Identify and name five (5) data management reports for the PCRT 04-001 protocol

Identify and name five (5) data management reports for the PCRT 04-001 protocol

Reference Material and Protocol is attached

Part 1:

• Identify and name five (5) data management reports for the PCRT 04-001 protocol
  • 50 points:10 points each
• List and define five (5) data management reports
• Select (1) of the five (5) reports you just identified and design the content
• Create the layout for the data management report using the tabular format outlined below
  • 20 points
• Populate the table with data to demonstrate your understanding of the report’s content and add a legend after the table explaining the contents
  • 10 points

Instructions:

• Assume you are a Data Manager in need of data reports
• Review the PCRT 04-001 protocol
• Recall the following about reports. Validation needs are critical to consider in the design stage. For this assignment you don’t have to address validation needs, but it is important to remember to consider them.
• Decide if your (5) reports will be standard, ad hoc, or some of both
• For each of the (5) reports you need to define, answer these 3 questions (about the data):
• List the titles of 5 recommended data management reports
• In addition to providing titles for the 5 DMR’s, provide details for the purpose of each report:what is being captured, what are you reporting
• Be sure the 5 reports you include are capturing data that is useful versus “nice to have” or that you think “will be needed in the future”
• Be sure that your 5 reports meet the criteria for a DMR:
• Do not use the example provided below for Unanswered Queries or Missing Data as one of your 5 reports
• Do not use Informed Consent or Ethics as one of your 5 reports
• Do not use any of these as one of your 5 (requires more detail than would feasible for this exercise):
• Notice the differences between the Acceptable/Unacceptable examples below and focus on providing enough details for data to be captured (in addition to the title).Examples:

Acceptable:PCRT 04-001 Study:Listing of Outstanding (Unanswered) Data Queries, Ordered by Site No.

Acceptable:PRCT 04-001 Study:Listing of all reported severe adverse events possibly or probably related to PTK787, action taken, ordered by SAE start date

Unacceptable:PCRT 04-001 Study:Audit Trail Report

Unacceptable:PCRT 04-001 Study:Coding Reports (MedDRA and/or WHO Drug Coded Data)

• Notice *why* 2 of these reports are acceptable.What is missing from the 2 unacceptable examples?

Part 2:

Instructions:

• Create the “shell” for your selected report illustrating your recommended content and layout of the report
• Populate the “shell” with a minimum of one (1) line of simulated data
• Add the legend explaining the data in the table

• Shown below is an EXAMPLE for Exercise: Part 2:

Include the following:

• Title of the Report
• The data (content) to be included in the report, organized in a layout you would recommend
• A placeholder for the date that the report would be generated from the database (often called “report run date”)
  • Placeholders = fictionalized content
• A placeholder(s) for the database table names from which the content for your report would be pulled

Example:

• Title:CRT 04-001 Study:Listing of Outstanding (Unanswered) Data Queries, Ordered by Site Number
• Data to be included in report:
  • Site number
  • Participant ID
  • Check_Name
  • Query
  • Query Post Date
  • Query Due Date
  • Days Past Due (as of Report Run Date)
• Report Run Date:1/1/2019
• Database Table(s) accessed for this report:SITE, PPT, QUERY

Title: CRT 04-001 Study:Listing of Outstanding (Unanswered) Data Queries, Ordered by Site Number

­­­­­­­­­­­­­­­­­­­­­ ________________________________________________________________________________________________

Report Run Date: 1/1/2019

Database Table(s) accessed for this report:SITE, PPT, QUERY

• This report lists *ALL* of the outstanding queries
• Queries are organized by site number
• All of Site 1’s outstanding queries (and relevant data) are listed first
• Site 2’s unanswered queries follow Site 1’s outstanding queries, etc.

Requirements: Per instructions

Subject: Health & Medical

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