Avoiding little mistakes — and bigger problems
Avoiding little mistakesand bigger problems
Date and document all notes
In clinical research documentation, the little things definitely count and often could lead to major regulatory problems.
Clinical research investigators and staff sometimes have habits and processes in place that could lead to regulatory audit findings and problems. And these might have been prevented by some simple changes, says JoAnn Jessen, president and principal consultant of Pharma Compliance Partners in Lindenhurst, IL.
Jessen offers these brief tips on how to prevent regulatory problems:
Notes to file: "Sites should not use 'notes to file' frequently because these can be seen as a red flag to an FDA inspector," Jessen says. "I've seen cases of clinical research associates not knowing how to deal with issues that arise, and so they just write, 'notes to file' to explain it all."
But when this becomes a habit, and documentation includes too many of these then it's a problem, she adds.
"It's a better idea to document explanations in the subject's source document," Jessen says. "Or if a site's policy differs from the sponsor's protocol then a general note to file that would cover all study conduct should be written."
Jessen recommends that sites be very cautious in how the notes to file are written: "Make sure they are dated, and make sure you document issues when things happen."
Date stamp informed consent forms: Typically there's a lag time between when an informed consent document is revised and when it's fully approved by the IRB.
"So it's a good practice to document the date with a date stamp when the document is received from the IRB so that it avoids problems down the road," Jessen says. "If the site doesn't have approval from the IRB for the revised form, then it can't use the form in consenting patients until approval is received."
The minute a site receives the IRB-approved revision, that revised informed consent form needs to be used with all subjects, new and ongoing. And this is where the site could prevent auditing and regulatory issues by date stamping the revised form as soon as it's received, Jessen says.
"For example, the FDA and any sponsor auditors would be concerned if they see an informed consent form approved by the IRB on Jan. 15, but patients weren't consented with that form until Feb. 1," she explains. "They would wonder why it took a site 16 days to use that revised form and may conclude the site was out of compliance."
But if the site can produce the revised IRB approved form with its date of receipt stamp, then regulatory officials and sponsor auditors are appeased.
"Without documenting the date of receipt, it can look like you were using the wrong version of the form," Jessen adds.
Likewise, sites should ensure those date stamps are correct. If a site stamps the wrong date on a form, such as a date with the wrong month, then this also could raise regulatory red flags. Also, the IRB sometimes might stamp the wrong date indicating when an informed consent form was approved, and this could cause the site regulatory headaches.
Jessen saw a case where the research site received a revised IRB-approved informed consent form that was stamped by the IRB with the wrong year: 2009 instead of 2010.
"You should review documents received from the IRB carefully and notify the IRB immediately if there's a mistake and have them correct the date and send the new consent form," Jessen says. "Also, document the conversation you had with the IRB office."
In clinical research documentation, the little things definitely count and often could lead to major regulatory problems.Subscribe Now for Access
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