10 - Clinical Research Study Coordinators’ Training - A Deep Dive into Informed Consent: An Assessment of CRC Knowledge

Background: Clinical research coordinators (CRC) need continuous trainings in Human Protection Research, Ethics, and Regulatory Updates. This training workshop was designed for clinical study coordinators but was open to clinical research personnel at all levels. The workshop was held to provide a deep dive and continuing education about informed consent processes.

Methods & Materials: We promoted the in-person workshop through the communication systems within member institutions. This in-person session was critical due to regulatory changes that had occurred as a result of the COVID pandemic. A detailed flyer was emailed using a list serve to all levels of clinical researchers. A registration form created on the REDCap platform provided a link for registration and the means to capture data. A follow-up email reminder was sent every two weeks.
The training was organized in modules, each of which included didactic materials, hands-on training, case studies, and teach-back sessions. A Jeopardy game was conducted at the end of the workshop to reiterate the information that was covered during the training.
A survey pertinent to regulatory and informed consent processes was developed. The survey, which contained a 15-item questionnaire, was provided to the attendees pre- and post-workshop to assess knowledge gained.

Results: A total of 42 people registered, and 30 people attended the event. Of the 30 attendees, 21 (70%) were study coordinators. Of the study coordinators, 8 (38%) had been a study coordinator for less than 1 year, 2 (10%) had been a study coordinator for 1-2 years, 4 (19%) had been a study coordinator for 3-4 years, and 7 (33%) had been a study coordinator for more than 4 years. Other attendees included investigators, administrators, nurses, and regulatory personnel.
Many of the questions that focused on consent elements were answered correctly by the participants prior to the workshop. Conversely, only 14% initially knew the correct Human Health Service regulations for the Common Rule. This number increased to 33% post-workshop. Additionally, knowledge of the required reading grade level language on informed consent forms (ICFs) improved from 71% pre- to 100% post- workshop.

Limitations: All responses to the survey questionnaire items were anonymous and were not connected in any way. Thus, a person-by-person comparison (pre-vs. post- workshop) was not able to be performed.

Discussion: Overall, there was a significant improvement in the number of correct responses to the questionnaire items post-workshop. The improvement shows that study coordinators benefit from continuous review of informed consent form elements. This includes a discussion on the information required in ICFs, government agencies that oversee clinical trials, and the reading grade levels for ICFs. Of importance, study coordinators need further guidance on where to find specific federal regulations for informed consent processes. Responses to a 6-Month Follow-Up also reflect these findings. As such, it may be beneficial to hold clinical research coordinator training workshops every 6-12 months to ensure knowledge is retained and correct practices are implemented.