Microsoft Word - Abbreviations List Approved Oct 2014

Source URL: www.acrpnet.org

• Medical research
• Medicine
• Health
• Clinical research
• Clinical trials
• Pharmaceutical industry
• Clinical data management
• Clinical pharmacology
• Serious adverse event
• Electronic patient-reported outcome
• Trial master file
• Case report form

Statement German Network for Evidence-based Medicine Berlin, 05 JulyThe German Network for Evidence-based Medicine endorses the

Source URL: www.ebm-netzwerk.de

• Medical research
• Clinical research
• Pharmaceutical industry
• Good clinical practice
• Clinical trial
• Serious adverse event
• Adverse event
• AllTrials
• Evidence-based medicine
• Trial master file

p-medicine – Grant Agreement noD2.1 – State of the art review of the p-medicine environment Deliverable No. 2.1 State of the art review of the p-medicine environment

Source URL: p-medicine.eu

• Medical research
• Clinical research
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• Clinical trial management system
• Clinical trial
• Clinical data management system
• Health informatics
• Clinical
• Academic clinical trial
• Electronic data capture
• Trial master file
• Good clinical practice

  Clinical Trial Associate (MP0125) We are looking for a committed, self-motivated Clinical Trial Associate (CTA) with a strong hands-on attitude to complete our Clinical Operations team. Your responsibilities:

Source URL: www.molecularpartners.com

• Clinical research
• Pharmaceutical industry
• Clinical trials
• Trial master file
• Molecular Partners
• Good clinical practice

Contents List for Trial Master File 1. Study Protocol [all versions with amendments (if any)] 2. Informed consent forms (all required languages), Translation and back translations with certificate 3. Case Report Forms 4

Source URL: globalhealthtrials.tghn.org

Regulatory Science Bootcamp “Clinical Trials Hurdles: Where are they and what should we do?” AGENDA

Source URL: www.icts.uci.edu

• Clinical research
• Pharmaceutical industry
• Clinical trials
• Trial master file

R: Regulatory Compliance and Validation Issues A Guidance Document for the Use of R in Regulated Clinical Trial Environments December 15, 2014

Source URL: www.r-project.org

• Pharmaceutical industry
• Validation
• R
• Title 21 CFR Part 11
• Good laboratory practice
• Medical device
• Good manufacturing practice
• Clinical trial
• Business process management
• Software
• Electronic trial master file

Minimum Criteria for ICH E6 GCP Investigator Site Personnel Training (Excerpt from TransCelerate BioPharma Operating Principles) Scope The intent of this document is to define the Minimum Criteria for Good Clinical Pract

Source URL: www.transceleratebiopharmainc.com

• Medical research
• Clinical research
• Pharmaceutical industry
• Good clinical practice
• Adverse event
• Source document
• Public Responsibility in Medicine and Research
• Informed consent
• Inclusion and exclusion criteria
• Serious adverse event
• Human subject research
• Trial master file

Task B Proposal Document APAC RA-EWG Task B Convergence of NDA Requirements

Source URL: www.jpma.or.jp

• Clinical research
• Food and Drug Administration
• Drug discovery
• Clinical trial
• FDA Fast Track Development Program
• Drug Master File
• Regulatory requirement
• Drug development
• Pharmaceutical sciences
• Pharmacology
• Pharmaceutical industry

1323 Burnet Avenue[removed]T Union, NJ[removed]3406 F www.drscorp.com

Source URL: www.drscorp.com

• Electronic trial master file
• DRS
• Clinical trial
• Research
• Clinical research
• Science