Clinical trial results database
[DOCX File]Guidelines for Developing a Manual of Operations and ...
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Jul 17, 2015 · Effective September 27, 2008, responsible parties are required to report basic results of clinical trials in ClinicalTrials.gov within 12 months of trial completion, or within 30 days of FDA approval of a new drug or device.
[DOCX File]Checklist For Study Close-Out
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Jul 17, 2015 · This randomized controlled trial aims to test the hypothesis that . strength training decreases obesity. This . ... A statement pertaining to protection of the database should be included, ... A statement reflecting the results of the ongoing data review will be incorporated into the Annual Report for the Independent Monitor.
[DOCX File]Example Data and Safety Monitoring Plan (DSMP) …
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Additionally, clinical and genomic data related to the analyses will also need to be registered by NCI and will be made available to qualified researchers via a controlled-access database (e.g., dbGaP) upon publication of the primary analysis described in the study proposal.
[DOCX File]Good Programming Practice for Clinical Trials - sasCommunity
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Good Clinical Practice (GCP) – A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial …
[DOCX File]ClinicalTrials
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This document is intended for the use of the DCP Consortia staff conducting cancer chemoprevention studies under contract with the NCI/DCP.. The . S. tudy closeout tasks may be completed in a different order for any given study. SOP13a: Study Closeout Checklist. Version Date: September 30, 2020Page
A Policy Study of Clinical Trial Registries and Results ...
Provide general introductory text as to the purpose of the clinical data management plan (CDMP) including its central role in making explicit to all stakeholders specific information regarding the data management practices needed to ensure appropriate handling of data at all steps of the project to assure a high-quality database at the end of the study, ready for analysis.
[DOCX File]Tool Summary Sheet: NIDCR Clinical Data Management Plan ...
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The ClinicalTrials.gov trial registry was released for the registration of studies on February 29, 2000. The database downloaded by the Clinical Trials Transformation Initiative (CTTI) and the Duke Clinical Research Institute (DCRI) on March 27, 2016 includes 211,437 studies.
[DOCX File]National Cancer Institute (NCI) Clinical Trial Sequencing ...
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mandates the establishment of a clinical trial results database. The inclusion of "basic results" information in the database is required by . 9/27/2008. ‘‘(i) DEMOGRAPHIC AND BASELINE CHARACTERISTICS OF PATIENT SAMPLE.—
[DOCX File]Guidelines for Developing a Manual of Operations and ...
https://info.5y1.org/clinical-trial-results-database_1_99fba8.html
From the International Conference on Harmonisation (ICH) guidance, GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial ...
[DOC File]Subject: Clinical Trials Registration New Federal ...
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This document provides guidance for good programming practices (GPP) for analysis, reporting and data manipulation of clinical data in health and life sciences organizations. ... Timelines for the trial, when is the database lock, when should the top line results be ready, and when should all the reporting be finalized. ... in order to avoid ...
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