Data Management Support Services
- Development of Data Management Plan
- Development of Data Management Manual
- Development of Data Quality Management Plan
- Development of Tables Manual
- Development of Mock Tables for reports
- Development of Data Validation Plan
- Review of any data management document
- Consultancy on optimizing return on investment through query process
- Monitoring plan for data queries (80% rule, PROC UNIVARIATE reviews)
- Interim assessment of data queries
- Data base audit
- Audit plan with random selection of case reports
- Audit report with process described
- Errors and observations clearly written
- Certificate of audit provided
Our team will consider the following:
- Are you querying the right things?
- Are you querying things that you should stop querying?
- Are there new queries that you should introduce because errors are getting
- Is the right proportion of queries coming back with changes in
- Are the changes properly documented?
- Are all data under site signature traceable to the Investigator and
accountable by the Investigator?
- Are there too many changes in the data?
- Are there changes without signatures or dates?
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