DOI:
10.1055/s-00034612
Yearbook of Medical Informatics
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References
Hecht A, Busch-Heidger B, Gertzen H, Pfister H, Ruhfus B, Sanden PH. et al.
Quality Expectations and Tolerance Limits of Trial Master Files (TMF) -Developing a Risk-based Approach for Quality Assessments of TMFs.
Ger Med Sci 2015;
13: Doc23.
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