PROTOCOL DOCUMENT REQUIREMENTS Human …
https://research.weill.cornell.edu/sites/default/files/policy_forms/wcm_clinicaltrials.gov_protocol_and_sap_upload_and_redaction_guidance_v1.0_11.9.19.pdf
WebNov 9, 2019 · ClinicalTrials.gov Protocol and SAP Upload Instructions. For clinical trials with a Primary Completion Date on or after 1/18/17, the regulations require the Responsible Party to, at the time of results entry, upload a protocol document and, if not included in the protocol, a statistical analysis plan (SAP). REDACTION. IRB-approved document.
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