Many sponsors in the medical device research industry are challenged with the decision between having a remote or on-site initiation visit. An initiation visit is imperative to the overall success of a study as many tasks are accomplished during these visits.
This week, during an on-site initiation visit, IMARC monitors played an integral role in helping a site brainstorm and plan through the informed consent process and device logistics for a study that includes an urgent procedure that could take place after the site’s clinical business hours.
Those familiar to clinical research are aware that 21 CFR 812.110 know that the ultimate responsibility is on the investigator to provide oversight and ensure that the study staff executes the study according to:
- Federal Regulations
- Agreements between the sponsor and the investigator
- Investigational Plan
- Requirements of the IRB
However, those same people familiar with the regulations know that the coordinators are the captains of the study team and help the investigator ensure compliance according to the regulations. During an on-site initiation visit, IMARC monitors were able to help coordinators walk through a unique type of study to develop systematic processes to secure compliance and set up for a successful study.
To begin, the site has three separate locations in which subjects could potentially present for an urgent procedure. Additionally, the subjects could present in the middle of the night when coordinators are not on site, leaving the physicians solely responsible for obtaining informed consent and product accountability during an already stressful situation.
The informed consent process, one of the most important parts of a subject’s participation in clinical research, must be established prior to subjects undergoing study procedures. The monitors and research coordinators discussed potential situations that subjects may present for this study and how the site would ensure that the subject is consented according to 21 CRF 50. The site plans on keeping a study specific binder, in which the primary coordinator is responsible for updating, at each location with the most recently approved informed consent and inclusion/exclusion criteria. The site also requested extra copies of study specific tools provided by the sponsor to keep with those binders at all three locations.
The site was anticipating that a complete stock of device could be maintained at each location. The sponsor is only providing 1 of each size of available device and several additional devices for each of the most commonly used sizes. The PI, primary research coordinator, and monitor brain stormed throughout the on-site initiation visit to determine the best way for the site to maintain device security and integrity and be prepared to overnight, urgent procedures.
On-site initiation visits can be very costly and pose a burden on the research coordinator and project manager to align multiple schedules. However, for complicated studies such as this one, the opportunity for study team members to come together face to face and brainstorm for several hours is invaluable.
Have you worked through difficult studies during an on-site or web based initiation visit? Did you find one method more successful than the other? What types of successes can you share from on-site initiation visits? Any challenges? Please feel free to share your thoughts with us.
Photo Credit: UBC Library