Review




Structured Review

OpenClinica LLC electronic data capture system
A full schedule of trial procedures from screening to the end of study follow-up. 5Q-5D-5L, EuroQol-5 Dimension-5 Level; CEA, carcinoembryonic antigen; FACT-C, Functional Assessment of Cancer Therapy – Colorectal cancer; HRQoL, health-related quality of life.
Electronic Data Capture System, supplied by OpenClinica LLC, used in various techniques. Bioz Stars score: 90/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
https://www.bioz.com/product/secure+web-based+randomisation+program/electronic+data+capture+system/pmc10305778-114-17-26
Average 90 stars, based on 1 article reviews
electronic data capture system - by Bioz Stars, 2026-11
90/100 stars

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1) Product Images from "A protocol for a pilot study to assess the feasibility of a randomised clinical trial of perioperative intravenous lidocaine on colorectal cancer outcome after surgery (FLICOR trial)"

Article Title: A protocol for a pilot study to assess the feasibility of a randomised clinical trial of perioperative intravenous lidocaine on colorectal cancer outcome after surgery (FLICOR trial)

Journal: Bja Open

doi: 10.1016/j.bjao.2023.100138

A full schedule of trial procedures from screening to the end of study follow-up. 5Q-5D-5L, EuroQol-5 Dimension-5 Level; CEA, carcinoembryonic antigen; FACT-C, Functional Assessment of Cancer Therapy – Colorectal cancer; HRQoL, health-related quality of life.
Figure Legend Snippet: A full schedule of trial procedures from screening to the end of study follow-up. 5Q-5D-5L, EuroQol-5 Dimension-5 Level; CEA, carcinoembryonic antigen; FACT-C, Functional Assessment of Cancer Therapy – Colorectal cancer; HRQoL, health-related quality of life.

Techniques Used: Functional Assay, Pregnancy Test (hCG) Assay, Computed Tomography, Histopathology

Related Articles

other:

Article Title: Second-Line Endocrine Therapy With or Without Palbociclib Rechallenge in Patients With Hormone Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: PALMIRA Trial
Article Snippet: PURPOSE Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors plus endocrine therapy (ET) represents the standard first-line treatment for patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HER2-negative) advanced breast cancer (ABC).. However, there is no definitive consensus on the preferred second-line treatment option.. The PALMIRA trial investigated whether palbociclib rechallenge with an alternative ET would improve the antitumor activity in patients progressing after a first-line palbociclib-containing regimen.

Article Title: Implementation and impact of an electronic patient reported outcomes system in a phase II multi-site adaptive platform clinical trial for early-stage breast cancer.
Article Snippet: Objectives: We describe the development and implementation of a system for monitoring patient-reported adverse events and quality of life using electronic Patient Reported Outcome (ePRO) instruments in the I-SPY2 Trial, a phase II clinical trial for locally advanced breast cancer.. We describe the administration of technological, workflow, and behavior change interventions and their associated impact on questionnaire completion.. Materials and Methods: Using the OpenClinica electronic data capture system, we developed rules-based logic to build automated ePRO surveys, customized to the I-SPY2 treatment schedule.

Article Title: Variation in Structural Characteristics Among Twenty Medical-Psychiatry Units in the United States: A Survey-Based Study.
Article Snippet: 20 Background Medical Psychiatric Units (MPUs) are specialized hospital units providing integrated 21 care for patients with co-occurring medical and psychiatric illnesses.. Despite their growing relevance, 22 data on their structural characteristics in the United States remain sparse.. This study aims to 23 inventory and analyze the structural characteristics of 20 US MPUs, categorizing them using Kathol's 24 and Van Schijndel's frameworks, and identifying shared components to inform future MPU design 25 and quality standards.

Article Title: Real-world comparative effectiveness of palbociclib plus aromatase inhibitor in HR+/HER2- metastatic breast cancer.
Article Snippet: OpenClinica, an electronic data capture system that is 21 Code of Federal Regulations Part 11 compliant, facilitated the data abstraction activities.

Article Title: Informatics Infrastructure in a Rural Pediatric Clinical Trials Network: Matching Specific Clinical Research Needs with Best Practices and Industry Guidelines
Article Snippet: It also provides access to all protocol documents and training materials; external data integration tables to load, integrate, and reconcile external data; and an open source, web-based electronic data capture (EDC), OpenClinica.

Software:

Article Title: Antiviral responses induced by Tdap-IPV vaccination are associated with persistent humoral immunity to Bordetella pertussis
Article Snippet: .. Clinical data of participants was recorded using OpenClinica, electronic case record form software that enables compliance with regulatory guidelines such as 21 CFR Part 11. ..



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MedSciNet UK Ltd secure web-based randomisation program
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Secure Web Based Randomisation Program, supplied by MedSciNet UK Ltd, used in various techniques. Bioz Stars score: 90/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
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Maternal demographic and pregnancy characteristics

Journal: Bjog

Article Title: Two‐year follow‐up of infant and maternal outcomes after planned early delivery or expectant management for late preterm pre‐eclampsia ( PHOENIX ): A randomised controlled trial

doi: 10.1111/1471-0528.17167

Figure Lengend Snippet: Maternal demographic and pregnancy characteristics

Article Snippet: The only exclusion criterion to participation was the clinician’s decision to initiate delivery within the subsequent 48 h. After providing written informed consent, women were randomly assigned to planned delivery or expectant management via a secure web‐based randomisation program provided by MedSciNet.

Techniques: