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3.3
c) ; e) - g) +
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ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - randomization +
3.42 - randomization +
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - recruitment +
3.42 - recruitment +
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EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.2 +
3.5.2 +
EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.3 +
3.5.3 +
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