Best Practices: Crucial steps to ensure good clinical practice
Crucial steps to ensure good clinical practice
Sites not documenting 're-consent'
The first step in improving a clinical trial site's good clinical practice is to make certain all informed consent processes and documentation are followed with exacting care.
"When I conduct audits, I find sites do not do a good job of documenting the process of obtaining informed consent in their records," says JoAnn Jessen, president and principal consultant of Pharma Compliance Partners in Lindenhurst, IL. Jessen conducts audits and consults with clinical research sites about improving regulatory compliance practices.
"Even more sites do not document the re-consent process," she adds. "Often times the trial will be revised to increase the number of patients or to add more information."
The informed consent form should be updated when this happens, and then subjects should be re-consented.
"That's a process that sites often forget to document," Jessen says.
Jessen outlines these basic steps sites should take to improve their good clinical practice:
Make re-consenting systematic: When in doubt, site coordinators should contact the IRB to see if the IRB believes study participants, who have completed their role in the study, should be contacted after the consent form has been revised, Jessen says.
"There are certain black and white cases where it's obvious they should be contacted, particularly where certain safety issues arise," she says.
But in other cases it might be up to the discretion of the IRB.
The easiest time to re-consent participants is when they arrive for their study visits.
"If a subject is still participating in the trial, it's much easier to explain," Jessen says.
In this case, the study sponsor and/or study site would submit the consent form revisions to the IRB for approval and wait for approval before speaking with subjects at their next visits.
"The source document should have a record that the subject was seen for visit four where the new consent was reviewed with the subject, and the subject had time to ask questions," Jessen says. "If the subject did ask questions then those should be written down within the source document unless they're just general questions about fees for participating or things like that."
For instance, the revised informed consent might include information about how an additional blood sample would need to be collected from subjects.
"Subjects would need to be made aware of this change because that's an invasive procedure," Jessen explains. "You have to make them aware of the changes that affect their safety and overall well-being."
Notify primary care physicians of study participation: Another area that clinical trial sites should address involves notifying participants' community/primary care providers about their trial participation.
This can be a little complicated because of privacy issues.
For example, if a subject is enrolled in a hypertension trial, the clinical trial site should attempt to obtain a medical history from the subject's primary care physician, Jessen says.
"Sponsors need to ensure sites are collecting as much medical history data as possible to make sure subjects are meeting all inclusion/exclusion criteria for the trial," she explains.
"But the site can't do that without a medical release/authorization form signed by the patient," she adds. "And if they do not want their primary care physician notified then that should be documented in the source document."
Preparing source document worksheets:" A recent trend is that sponsor companies will prepare a source document worksheet that is supposed to follow the protocol," Jessen says.
"It helps to ensure a source record for every piece of information in the sponsor's database," she says. "Often, because of resource constraints, including personnel, sites will rely on the sponsor for the source documentation worksheet."
But sites have to be accountable for those worksheets and make sure they accurately reflect the protocol, she adds.
For instance, if the sponsor forgot to include one visit intervention or a lab test in the source document worksheet and then the clinical trial site forgets to document this activity, then the record is inaccurate, she says.
"Without the source document there's no way to verify that information is captured appropriately," Jessen says.
"At the beginning of the study, sites should compare the source document worksheets against the protocol, and the best recommendation is to make sure the clinical research monitor, at initiation site visit, reviews thoroughly the source document worksheet with them and compares it to the protocol," she advises.
Completing delegation of authority log: The Food and Drug Administration (FDA) is closely looking at the issue of delegation, Jessen says.
"Often, the study coordinator is responsible for making sure the delegation of authority log is completed," she adds. "But the principal investigator (PI) also needs to look at it closely because they're signing off on that delegation of authority."
PIs have to sign off on the names of people who are working on the study.
Some sponsors do a good job of writing a thorough delegation of authority log, but others lack necessary details, Jessen notes.
"For example, if a study requires certified people to perform a test then these people should be listed on the delegation of authority," she explains. "This could include the person who is in charge of applying the ambulatory blood monitoring device cuff to the patient, so the patient's blood pressure is monitored."
Also, sites are responsible for making certain that everyone listed on the delegation of authority is experienced and certified for the tasks they'll be performing.
"The FDA wants to ensure that people who have been delegated by the PI are qualified to do the task required," Jessen says. "PIs should ensure proof of professional licenses from all staff members to avoid fraud."
The first step in improving a clinical trial site's good clinical practice is to make certain all informed consent processes and documentation are followed with exacting care.Subscribe Now for Access
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