Data Management & Informatics in Clinical Research

Wednesdays, April 3 – June 12, 2013

UC San Diego Extension, University City, 6256 Greenwich Dr. Room # 117 4:00PM – 6:00PM

The following contains information about:

1.  Faculty

2.  Educational Objectives

3.  Concept Project

4.  Work Groups

5.  Quizzes

6.  Evaluation

a.  Student Evaluation (grades)

b.  Course Evaluation

1. Faculty

–  Joe Ramsdell, M.D. ( Module Director)

–  Zia Agha, M.D.

–  Victor Bagwell, Ph.D.

–  Lucila Ohno-Machado, MD, Ph.D.

–  Carl Stepnowsky, Ph.D.

–  Brian Clay, M.D.

–  Robert El-Kareh, M.D. MPH

–  Paul Shragg, M.A.

•  Module Support: Paul Shragg;

–  Facilitator

–  Quiz and home work grader

–  Source of practical advise on data management

2. Educational Objectives

At the end of the course, the participant will

·  Discuss 3 principles that make the foundation of the FDA’s Clinical Practice Guidelines in clinical research

·  Create a rational form design that will include concepts for ease of completion, ease of computerized data-entry, and validation and reliability checks.

·  List 3 methods for data confidentiality of Personal Health Information

·  Discuss the differences between database management and clinical research, medical informatics and viral informatics

·  Create and write a data management plan

·  Review and critique data management plans for clinical trials.

3. Concept Project

The interim draft will be 15% of your grade and the final project will account for 25% of your grade. 5% is from participation in the mock study section on the last day of class. This is a total of 45% of your grade.

Prepare a Data Management Plan for a hypothetical (or real) project to include:
A. A synopsis of the research goals of the clinical study and its general design (this would normally be elsewhere is a project proposal but is needed so that reviewers can understand the context and requirements for the data management section of the proposal) < 1 page

B. A Data Management Overview (up to 3 pages) that addresses each of the following elements:

·  Data management goals

·  High level description of procedures for data management

·  Data completeness

·  Data accuracy (correctness)

·  Source verification (auditing)

·  Data security and methods for maintaining confidentiality

·  Data availability

·  Study Communications and Coordination functions

C.An Appendix (no limit on length) that includes:

·  A table of contents

·  A sample on-study enrollment form and

·  One study-event-related form

·  Other detail associated with the elements described in #1 above, as needed to “make it obvious” the study is well planned

D. A Budget in PHS 398 format and narrative budget justification

4. Workgroups

•  Pre-assigned – see Blackboard for assignments

•  Work together for group exercises during class

•  Constitute an “NIH Study Section” on final day of the course

5. Quizzes

Each week, quizzes based from the assigned readings will post on the blackboard. These are due at the beginning of the class.

6. Homework: CREST policy is that there are two hours of homework for every one hour of class time. It is anticipated that the homework necessary for this module should take about three hours.

7. Student Performance Evaluation

45% PROJECT divided by 15% Interim submission, 25% final project, & 5% mock study

25% quizzes

10% mini –IRB project (Dr. Agha)

10% Investigator training (NIH website)

10% attendance/evaluaton;

8. Course Evaluation

Evaluations for each individual session must be completed before leaving that session

CREST Data Management & Informatics -Schedule

Week / Date / Topic / Instructor / Required Readings For Following Week / Quizzes, due by 5:00 pm Wednesdays / Projects
1 / 4/3/13 / Course introduction and overview / Ramsdell / Chapters 1 & 2:
Chapter 1: Introduction
Chapter 2: Study Design & Planning
2 / 4/10/13 / Creating a Data Management Plan / Ramsdell / Chapters 3 & 4
Chapter 3: Data Definitions, Forms and Database Design Chapter 4: Computer Systems Management and Data Design / Quiz, Chapters 1 & 2
3 / 4/17/13 / Clinical Research Databases / Bagwell / Chapters 5 & 6
Chapter 5: Patient Registration
Chapter 6: Local Data Management Systems / Quiz, Chapters 3 & 4 / Title and summary paragraph of final project
4 / 4/24/13 / Introduction to REDCap / Shragg / Chapters 7 & 8
Chapter 7: Central Quality Control of Data
Chapter 8: Data Management and Good Clinical Practice / Quiz, Chapters 5 & 6
5 / 5/1/13 / Data Quality & Safety Monitoring Clinical Trials / Agha / Chapters 9 & 10
Chapter 9: Software Tools for Trials Management
Chapter 10: Follow-Up and Close-Out Phase / Quiz, Chapters 7 & 8
6 / 5/8/13 / Data Quality & Assurance for Administrative and Large Data Bases / Agha / Chapters 11 & 12
Chapter 11: Training Education, and Documentation
Chapter 12 Clinical Trials Collaboration Models / Quiz Chapters 9 & 10 / Data Safety Plan (1 page)
7 / 5/15/13 / Remote Data Collection via Electronics / Stepnowsky / Quiz Chapters 11&12 / Interim Draft
Submission
8 / 5/22/13 / Study Section Exercise / Ramsdell
9 / 5/29/13 / Healthcare Related Data and Principles of Database design / El Kareh
Clay
10 / 6/5/13 / Principles & Practice of Information Security and Confidentiality in Research Settings / El-Kareh
Clay / NIH training due
11 / 6/12/13 / Bioinformatics / Ohno-Machado / Final Project Due

U:\CREST\2011\Data Mgmt\schedule 2011.doc