Scan. E-mail. Re-scan. Set weekly reminders.
Scan. E-mail. Answer questions. Resend e-mail.
Defend self, stating that the documents have already been scanned and e-mailed.
Re-resend e-mail anyway.
I had occasion for the past few months to return to where I started in research—being a clinical research coordinator (CRC). It is the job that holds the entire site operation together.
Coordinating is, indeed, what a good CRC does best. For every trial under their domain, CRCs coordinate the patients, investigators, sponsor representatives, regulatory authorities, and data managers. At larger sites, such as hospitals and academic medical centers, add to this coordination of the laboratory, patient schedulers, pharmacy, and quality assurance personnel.
I have always held great respect for high-quality CRCs because they are the unspoken heroes of most sites and many trials. Returning to such duties after six years in management, though, forced me to recognize that the amount of wasted time is…what’s the technical term?…mind-blowing.
The Solution Presents Itself…
More patients could be enrolled, protocols better attended to, trials covered per CRC, and profit margins improved for sites and sponsors alike if the industry committed to doing what every other service industry has done—get off of paper!
My calendar looked like this, and the example is from only one trial (let’s be honest, no CRC ever has only one trial):
- Every Monday: Scan and e-mail the pre-screening log to Person A.
- Every Tuesday: Remove the drug accountability log from each subject’s binder individually, then scan and e-mail the logs to Person B. Re-file each log.
- Every Wednesday: Remove the patient questionnaires from each subject’s binder individually, then scan and e-mail the logs to Persons C and D. Re-file each log.
- Every Thursday: Scan and e-mail the screening log to Persons A, D, and E.
- After enrollment: Print digital imaging files in color and de-identify each page three times (because that’s how many places the subject’s name is noted). Scan the de-identified files to a USB drive. From a computer, compress the file due to size, so it can be e-mailed all at once, or split the file into multiple parts and multiple e-mails.
- Also after enrollment: Complete an enrollment form. Scan and e-mail it to Persons A, C, D, E, F, and G (not kidding).
- Re-scan all patient questionnaires (Wednesday’s task) because Person C claims not to get most of them. It is entirely without exaggeration that I tell you that this singular trial cost me two hours per week in scanning, e-mailing, and re-e-mailing. Another hour or more would be added per enrollment. I assume the workload was similar on the contract research organization (CRO) side.
Let’s Think This Through
Does this seem logical? How can we be scientists and be this illogical and redundant in our processes?
Pre-screening and screening logs can be entered into an online system just as easily as they can be entered on a paper log, but with the benefit of real-time review. This is also true for drug accountability logs—and what is especially odd about having to e-mail these is that the data have already been entered into the electronic data capture (EDC) system by the time the weekly deadline rolls around.
The patient questionnaires are likewise already entered into the EDC. Electronic source documents would help even more, but the site cannot implement its own electronic source documents because the sponsor insists on use of its specific paper form. The enrollment form also has to be the sponsor’s paper-based form, even though all of the information summarized on the form comes from the screening visit data that are in the EDC.
Which Leaves Us With…
Until sponsors and CROs allow or foster electronic source documents, and until they utilize the data in EDCs for more than just data analysis, we as an industry will always be underperforming compared to our potential.
Christine Senn, PhD, CCRC, CPI, (firstname.lastname@example.org) is the chief implementation officer and a member of the Quality Assurance and Compliance Committee with IACT Health in Columbus, Ga.