Please create a high-level masters level PowerPoint (13 slides) with speaker notes on each slide for the following 2 questions Please address following questions: 1. How would you as a Clinical...

Running Head: Clinical Research Manager                  1
Clinical Research Manager                             8
CLINICAL RESEARCH MANAGER
Table of Contents
Slide 1: Title    3
Slide 2: Management of team's study files and essential documents    3
Slide 3: Review and completion of the study's documentation    3
Slide 4: Designing databases    4
Slide 5: Data gathering    5
Slide 6: CRF monitoring    5
Slide 7: Input information    5
Slide 8: Validation of data    6
Slide 9: Discrepancy control    6
Slide 10: Healthcare coding    7
Slide 11: Securing a database    7
Slide 12: Responsibilities and roles    8
Slide 13: Conclusion    9
Slide 14: References    10
Slide 1: Title
· Title:
Slide 2: Management of team's study files and essential documents
· Tools
· Review and completion of the study's documentation.
· Designing databases.
· Data gathering.
· CRF monitoring.
· Input information.
· Validation of data.
· Discrepancy control.
· Healthcare coding.
· Securing a database.
· Responsibilities and roles.
Data collection, cleansing, and management (CDM) is the procedure for gathering, managing, and handling subject data in accordance with legal requirements. The main goal of CDM procedures is to produce high-quality data while collecting the most data feasible for analysis. This is done through minimizing mistakes and missing data. This article outlines the CDM procedures and provides an overview of clinical trial data management.
Slide 3: Review and completion of the study's documentation
· As the initial stage in converting the protocol-specific actions into data being created, the CDM team designs a Case Report Form (CRF).
· The data fields should have uniform definitions across the board.
· In CDM tools, variables are identified via annotations, which are coded phrases.
· All potential answers will be suitably coded in questions with discrete value alternatives.
· The data handling process is mapped out in a data management plan (DMP).
The procedure is examined for consistency and clarity from the standpoint of database design. As the initial stage in converting the protocol-specific actions into data being created, the CDM team designs a Case Report Form (CRF) (Zhuang et al. 2022). The data fields should have uniform definitions across the board. For instance, the data entry field should have two data boxes positioned after the decimal if weight must be recorded to two decimal places.
In CDM tools, variables are identified via annotations, which are coded phrases. The variable is named using either internal naming standards or the SDTMIG when CRF annotation is performed (Wake Health). All potential answers will be suitably coded in questions with discrete value alternatives, such as the variable gender, which accepts the values male and female as responses. The data handling process is mapped out in a data management plan (DMP).
Slide 4: Designing databases
· Databases are created to make it easier for the CDM duties to conduct several researches.
· To guarantee data security, "system validation" is ca
ied out, during which system specifications
· The database contains defined study information, and CRF layouts are created for data entry.
· Before being used for real data gathering, these input screens are validated using fake data.
The clinical software programs known as databases are created to make it easier for CDM to do several investigations. Data security is ensured through a process known as "system validation," which involves assessing the system needs and regulatory standards (Zhuang et al. 2022). The database contains study details such as objectives, intervals, visits, investigators, sites, and patients, and CRF layouts are built for data entry.
Slide 5: Data gathering
· Data is gathered using the CRF.
· The typical way of collecting data responses is to use paper CRFs, which...