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Other Research

Creation, Control, Amendment and Storage of Standard Operating Procedures for Research Governance

Development, Review and Amendment: Study Protocol

The Ethical Approval of Research

Informed Consent for Research

Consent Form Template (Consent forms may vary according to the nature of the study.  The template consent form is suitable for most studies but may require alteration.  Text in red or within square brackets indicates wording that should be included if appropriate for the study).

Delegation of Responsibilities 

Preparation, Completion, Signing and Correcting Case Report Forms

Education, Training and Experience

Amendments to Protocols and Essential Documentation

End of Study Declaration

Production of Progress, Safety and Final Reports

Indemnity and Sponsorship of Research Studies

Data Management: Collection, Validation and Storage

Research Governance: Audit

Matters of Non-compliance with Study Protocol

Termination or Suspension of a Research Study

Risk Assessment of Research Studies

Publication and Dissemination of Study Outcomes

Complaints from Research Participants

Maintaining Laboratory Books

Archiving Research Study Documents

 

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