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Medical Statistics and Methodology x clear all

Archiving

Edited by Sumantra (Shumone) Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher and Sarah Gibbings.

in Oxford Handbook of Clinical and Healthcare Research

February 2016; p ublished online March 2016 .

Chapter. Subjects: Medical Statistics and Methodology. 5703 words.

This chapter discusses the importance of archiving the data. As well as regulatory advice the requirements of the most useful reference guide, ISO11799, is reviewed. Practical advice on...

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Audits and inspections

Edited by Sumantra (Shumone) Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher and Sarah Gibbings.

in Oxford Handbook of Clinical and Healthcare Research

February 2016; p ublished online March 2016 .

Chapter. Subjects: Medical Statistics and Methodology. 6759 words.

Audits and inspections are a vital and well recognised part of the clinical trial process. The requirement for quality data is recognised by everyone who works in clinical research. The...

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Authorship

Edited by Sumantra (Shumone) Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher and Sarah Gibbings.

in Oxford Handbook of Clinical and Healthcare Research

February 2016; p ublished online March 2016 .

Chapter. Subjects: Medical Statistics and Methodology. 2135 words.

This chapter begins with a definition of authorship and provides the The Proposed Rapid Review Checklist for Authors (the 5Ds: design, data collection, data analysis, discussion of...

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Cardiovascular preoperative risk assessment: a calculated gamble?

Joseph Tomson and Aung Myat.

in Challenging Concepts in Cardiovascular Medicine

September 2011; p ublished online July 2013 .

Chapter. Subjects: Cardiovascular Medicine; Medical Statistics and Methodology. 3369 words.

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Clinical trial design

Edited by Sumantra (Shumone) Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher and Sarah Gibbings.

in Oxford Handbook of Clinical and Healthcare Research

February 2016; p ublished online March 2016 .

Chapter. Subjects: Medical Statistics and Methodology. 12348 words.

This chapter outlines the various study designs and their uses. The phases of drug development are described and the appropriate study design employed at each phase of development is...

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Clinical trial protocols: study protocol

Edited by Sumantra (Shumone) Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher and Sarah Gibbings.

in Oxford Handbook of Clinical and Healthcare Research

February 2016; p ublished online March 2016 .

Chapter. Subjects: Medical Statistics and Methodology. 7103 words.

This chapter defines protocols and the requirements to be considered when writing a protocol, The protocol is one of the most important documents and must be clear, concise and well...

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Clinical trial supplies: investigational medicinal products (IMPs)

Edited by Sumantra (Shumone) Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher and Sarah Gibbings.

in Oxford Handbook of Clinical and Healthcare Research

February 2016; p ublished online March 2016 .

Chapter. Subjects: Medical Statistics and Methodology. 8652 words.

This chapter describes the procedures and records associated with accountability of investigational and non-investigational medicinal products (IMP and NIMP) used in clinical trials, to...

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Data capture tools: case report form (CRF)

Edited by Sumantra (Shumone) Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher and Sarah Gibbings.

in Oxford Handbook of Clinical and Healthcare Research

February 2016; p ublished online March 2016 .

Chapter. Subjects: Medical Statistics and Methodology. 4631 words.

This chapter outlines the overall design process, highlights the aspects of design that are significant for the success of the case report form (CRF) and considers the effects of electronic...

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Data management

Edited by Sumantra (Shumone) Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher and Sarah Gibbings.

in Oxford Handbook of Clinical and Healthcare Research

February 2016; p ublished online March 2016 .

Chapter. Subjects: Medical Statistics and Methodology. 4197 words.

Ensuring confidentiality of data - Planning the trial and the database - Data entry - Validation of data systems

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Essential documents

Edited by Sumantra (Shumone) Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher and Sarah Gibbings.

in Oxford Handbook of Clinical and Healthcare Research

February 2016; p ublished online March 2016 .

Chapter. Subjects: Medical Statistics and Methodology. 6122 words.

It is a legal requirement for sponsors and investigators to maintain essential documentation. This chapter outlines the ICH GCP E6 requirements for documentation before, during and after...

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