CONSORT
statement , CONSORT statement
text from 3rd
edition of Clinical Epidemiology and a CONSORT diagram template
CONSORT
statement , CONSORT statement
text from 3rd
edition of Clinical Epidemiology and a CONSORT diagram templateThis is a set of recommendations that aim to improve the reporting
of randomised, controlled trials. This CONSORT statement text has
been contributed by Dave Sackett, who prepared it
for
the forthcoming 3rd edition of Clinical Epidemiology; A Basic Science
for
Answering Questions about Health Care, to be published by Lippincott,
Williams
& Wilkins in 2005.
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The Declaration of
HelsinkiWorld Medical Association has prepared the a set of recommendations as a guide to every physician in biomedical research involving human subjects.
Cochrane Collaboration Methods Groups - Overview of systematic methodology reviews
of the design and conduct of randomized trials
and systematic reviews of healthcare
interventionsThis overview of reviews aims to support Practihc guidance for designing pragmatic randomized trials; to inform future revisions of the CONSORT guidelines for reporting randomized trials; to inform guidelines for conducting and reporting systematic reviews; and to inform decisions about priorities for Cochrane methodology reviews.
The ICH General Considerations for Clinical
TrialsA document giving general advice for the conduct of clinical trials.
ICH Statistical Principles for Clinical TrialsA link to a document giving general statistical advice for clinical trials.
The ICH Guidelines for Good Clinical PracticeA document giving general advice relevant for clinical trials. Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
Standard Operating Procedures for Clinical InvestigatorsA document giving general advice for the conduct of clinical trials.
Ethical
issues for trials in developing countries with special reference to
preventive HIV vaccine trialsA document giving ethical advice for the conduct of clinical trials in low- and middle income countries countries.
Guidelines for trials in South AfricaA document giving guidance for good practice for the conduct of clinical trials with human participants in South Africa.