Physicians who are involved in research must be careful not to accidentally exert their influence when dealing with patients. This is especially true in academic research where an entire institution can have a large degree of influence. Meanwhile, PI’s in the private sector must ensure that they document as much as they can in order to show that they have their patient’s interests in mind.
When a PI is interested in becoming a partner at a researcher site it is important that the PI understands what their obligations are. Such obligations will vary depending on the type of facility that research will take place. Ideally, the best PI to become partners with is one who is able to provide oversight and is readily available during all business hours.
Starting a research site requires an enormous amount of patience. What’s more it will require that you find business partners who understands that they must wait for an investment to pay off. PI’s are not known for their patience and will typically require reassurance when they don’t see a steady income.
When it comes to consent, the FDA will always take note of any potential threats to patient safety. Nevertheless, there are physicians who change their patient prescriptions before a study starts to ensure that the patient will qualify for a study. While making such changes may not seem harmful, failing to document legitimate reasons for the change can quickly cause FDA officials to become suspicious.
The tuskegee incident is one of the most significant events in history which has shaped many of the ethics behind human research. Unfortunately, many people who are not involved in research hold many misconceptions about what human research is. For this reason, site owners are advised to be familiar with GCP and should be familiar with some of the historical events that have influenced human research.
Corrective Action Preventive Action plans help sites maintain a high level of accountability. Sometimes these are initiated by the sponsors but they can and should be implemented by PI’s as a means to demonstrate oversight. The main purpose of a CAPA plan, is to systematically reduce deviations or safety hazards during a study.
Site owners must constantly be aware of the ways that their site can either make or lose money. One strategy is to incentive their staff to enroll but must take extra precaution when paying for bonuses. Paying bonuses may actually be common but regulatory agencies might not agree with such practices if there is a chance that individuals will perform unnecessary tasks or potentially endanger patients.
Getting new studies can be challenging for a clinical research site. This webinar teaches some tools and tactics that could help.
During this conversation with an experienced CRA, it becomes apparent that larger CRO’s are able to organize themselves in such a way that they allow for employees to specialize in specific tasks. Specializing can have mixed results but one outcome is that specializes employees are able to handle larger workloads more efficiently. With less stress and more time, employees may choose to invest their time in other projects.
Many people underestimate the value behind working for a research site. People who are research naive may benefit the most from being involved at a research site because it gives them an opportunity to learn about other research related occupations. For people who may have initially considered becoming a CRA, gaining experience at a research site may actually help them consider other options.
One of the best ways to get CRA experience is to intern. In this video a a CRA student runs through her report and discusses the findings from her chart reviews. Once students like her have enough experience, they may then choose to position themselves as a regulatory specialist which can quickly turn into a CRA position.
One of the current trends in research include more studies that are efficient and don’t have a middleman between the site and the sponsor. The role that electronic source will play is still unknown but will most likely synergize with other technologies that also aim to give sponsors data at a faster rate. The fact that electronic source documents allow monitors to find errors in real time is also something that can be used to identify common errors.
E-source is currently used by most sites to track patient history as well as for recruitment purposes. However, this type of technology has the potential to be an effective tool for coordinators and CRA’s. E -source can even be a useful tool for PI oversight because it allows PI’s to access more information for their patient.
Investigator meetings can seem repetitive to research professionals who have attended them for many years. While it may not seem beneficial to attend investigator meetings, these meetings can help everyone understand what the sponsor’s goals are. Understanding the sponsor’s goals can help sites provide better data which may increase the chances of being selected for a future study.
Study delays are common in the research industry and can occur because of things that the site needs to complete or because of requirements from sponsors or vendors. Sites are advised to complete required training and complete all startup requirements as soon as possible. Doing so can help the site focus on recruitment once the study is no longer delayed.
Most studies are beginning to increase in their level of complexity. The increased level of complexity has forced sites to review SOP’s so that each site can address sponsor requests or site necessities. A simple addendum to your SOP’s will resolve any conflicts that regulatory agencies may find.
Site owners will often rely heavily on their coordinators and will try to leave them in charge of as many studies as possible. While this tactic may be the easiest to follow, it is important to know when the coordinator needs assistance or requires monetary incentives as the workload increases. Failure to react to the coordinator’s needs may result in the coordinator feeling over worked and eventually quitting.
This video includes a mock Site Selection Visit with a new site that is preparing for their first study. One of the important tasks that the monitor will complete during the visit is the site tour where all equipment, exam rooms, IP rooms and laboratory will be reviewed. Aside from the tour, the site will be expected to demonstrate experience conducting research have specific forms of training completed.
There is often confusion about the difference between satellite sites and additional sites. Satellite sites are usually in separate locations from the main site but have the same PI as the main site allowing the PI to have full control over both sites. Additional sites are often owned by different companies, have different PI’s, independent sets of FDA Form 1572 in their own sets of regulatory documents.
The purpose of a clinical research trial is explained in this video. Some of the steps to getting a product developed and then approved are explained. One major event that occurs is that a protocol is developed following guidelines set by the FDA, which is the agency responsible for deciding to approve new medical products.