Instructions: Peer Responses: Start with a formal salutation; use your peer’s proper name Do not start with something like “Hey I really loved your post!” or “I agree completely!” Lead with (1) sentence restating the peer’s main point and express agreement/disagreement with a specific part of their point Do Not: fill your post with compliments and neglect adding your thoughts/opinions and evidence to back up your critical thoughts Do Not: simply repeat the points you made in your initial posts – peer responses need to include fresh content and references References: a minimum of (1) (with APA 7th Edition formatting) Length: approximately (2) full paragraphs Kimberly Question 1 Unresolved discrepancies related to SAE data could lead to the study not correctly having the correct data in the end. If the specific SAE was caused by the drug/product being studied but the discrepancy was not updated properly to indicate if it truly meets the criteria, then this could affect the outcome of adverse events caused by the drug/product. If data is not being updated or recorded in real time, it can lead to a lot of reconciliations towards the end of the study (Cobert, 2018). This could lead to delays in database locks, and possibly having to create and send an expedited report to the proper people, such as the FDA, sponsor, etc (Cobert, 2018). Reconciliation of SAEs is needed for those in the appropriate roles to discuss the discrepancies in the item and decide if it is appropriate for the SAE and then determine the correct course of action (The SAE Reconciliation Process, n.d.). If the data does not match in the databases, when it comes time for an audit, this could be picked up on and then reported to the site/sponsor. It could also lead to question on why it wasn’t caught and why it wasn’t resolved prior to now, what data is missing or needs to be clarified, etc. (Cobert, 2018). This can also lead to inaccurate data being put into the system if a long amount of time has passed since it was originally recorded. This should try to be avoided as you want to be as accurate as possible when recording AEs/SAEs and reconciling discrepancies in real time will help avoid the chance of being inaccurate. Question 2 Data management having a strong relationship with those conducting monitoring visits is important as these positions need to ultimately work closely with each other. When monitoring visits occur, the monitor will verify the data in the EDC against the sites source documents. If there are queries that have been issued by the data management team, the monitor will be able to help address any questions they may have to clear up any queries or discrepancies. Being able to discuss these with each other is important for the study and will help clear up any questions or problems found. Being able to build a strong relationship starts at the beginning. When you are able to first reach out to the data management team or the monitoring team, I believe it’s important to first introduce yourself and get to know the person. If you know the persons characteristics and can effectively communicate with them it will make having to discuss queries or problems with data vs source later. I believe that open communication and expressing the goal in your work is important to creating a strong relationship. Without this, things could be misunderstood, and details could be overlooked, missed out on. Should you be in a situation where the relationship between you and the data management or monitoring team wasn’t strong. You could develop strategies together to have a plan in place for those times when they are needed. If someone is not able to answer common questions when needed, maybe implementing a standard ‘cheat sheet’ to look back on for the answers. Strong relationships again, start with communication, if the relationship is causing work not to be completed then maybe it could be looked into a different team member to work with. Being able to talk more to either person regarding what they are looking for specifically could help turn a relationship around that didn’t have any or much communication to begin with. Being willing to also learn common terms each person will use in their respective jobs can help turn the relationship around as each person will see that they are making an effort to help their job flow a little better. References: Cobert, B. (2018, April 19). Reconciliations – Clinical Trial & Drug Safety Database – C3iHC. C3i Solutions. Retrieved January 27, 2022, from https://www.c3isolutions.com/blog/reconciliations/ The SAE Reconciliation Process. (n.d.). Www.Datareconciliation.Com. Retrieved January 27, 2022, from https://www.datareconciliation.com/Data-Reconcilia… Ashani Question 1. SAE Reporting The primary goal of clinical trials should be improvement of patient care, either it is biomedical device, pharmaceuticals, or vaccine related research. However, most medicines or medical devices even vaccines fail to help once it reaches market despite showing hope during clinical trials. In majority of these cases, there is a safety recall associated with the investigational drug that is discovered much later in the process. One of the major reasons for such a recall is discovery of a serious adverse effect associated with the investigational product. Serious adverse reactions, SAE, is a medical outbreak in the form of a life-threatening occurrence that is life -threatening and requires the patient to be hospitalized and as a result could cause disability or cognitive defects or even result in birth defects or death that can occur due to any amount of exposure or dose administered. The Food and Drug Administration, FDA, requires that data associated with SAE should be reconciliated. This can be done by review, comparison and resolution of data discrepancies followed by update of databases. In most cases, the safety database, such as ARCUS, ARIS-G, AERS and SAFIRE, are databases used for management of SAE data from clinical trials and marketed products and are updated when a follow-up information is available. In addition, the same information is expected to be available on clinical database such as RAVE, InFORM and ORACLE CLINICAL, where clinical teams collect information to be filed as clinical data for the clinical trial. According to Hartung et al., 2014, it is a joint responsibility of the investigator and the sponsor of a clinical trial to report all the valid SAE to all appropriate regulatory authorities such as the Institutional Review Board, IRB, in a timely manner. Furthermore, according to Hughes et al., 2014, discrepancies in SAE data reported can be found in journal articles and registered summaries of antidepressant and antipsychotic drug trials that occurs when researchers are limited by incomplete, ambiguous, and inconsistent reporting. When incomplete data is reported, the approval process of a pharmaceutical drug could jeopardize the lives of humans due to inadequate or incomplete data used for making decisions in clinical trials. According to Heneghan et al., 2017, it is still unclear how to justify missing data that requires imputation, while signs and systems may be used to form outcome scales, it is still difficult rationalize. In addition, the published data in clinical journals can have a negative impact on future clinical trials. As a result, the integrity of data generated from the clinical trial may be considered biased which leads to question the validity of the trial and any approved investigation product may be removed from shelfs if it was approved bases on inadequate and correct SAE data. According to Heneghan et al., 2017, clinical trials developed with patients in mind are reported completely, transparently, and competently. In most cases, discrepancies in reported data occurs due to miscommunication between the IT team, the drug safety group, the quality assurance group, and the data management team. As a resolution, it is important that a decision is taken regarding the best databased to use for all data reporting and who would be the responsible person for ensuring everyone has communicated when data is collected and reported. Large pharmaceutical or medical device companies use many channels of communication such as email, meetings, zoom meeting, slack messages, notion pages, however, valuable information is still not delivered to the correct group of people and delegation of duties is affected when data reporting is in question. A drugs or medical devices’ safety profile is not completely known when it is initially launched on market therefore, continuous surveillance is important for patient safety. Reference Hartung, D.M., Zarin, D. A., Guise, J-M., McDonagh, M., Paynter, R., Helfand, M., 2014., Reporting discrepancies between the clinical trials.gov results database and peer-reviewed publications., PubMed-NCBI., Apr 1; 160(7):477-83., Cited: Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications – PubMed (nih.gov) (Links to an external site.) Heneghan, C., Goldacre, B., Mahtan, K. R., 2017., Why clinical trial outcomes fail to translate into benefits for patients., Trials Journal: BioMed Central., 14 March; 18(122)., Cited: Why clinical trial outcomes fail to translate into benefits for patients | Trials | Full Text (biomedcentral.com) (Links to an external site.) Hughes, S. Cohen, D., Jaggi, R., 2014., Difference in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: A cross-sectional study, BMJ-PubMed-NCBI., July 9;4(7)., Cited: Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: a cross-sectional study – PubMed (nih.gov) (Links to an external site.) Question 2. Clinical Monitoring Team and Clinical Data Management Team A clinical trial is a long cost-enduring process which can be terminated if the data collected is not comprehendible. In clinical research, the clinical monitoring team, CMT, have the highest interaction with study sites and therefore are effective in data review to ensure the quality and integrity of clinical trials are maintained. On the other hand, the data management team, CDM, are responsible for ensuring data is valid as it is collected from various sources such as the Case Report Form, CRF, databases, and data entry. Data cleaning requires a team effort that includes the CMT and the CDM team to collaborate effectively. The clinical data management team ensure that the discrepancy in data that is generated from medical coding, data extraction, or the ambiguous handwriting, are clarified before it is incorporated as part of clinical trial data. Discrepancy management helps in cleaning the data and assists with the documentation of a deviation which would require a corrective action and preventative action plan. According to Krishnankutty et al., 2012, the CDM reviews all discrepancies at regular intervals, where flagged discrepancies on a data clarification form that requires clarification from the investigator would be sent to the site and if it is self-evident corrections such as spellings, it can be done in-house. Krishnankutty et al., 2012, further adds, that most CDMs have a computer programing based educational background and may not be as advanced in their medical terminology or abbreviation knowledge as compared to a clinical trials manager. Most computer software used for detecting discrepancies, use centralized monitoring system where a sound-based indicator is used to capture data related errors. Most errors frequency is calculated using statistical measurements. This does not capture all medically coded errors for which the CMTs are more effective. According to Riddle, 2018, the CMT is composed of experienced physicians with deep and specific therapeutic expertise in clinical research and safety arena. When the communication strategies used between the CMT and CDMs are effective and productive, it helps catch errors that could lead to adverse events or severe adverse events and jeopardize the clinical trial outcome. Most physicians are too busy to communicate on the phone or check emails, therefore, use of updated apps such as slack messages or texts are more effective methods of communication. However, when the CDMs have a good working relationship with the monitors, it is easier for the team to inform the monitors and vice versa so that the investigational site can be alerted of the errors that needs clarification. In most cases, when a sponsor has clinical trials, the clinical monitoring team and clinical data management team all fall under the clinical division of the company. Most companies invest a generous sum of finances in the social atmosphere for the team that helps communication with catered lunch during team meetings to ensure everyone on the teams are present for the observable metrics that influences the key operating indicators. In addition, the freedom to communicate on your cell phones with apps that helps to exchange data files such as google drives or slack assists in reviewing the data that needs immediate attention. In many cases, it may be difficult to agree with everyone on the team when working together, however, a dedicated team leader usually cultivates a good communicable environment where ideas can be shared and discusses, and this is done with a well formatted data management plan. If the protocol designs are established and the regulatory team examines the compliance aspects, then the data management team can create a well-structured data management plan that can assist the clinical trial monitoring team to review and communicate their obstacles experienced during data capture. This way, a team effort is put forward to ensure good documentation practices in alliance with ALCOA and collection of adverse or serious adverse events before the close of the study. A clinical trial is only valid if it is documented correctly. Documentation practices requires assurance of information being valid and hence it is important that a good relationship is maintained between the clinical monitoring team and the data management team so that the records for events are established and any discrepancy documented can be clarified before publications of any kind. Reference Krishnankutty, B., Bellary, S., Kumar, N. B. R., Moodahadu, L. S., 2012., Data management in clinical research: An overview., Indian Journal of Pharmacology., 44(2): 168-72., Cited: (PDF) Data management in clinical research: An overview (researchgate.net) (Links to an external site.) Riddle, W. M., 2018., Medical monitoring 101: Providing medical expertise for clinical trials., C3i Solutions., April 26., Cited: Medical Monitoring 101: Providing Medical Expertise for Clinical Trials – C3i Solutions

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.