Data Management Plan-Reference-Cited by-同舟云学术

Data Management Plan

Published:2021-12-01 Issue:1 Volume:1 Page:
ISSN:2694-1473
Container-title:Journal of the Society for Clinical Data Management
language:
Short-container-title:

Author:

Lebedys Evaldas¹,Famatiga-Fay Carolyn²,Bhatkar Priyanka³,Johnson Derek⁴,Viswanathan Gayathri⁵,Zozus Meredith Nahm⁶

Affiliation:

1. Scope International AG

2. Amgen Inc., US

3. IQVIA, US

4. Inflamax Research Inc., CA

5. Icon Plc., UK

6. University of Texas Health Sciences Center, San Antonio, TX, US

Abstract

Every clinical study should have prospective plans for how data will be collected, processed and stored. Likewise, every study should have defined data elements and objective evidence of how data were processed. This chapter outlines the purpose of, and regulatory basis for, such documentation in the form of a Data Management Plan (DMP). Although the clinical data manager (CDM) may not personally prepare all sections of the data management plan, he or she is often responsible for assuring that comprehensive data documentation exists.

Publisher

Society for Clinical Management

Subject

General Medicine

Reference41 articles.

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