CASE REPORT FORM
- CRF designing and development
- Electronic data capture
- Standard operating procedure
- Data privacy
- Physical and electronic data security
- Electronic data capture principles
- Preparation and preservation of crf completion guidelines
- CDM presentation at investigator meetings
DATA STORAGE
DATA ARCHIVAL
- Database validation ,programming and standards
- Data entry and data processing
- Data Cleaning
- Data transmission
DATA MANAGEMENT
- Dictonary selection
- Auto-encoder
SAFETY DATA MANAGEMENT AND REPORTING
- Serious adverse event data reconciliation
- Procedures
- Assuring data quality
- Database closure
- Recommende standard oerating procedures
- Clinical data archiving
- Vendor evaluation
- Vendor management
METRICS FOR CLINICAL TRIALS
- Data management metrics
- Cost
- Time
- Quality
- Audit of clinical trails
CHOOSING AN AUDITOR
- Conducting the audit
- Audit checklist
- Chronology lists
- Areas to review
- Regulatory documentation
- Clinical documentation
- CRF and sourse documentation consistency
CRF correlations
- Ade documentationand reporting
Investigational device accountability records
- Special challenges for auditors
- Using the findings
- The audit report
GLOBAL ISSUES
- Introduction
- Principles
- Operational benefits of data interchange standards
- Scientific benefits of data interchange standards
- CDISC Standards
- ODM –Operational Data Model
- SDTM
- ADaM–Analysis Dataset Model
- Lab –Clinical Laboratory Data Model
- Case Report Tabulation Data Definition Specificatio
- Protocol Representation Standard
- CDISC standards integration
Clinical trials
- Responsibilities of Sponsor
- Post marketing surveillance
- 21 CFR PART 11
- Introduction
- Electronic Records
- Electronic Signatures
Posts
