Best Practices Spotlight

Create a more efficient source document form

Start with creating templates

Be prepared' is a clinical trial coordinator's best practice motto. This means finding or creating templates that will facilitate faster, more efficient, and better quality data collection.

"Generally, the best thing to do is to try to get a copy of the electronic data capture (EDC) forms and whatever kind of template the sponsor can provide for you, and, of course, the protocol," says Deanna M. Hill, NCMA, CCRC, clinical research coordinator-2, at Emory University in Atlanta, GA.

"I like to read the protocol first because it has the extra details the EDC is not going to tell you," Hill says. This information might include the order of procedures, she adds.

From the EDC, research coordinators will find demographics and disease information.

"It's essential you get all of this information and sit down to pull it all together," Hill advises.

For this process, Hill refers to master templates, which can be tweaked for each study.

Hill describes the steps she follows in creating and revising templates:

1. Tailor existing and create new templates.

"There are all kinds of templates for medications, adverse events, and even product performance," Hill says. "You can see other templates, but you need to tailor them to your liking and your needs."

When creating new templates, research coordinators should think about which tasks they do most often in their practice, focusing on those that do not change much, she suggests.

"If you're doing different studies and keep seeing the same procedure over and over again, then you know that's something you have to recreate each time," Hill says. "So instead, hold onto the template and make sure it's the same as what the sponsor wants you to capture."

Use a coordinator checklist to see which procedures have to be done throughout the study process, including items like a physical exam. Then tailor templates to what will work best for your site and study, she adds.

"The best templates hardly ever change, needing maybe one or two adjustments," Hill says. "But they're standard."

It's also important to have the study team using the same templates, avoiding confusion.

"Whenever I make templates or put together source documents for another study or another coordinator, we all use the same template," Hill says. "So we all know independently what has to be filled out."

This is useful in the event that one study coordinator is covering for another one who is out sick or on vacation, she adds.

For each new study, research staff should review the template and make themselves familiar with the data being collected.

2. Review worksheets online.

"Look at other people's worksheets, and see how they were put together," Hill says. "Look at what looks nice on the page, what flows well, and tailor it that way."

The order and style of these worksheets are subjective. What looks nice and seems to flow in one person's opinion might need to be moved and revised according to another person, she notes.

"I put the title and sponsor and patient's name on top, and the other information is below it," Hill says. "I use boldfaced information, and any special instructions are put in parentheses next to it."

For example, Hill uses a brief enrollment visit template that is tailored to each study and visit. A sample template has these boldfaced checkbox items:

• Verify inclusion exclusion criteria

• Call [investigator] to inform [that] possible patient being pre-screened (telephone number)

• Sign consent and process form

— Make 2 copies (One for subject and one for chart)

• EKG 3 Lead

— 2 EKGs are to be obtained and measured with screening tool

• Medical history

— Complete enrollment source packet (7 pages)

• Medications

— Current medications to be completed on conmed log

• Fill out clinical trial participation form fax with consent to OCR (8-4989)

• Surface EKG recorded with each VF induction/conversion during implant

• Remind physician to order Standing P/A and Lateral Chest X-ray after implant

• Medications

— Get copy of current meds from Power chart or subject

— Pre-implantation medications taken must be recorded

— Medications given during implant must be recorded

— Medications given post implant must be recorded.

3. Put template through a trial run.

Through trial and error, research coordinators can improve their templates, Hill says.

The first patient is the next test of the study-specific template.

"The first patient is the hardest one; there's always something missing or something in it you don't need," Hill says.

These findings are lessons in editing and checks and balances.

"Look at the EDC and look at what the sponsor has given you," Hill suggests. "You think it's perfect, so you should work with it and see if it works."

Research coordinators always can make adjustments after the first couple of patients, she adds.

"Maybe there is a question that needs to be asked of the patient, and you didn't pick up on it until it's too late," Hill says. "So you can scribble that information in it."

Another good checks and balance is to ask other staff for feedback.

"They're good at giving feedback because everyone wants something they can work with," Hill says.

4. Keep template for future use.

Once a study ends, research coordinators can file and save the template they've modified for that study.

"I keep an electronic copy on my Desktop, and I make a paper copy that I keep in a binder," Hill says. "Whenever an assistant or student needs to fill a binder they can make copies and give it to everyone using the study."

Also, the completed templates are kept in patient binders and are used as original source documentation, she adds.

They can provide a ready-made template for the next study in that disease area or which uses the same patient population.

For instance, a template on demographics and medical history might be revised to reflect a study's cardiovascular focus. Hill uses a master demographics template that includes these main sections:

• Demographics, including gender, height, age, birthdate, and race

• Cardiovascular history, including etiology and atrial fibrillation use

• Coronary heart disease, listing the most recent myocardial infarction

• Prior cardiac intervention, listing dates of recent CABG or PTCA procedures

• Ventricular arrhythmia history

• Other underlying disease, including diabetes, chronic lung disease, hypertension, peripheral vascular disease, and others

• ECG diagnosis with date and measurements

• Optimization of heart failure medication, asking about Ace inhibitors and beta blockers

• Visit comments.

Hill has received positive feedback about the templates.

"Monitors seem really pleased with them," she says. "I color code the pages, and they like that."