You have been assigned as the Clinical Research Manager "CRM" for new drug study on diabetes....

Question

You have been assigned as the Clinical Research Manager "CRM" for new drug study on diabetes. Describe best practices you would use to begin the process of moving this study forward. Specifically, address:

Quality: How you would ensure the quality of the study?

Policy: What, if any, policies might be in place supporting the study?

Risk: What risk assessment tools would you use?

Audit: How would you prepare for an audit?

Directions:

This assignment requires writing a paper that explains how you would accomplish the four (4) issues noted above. Remember that words matter - therefore, your writing should be in a scholarly format. Please include headings for the four topic areas (Quality, Policy, Risk, and Audit) for consistency in explaining your responses.

Length: 4-6 double-spaced pages
excluding cover page and references

Font: Arial 11 pt

Margins: 1" all around

Requirements:
- Cover page
- 4-6 pages for text/description
- Introduction (the introduction explains how you, as the CRM, will address the topic)
- Four topic areas
  - Quality
  - Policy
  - Risk
  - Audit
- References (Please use APA 7 formatting, see thisLink)

You have been assigned as the Clinical Research Manager “CRM” for new drug study on diabetes. Describe best practices you would use to begin the process of moving this study forward. Specifically, address: 1. Quality: How you would ensure the quality of the study? 2. Policy: What, if any, policies might be in place supporting the study? 3. Risk: What risk assessment tools would you use? 4. Audit: How would you prepare for an audit? Directions: This assignment requires writing a paper that explains how you would accomplish the four (4) issues noted above. Remember that words matter - therefore, your writing should be in a scholarly format. Please include headings for the four topic areas (Quality, Policy, Risk, and Audit) for consistency in explaining your responses. · Length: 4-6 double-spaced pages excluding cover page and references · Font: Arial 11 pt · Margins: 1" all around · Requirements: · Cover page · 4-6 pages for text/description · Introduction (the introduction explains how you, as the CRM, will address the topic) · Four topic areas · Quality · Policy · Risk · Audit · References (Please use APA 7 formatting, see this Link) https://owl.purdue.edu/owl/research_and_citation/apa_style/apa_formatting_and_style_guide/reference_list_electronic_sources.html Case Evaluation Case Evaluation Criteria Ratings Pts This criterion is linked to a Learning OutcomeRequired Components The paper includes all 4 section requirements 5 pts Full Marks 3 pts Partial Description The paper describes 3:4 components 2 pts Partial Description Paper includes 2:4 components 0 pts No Marks The paper fails to effectively describe the 4 components noted in the assignement 5 pts This criterion is linked to a Learning OutcomeFormating The paper uses all required formatting including cover page, 4-6 pages of appropriate text, reference page. 5 pts Full Marks 3 pts Partial Description The paper includes a partial representation of the required components 0 pts No Marks The paper fails to meet assignment requirements for the paper 5 pts This criterion is linked to a Learning OutcomeGrammar & Spelling The paper is free from spelling and grammar errors 5 pts Full Marks 3 pts Partial Description The paper has minimal (<5) grammar="" or="" spelling="" errors="" 0 pts="" no="" marks="" the="" paper="" has="">5 grammar or spelling errors. 5 pts This criterion is linked to a Learning OutcomeReferences The paper uses appropriate peer-reviewed journal references 5 pts Full Marks 3 pts Partial Description The paper uses a minimal number of peer-reviewed journal article references 0 pts No Marks The paper fails to use peer-reviewed journal article references 5 pts Total Points: 20

crm-731-paper-offq3vmj.docx

Sunabh · Accepted Answer

Running Head: HEALTHCARE			  					    1
HEALTHCARE										    7
HEALTHCARE
Table of Contents
Introduction	3
How you would ensure the quality of the study?	3
What, if any, policies might be in place supporting the study?	4
What risk assessment tools would you use?	5
How would you prepare for an audit?	6
Conclusion	7
References	8
Introduction 
Clinical Research Manager (CRM) holds one of the most critical position within the healthcare industry. This is majorly because CRM are required to oversee all aspects of a clinical trial along with the evaluation of new medical devices and medications proposed by new findings. CRM carry the responsibility to ensure that the clinical trials are conducted under specific and strict guidelines and this is because clinical trials are vital to the development of any new medical device or medication. Being a CRM, it becomes a part of their reasonability to act as liaison between clinical study sponsor and the trial site. This paper will focus upon the roles and responsibilities of a CRM through a new drug study on diabetes. Further, efforts will be made to present the aspects of quality assurance, policy adherence, risk assessment as well as audit preparation, which are the core competencies of a CRM. 
How you would ensure the quality of the study?
	As mentioned above also, CRM has some of the most critical roles and responsibilities. Planning, directing and coordinating can be considered as three vitals of ensuring quality of this new drug trial study. It would be essential to consider that once a company develops a new healthcare product, they are required to adhere with the government regulations and compliance before it is launched in the market. Therefore, here clinical trials are performed in order to determine and justify that the product is safe for public use in short as well as long terms. Quality in a clinical study refers to a set of characteristics of a product or a device, which could affect its ability to ensure customer satisfaction (Salzman, 2020). Therefore, considering the current drug study, quality aspect could refer to adherence of regulations and guidelines as per Unites State Pharmacopeia (USP), following the protocols, ensuring compliance to research ethics. Likewise, being a CRM it would be my responsibility to ensure that the data generated by the researchers during study reflect as per what is specified in the protocol or the standard operating procedure (SOP).
	Moreover, ongoing challenge in managing the quality of drug development study would be to continuously monitor data collection procedure proposed by the researchers along with the data management practices as mentioned in the proposal at every level of study. Likewise, I will also have to ensure that the data analysis is accurate as per the recorded data in the CRF (case report form). Further, ensuring ethics of the study and no manipulation of data during the study will also be one of the most essential responsibility of CRM in this research (Chang, Tan, Duke & Ng, 2017). 
What, if any, policies might be in place supporting the study?
	It would be essential to consider that clinical trials of a drug are performed in order to ensure its safer use on rest of human population. Therefore, there can be existing policies and procedures supporting the clinical trial or study. 34.

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