Clinnovo.com offers Services & Training in Clinical Research and Clinical Data Management
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Major Roles of a programmer is:
1. Captures data from different sources like external source formats like excel, access or text or from DBMS tables. I.E from SQL / Oracle database servers.
2. Convert the data from an un-standard to a standard format like un-blinding the data values like in simple terms converting of decoding the values, which internally making the data ready for analysis.
3. Validate the data for standards using CDISC standards guidelines, where following CDASH, ODM, SDTM & ADaM standards and by maintaining SOP standards of the client and also maintain 21 CFR part 11 compliance data. Which can be used in archiving the data into database for analysis?
4. Subset the data using conditional statements like IF THEN, WHERE, WHEN, and also sorting the data for full or partial analysis.
5. Evaluating the values of dates and time for validations during analysis like maintaining submission standards of ISO8601 basic and extended notations.
6. Convert the data according the ICH GCP guidelines for any internal submissions.
7. Converting the raw format of the data into Regulatory submission standard format which has to be mostly in .Xml format. That is generating submission standard formats
8. Apply different procedures like PROC MEANS, FREQ, TABULATE, REPORT, UNIVARIATE, TTEST, PVALUE, SUMMARY, CHART, PLOT, SGPLOT to generate reports like statistically strong tables, Subject information listings and also graphical reports.
9. During these analysis activities, programmers have to implement Macros and SQL programming codes wherever necessary to concise the programming methods and reusability of programming codes.
10. Finally, generating standard reports using ODS (Output Delivery System) to generate different reports based on the requirement of the clients which will demonstrate the significance of the data that is used in the clinical trials, which internally help to get approvals from the Regulatory authorities like FDA / DCGI.