CRC 245 - Data Management and Informatics

4 Contact Hours, 4 Credits
4 Lecture periods 0 lab periods


Essential knowledge of the organization and management of research data, and effective presentation of data in reports. Includes how data is acquired and managed during a clinical trial, including source data, data entry, queries, database structures, data management systems, quality control, and quality assurance. Also includes data confidentially and security; and preparation of case report forms.

Information: Students must be admitted to or have conditional status in the Clinical Research AAS or Post-Degree Certificate program or obtain the consent of the instructor before enrolling in this course.
    

1. Identify the role of statistics and informatics in clinical trials.
2. Interpret the origin, flow, and management of data through a clinical trial.
3. Apply best practices and resources used for data collection, capture, management, and analysis.
4. Formulate communication methods to stakeholders about study findings and reporting.
5. Create processes for data quality assurance.
6. Evaluate data collection forms for completeness and accuracy.

1. Clinical data management process for clinical trial
2. Elements of a data management plan
3. Appropriate database design and its development

II. Various Data Collection and Data Capture Procedures

1. Various schemes and methods of data collection
2. Methods of randomization and documentation procedures
3. Various methods for data capture

III. Designing Data Collection Forms

1. Relevant data and outcome parameters
2. Methods to capture baseline and follow-up data
3. Appropriate closed-end questions to capture unambiguous data

IV. Reviewing Data Collection Forms

1. Completeness and accuracy
2. Advantages and disadvantages of single entry versus double entry
3. Data validation methods and the role of database definition in validation
4. Computerized checks, data queries, and appropriate methods for data correction
5. Common errors and omissions on case report forms
6. Function of quality assurance related to clinical data management

V. Collecting Pertinent Data to Assist in Specified Research Publication

1. Basic principles of coding dictionaries and their function
2. Appropriate method for handling expedited safety reporting for investigational drugs and devices
3. Appropriate method for handling safety reporting for marketed drugs and devices
4. Content of periodic update reports to the IRB
5. Structure and content of an integrated study report filed with a regulatory agency in support of a request for marketing approval
6. Methods for database changes, and appropriate timing for changes once a clinical trial is started

VI. Reviewing Research Data for Subject Safety

1. Patient case report forms, data listings, and instances of deviation from the approved study protocol
2. Patient case report forms, data listings, and subjects who received concomitant medication, or experienced concurrent illness during the study, or had secondary diagnoses
3. Patient case report forms, data listings, and subjects who died or experienced serious adverse events, or withdrawals from the study due to adverse events
4. Patient case report forms, data listings, and subjects with significant (as defined in the protocol and analysis plan) deviations from a defined normal limit in laboratory parameters

VII. Generating a Final Study Report and Publications

1. Regulatory requirements for a final study report
2. Required elements of a final study report
3. Generate draft sample final study report
4. Structure and content of a paper prepared for peer-reviewed journal publication of clinical research data