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Please create a high-level masters level PowerPoint (14 slides) with speaker notes on each slide for the following 2 questions 1. Who do you think bears responsibility for the conduct of clinical...

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Please create a high-level masters level PowerPoint (14 slides) with speaker notes on each slide for the following 2 questions

1. Who do you think bears responsibility for the conduct of clinical research?

2. What steps if any would you take as a Clinical Research Manager should you observe or suspect misconduct on the part of a principal investigator? What would be the potential ramifications of those actions or inactions?

**Please utilize the following YouTube videos as well as the Attached PDF, which is requirement of the paper – feel free to utilize other resources if needed but these videos and pdf are part of the requirement**

(Project management and leadership for Clinical Research) https://www.youtube.com/watch?v=rZB7E8cZSKM&t=3s

(Project management factors) https://www.youtube.com/watch?v=M5aADEEkLIk&t=1s

(Clinical trial challenges & success factors) https://www.youtube.com/watch?v=u7G9lHWRqvs

Answered 2 days After May 31, 2022

Solution

Dr Raghunandan G answered on Jun 02 2022
96 Votes
PowerPoint Presentation
PRINCIPAL INVESTIGATOR
    The individual(s) who are in charge of a clinical trial or a research grant for scientific study. The principal investigator is the person who is responsible for preparing the clinical trial protocol (the plan for the study) as well as ca
ying out the research that is funded by the grant.
    The PI is responsible for ensuring that the study complies with all regulatory requirements and is conducted in accordance with the standards for Good Clinical Practice that are recognised internationally (GCP).
In addition to this, the PI is accountable for ensuring that all participants in the clinical research receive the necessary medical attention in connection with it.
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    Monitor. Monitoring and reporting is done by the sponsor or the CRO's monitor, who is responsible for verifying data.
Following are the key responsibilities of a monitor:
    To ensure a successful trial, make sure that the investigators are well-qualified, experienced, and equipped with the necessary resources.
    It is also important for the monitor to verify that the investigator is available for the trial's duration. Make sure that all the necessary facilities (laboratories, equipment, staff, storage space, etc.) are available for the duration of the trial. '
    Ensure that the following (the monitor's role) is met:Only those who meet the eligibility criteria are included in the study.The site has a sufficient amount of IP and is storing it in a proper manner.Only those individuals who are eligible for IP get it, and only at the dose(s) and time(s) stated (s).The site strictly controls and documents all aspects of IP receipt, use, return, and disposal.The protocol is adhered to, together with any and all modifications that have been accepted.The most recent edition of the Investigators Brochure, as well as any trial materials needed, were sent to the appropriate investigator(s).The investigator is in charge of all necessary paperwork while on the jobsite.There are no misunderstandings about the experiment and its different parts, and all parties involved adhere to the GCP principles and SOPs.Documented agreements with the sponsor and concerned party dictate that all parties adhere to their designated roles.A duty or function allocated to one party may not be delegated to another without the express permission of all parties involved.
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Site / Investigato
    All medical decisions relating to the trial must be made by a competent medical professional. All participants in a clinical trial must be given adequate medical attention if they experience any adverse effects. A
angements for medical treatment and follow-up must be prepared in the event that a participant withdraws from the experiment or the trial is terminated early.
    Whenever a clinical trial begins, an Investigator Site File (ISF) needs to be created for each participant. The International Standard Form (ISF) is a list of the most important documents that must be kept during a clinical research.
Site / Investigato
At a clinical trial site, a clinical trial investigator is responsible for overseeing all aspects of the clinical experiment. A clinical trial's responsible leader is known as the Principal Investigator when it is done by a team of individuals at the trial site.It is a unique clinical trial in which the clinician is both the sponsor and the investigator. The investigator-initiated trial (IIT) clinical investigations are described as experiments involving the use of a drug or medical device that involve one or more people participants.
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Clinical Research Nurse
    Additionally, clinical research nurses play an important role in ensuring the safety of participants, maintaining informed consent, ensuring protocol execution is accurate, and following up on data.
    There is still another way to coordinate your study schedule. Medical monitoring, prescription management, study visits, and patient education can all be done in-house rather than paying an outside company.
    a lot more expensive than using CRC.
    The work as a clinical research nurse is going to put you in a position to help create new medical treatments and cures. Some patients' lives can be improved or extended as a result of the job you conduct during your profession.
As a part of clinical trials, research nurses assist in defining study criteria, drafting standard operating...
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