Principles and procedures for data and safety monitoring in pragmatic clinical trials
Abstract Background All clinical trial investigators have ethical and regulatory obligations to monitor participant safety and trial integrity. Specific procedures for meeting these obligations, however, may differ substantially between pragmatic trials and traditional explanatory clinical trials. M...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2019-12-01
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| Series: | Trials |
| Online Access: | https://doi.org/10.1186/s13063-019-3869-3 |