APA Paper on Clinical Research Monitoring

I need a skilled writer to craft a 5-page APA format paper focusing on Clinical Research Central Monitoring and Analytics. Your paper should cover: - An introduction to clinical research monitoring and analytics - The significance of these processes in clinical research - Potential challenges and solutions in monitoring and analytics - Future trends and possibilities in this field Ideal candidates should have: - A strong background in clinical research, data analytics, and/or healthcare - Excellent academic writing skills - Familiarity with APA formatting and citation - Ability to conduct thorough research and present complex information in a clear, concise manner. RUBRIC: (review) The attached Central Monitoring Plan and Central Monitoring Analytics excel (below) are both examples of what central monitoring plans and outputs would look like. These would go to the CRA and the CRA lead for that study. These are "given" as a result of the central monitoring effort. These are listed here to help you see an example of what an actual central monitoring plan would look like. The second excel sheet would be an example of an ongoing "output" from the central monitoring team to give you a view of what types of data would come directly to you as a CRA or CRA lead. Are these elements useful from the perspective of the study team? These elements help you to craft your position paper "to the committee" for this assignment on the benefits of central monitoring. Paper Scenario You are a pharmaceutical project manager associated with a compound that is planned to have 4-5 co-occurring/overlapping trials of this compound. The success of these trials is extremely important, and you are on the executive committee with the goal of overseeing and verifying these trials are set up with a focus on quality. Because of the tight timelines to get the compound ready for FDA submission, some of the required trials will have to overlap (although minimally). As such, the monitoring of the trial is critical to the success of the compound overall. You propose instituting central monitoring (off-site monitoring that will feed in findings to the on-site monitoring team). You are proposing monthly calls with the central monitor so you can see the central monitoring team’s analytical information (negative deviation trend information with pre-set parameters such as data entry, protocol deviations, re-querying rate, and SAE/AE rates per subject). Your job at this time is to propose this central monitoring (CM) approach to the other executive committee members. Assignment Files Analytics Paper [login to view URL] Transcelerate [login to view URL] Central_Monitoring_Plan_(25-Aug-2018) (1).docx This document describes the agreement on how analytic reports (in this case, the Example Central Monitor Report) will be framed/prepared. Includes agreed-upon definitions and criteria. Statistical Monitoring in Clinical [login to view URL] (This can serve as one of your referenced ) Knepper et al. (2016). Statistical monitoring in clinical trials: Best practices for detecting data anomalies suggestive of fabrication or misconduct. Therapeutic Innovation & Regulatory Science, 50(2) 144-154. Example Central Monitor Report [login to view URL] Download Example Central Monitor Report [login to view URL] is a simplified and mock version of the report that would be received monthly (or per agreement) for a study to meet the agreement as outlined in the above document Central Monitoring Plan. It would be presented to the lead CRA/Clinical Lead/ or PM depending on the study set up and the size/scope of the study. This is a document specific to the Sponsor side of the business although it does discuss the activities of the site. These activities of the site are, however, a reflection of the CRA since site success, or lack thereof, is a metric for the CRA. attachments Paper Scenario Review these documents. An additional one can be used but is not required. Build a case for the use of the risk-based monitoring approach. The central monitoring plan and analysis report (attached) are in line with risk-based monitoring. They are used in a way to support this type of monitoring by reviewing the "highest risk" issues at sites. In this case, its evaluation of SAEs and AEs, query generation and solution timelines, and issue trending. Submit: Must include (this is the rubric): 15 points: Introduction and conclusion. Be thorough - consider what you are covering in the paper and highlight that in the intro. The intro must include a concise yet clear idea to the reader on what you plan to cover in the paper, which does include your general position on Risk-Based Monitoring (RBM)/Central monitoring. Drive home your key points in the conclusion. 20 points: APA version 7 style and formatting (for example, include the following, but this is not an all-inclusive list. Use the link below to APA version 7 student paper examples and/or websites for APA that will help you: title page, page numbering, spacing, margins, font size and type, references, and flow but no need for abstract. Indenting paragraphs are part of APA. If you use subheadings and headings, make sure they are APA style - see the link below to a student example paper that has the rules for headings and sub-headings). YOU CAN USE FIRST PERSON FOR THIS PAPER since you are expressing your opinion to your clinical trial group, within a CRO or sponsor, on the benefits of the central monitoring approach. 20 points is a lot - be sure to address this part fully so you maximize your points. 15 points: at least 3 appropriately cited references (two can be from the articles here). These citations MUST be appropriately peer-reviewed from journals and textbooks. Sources such as blogs or CRO advertisement websites are not appropriate and will have a deduction of points. It is paramount that you have proper APA formatting to gain all 15 points. For example, in-text citations must be per APA version 7, and the reference list must be documented per APA version 7. You can use the APA website or Owl PurdueLinks to an external site. website to find out how to reference the source you are using properly. Want to view a sample APA Version 7 student paper? Here is one to use and verify that you are properly using APA version [login to view URL] to an external site. 30 points: List at least two (3 is optimal) steps on how Risk-Based Monitoring (and therefore, central monitoring) is set up/functions. So you are "educating" your team on this approach. This way, there is a natural flow from the benefits of central monitoring to mitigating risks. 30 points: Three (3) benefits of the risk-based monitoring approach/central monitor usage. Examples are recommended. Use liberties or use the central monitoring report and attachments as a means to find the right "benefits" to highlight. 20 points: Two (2) robust ways to mitigate the risk with one example each (specific or general is fine) of a site trending negatively (for example: what would you do as the monitor or monitor manager for the sites that may be showing higher "risk"); (hint: would you recommend a certain type of action? Check the textbook for ideas - remember ideas such as CAPA, additional monitoring, etc. You can take liberties here since you do not have the "monitoring plan" for this study -that's ok. Just think about what options may help). **Use examples!! The example report in this assignment can be used or some aspects can be highlighted/referenced. Consider this paper going to your internal clinical team members. Consider that you are sharing some insights you have gained on central monitoring from the reports you have (let's say, for example, this is the first time you employed the central monitoring strategy on your clinical trial (CRO or sponsor) and you are now reporting on its success/ whether the team should use this same approach in the future. Change is hard for companies, so how would you relay the importance of what was gained from this approach? Examples help a lot). 20 points: Identity two follow-ups from these two mitigations. For example, if you are setting up a CAPA, what follow-up may be needed for that CAPA? If you are setting up additional monitoring visits, what is going to be the potential trigger to stop the added monitoring visits? For example, how does this central monitoring approach/risk-based monitoring approach possibly HELP with risk follow-up (hint: often, it's already built into the monitoring plan, so there is no additional thinking that has to be done on the spot. Instead, the risk and plans for risk is built in so all monitors may be able to be more consistent in their approach globally or across the study sites for the entire study)? *** Food for thought: how does RBM/CM potentially benefit an institution financially in the short term versus the long term? What is the evidence, thus far, on the benefits of RBM/CM? How might this impact the CRA/monitors on a trial short term/long term? How about the team itself in regards to the data they would have available at any given time? How would this impact the medical monitoring team (more "live" data for review)? These do not each have to be addressed, but I am giving you a leg up so you can focus on the critical aspects of this approach.