One-stop shop web site provides CR sites with tools, templates

Content offers raw materials

Clinical research sites in the process of revising tools or forms might find a new web site, funded by the National Institutes of Health (NIH) a useful place to begin the process.

Called CTNBestPractices, the web site was created three years ago at the Duke Clinical Research Institute (DCRI) in Durham, NC. A study coordinator advisory committee, consisting of 10 coordinators representing nine research sites, met twice a month to identify content for the web site, says Buddy West, webmaster of CTNBestPractices and a clinical research communications specialist at DCRI.

The committee designed the page and content and provided their own tools, which were revised to be more general, he says.

"The study coordinator advisory committee tries to get together twice a month to review the content we have posted and look at new content and improve it, edit it, and discuss it," West says.

Initially the web site was launched in March, 2005, at a meeting of the American College of Cardiology (ACC), West says.

"We presented it at an investigator meeting of ACC, and they used an audience response system to get immediate feedback during the meeting," he explains. "With the feedback, we overhauled the web site dramatically."

The web site now features a variety of assistance for clinical research professionals and sites.

"We wanted to provide a lot of tools for people new to research," West says. "It's difficult for them to find out more about clinical research and processes, and this provides that background."

If web site hits are any indication, the project has been a success: It had nearly 12,000 hits in September 2007, and the average daily count has increased to more than 400, West says.

"It's increasing dramatically," he says.

All but 20% of the site can be accessed without registration and a password, West notes.

"That's part of the web site's success," he says.

Frequent updates and additions

Another reason for the web site's popularity might be its dynamic nature. The web site is continually being updated and added to.

For instance, there will be three new modules added to the essential regulatory documents web page in early 2008. These include a module on device studies, a module about federally funded studies, and a module about Canadian regulations, West says.

"Our newest edition to the web site involves central regulatory documents," West says. "It talks about sponsors' responsibilities and investigator responsibilities."

As new programs and modules are added to the web site, they make use of improvements in design and technology.

For example, the latest modules permit a participant to click on a link to the precise page he or she desires, rather than forcing them to scroll through the program, one page at a time, West explains.

Unfortunately, there aren't enough resources to revamp the existing modules and provide the same luxuries, he says.

"We have to cut our costs, so while it'd be wonderful to go in there and put in that new format, it would take more money and time," West says. "We'd rather put more money on expanding the web site."

The education and training section includes some modules and some links, such as:

  • Building a successful research site;
  • Clinical research introduction;
  • Clinical research writing;
  • Essential regulatory documents;
  • Evidence-based medicine;
  • Human research subject protection; and
  • Therapeutic area training.

"The second biggest area we've worked on, and I've focused on this area, is the clinical site resources, where we provide templates and tools that coordinators need every day," West says.

"Most of the templates came from the committee members' sites," West adds. "We first took out any site-identifying information and made them generic, and then we focused on the content itself."

The web site's clinical site resources include:

  • Adverse event/serious adverse event sample forms (see AE/SAE chart, below);
  • BMI table and calculator;
  • Budget tools;
  • IRB facts and functions;
  • Master subject log;
  • Materials readability;
  • Pre-study activities checklist; and
  • Suggested site standard operating procedures.

A library link contains this information:

  • Acronyms, abbreviations, initials;
  • Clinical study terms;
  • Links;
  • Presentations;
  • Publications/articles; and
  • Site personnel profile library.

There's a best practices forum where coordinators and investigators can share information and best practices, West says.

The best practices forum includes these links:

  • Add/edit your profile;
  • Share our site with others;
  • Share your best practices;
  • Provide your feedback;
  • Meet our principal investigator; and
  • What is CTN Best Practices?

The web site also provides links to various other resource web sites and research institutions.

Under a hot topics link, there are topics addressed at investigator meetings.

Some of the site's most popular features were a complete surprise.

"When we first posted temperature conversion charts, which I assumed every site could get their hands on quickly, we had 400 to 500 downloads on it in the first month," West says. "That was a surprise, but when I tell study coordinators this, they have nodded their heads knowingly."

Adverse Events and Serious Adverse Events

Exploring alternate funding

The web site's popularity will ensure that it has a future even when the NIH money runs out next fall, West says.

"We will be an operation under this name and contract through Sept. 30, 2008," West says. "I always get the question of whether the web site will end, but there's no way the web site will end."

DCRI will explore different options in funding and continuing the web site, he adds.

"My personal favorite option is if several academic research organizations (ARO) would band together and support it financially," West says. "Representatives from each ARO could have a study coordinator on an advisory committee that continues to broaden content and improve content."

One of the goals is to provide one-stop shopping on the web site, West says. "We would like everything you need for research to be in one location," he adds.

For instance, the upper right hand corner of the site's home page has a link where CR sites can submit profiles and find information about available studies.

"They have a list of clinical trials currently en-rolling sites," West says. "And there's a link where they can indicate their interest in those trials."

Right now that service is limited to DCRI studies, but it has already proven useful, West notes.

"We've recruited some good sites that otherwise might not be a part of our trials," he says. "It's a pilot project until Sept. 30, and we've had about 120 people enroll in the program since we unveiled it around April 1, 2007."

This service could be expanded, and the web site also could serve as a repository for repetitive CR information, such as an investigator's curriculum vitae (CV) and other site biographical information, he says.

If this occurs, then investigators and CT administrators won't have to fax over every CV and other general information each time they are negotiating a new study contract.

These possibilities and others would make the web site a time-saving tool for CR sites.

"I hope the web site will be the place every clinical site would go to for anything involving their research efforts," West says. "So they wouldn't have to hunt around."