "Adverse events need to be defined, and sites should be familiar with the definitions and reporting requirements for their particular trial."
Also, investigators need to be the person evaluating all adverse events with respect to their relationship with the drug or device being studied, she adds.
Problems arise when the study coordinator makes the determination and the investigator may or may not review that determination, but there's no documentation verifying the investigator's input, she says.
"This is something that needs more attention at research sites because it's considered a medical decision or assessment, and it needs to be completed by an investigator," Busheikin says.
Documentation of adverse events should include additional data, such as a description of the event and the severity of the event. The protocol will have pre-defined criteria for assessing that severity, she notes.
"If an investigator feels the event is related to the investigational product because that's the information that will be provided as safety information when the product is marketed, then it's the investigator's responsibility to make the assessment," Busheikin says. "The investigator should be familiar with the investigational product from the product brochure and make the assessment based on this knowledge."