Integrated systems keep all connected

Software reduces paper trails

It’s pretty much a given that computer-based recordkeeping will play a part in a clinical trial. Someone, somewhere, has at the very least created a database to track protocols, participants, and IRB requests. In recent years, however, institutions have recognized the need for more integrated systems — those able to lessen paper output while enhancing the flow of information between investigators and IRBs. Clinical Trials Administrator is taking a look at three such systems. These web-based applications are designed to streamline the protocol submission and IRB review processes.

Baylor uses its BRAAN

Two years ago, Baylor College of Medicine had a dilemma: Double its staff to accommodate the increase in study protocols being submitted to its IRB or find an electronic solution to its problem. BRAAN, the Baylor Research and Assurance Network system, was born.

Developed by end users, BRAAN is a web-based application that allows investigators and IRB members to do everything from submitting protocols to tracking and reviewing studies on-line to training investigators on human subject protections.

The application is menu driven, providing pull-down selections for users in every aspect of protocol creation, submission and review. From the home page, administrators and investigators can select the appropriate path — animal or human protocol, existing or new protocol — and they then will be directed step-by-step through the program to supply information that must be included in the protocol application.

BRAAN is divided into sections, with each containing questions or prompts designed to gather pertinent information about the protocol. For example, investigators creating a new protocol must answer questions such as "What is the purpose of the protocol?" or "Will research data be tied to individual’s names or record number?" They also will be asked to provide specific information on inclusion and inclusion criteria, sample size, potential risks or discomforts, and consent procedures (e.g., who will be recruiting subjects, how research population will be identified, and how consent will be obtained). Investigators can generate a preliminary informed consent form that contains autopopulated information provided in previous answers.

Required fields, such as risk categorization or a series of questions to determine whether a protocol qualifies for expedited review, are highlighted in red. The system will not allow investigators to move forward if those fields are left blank. There also is a "Review for Completeness" section that will list areas that require more information before submission.

If investigators would like to use information from an existing study, they can select the study from a drop-down menu, and all pertinent information will autopopulate in upcoming screens. Investigators then may revise or update autopopulated fields as they go along. Additionally, personnel information can be autopopulated with data provided by the human resources department.

IRB administrators can use the program to schedule meetings and report findings using templated memos. IRB board members can access protocols on-line and provide comments that can be viewed later by investigators.

"One example of a BRAAN feature that has made life easier is as an investigator, I have access to the protocol and all documents related to the protocol," says Addison Taylor, MD, PhD, associate dean for clinical research at the Houston-based medical college.

"These are stored on-line and can be printed for regulatory authorities or clinical monitors wherever needed. Also, as an IRB member, I can now review protocols off-line by downloading them to my laptop for review away from the office. I can access protocols from anywhere in the world as long as there is Internet access."

BRAAN contains education modules on research ethics; investigator responsibility; the role of the IRB; and special topics, such as informed consent and scientific integrity.

The application won the 2002 Award for Excellence in Human Research Protection given by the Bethesda, MD-based Health Improvement Institute and sponsored by the Office of Human Research Protections.

For more information about BRAAN, contact API, 167 W. Main St., #210, Lexington, KY 40507; Telephone: (859) 233-2006; web site: www.api.md.

ImedRIS: Something for everybody

One of the challenges facing Texas Tech Medical Center several years ago was to start a clinical trials office that covered four academic health center campuses, located long distances from one other.

"We had identified that we would have to have some way to try and communicate from the business side with the clinical trials office here," says Stacey Pugh, RN, BSN, CCRC, director of clinical services in the clinical trials office of Texas Tech Medical Center in Lubbock.

"We made attempts at developing internal clinical trials software, but we didn’t have the expertise to take it to the next level," she recalls. "We started on a quest, and we have searched out and talked with every clinical research system or software system that’s out there for the past two years."

Then last year, Pugh met with representatives from iMedRIS Data Corp. of Yucaipa, CA.

"When we looked at their study assistance software and were looking at it from the patient management side, we thought their study assistance was far superior," she reports. "We knew we had to have an IRB component. We met with iMedRIS a few times and communicated by telephone; and the next thing we knew they were providing us with a product that allowed us to go to an electronic, virtual IRB," Pugh says. "That completely addressed our compliance program and systems program."

The iMedRIS product marries the site management piece with the IRB agenda, says William Schroeder of iMedRIS, which stands for Internet Medical Research Information Systems.

Pugh says the result of the cooperation between Texas Tech and iMedRIS has been a software system that is efficient and integrates every aspect of research management — from compliance to data collection. The application has these features:

Site assistant: This provides the ability to manage all aspects of clinical studies, including patient data, study information, visit tracking, screening, etc., and incorporates data from individual clinical visits.

IRB assistant: Site activities are directly integrated with the IRB. Meeting agendas are built from requests to the IRB, and this in turn results in automatic records attendance, voting results, and meeting minutes. Any meeting outcome is sent electronically to study coordinators, and all pre-meeting study information is available to IRB members.

Contract assistant: Negotiations between an institution and sponsor are recorded throughout the process.

Compliance assistant: Study audits are performed, and the software ensures compliance.

"We have found that by developing the software with Texas Tech, that this is a software that’s available for multiple sites with everything flowing automatically right to the agenda for the central IRB," Schroeder says.

Integrating a new software system is not easy, but the cost and effort can be worthwhile, Pugh says. "It has been a real struggle for us to get to this point, but we just made a light-year transformation here," she says. "A year ago, if someone had said, How many human subjects do you have on any protocol now?’ I would say, I don’t know,’ and I’d have to pick up the phone and ask the principal investigator how many people were on the protocol."

Now, if Pugh is asked to obtain the same information, she could ask them to hold a minute while she pulls up the report on the computer. "It’d take me all of 25 seconds to requisition that information," she says.

The financial investment was considerable, but it was money well spent, Pugh says. "It addresses so many of our problems in one fell swoop. How do we know whether we have a system oversight without an electronic system that ties in like this one does?"

Previously, investigators could be late in reporting serious adverse events (SAEs), and it would be difficult for the IRB to learn that this was a problem. Investigators now submit SAEs electronically as soon as they occur. The IRB has real-time data of what is going on, and the compliance officer can do audits with current information, Pugh says.

Also, the electronic documentation system allows PIs to amend the protocol as they go along. For instance, they should note how many people have withdrawn from a study each time the tally changes, and doing so is a great deal simpler than with a paper documentation system, Pugh says.

For more information about iMedRIS, contact iMedRIS Data Corp., 1960 Chicago Ave., Suite E9, Riverside, CA 92507; Telephone: (909) 784-1013; Web site: www.imedris.com; E-mail: info@imderis.com.

PRAMS saves on staff and time

Penn State University of University Park, PA, began to develop a web-based electronic documentation system in response to recent growth spurts at the same time that the university needed to keep staff growth relatively stable.

"We needed to find a way to use our resources more efficiently, and that prompted us to look at electronic data systems," says Candice Yekel, director of research protection at Penn State.

"Our hope is that this will ensure that not only will we have an efficient system within the administration, but that we can provide electronic data to investigators who are submitting and provide more efficiency within the review process," she explains.

The university stands to benefit a great deal from the university’s homegrown electronic documentation system, which is called Protocol Review and Approval Management Systems (PRAMS). PRAMS development began March 2001, says Kenneth Forstmeier, director of the office of research information systems. By March 2002, PRAMS was rolled out in its first phase. Other institutions will have an opportunity to purchase and use PRAMS, which is being marketed by ERA Software Systems of Monterey Park, CA, Yekel reports.

"The application we developed is not only for the human side of things, but for all protocol types used at Penn State," Forstmeier says. "So we had to bring in data from five different regulatory systems and bring these into the new applications."

Yekel and Forstmeier offer these details about how PRAMS works:

• Eliminates most paperwork. The paperless system will eliminate the need to send paper documents to IRB members, who simply will log onto the system and see protocols ready to review, Forstmeier says.

"All of it will be stored electronically — all records — and any documentation that comes in," Forstmeier adds. "We’ll receive paper from time to time, and those records will be scanned into the system and indexed and placed in a nonvolatile storage where it will be available for audit in the future."

Protocols may be submitted and reviewed electronically. There are up to 3,000 protocols that the university tracks at any time, and the Hershey Medical Center, which is within the Penn State system, also has 2,500 protocols to track, Yekel says.

With PRAMS, the computer will search the protocol database for expiration dates, find e-mail addresses for investigators who have studies that are about to expire, and send them a notice via e-mail along with a form they’ll need to complete, she notes.

"When the expiration date arrives and nothing has been received or entered in our system, PRAMS will prepare a report that says the following protocols are set to be inactivated," Yekel adds. "It’s just a matter of pushing a button. We see this as a big plus in making sure we’re not missing deadlines."

Principal investigators also are able to submit their protocols electronically. "We’ll do a distribution of protocols electronically," Forstmeier adds. "And the other thing the system does do is audit all transactions, so as things change, we know who made the change, when, and so on."

This way, the system keeps track of what went wrong in the event something doesn’t work, and the electronic data can be used to figure out which areas of business processes need to be bolstered with more resources and changes, he says.

IRB and research training and other data electronically tracked. PRAMS will track adverse events and whether investigators and IRB members have had the required training and when the training expires.

A list of training credentials will appear with the principal investigator’s name, and this information can be updated when people receive new training or continuing education credits, Forstmeier says.

The system will load data into the protocol application rather than having someone reload the entire protocol with the updated information, he adds.

With more than 9,000 faculty, staff, and students conducting research at Penn State, this electronic ability to track their training will save the university significant time and money over the years, Yekel says.

• PRAMS will cover all research and regulatory information. Another unique feature of PRAMS is that it will cover all human subjects research, as well as all research involving biohazard materials, animal use, regulatory changes under the Health Insurance Portability and Accountability Act, and conflict of interest issues, Yekel says.

"This system is built to integrate all of those areas," Yekel says. "We keep data on animal use protocols and biosafety information. What’s neat about the system is if I have a human subjects protocol that involves some pathogen, then this system will alert me to that issue."

The system also will provide continuous documentation from a study’s in vitro and animal trials, following the study as it moves into the arena of human subjects research.

If an IRB member or coordinator would like to learn more about a particular investigator who has not conducted human subjects research before, but will soon start, then it would be easy with PRAMS to call up that investigator’s name and learn about all of the investigator’s animal research, use of biohazardous materials, training, and funding, Yekel says.

For more information about PRAMS, contact ERA Software Systems, 1255 Corporate Center Drive, Suite 305, Monterey Park, CA 91754; Telephone: (323) 980-4900; e-mail: dianne@erasoftwaresystems.com.