Trip reports or annotated trip reports are summaries including notes regarding a site visit. The information on these reports is reviewed by lead CRA’s and sponsors for review. Follow up letters which are given to sites contain observations made by the monitors based on the contents of the trip reports.
Regulatory binders can be confusing for people who are research naive. Regulatory binders are typically paper based but are increasingly becoming electronic. Most regulatory binders include items such as the 1572, protocol signature page, or Financial Disclosure Forms among others.
The CRA Academy offers excellent internship opportunities for it’s students, one of which is featured as a guest in this video. The former student tells the story about how he became involved in a large company. During his story he stresses the importance of being familiar with research terms such as DoA, 1572, FDF or ALCOA to name a few.
Many site owners are not aware that they have control over their SOP’s. Sites can actually modify SOP's as needed in order to describe a procedure that is new to the site or which requires further details. Sponsors typically don’t request changes to SOP’s but do provide feedback on these depending on the complexity of their study.
Everyone in the clinical research field knows that the ICF is most important document in the ISF. The ICF uses simple language to explain what the study is about and makes it clear to patients that they can withdraw at any time they choose to do so. The ICF can be given at different points of the study including when a new amendment which affects patient participation is added to the protocol.
A seasoned coordinator describes his roles at different sites. Through his experience at small and large sites, he has constantly looked to obtain valuable experience. Because going from coordinator to CRA can take a long time, coordinators are also advised to go beyond their current responsibilities in order to gain relevant CRA experience.
A highly accomplished monitor talks about his experiences in the industry which have given him the proficiency to establish an online presence. This guest has seen how varying levels of PI involvement between sites affects each site. Another thing that this monitor has seen is the onset of CRA burnout caused by heavy travel requirements coupled with report deadlines and verifying action items.
Essential documents can be broken down into three categories: before, during, and after study completion. Study startup documents which must be in good standing before a study begins include 1572’s, financial disclosures, IRB approvals, delegation of authority and many others. These documents require regular upkeep during study and require additional attention during study closure.
The electronic Trial Master File is kept at the sponsor or CRO level. The TMF consists of various study related documents which are uploaded by monitors and other regulatory specialists. A typical TMF will include contracts, monitoring reports, signed acknowledgements and other documents which can be found in a site’s ICF.
Monitors must be able to recognize any site errors they see during their onsite visits. Whether there is a protocol deviation, consistent data reconciliation errors, or errors in the ICF, monitors should be able to note such problems in their reports and create action items as needed. Monitor reports are typically written by the monitor then reviewed by a supervisor and eventually reviewed by the sponsor in order to ensure quality.
Clinical trial assistants or clinical research assistants have responsibilities which vary within the organization in which they operate. At a clinical site, a clinical research assistant will usually help the CRC perform daily tasks or simply enter data. Meanwhile clinical trial assistants will typically work within a CRO and will assist CRA’s on things such as regulatory or trial master file maintenance.
Source documents are used to record different forms of data points for each trial. These may include a patient’s medical history, lab results, visit notes, or patient completed scales. While most source has been kept in paper form, electronic source has made an appearance and is commonly used by research sites.
This video aims to help those seeing to expand their business or simply enter the research industry. Different areas of clinical research are explained in simple terms as well as from the point of view of research sites, vendors and other research professionals. While this video is notably long, further information is available in the boo titled “The Comprehensive Guide To Clinical Research: A Practical Handbook For Gaining Insight Into The Clinical Research Industry.”
Most studies make use of Interactive Web Response Systems to perform drug related tasks. An IWRS can assign identification to patients for patients, which can help during future randomization. Sites also use IWRS’s to randomly assign medication during double blind trials.
Clinical Research Coordinators are often described as the backbone of a site. CRC’s are generalists because they perform tasks which range from from patient intake to data entry or query resolution. Because of these tasks require a high level of attention and knowledge, coordinators typically have no trouble entering other areas of the research field.
There is a major difference between working in your business and working on your business. Most business owners understand how to work on their business but don’t see the value of working in the business. However, successful owners have an understanding of both.
New sites may encounter double blind studies which are very common. The blind for this type of study refers to both the site and the patient not knowing which treatment arm the patient belongs to. This is typically done by using an IVRX system that can randomize patients and generates a bottle numbers corresponding with the treatment arm.
Virtual trials are a new method of collecting clinical data which has been available as far back as 2010. This type of approach has not managed to dominate the entire research field primarily because of the industry’s slow adoption rate. However, when these type of trials are implemented they have the potential to reduce a sponsor’s spending.
The CRA Academy is a great resource for both inexperienced and new research professionals. One of the best aspects of the the program is that it offers internships at different sites to every student. This added exposure to research field is essential to anyone entering and can easily be attained by networking with local research sites or even universities.
People who are research naive often struggle to understand the difference between a CRA and a CRC. One of the major differences between these two is that a CRA is required to have at least a bachelor's degree or equivalent while a CRC can work with only a high school degree. Another difference is that a CRA will not interact with patients and will focus on data quality while a CRC does interact with patients and collects data.