Topic1:(Electronic Data Capture);Topic2( Clinical Trial Management Systems)

Topic1:(Electronic Data Capture);Topic2( Clinical Trial Management Systems)

Topic1:(1Page)((Electronic Data Capture);Electronic data capture (EDC) offers the possibility of entering study data directly into the electronic database, bypassing the need to use and/or transcribe paper CRFs. It not only will alter the way data are collected and prepared for analysis, but it also will have a profound effect on the sequence in which critical data management tasks are accomplished and by whom.

To prepare for this Assigment, reflect on the practical implications EDC has for clinical trial procedures and the potential effect on the roles and responsibilities of clinical personnel.
Write a (1 page)comprehensive response to the following:
1) What are the most important ways that EDC affects the conduct of a clinical trial?
2) How does EDC affect the role and responsibility of a CRA?
Please include citation through out the paper;please answer all the questions;
Topic2:(1page)(Clinical Trial Management Systems);To prepare for this Application Assignment, examine and explore the Web sites for clinical data management system vendors. Compare the features offered by each, focusing on which features or capabilities they share and which are unique. Examine the sample forms and/or computer interface pages displayed on the Web sites to get a sense of how the systems “feel.”

To complete this Application Assignment, write a 1–page paper based on your examination of the Web sites. For each of the vendors listed in the Required Resources section:
1) Identify a particular product, component, or feature that you think is particularly valuable for conducting a clinical trial leading to a regulatory submission.
2) Describe how it would be used.
3) Explain why you think it would help advance the data management goal of the trial.
Identify at least one potential difficulty in using that system.
Please include citation throughout the paper;Please answer all the questions

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