As we discussed in this module, the study needs to tell a story, and a lot goes into study storytelling.  After reading the module web-pages, answer the following questions.  Each question should be more than a few words, and reflect what you learned in this module as well as apply what you have learned in previous CRC courses. Describe each component of ALCOA-C. Describe steps taken during documentation audits.  How should one correct a written mistake, and who should make the correction?  Select one of the FDA citations (table 4) from the Clinical Researcher article.  To the best of your ability describe how a mistake such as this can occur?  What steps would you take (beyond the listed prevention strategies) would you take to ensure this doesn’t happen to you? 4.Describe the elements of an effective source documents.  What are some elements of a poorly designed source document? Table 4: FDA Citations Using the Code of Federal Regulations and Examples FDA Citation   21 CFR 312.60: Failure to ensure that the investigation was conducted according to the investigational plan. Violation Examples 1. Enrolling ineligible subjects not meeting study entry criteria. 2. Missing study procedures indicated in the protocol, such as chest X-rays or electrocardiograms. 3. Disqualifications during study run-in period, yet patient enrolled. Prevention Strategies 1. Have a colleague double-check study entry criteria before a patient is enrolled. 2. If using an EMR, capitalize on tools to help you find information quickly. 3. Cross reference protocol with Schedule of Events to make sure procedure milestones are met. FDA Citation   21 CFR 312.62(a): Failure to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. Violation Examples 1. Drug dispensed does not match the amount taken by the research participant. 2. The amount of drug returned does not match what should have been returned. Prevention Strategies 1. Count and document drug return with the subject present, not after the person has left. 2. Count medication before dispensing. 3. Discrepancies should be explained in source or note to file. FDA Citation 21 CFR 312.62(b): Failure to maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation. Violation Examples 1. Absence of accurate histories documented. 2. Failure to complete forms required. Prevention Strategies 1. Keep medical history section updated. 2. Use source documents that have been verified by sponsor or CRO. FDA Citation 21 CFR 312.62 (c ): Failure to retain records required to be maintained under 21 CFR Part 312 for a period of two years following the date a marketing application is approved for the drug for the indication for which the drug is being investigated; or, if no application is filed or if the application is not approved for such indication, until two years after the investigation is discontinued. Violation Examples 1. Not maintaining records related to drug disposition, including dates, quantities, and usage. 2. Not retaining consent forms and case report forms. Prevention Strategies 1. Keep a drug dispensation log with study drug accountability. 2. Check with sponsor prior to shredding documents. 3. If possible, scan informed consents into the electronic medical record.

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.