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- CLINICALTRIALS. GOV Results Reporting - Dana–Farber Harvard Cancer Center
• Final Rule (42 CFR Part 11): Final Rule for Clinical Trials Registration and Results Information Submission (2017) – Applies to ACTs with PCD on or after Final Rule effective date 1 18 2017 • https: www federalregister gov documents 2016 09 21 2016-22129 clinical-trials-registration-and-results-information-submission
- Clinical Trial Data – Reducing The Time To Submission - ISMPP
To determine the baseline time from PCD to submission, all primary manuscripts in one therapeutic area with a PCD between 2009 and 2011, and a journal submission date were identified A process map was generated and analyzed Process improvements were made and piloted
- ClinicalTrials. gov
Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information Search for terms
- ClinicalTrials. gov: Definitions, Laws, and Regulations
Primary Completion Date (PCD) or Completion Date • Date that the final subject was examined or received an intervention for purposes of final collection of data for the primary outcome measure
- A GUIDE TO CLINICAL DATA MANAGEMENT FOR BIOTECH COMPANIES
The use of EDC systems has become essential, especially in multi-centric trials, to handle the huge amount of data collected while maintaining quality data ELECTRONIC DATA CAPTURE (EDC) SYSTEMS ARE WEB-BASED SOFTWARE APPLICATIONS USED TO COLLECT, CLEAN, TRANSFER AND PROCESS DATA IN CLINICAL TRIALS
- How to Determine Primary Completion Study Completion Dates
If a study closes early due t o slow accrual and a full clinical study report is not necessary, the primary completion date will be considered the last date of treatment The status of the study in clinicaltrials gov would be “Terminated ” Results reporting is still required
- Clinical Research Acronyms and Abbreviations You Should Know
Whether you’re new to the clinical research world or need a refresher, here’s a condensed list of common acronyms and abbreviations you may come across AACI: Association of American Cancer Institutes AAHRPP: Association for the Accreditation of Human Research Protection Programs ABSA: Association of Biosafety and Biosecurity
- Best Practice and Procedure - ctrrtaskforce. org
PCD: Primary Completion Date - Per final rule in 42 CFR 11 10(a), Primary Completion Date is defined as the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated
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