Data Management Education Series

All sessions will take place in the Lakeside 1400 Conference Room

Title

Description

Date/Time

Basic 1: It’s a System!

Talking through the critical questions, the march of science, systems and diagrams. Start here to understand the entire process.

9/29/15:

9am-10am

 

Basic 2: Research Plan

Learn the elements of a well-developed Research Plan including an Introduction, Background, Goals, Clinical Plan, Data management Plan, Statistical Analysis Plan, Regulatory Considerations Human Subject Protections.

10/6/15:

9am-10am

 

Basic 3: Building a Data Management Plan

Outline the basic data management process and data flow. Examine the elements of a data management plan. Define individual roles, responsibilities, and access privileges.

10/13/15:

9am-10am

 

Basic 4: Data Entry and Quality Control (including CRF design)

Ensure the CRF reflects the protocol’s main points. Develop clear unambiguous questions. Discuss the development of CRF instructions. Address common design challenges and design the CRF to record data that can be used in the final study report. Develop methods to track CRFs.

10/20/15:

9am-10am

 

 

 

 

Advanced 1: The Regulations: HIPAA for Research

Ensure data collection and management complies with HIPAA privacy laws. Review PHI and identifiers. Common Rule vs. Privacy Rule.

10/27/15:

9am-10am

 

Advanced 2: The Regulations: 21 CFR Part 11

Scope and application guidance, electronic records, electronic signatures, and validation.

11/3/15:

9am-10am

Advanced 3: Data Safety Monitoring Board

A system for the oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data.  The data and safety monitoring functions and oversight of study activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB).

11/10/15:

9am-10am

Advanced 4: Study Infrastructure Template

A template to help organize the entire study.

11/17/15:

9am-10am