/ Published in HOMEWORK QUESTIONS

Sample Management Research Paper on Data Management Reports

Part 1: (50 pts)

  1. Identify and name five (5) data management reports for the PCRT 04-001 protocol
    • 50 points: 10 points each

Instructions:

  1. List and define five (5) data management reports
  • Assume you are a Data Manager in need of data reports
    • Reports: standard or ad hoc
    • Audience: Data mgmt. staff, CRA, QC auditors etc
  • 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.
    • Requires full validation: std or ad hoc report used to evaluate or make a decision concerning safety and efficacy of a treatment
    • Doesn’t require full validation: reports that are operational in nature (administrative, tracking, data mgmt. review)
  • 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):
    • From where: study or studies from which the data is extracted (used to id the source)
    • Exactly what: selection criteria
    • When: date of the report
  • 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:
    • For example, an informed consent deviation that occurs prior to a study-related procedure is critical information but not for the database. Instead this information should be captured as a protocol deviation.
    • When designing your DMR recall that DMR’s are for data.
    • EDC systems typically have standard reports that can be used to gauge important study elements such as status, outstanding data queries, missing visits, and expected dates of visits
    • EDC systems (versus DMRs) can also be programmed to produce reports containing more granular data such as AE’s per site, etc
  • 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):
    • Treatment summary
    • Response Summary
    • Edit Check Summary Report
    • Audit Trail Report
  • 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: (25 pts)

 

  1. Select (1) of the five (5) reports you just identified and design the content
  2. Create the layout for the data management report using the tabular format outlined below
    • 20 points
  3. 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:

  • 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