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Wheel reinventors take note: A compliance tool
Guide investigators with great templates
Research organizations increasingly provide guidance to investigators, assisting them with compliance and regulatory documentation, but typically they leave the Good Clinical Practice (GCP) training to sponsors and others.
However, one large research organization has developed a GCP compliance program that helps investigators learn everything they need to know about regulations, best practices in protocol development, and compliance. And investigators are trained through use of carefully-developed protocol tools.
"We wanted to help investigators so they're not reinventing the wheel each time," says Gregg J. Fromell, MD, executive director of the office of human research at the University of Pennsylvania School of Medicine in Philadelphia, PA.
"Good Clinical Practice guidelines are a lot more specific about the elements of protocol," Fromell explains. "So it's not just a document that defines science and methodology; it's a game plan for the whole trial no matter who you are."
The research office provides tools to assist principal investigators (PIs) with building their regulatory binders.
"These are the documents you need to collect before beginning a study," Fromell says. "It's every possible document the FDA would want you to store."
These include personnel qualifications, curriculum vitae, IRB submission and approval documentation, tracking logs, enrollment, among others.
"You can take the standard administrative file template and remove sections that don't apply," Fromell says. "This keeps the investigator better organized."
And the regulatory binder can be used by others at the research site when the investigator is on vacation or leave.
This type of tool should be made available electronically, perhaps even Web-based, he suggests.
While investigators typically do their best in creating a GCP-compliant protocol, the process is more time-consuming and inefficient than is necessary. So the University of Pennsylvania's research office has developed a protocol template that guides them through the process.
The university's research office was opened in 2001 with the mission of oversee and audit research projects and ensure studies are operated according to regulations, Fromell says.
"We teach investigators and coordinators how to manage research studies in a compliant way and how to understand regulatory requirements," he adds. "We have tools to help train and teach people."
The tools are a small, but important part of compliance, he notes.
"It sounds simple, but its impact is huge," Fromell says. "IRB reviews are easier and quicker because everyone can find everything they need."
The tools include a template for writing a protocol, study administrative file templates, including sample correspondence, study documents, study tracking logs, research personnel
information, protocol evaluation checklist, and others.
Correspondence, tracking logs, et al
For instance, the study administrative file for a drug study contains a table of contents with
the following categories:
- IRB correspondence;
- Penn reviewing committees;
- Sponsor/CRO correspondence;
- General correspondence.
* Study documents:
- Informed consent & HIPAA authorization;
- Case report from sample;
- Investigator's brochure;
- FDA Form 1572;
- Laboratory documents.
* Study tracking logs:
- Subject logs;
- Adverse events;
- Investigational product accountability;
* Research personnel:
- Curriculum vitae and licenses;
- Signature and delegation of responsibility log.
Little training needed
The protocol template is a long, detailed document that covers every facet of a protocol. However, the template itself is self-explanatory, and all investigators have needed is assistance in navigating the software, he says.
"When we launched this six or seven years ago, we thought we'd have to train them about the content's different elements," Fromell says. "But the guidance language was so obvious and straight-forward that they instead asked if we could train them on how to get Microsoft Word to alter that self-generating table of contents."
"Any time there's a regulatory change at the Food and Drug Administration (FDA), we go back to the template right then and make changes," Fromell says.
At 16 printed pages, the empty template roughly is the size of a modest study protocol, and there now are separate templates for device studies and drug studies, he says.
Use of the protocol is voluntary, but increasing numbers of investigators have been using it, Fromell says.
"When we first introduced it very few people were using it, but now it's very common," he says. "When we do audits we typically see quite a few of them."
The second year after the protocol template was launched, a study coordinator called the research office, expressing concerns about being asked by her PI to write a protocol that the PI would review, Fromell recalls.
The coordinator received protocol training and used the template as she wrote a protocol that eventually was submitted to the IRB for review, he adds.
"The PI told her to not worry because the IRB would mark up the protocol, so she shouldn't take it personally," Fromell says.
But to everyone's surprise, the IRB had only two comments about the protocol, he adds.
As the story spread around the unit, more investigators and CR staff were sold on the idea of using the protocol template.
Studies that have used the protocol typically can be audited more quickly and efficiently, Fromell says.
"The protocol is one of several tools designed to help people get the job done," he says. "It sells itself: it's a tool that helps people gain a better understanding of compliance, and it's flexible so it fits everyone."
Another GCP tool is the university's protocol evaluation checklist, which is an assessment of inclusion of GCP standards and regulatory requirements.
The three-page checklist has 16 sections with checkboxes next to items that need to be included in the protocol. For example, here are the items in the section on the statistical plan:
Sample size determination (for multicenter studies, include planned number of subjects to be enrolled at each trial site);
Description of statistical methods including level of statistical significance to be used;
Criteria for termination of the trial;
Method for accounting for missing, unused, or spurious data (if applicable);
Procedures for reporting deviation from the statistical plan;
Subject populations for analysis (e.g. all randomized subjects, all dosed subjects, all eligible subjects, all evaluable subjects).
The research office provides all of the tools through an electronic download at no charge to investigators, Fromell notes.
"They can print it themselves or order it on-line in a preprinted and packaged version," he says.