A Model Data Management Plan Standard Operating Procedure: Results From the DIA Clinical Data Management Community, Committee on Clinical Data Management Plan
| Autor: | Mary Farley, Miriam Fogelson, Jan Bart Hak, Kristin Neff, Scott Brand, Jan Holladay Pierre, Peter Stockman, Grace Hu, Johann Proeve, Olivia D. Montana, Samina Qureshi, Anita Shen, Diana Bartlett, Richard Chamberlain |
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| Rok vydání: | 2018 |
| Předmět: |
Electronic data capture
Management science business.industry Data management Public Health Environmental and Occupational Health Data management plan Plan (drawing) Clinical trial Engineering management Clinical data management Medicine Pharmacology (medical) business Pharmacology Toxicology and Pharmaceutics (miscellaneous) Case report form Standard operating procedure |
| Zdroj: | Therapeutic innovationregulatory science. 49(5) |
| ISSN: | 2168-4804 |
| Popis: | The DIA Clinical Data Management Community created a committee to develop a model standard operating procedure (SOP) for writing a data management plan. The goal of the committee was to develop a plan that could be used by industry and academic institutions. The model was based on contributed examples from committee members and their experiences with current practices and technologies. It is understood that as new clinical trial technology is implemented, the SOP will require modification. The model SOP and associated templates are presented as a starting point, and each company or institution will need to modify them to meet its individual needs. The model DMP SOP produced addresses most data management issues that are present in any phase clinical trial while providing a flexible framework. |
| Databáze: | OpenAIRE |
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