Research coordinators are the reason that many clinical trials are successful.
Setup, screening, enrollment, data collection, and regulatory maintenance are just a few tasks that coordinators manage for their study teams and investigators. The best research coordinators possess an attitude of credible excellence and a combination of learned/innate skills. Organization is key. Below are a few tips we have picked up from research coordinators over the years to help keep their studies organized.
Start Your Own Binders
Many sponsors wait to provide study materials until the site initiation visit, but you can start to gather and file study materials immediately. For example, filing IRB correspondence as you receive it will reduce any backlogs. Also, if you can identify the study staff in advance you can collect/file CVs, licenses, financial disclosures, etc. and have them ready when requested by the Sponsor.
Prepare For The First Potential Subject
It is a good idea to run through the screening items/first study visit ahead of the first consent to ensure that you start the enrollment process successfully. For example, you can develop a pre-screening process or checklist to outline talking points to discuss with potential subjects and map out the timeline for different screening activities.
Plan The Frequency Of Your Study-Specific Activities
Determine if screening, study visits, and regulatory activities should be reviewed on a daily or weekly basis. Setting aside specific time intervals will ensure that the visits and regulatory activities are completed in a timely manner. A good suggestion is to use an electronic calendar to block off your time to devote to the study. When planning your schedule, you should also consider any overlap with clinic days.
During The Study
Use A Spreadsheet For Tracking Subjects
Maintaining a digital spreadsheet with basic information of the study subjects, such as name, contact information, and subject number, allows you to quickly keep track of and add new subjects. While this list is outlined in ICH GCP E6 8.3.21, more detailed information can be added by using equations that calculate visit windows for each subject to ensure that each visit is completed within the appropriate time frame. Tailor the tracker to fit the needs of the study/protocol, for example, by adding in the dates of consent/re-consent, the dates imaging was completed/submitted for review, or the dates you contacted the subject.
Use Binder Tabs
Whether you were provided with pre-populated study binders or created your own, adding detailed binder tabs can help you and your monitor access information quickly. For example, having CV/medical license tabs for each study staff member versus one general tab for CVs/medical licenses can help. Another example is for IRB correspondence, you can group together and label each IRB submission/approval letter that was made for the study.
Centralized Binders/File Storage
Odds are, you are participating in multiple studies, and so is your investigator. With that being said, it may be a good idea to place all CVs/medical licenses for all investigators, co-investigators, and research coordinators in one central binder. Doing this will allow you to file these documents once versus having to file these documents multiple times for multiple studies and multiple binders.
Do you prefer to maintain study materials electronically? Consider creating an electronic, secure, central, shared file system where documents can be stored and accessed by the study team at your site.
This will make it much easier to grant third-party oversight for remote monitoring or auditing later.
Use An Investigator Signature Folder
Having an easily-accessible study folder filled with any documents that require investigator review and signature allows you to grab these documents at a moment's notice, especially when the investigator has a sporadic schedule.
There is no doubt that the research coordinator plays a critical role in any clinical trial. They are responsible for coordinating and completing many study related activities on a daily basis. Strong organizational skills are essential to ensuring that a clinical trial is successful and implementing some of these examples will help reach this goal.
There is no right or wrong answer when it comes to keeping your study organized. For more tips on organization, check out Organization: The Master Key to Compliance.
It is never too late to get organized! How are you keeping your studies organized? Please share your examples and tips below.