CR sites increasingly have to make their own source documents
Here is advice on how to do so
Clinical study sites are carrying a greater part of the compliance burden these days as sponsors increasingly are shifting responsibilities their way such as the task of making source documents, an expert says.
"For years the sponsor supported us in making source documents and providing them to sites," says Cindy Mendenhall, CCTA, clinical research coordinator at Evergreen Healthcare in Kirkland, WA. Mendenhall also is the founder of a consulting firm called CRC Services that focuses on clinical research.
"More and more lately, sponsors have stopped making source documents because they don't want to get blamed for missing something," she adds. "So as sites we need to make source documents ourselves."
The U.S. Food and Drug Administration (FDA) has certain rules about source documents, and one is that research sites should not simply use copies of case report forms, she says.
"It's not good clinical practice," Mendenhall says. "Your source document needs to have some sort of change, whether it's adding in time or something else; you have to change it a bit and not copy the case report form verbatim."
Mendenhall offers these tips on how to create or improve source documents:
Determine every documentation detail: For example, a study on hypertension might say that subjects have to be sitting for five minutes prior to doing their blood pressure test, Mendenhall says.
"That needs to be documented," she says. "If the FDA auditor comes in and looks at the chart, how will the auditor know you've been doing it if it isn't written down?"
Everything that is done on the study needs to be documented, and so the source document needs a space for recording when these were done.
"This includes inclusion/exclusion criteria," Mendenhall says. "If the principal investigator (PI) says, 'Yes, this subject meets all inclusion/exclusion criteria,' then you have to write down the time the PI signs off on it and says the subject is okay to screen."
The signature with a date proves the inclusion/exclusion criteria was checked before study randomization occurred.
Other details include dating when the subject last took the study drug and what time the subject last ate, in the cases of fasting lab work.
Keep synchronized clocks: "Time is a key factor when making FDA-friendly documents," Mendenhall says.
Clinical trial coordinators should jot down the time they perform each procedure or part of the protocol. To make certain their time is in synch, trial sites should have synchronized clocks, she adds.
"Use the same clock source you've been using throughout the entire day," she says. "We had a phone in our room and used the time on the phone."
Even if clocks are off by a few minutes, it can make a big difference in a clinical trial, Mendenhall notes.
"In our standard operating procedures (SOPs) it says the clock on the phone in every room must be used for every documentation, and all of the phones are synchronized," she says.
Mendenhall puts reminders on the phones in the form of bright orange Post-it® notes that say, "Document the time."
Staff will forget about this, so CR sites should train and remind employees to document time, using the synchronized clocks.
"Retrain and remind," Mendenhall says. "You hope you wouldn't have an FDA audit, but it's always a good idea to make sure people are trained properly."
Check protocol events table and lab manual: One best practice in creating a source document is to use the protocol events table, which lists some of the procedural details.
"Get the general schematics and minor details, all of those nitpicking things out of the protocols," Mendenhall says. "Look at the lab manual and list the tubes used, capturing all lab draws."
It's best to go through the events table, examining each visit's procedures and then add these to the source document.
"The lab manual is self-explanatory," she says.
These items should be listed on the source document in the order in which the labs need to be drawn, so they'll be easy to document.
"I make a lot of check boxes as reminders," Mendenhall says. "So you don't need to know this one needs a cold centrifuge."
Having this information on the source document makes it easier for CR coordinators to remember what comes next and saves them time from having to go to the lab manual for the details, she adds.
While sponsors often did not provide that much detail on source documents for sites, it's a best practice idea for sites to add more details to the documents they create, she notes.
"It's a nice practice to make sure you've covered yourself and have not forgotten something," Mendenhall says.
Add reminders and use checklists: "At each place where someone might forget something, add a reminder," Mendenhall says. "Put these in the order that you'll do things, so the informed consent should be prior to doing any procedures."
If a study has a questionnaire for subjects to complete before their vital signs are taken, then the questionnaire should be listed first, she adds.
Also, checklists can help with source documentation and completing case report forms.
CR coordinators should write progress notes, using checklists, and recording every subject visit and activity.
"It's a little time-consuming, but it's definitely worth the effort because it makes for faster and easier monitor visits," Mendenhall says.
The progress notes should be kept at the front of the source document binder, she adds.
"Show that you took extra time to initial items," Mendenhall advises. "Write things, such as the subject was given plenty of time to review informed consent and that the subject was given a copy of the informed consent document."
Mendenhall has a time-saving, informed consent discussion tool that includes lines to document the date and time of the IC discussion, as well as the names of people present and their relationship to the subject.
The tool also asks a number of "yes" or "no" questions, including these:
- Were questions from the subject and family, if present, encouraged and answered?
- Were all questions resolved?
- Were there any outstanding issues at the end of the discussion?
- Was the subject given adequate time to read, review, and consider the entire informed consent form?
- Did the subject agree to all protocol-required tests, procedures, and follow-ups?
- Was the subject given a copy of the signed informed consent form?
- Was the informed consent form signed by the subject prior to performing any study procedures?
- Did the subject agree to all protocol-required tests, procedures, and follow-ups?
- Does the subject understand possible risks and side effects of being in the study?
- Were alternative treatments (besides being in this study) discussed with the subject?
- Keep source document material together: "Buy gallon-sized plastic bags and put everything in that bag as they're needed for the next visit," Mendenhall suggests. "Include sticky pads, phlebotomy lab tubes, source documents, and even a binder."
This keeps the study visits running smoothly.
"If you do this for each patient on the day that you've made an appointment for the patient, then it's done and you don't have to think about it a month later," she adds. "You can store these on the shelf where the binders are kept."
Clinical trial sites that improve their source documents likely will find that monitor visits and even the day-to-day study operations become more efficient and faster, Mendenhall says.
Creating source documents will take some upfront time, but it will result in time saved over the long run, she adds.
"Everything you need is in one spot," Mendenhall adds. "I can do a moderately busy visit with EKGs and blood draws in 30 to 45 minutes versus 1.5 hours, so it cuts my time in half by being more efficient and creating source documents."
Clinical study sites are carrying a greater part of the compliance burden these days as sponsors increasingly are shifting responsibilities their way such as the task of making source documents, an expert says.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content