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: 14/12/2011
The purpose of a Personnel Form is to provide a consistent documentation of all of the people involved in a
study, their qualifications, contact details and their roles and responsibilities for the study.
SOP ID: SOP_3.3.1-Protocol
FORMAT: MS Word
DATE: 14/12/2011
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_3.3.2-Protocol
FORMAT: MS Word
DATE: 14/12/2011
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_3.3.2-Protocol
FORMAT: MS Word
DATE: 14/12/2011
The purpose of this template is to assist in providing recruitment sites with a consistent method of documenting
information about potential participants (or ‘cases’).
SOP ID: SOP_3.3.3-Protocol
FORMAT: MS Word
DATE: 14/12/2011
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_3.3.4-Protocol
FORMAT: MS Word
DATE: 14/12/2011
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: 14/12/2011
The purpose of this template is to outline the positions and roles for development of each section of a protocol.
SOP ID: SOP_3.3.5-Protocol
FORMAT: MS Word
DATE: 14/12/2011
The purpose of the Protocol Checklist is to provide a simple means of ensuring all aspects of the protocol have
been addressed.
SOP ID: SOP_3.3.6-Protocol
FORMAT: MS Word
DATE: 14/12/2011
All studies, even low risk studies, are advised to have an AE system in place. The purpose of this template is to describe the process for managing Adverse Events and should be an attachment to the study protocol. TEMPLATE WITH INSTRUCTIONS AND EXAMPLES.
SOP ID: SOP_3.3.7-Protocol
FORMAT: MS Word
DATE: 14/12/2011
All studies, even low risk studies, are advised to have an AE system in place. The purpose of this template is to describe the process for managing Adverse Events and should be an attachment to the study protocol. BLANK TEMPLATE.
SOP ID: SOP_3.3.7-Protocol
FORMAT: MS Word
DATE: 14/12/2011