Recruitment for clinical trials

Recruitment In connection with a clinical trial requires that the Clinical Research Coordinator pay attention to all facets of the recruitment process. Recruitment is very time-consuming, often requiring contacting many potential subjects to obtain one randomized subject.

The various recruitment facets include, first and foremost, that the Clinical Research Coordinator is good at communicating and conveying a message. It is important that the Clinical Research Coordinator informs the message neutrally and objectively so that the Clinical Research Coordinator does not persuade potential trial subjects but gives them the opportunity to take their own decision. A clinical trial containing many medical terms must be communicated in an understandable language for potential trial subjects. Trial subjects may have many concerns in connection with participating in a trial, and the Clinical Research Coordinator must be able to handle this in an understanding and empathetic manner. Time must be set aside, and arrangements must be made for potential trial subjects to have the opportunity to contact the Clinical Research Coordinator after the pre-screening interview, if this is needed.

The protocol is the foundation of a clinical trial, in which, among other things, the inclusion and exclusion criteria and endpoints are described. It is crucial that the Clinical Research Coordinator has a full understanding of the protocol and the informed consent form, to be able to communicate to potential trial subjects in the best possible way. This is also to prevent potential trial subjects being asked to meet on site unnecessarily for screening visits. This will also be unnecessary resources for the site.

If a site uses a freelance Clinical Research Coordinator to recruit, it is important that the freelance Clinical Research Coordinator is associated with the site and trained by them. In addition to training, the freelance Clinical Research Coordinator must understand how the site works, their resources and the recruitment schedule for the study the freelance Clinical Research Coordinator is employed for. Throughout the recruitment process, the freelance Clinical Research Coordinator must have contact and meetings with the site to regulate any challenges in connection with recruitment and screening of potential trial subjects. If the study has approved recruitment material to be sent to potential trial subjects, it is important that the freelance Clinical Research Coordinator is informed of this, so that it can be sent along with the informed consent form.

Recruiting potential trial subjects requires the Clinical Research Coordinator to be focused on their conversations with potential trial subjects. If there are too many screen failures in a study, it is an additional expense for the sponsor and can delay the schedule. If there is competitive enrollment in a study, it can also be a financial burden for a site if the recruitment process does not proceed as planned.

The Clinical Research Coordinator must be familiar with GCP guidelines and regulatory requirements to ensure that potential trial subjects are properly informed of their rights in connection with participation in a clinical trial. The Clinical Research Coordinator must ensure that the site has received approval of the protocol before the recruitment process begins.

When a potential trial subject is deemed suitable for screening after the telephone interview, the Clinical Research Coordinator must ensure that the informed consent, including any approved recruitment materials, is sent to the potential trial subject, including a letter with the date and time of the screening visit. The Clinical Research Coordinator must update the pre-screening log.

The Clinical Research Coordinator must be informed of what has been negotiated between the sponsor and the site regarding the possibility of compensation in the form of a transport allowance or the possibility for the site to book flights or taxis for trial subjects in connection with the visit to the site. This, together with flexibility on the site in relation to visit times, is important to make it as easy as possible for trial subjects to participate in both the screening visit and the remaining visits, if the trial subject meets the inclusion and exclusion criteria to participate.

The clinical trial recruitment service that Clinical Nursing can offer is dedicated Clinical Research Coordinators who are experienced in speaking with trial subjects. They have many years of experience working with humans and in clinical trials. They can step in quickly and can be hired for the exact needs of the individual study.