Document library

For researchers

Please note that the list below can be sorted (by selecting click to sort) and key word searched.

For Word versions of the templates found below please email cctu@addenbrookes.nhs.uk

Title of document (click to sort)	Document type (click to sort)	Ref no. (click to sort)
Adverse event log	Form	CCTU FRM006
Annual safety report	Form	CCTU FRM019
Annual safety reporting and annual progress reporting for investigator teams	Standard operating procedure	CCTU SOP003
Archiving box label	Form	CCTU FRM015
Archiving check list	Form	CCTU FRM016
Archiving record form	Form	CCTU FRM017
Breach of GCP or the trial protocol	Standard operating procedure	RD SOP003
Case report form design	Standard operating procedure	CCTU SOP013
Clinical trial protocol	Template	CCTU TPL001
Commercial research activity	Policy and procedure	RD POL001
Delegation of responsibilities and signature log	Form	CCTU FRM020
Delegation of roles and responsibilities for Trust sponsored clinical trials of investigational medicinal products (CTIMPs)	Standard operating procedure	RD SOP001
eSUSAR reporting - investigator's guide	Guidance note	CCTU GD003
Electronic susar reporting registration form	Form	CCTU FRM028
End of trial procedures (CTIMPs)	Standard operating procedure	CCTU SOP004
EU clinical trial of investigational medicinal product (CTIMP) archiving	Standard operating procedure	CCTU SOP006
Expedited Trust approval process	Standard operating procedure
Intellectual property (IM) management	Policy and procedure
Letter of access information form - NHS	Guidance note
Management of contracts for research projects	Standard operating procedure
Misconduct and fraud: good research practice - policy	Policy and procedure
Misconduct and fraud: good research practice - procedure	Policy and procedure
NHS permission for research studies	Policy and procedure
Non-compliance report form	Form	CCTU FRM013
Obtaining informed consent for studies	Guidance note
Other important safety issue reporting form	Form	CCTU FRM004
Test of out of hours medical cover arrangements	Standard operating procedure	CCTU SOP005
Participant information sheet and informed consent form	Template	CCTU TPL002
Pharmacovigilance process for investigator teams	Standard operating procedure	CCTU SOP002
Pre trial procedures for investigators (CTIMPs)	Standard operating procedure	CCTU SOP021
Pregnancy reporting form	Form	CCTU FRM003
Preparing for and facilitating a Regulatory (MHRA) Inspection	Standard operating procedure
Quality assurance audits	Standard operating procedure	RD SOP002
Research passport – information for researchers	Supporting Document
Research passport, honorary research contracts and letters of access	Policy and procedure
Review and approval of protocols and amendments	Standard operating procedure
SAE/SAR reporting form	Form	CCTU FRM001
SAE/SAR query form	Form	CCTU FRM002
Sample tracking log	Form	CCTU FRM033
Sample tracking procedure for laboratory samples	Standard operating procedure	CCTU SOP028
Study contact sheet	Form	CCTU FRM027
Subject screening/enrolment log	Form	CCTU FRM023
Tissue request form	Supporting Document
Tissue transfer agreement	Supporting Document
Transfer of expenditure request	Supporting Document
Transport of biological samples	Standard operating procedure	CCTU SOP016
Unblinding subjects in an emergency situation	Standard operating procedure
Urgent safety measures for CTIMPs	Standard operating procedure	CCTU SOP019

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