clinical trial protocol manuscript


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PDF Clinical study protocol template

Clinical Trial Protocol Template Version 1 0 (01-Dec-2017) This document (090095af8aea8d7f in docbase CREDI_EH) has been digitally signed with external signatures using Entrust PKI

  • How can a study protocol be structured for randomised trials?

    Trials is experimenting with a new way of structuring study protocols for randomised trials. The simple innovation is to include all 51 SPIRIT headings and item identifiers within the protocol itself. Readers will then benefit from the ability to search by item identifier, which are contained within curly brackets.

  • How do I submit a study Protocol reporting a clinical trial?

    Study protocols reporting a clinical trial can be formatted for submission to Trials in two ways: By following the guidance set out in our structured study protocol template. This is the preferred option if you have not yet started writing your manuscript. By submitting a populated SPIRIT checklist and SPIRIT figure alongside your manuscript.

  • When will a study Protocol article be considered?

    Study protocol articles will generally only be considered for proposed or ongoing trials that have not completed participant recruitment at the time of submission.

  • Can NIH applicants use a template to write clinical protocols?

    NIH applicants can use a template with instructional and sample text to help write clinical protocols for the following types of research: Phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications

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