Development of a Study Protocol
This SOP describes the process of developing a study protocol in line with regulatory requirements.
SOP ID: SOP_3.0.0-Protocol
FORMAT: pdf
DATE: 27/08/24
Different research studies will have different requirements as to content of a protocol. The purpose of the Protocol Template is to guide the developing the study protocol. Utilising the template document acts as a prompt for considering which sections and what information is relevant for a study (some sections may not be relevant to all studies). BLANK TEMPLATE.
SOP ID: SOP_3.3.2a-Protocol
FORMAT: MS Word
DATE: 22/08/24
Protocol Template - with instructions and examples
Different research studies will have different requirements as to content of a protocol. The purpose of the Protocol Template is to guide the developing the study protocol. Utilising the template document acts as a prompt for considering which sections and what information is relevant for a study (some sections may not be relevant to all studies). TEMPLATE WITH INSTRUCTIONS AND EXAMPLES.
SOP ID: SOP_3.3.2b-Protocol
FORMAT: MS Word
DATE: 22/08/24
Adverse Event Case Report Form (AE_CRF) - blank template
The purpose of this template is to provide sites with a consistent format and information to be documented in the event of an Adverse Event (AE). BLANK TEMPLATE.
SOP ID: SOP_3.3.4a-Protocol
FORMAT: MS Word
DATE: 07/05/24
Adverse Event Case Report Form (AE_CRF) - with instructions and examples
The purpose of this template is to provide sites with a consistent format and information to be documented in the event of an Adverse Event (AE). TEMPLATE WITH INSTRUCTIONS AND EXAMPLES.
SOP ID: SOP_3.3.4b-Protocol
FORMAT: MS Word
DATE: 08/05/24
TEMPLATE: Adverse Event Case Report Form (AE_CRF) - blank
The purpose of this template is to provide sites with a consistent format and information to be documented in the event of an Adverse Event (AE). BLANK TEMPLATE.
SOP ID: SOP_3.3.4-Protocol
FORMAT: MS Word
DATE: 07/05/24
Protocol Checklist and Responsibilities
The purpose of the Protocol and Responsibilities Checklist is to provide a simple means of ensuring all aspects of the protocol have been addressed including the positions and roles for development of each section of a protocol.
SOP ID: SOP_3.3.5-Protocol
FORMAT: MS Word
DATE: 22/08/24