One alternative to communicating with a confrontational Clinical Research Associate (CRA) is to seek the help of your assigned Institutional Review Board. Unfortunately, CRA's vary and some may not be as approachable as others.
If you decide to take on a study that you are not confident that you can complete, be aware of the differences between sponsor size, the performance of other sites, and protocol requirements. Challenging yourself beyond the capabilities of your site may leave a bad performance record.
Various trainings are often revered are important in clinical research. However, Principal Investigator (PI) oversight and staff experience are often erroneously overlooked as being important.
The research industry is heading towards an electronic era. Things such as Principal Investigator (PI) e- signatures for safety reports are becoming more common.
A site owner or study coordinator that is taking over a study from another coordinator will quickly discover how many challenges this situation encompasses. The most important thing to do is to figure out which items take the highest priority.
Sponsors usually reimburse sites for their advertising efforts. The only catch is that the site must be able to provide proof of payment in order to be reimbursed.
Another money earning tactic is to run recruitment campaigns. Unfortunately, many inexperienced sites will often commit dangerous mistakes such as running an ad that is not Institutional Review Board(IRB) approved.
Lead generating can be thought of as an offensive tactic because it helps generate revenue. Activities that help retain business such as having Quality Assurance(QA) staff, can be thought of as defensive.
There are several options for keeping track of a research site's money flow. Once short term and long term strategies have been identified, site owners can then decide what expenses can be cut as well as determine which studies are most profitable.
Purchasing a new site can be risky when the site only has one Principal Investigator (PI). A better option is to buy a site with more than one PI.
Clinical research often involves more than the research sites. Other services are necessary to improve the way data is captured, transferred, and processed.
Whenever someone is considering restructuring a Principal Investigator (PI) payment, it is important to reconsider all of the business costs. The type of location where the research will be held will also affect the price of the PI payment.
A Clinical Research Associate (CRA) must check off on a long list of items before before a decision can be made. Items ranging from scale calibration to cleanliness are take into consideration.
Clinical Research Associates (CRA's) serve several functions during their different visits to research sites. Each visit must ensure that sites are able to perform.
Project Managers (PM's) must oversee Clinical Research Associates (CRA's), and usually work at Contract Research Organizations (CRO's). Project Managers are known to work around 80 hours per week and must be available at all hours, often for several protocols.
Starting a research site with new partners is not an easy commitment for some. Future site owners should think of ways to develop relationships with physicians who do not seem confident in investmenting.
Deciding the salary of a research coordinator (or a potential coordinator) can be a challenge because each coordinator will have a different background. Potential coordinators who will require training may have to take a lower salary until they can demonstrate adequate skill.
Several mechanisms are in place to prevent discrepancies between the data recorded on source documents and on electronic data capturing systems. Having these systems in place helps sponsors obtain reliable data for further analysis.
The time it takes to start screening depends on when the Site Initiation Visit (SIV) occurred. Add on sites usually have the advantage of starting an SIV sooner.
Risk based monitoring is one of the best developments in clinical research. But because of all of the advancements in research technology, it may seem more difficult to remember the purpose of clinical research.