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Search Category: Writing a Research Protocol

COS-STAP (Core Outcome Set-STAndardised Protocol Items)

Type: Guideline
Author: Jamie J. Kirkham, Sarah Gorst, Douglas G. Altman, Jane M. Blazeby, Mike Clarke, Sean Tunis, Paula R. Williamson1* and for the COS-STAP Group
Keywords: protocol standards, core outcome set, protocols, PPI, Sponsorship, study development, design, Sponsor
Link Reference: 3289
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Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols The SPIRIT-PRO Extension

Type: Guideline
Author: Melanie Calvert, PhD; Derek Kyte, PhD; Rebecca Mercieca-Bebber, PhD; et al
Keywords: PRO, SPIRIT-PRO, SPIRIT Guidelines, Protocol, Clinical Trials, Patient Report Outcomes
Link Reference: 1717
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Preparation, Review and Approval of Study Documents

Type: Example SOP
Author: Nottingham University Hospitals NHS Trust.
Keywords: Study Documents, Protocol
Link Reference: 947
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Protocol templates for all research types

Type: Website resources
Author: HRA
Keywords: Protocol
Link Reference: 948
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Recommendations for minimum elements for a clinical trial protocol

Type: Website resources
Author: SPIRIT Group
Keywords: Protocol, Interventional Trials
Link Reference: 950
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SOP for Developing a research protocol

Type: Example SOP
Author: Norfolk & Norwich University Hospitals NHS Foundation Trust
Keywords: Protocol, SOP
Link Reference: 949
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Standard Operating Procedure for Qualitative Components of Trials & other Rigorous Studies in Health & Social Care

Type: Example SOP
Author: West Wales Organisation for Rigourous Trials in Health
Keywords: SOP, Wales, Qualitative, rigorous, trials
Link Reference: 951
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