Case Study

Survival Guide for New Study Coordinators

Organization, perseverance and a clear mind are critical.

Kathleen Dowell, CCRP

If I were ever to participate on the reality TV show, “Survivor,” I’m certain I would be the first one voted off the island. I would immediately start organizing and compartmentalizing while providing written Standard Operating Procedures (SOPs) to both teams. I’m sure my fellow contestants would not apprciate me ordering, “print your name, sign, initial and date this roles and responsibilities log so I can assign you as lead hut builder!” Such is the life of a study coordinator.

However, I wish someone had given me a field guide to survive my first time as a study coordinator. I knew the field of ophthalmology, specifically the retina specialty, from my experiences as a technician, optician, photographer and clinic manager for many years. When Visudyne and the VAM trial came along, we suddenly found ourselves shopping for a scale and an infusion pump. By conducting this trial in our clinic, exudative AMD patients now had photodynamic therapy as a new treatment option if they could be included in the study. I was excited to be part of it. My investigator was excited to be part of it. Clearly, I had no idea the increase in workload, longer hours and additional major responsibilities I was to undertake. Here is my survival guide with chapters taken directly from the US Army Survival Manual. Think of yourself like Sergeant R. Lee Ermey with a little smidge of Mary Poppins and that will give you an idea. (To all of you movie/military buffs: For the record, R. Lee Ermey was a US Marine Corp Gunnery Sergeant and not US Army.)

Psychology Of Survival

To quote Richard Gere, in his role as Zack Mayo from “An Officer and A Gentlemen” getting ready to eat in the mess hall, “Sit, adjust, pray, attack.” What I really mean is: Sit and clear your mind. Grab that protocol and start reading and absorbing. The protocol is your map and Bible for all study procedures. Forget about your routine and office SOPs for a regular clinic patient – this is not a regular patient. Prior to study start-up, your investigator signed a legally binding document called a FDA Form 1572. The FDA Form 1572 is the statement of the investigator saying he will abide by the protocol and the federal guidelines as listed in the Code of Federal Regulations. Frequently, these study procedures may not be what your practice or your investigator would normally do and may not be the most expedient way of performing the same task. Conducting research is never about speed. It, unfortunately, takes on average 10 years from pre-clinical testing to FDA approval and that’s if the drug or device even makes it past Phases I and II. Research is about accuracy and reproducibility. All sites must perform all study specific procedures the same way to produce clean data.

Survival Planning And Survival Kits

Remember that line from the movie “The Deer Hunter” where Robert DeNiro comments to his friends in frustration about Stan, played by John Cazale? Stan is his friend, but totally unprepared. DeNiro states, “Every time he comes up, he’s got no knife, he’s got no jacket, he’s got no pants, he’s got no boots. All he’s got is that stupid gun he carries around like John Wayne.” As a study coordinator, you need to have a plan, not be like Stan! If your practice does not have written SOPs for conducting a clinical trial, it is well worth your time and effort to work with your investigators and ancillary personnel to put one in place. While each protocol will vary, the regulatory and investigator obligations do not. The SOP should include your clinic’s commitment to the principles of good clinical practices (GCPs) and adequate human subject protection (HSP). GCP and HSP are globally recognized as a critical requirement to the conduct of research involving human subjects.

Basic Survival Medicine

The definition of an adverse event as written by the FDA in 21CFR Part 312 is “any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.” The FDA has very specific safety reporting requirements and timelines from the sponsor and you are required to document all adverse events endured by the subject once the subject is enrolled in the study. This may range from a subconjunctival hemorrhage, of which you are probably familiar, to a serious adverse event like septicemia.

Generally speaking in clinical research, ophthalmology is merely one of many therapeutic areas. The guidelines for coordinating and managing clinical research do not change from one therapeutic area to another. You may be an expert in your field of ophthalmology, but learning outside the eyeballs is an absolute must. Learn, not just basic medical terminology and medical history, but commonly prescribed medications.

Shelter And Water Procurement

You need nourishment and you need shelter. In research, this translates to a need for adequate desk and office space as well as a computer with dedicated internet access. A wireless connection is too unstable for completing an electronic case report form or transferring very large imaging files to an independent reading center.

You also need shelter for all your study supplies and your super-sized, mega-heavy three-ring binders with 2-inch thick spines. First, your regulatory binders for all essential documents must be maintained before, during, and after study completion. You will also need adequate record storage for paper case report forms and source document binders. There must be secure storage for the investigational product. This may be a locked refrigerator or locked cabinet, along with a separate refrigerator/freezer for blood samples. Many more supplies are needed specific to the study including lab kits for blood draws, pregnancy test kits, intravitreal injection supplies and so on. All of these items should be stored away from your regular clinic inventory so they can be accounted for and not accidentally used for a non-study subject or misplaced and mistakenly thrown out.

How To Build A Fire

Building a fire is certainly better than having to put fires out. As a study coordinator, you are put in the position of building a fire with your team. Training and the documentation of training is a requirement, but the best way to keep your team informed and up-to-date on their roles and responsibilities is to have regular meetings with the principal investigator, sub-investigator, visual acuity examiners, technicians, and photographers. Most sponsors will publish periodic newsletters containing pertinent study information including, but not limited to, safety reporting, potential protocol amendments and protocol FAQs. The newsletters should be shared and distributed to your staff. Regular communication with your research staff keeps them on track and motivated. Knowledge plus training equals less protocol deviations.

Building that fire with your staff is important, but you will also be building a long-term relationship with your subjects. From the screening to the last subject visit, these studies take a long time, possibly years. These good people are volunteering not only their eye, but so much of their personal time. It’s a huge commitment for them and if they can no longer drive, a huge commitment for their extended family. Make greeting them and taking personal time with them for every visit your priority. Subject retention is always a concern for sponsors. The subjects want to know you care. Building that relationship may encourage them to come back for their scheduled appointments because they’re made to feel respected as a person and not just an anonymous volunteer.

Survival Movement In Hostile Areas

Some people in the research industry might consider the FDA “hostile.” An FDA audit or inspection is enough to strike fear into the hearts of even the most tightly run research clinic. Always be inspection ready. Complete case report forms on time. Make sure study subject images and lab samples are transferred and shipped in a timely manner. What is not documented did not happen. You should run your trial like an inspector from the FDA could walk in tomorrow.

Keep A Positive Attitude

The importance of having a positive attitude about your job and the work you are doing cannot be stressed enough. Keep reminding yourself that the commitment from your clinic to perform clinical research is really providing an opportunity for you and your patients to helping facilitate new and promising treatments.

Miguel de Cervantes in Don Quixote said it best: “Forewarned, forearmed; to be prepared is half the victory.” Take these tips with you as you go into to the clinical research field and you will not only survive, you will be triumphant! OP

Kathleen Dowell, CCRP, has over 20 years of experience in the field of ophthalmology as a clinical research coordinator, clinical research associate, ophthalmic photographer, retina practice administrator and optician. Ms. Dowell has been an invited lecturer and workshop trainer for the Joint Commission for Allied Health Personnel in Ophthalmology, the Ophthalmic Photographer's Society, and The Vitreous Society Technician's Program to name a few. She is currently a Senior Project Manager at the Digital Angiography Reading Center (DARC) in New York.