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  • CDM 2nd Assignment by Urmila

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    Prabuddh Shakya
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    The document outlines an assignment for a clinical trials management course. It includes 11 multiple choice and short answer questions worth a total of 20 marks. The questions cover topics like tools for clinical trial data management, the Belmont Report principles, data management plans, clinical research forms, clinical data acquisition standards harmonization, artificial intelligence in clinical research, and clinical trial stakeholders. Students are instructed to answer all questions in their own language and submit the completed assignment to the specified email address.

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    Pharmacy training assignment

    Original Title

    CDM 2nd assignment by Urmila (1)

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    The document outlines an assignment for a clinical trials management course. It includes 11 multiple choice and short answer questions worth a total of 20 marks. The questions cover topics like tools for clinical trial data management, the Belmont Report principles, data management plans, clinical research forms, clinical data acquisition standards harmonization, artificial intelligence in clinical research, and clinical trial stakeholders. Students are instructed to answer all questions in their own language and submit the completed assignment to the specified email address.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as docx, pdf, or txt
    18 views2 pages

    CDM 2nd Assignment by Urmila

    Uploaded by

    Prabuddh Shakya
    The document outlines an assignment for a clinical trials management course. It includes 11 multiple choice and short answer questions worth a total of 20 marks. The questions cover topics like tools for clinical trial data management, the Belmont Report principles, data management plans, clinical research forms, clinical data acquisition standards harmonization, artificial intelligence in clinical research, and clinical trial stakeholders. Students are instructed to answer all questions in their own language and submit the completed assignment to the specified email address.

    Copyright:

    © All Rights Reserved
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    of 2

    CTM Assignment 1

    Total Marks - 20

    CANDIDATES DETAILS

    Candidate Name-

    Email ID-

    Program taken-

    Instructions

    1. Please mention your name and email id


    2. All questions are compulsory
    3. Answer should be in your language
    4. After completion of assignment, send it on vishal.chaudhari@cliniversity.com
    5. Marks will be counted for your final grades

    Q1 Name the tool used in clinical trials for data management. 1 mark

    Ans:

    Q2 What is IRT? 2 mark

    Ans:

    Q3 List two principles of Belmont report. 1 mark

    Ans:

    Q4 Which is/are the document referred for DMP organization? 1 mark

    Ans:

    Q5 What is DMP? How does it maintain? 3 Marks

    Ans:

    Q6 Why do we need CRF? List two reasons. 2 marks

    Q7 What are the considerations implemented during CRF development? 3 Marks

    Ans:

    Q8 What is CCG? Explain all the domains of CDASH. 2 Marks

    Ans:
    Q9 How AI is useful in CRF preparation? Write two benefits and limitations of using AI in CRF
    designing. 4 Marks

    Ans

    Q10 What are the general CCG guidelines? 2 Marks

    Ans

    Q11 Who are the stakeholders in Clinical trials? 2 Mark

    Ans:

    Q10 What is SDTM? Write one advantage of using CDASH in CRF designing. 2 Mark

    Ans:

    END

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