Template Downloads

This section contains templates, forms and reference documents. The templates can be adapted for use in any Oxford Radcliffe Hospitals NHS Trust department conducting clinical research where there are no such documents in place. They have been written to comply with relevant regulations and guidelines. Their content should be reviewed in conjunction with any guidelines/procedures which are unique within your department and the text should be altered accordingly.

The text highlighted in yellow within the documents is advisory and should be deleted when the documents are finalised. If there is a footnote with details of the original author and the copyright logo of the University of Oxford, please retain them.

	01 A Template for Creating Other SOPs
	02 Application For Trust Managment Approval (currently under review)
	03 Archiving of Essential Documents
	04 Case Report Form Completion
	05 Database Design
	06 Design and Development of Case Report Forms
	07 Document Control
	08 Preparation and Approval of Protocol Amendments
	09 Provision of Training
	10 Qualification Experience and Training of Clinical Research Personnel
	11 Safety Reporting Responsibilities and Processes
	12 Study Protocol Development and Review
	13 Trial Master Files
	14 Annual Safety Report
	15 Case Report Form
	16 Clinical Research Protocol
	17 Clinical Trial Protocol Template
	18 Template - Clinical Device Protocol - ORH v1 2
	19 Delegation of Sponsor Responsibilities
	20 Final Study Report
	21 Research Master File Table of Contents
	22 Safety Reporting Requirements In Clinical Trials
	23 Serious Adverse Events Reporting Form
	24 Serious Adverse Events Reporting Form Completion Guidelines
	25 Subject Indentification and Code List
	26 Training Form
	27 Preparation of a Clinical Trial Authorisation Application
	28Ethics Committee Application
	29 Informed Consent
	30 Site Personnel Delegation and Signature Log