Data Management Staff Roles and Responsibilities

Data Management Staff Roles and Responsibilities

It is 2 sections out of a data management plan: 1- Roles and Responsibilities and 2- Data Base and Study Closure.. I can provide you with real life examples and documents both just need to be customized to a specific protocol

I had another tutor attempt to complete this but they obviously have no idea of what they are doing –  I have attached his work which was poor.

 

See instructions below:

Please use the attached PPT Recording to complete this assignment. The sections that need to be completed based on the protocol are: Section 2 and Section 7.

Each paragraph must be 7 sentences minimum

Information must be presented and written in your own words and not copy and pasted from the protocol or include references

For this assignment, consider that all data captured is done electronically via EDC

Please Note:

Data Management Staff Roles and Responsibilities:
Tables work well here also – a simple 2 column table demonstrates Roles/Responsibilities
Bulleted lists also work well within the table
Include all major roles + some secondary roles
It is not sufficient to only list “PI, DM, Proj Mgr, Statistician”

Database closure checks, quality assurance at closure and database lock, and database unlock:
CRA’s role prior to lock/freeze
Once locked…then what?
Steps to be performed prior to DB closure and why
What does the PI have to do?
If mention GCP for DB lock be sure to define what that means
Who does the closure checks?
What roles does the Sponsor have?

Requirements: Per instrtuctions

 

Subject: Health & Medical

 

all attachments, examples, and instructions attached

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