Question 1 Centralized CRFs Data: Collecting lab data on a CRF or eCRF is a common occurrence with clinical trials but, generally a more common way lab data is received is when lab samples are sent to the central lab, and then sent back to the site with the results (Prokscha, 2012).  When lab data is received back from the lab via electronic file, they are typically listed in a table format that includes the lab test name, and result, as well as the normal ranges and a place to indicate if the result is clinically significant or not (Prokscha, 2012).  The CRF typically comes in what Prokscha (2012) describes as a tall-skinny format, which makes it easier to check the results against the normal range.  Data collected in a centralized fashion typically is already calculated to include the subjects gender/age, etc. to calculate the result correctly.  One problem associated with the tall-skinny format and recording the data is that since it’s already programmed, the data must fit the characteristics for that particular column.  You also have more room for error when it comes to checking queries, and reports depending on the type of format that you use.  Using CRF lab information you could also have multiple tests listed, and the lab interpreter must ensure that they are correctly reading the correct test to ensure that any medical decisions are based on the correct reading.  You also have to be sure to identify that the information regarding fasting and non-fasting status is correctly recorded as this could affect the results listed. Non-CRF Data: Some data that is not included on a CRF include ECGs, and reports directly from patient devices, or written down (Prokscha, 2012).  You could also have voice response systems that give you data that would not be included on a CRF (Prokscha, 2012).  This data, although not necessarily lab data still has to be looked at and verified that the data obtained is accurate and complete (Prokscha, 2012).  While CRF/e-CRF data automatically has tables created, non-CRF files has someone creating the tables for them and are responsible to ensuring that all applications/columns are listed, and able to pick up duplicates, and normal vs abnormal results (Prokscha, 2012).  Loading data from non-CRF labs is done via software that is specific for that study, and it must be 21 CFR Part 11 compliant.  One problem with non-CRF data is there is room for error, and data cleaning is important to ensure that the data is accurate and complete.  This includes having to compare the data to that on the CRF/eCRF and if it doesn’t match, data reconciliation is needed (Prokscha, 2012).  If data reconciliation is needed, it is important that all data received is accurate and complete and assigned to the correct subject to protect data integrity. One other disadvantage to non-crf data is that labs may not have all of the required information needed for some lab results that may result differently for men/women and different ages (Prokscha, 2012).  Using a CRF that typically includes this information and therefore it is already resulted, and extra work is not needed.  With non-CRF data, you have to also make sure that if you are transferring data that you have a SOP in place to ensure that the transfer of data is safe and protected and compliant with all laws and regulations.  Cleaning non-CRF data can be time consuming as you are having to match it to another source, where as CRF that are already created are typically able to catch mistakes, or something that is missing. Question 2 I believe one problem that would ensure quality data management would be the use of abbreviations.  If the person that is recording the data is unfamiliar with the correct medical abbreviations, they may end up incorrectly abbreviating something incorrectly.  This would cause problems in the long run as someone could read the incorrect abbreviation and incorrectly code it as something else, of if it’s not listed, or added to the code to be put into the system then it could be left up to interpretation on what the correct response should be.  For example, incorrectly coding something as taken as three times a day (TID) instead of four times a day (QID) would lead to having to have make corrections for the person reviewing it that is ensuring the data is complete and accurate.  Ensuring that items are abbreviated correctly is important to ensuring that data is complete and accurate.  I believe that if the website that data is being entered into provided the MedDRA (Babre, 2010) this could potentially avoid having to fix errors and would provide good quality data. Another common problem that was listed, that I believe would cause problems with ensuring quality data management is having illegible verbatim terms.  Medical coders who are creating the terms and coding to be used need to be able to appropriately categorize all medical terms (Babre, 2010).  Being able to create quality data starts with being able to properly identify medical terms ranging from adverse reactions, to how often a medication is taken.  Coders need to ensure that if they are coding a system for multiple providers, that the terms they use are correct and recorded properly.  If they are given a term that is ineligible it could cause the term to not be entered correctly when coding, and thus not being able to enter the data.  References: Babre, D. (2010, January). Medical coding in clinical trials. Perspectives in clinical research. Retrieved January 24, 2022, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC31494… Prokscha, S. (2012). Practical guide to clinical data management. CRC Press. Nancy Question #1 Laboratory data collection is the classic tall-skinny format used in trial databases. The lab results include the test’s name, the result, and the test value in separate columns. The lab values are obtained from a central lab, which results in an electronic file format. The central lab data provides normal ranges to help identify abnormal or out-of-range results. In addition, the electronic result helps alleviate time from the provider and flags for the data entry of a result that needs to be identified as “clinically significant” Or “not clinical significate.” “Normal ranges may be stored in the same storage area as the clinical trial data, or they may be stored centrally and available to multiple studies” (Prokscha, 2012). In contrast, loading non-CRF laboratory data into a database is done through programs as a copy. This process needs validation with specification on the proper electronic structure allowed. For example, if the non-CRF laboratory uses different test names than the CRF, the resulting labs must map the data for translation according to protocol. The sponsor program may not support this data and will cause issues with validating labs. Question 2.  A high level of data integrity is expected with data management. Many problems can occur with medical coding when data managers do not follow eCRF guidelines. For example, abbreviations can cause issues with reimbursements for clinical trials. Medical abbreviations are unique to the Latin language. Training and knowledge on proper abbreviations can be used when documenting and charting when appropriate. However, the use of abbreviations at times is misunderstood and can be misinterpreted. ‘One of the problems observed was that one abbreviation might have two or more contradictory or ambiguous meanings, which can create dangerous communications’ (Davis, 2020). When possible, refraining from abbreviations is critical with medical coding in clinical trials. Another common problem faced by medical coding experts is spelling errors. Many medical terms sound alike and have similar spelling. For example, two medications with similar spelling with different modalities are Oxybutin and Oxycodone. Nevertheless, misspellings are common. Therefore, it is essential to understand the potential of making an error and taking the time to prevent mistakes. According to Bare (2010), ‘maintaining uniformity in reporting a term is next to impossible in any given clinical trial. However, for a coder, it is a challenging task to ensure that the term recorded/reported on data collection instrument (CRF/eCRF) is coded appropriately.’ It is essential to maintain creditable data comes down to the acronym ALCOA+. The principle of ALCOA+ is that data should be attributable, legible, contemporaneous, original, and accurate. In summary, free from error and following the protocol. Reference: Babre, D. (2010). Medical coding in clinical trials. Perspectives in clinical research, 1(1), 29–32. Davis, N. (2020). Medical Abbreviations That Have Contradictory or Ambiguous Meanings. Institute for safe medication practices. https://www.ismp.org/resources/medical-abbreviations-have-contradictory-or-ambiguous (Links to an external site.) meanings. Prokscha, S. (2012). Practical Guide to Clinical Data Management, 3rd Edition. London. UK: Taylor & Francis, London, UK. ISBN: 978-1-4398-4829-6

Mastering the Art of Online Learning: Your Guide to Acing Online Courses

Introduction

In recent years, the popularity of online courses has skyrocketed, offering learners the flexibility to acquire new skills and knowledge from the comfort of their homes. However, succeeding in online courses requires a different approach compared to traditional classroom settings. To help you make the most of your online learning experience, this article presents essential strategies and tips to ace your online courses.

1. Set Clear Goals and Plan Ahead

Before embarking on an online course, establish clear goals and objectives. Determine what you hope to achieve by the end of the course and break down your goals into manageable milestones. Create a study schedule that aligns with your other commitments, ensuring you allocate dedicated time for coursework, assignments, and revision.

2. Create a Productive Study Environment

Establishing a conducive study environment is crucial for online learning success. Find a quiet, well-lit space where you can concentrate without distractions. Remove any potential interruptions, such as notifications from social media or email. Organize your study materials and have a reliable internet connection to ensure seamless access to course materials.

3. Actively Engage in the Course

Active participation is key to mastering online courses. Engage with course materials, including videos, readings, and interactive components. Take comprehensive notes, highlighting key concepts and ideas. Participate in discussion boards, forums, and virtual meetings to interact with instructors and peers, fostering a sense of community and enhancing your understanding of the subject matter.

4. Manage Your Time Effectively

Online courses offer flexibility, but it’s essential to manage your time wisely to avoid falling behind. Create a detailed schedule, allocating specific time slots for coursework, assignments, and studying. Break down larger tasks into smaller, manageable segments to prevent procrastination. Prioritize tasks based on deadlines and dedicate focused time to each one, ensuring consistent progress throughout the course.

5. Develop Effective Communication Skills

Online courses often rely on written communication, making it crucial to hone your skills in this area. Be concise and clear in your written responses, paying attention to grammar and spelling. Actively participate in discussions, asking thoughtful questions and providing constructive feedback to your peers. Regularly check your course emails and notifications, ensuring you stay updated with any important announcements or changes.

6. Utilize Available Resources

Take full advantage of the resources provided by your online course platform and instructors. Familiarize yourself with the learning management system (LMS) and explore its features. Access supplementary materials, such as textbooks, lecture slides, and external resources recommended by instructors. Utilize online libraries, research databases, and tutorial services to deepen your understanding of the subject matter.

7. Stay Motivated and Engaged

Maintaining motivation throughout an online course can be challenging, particularly when faced with competing priorities or a lack of face-to-face interaction. Set short-term goals and reward yourself upon their completion. Connect with fellow learners through virtual study groups or online forums to foster a sense of camaraderie. Regularly remind yourself of the benefits and personal growth associated with completing the course successfully.

8. Seek Support and Clarification

Don’t hesitate to seek support or clarification when needed. Reach out to your instructors for guidance or clarification on course material. Utilize online discussion forums to ask questions or engage in collaborative problem-solving. Leverage the support services provided by your course platform or institution, such as technical support or academic advising.

Conclusion

Online courses present unique opportunities for self-paced learning and personal growth. By setting clear goals, creating a productive study environment, actively engaging with course materials, and managing your time effectively, you can maximize your chances of acing online courses. Remember to stay motivated, seek support when needed, and make the most of the available resources. Embrace the flexibility and adaptability of online learning to achieve your educational goals.