Study Management
This SOP is designed for Principal Investigators or a delegated authority (chief investigators, study managers or co-ordinators, support staff) developing a PoCoG study. The purpose is to guide researchers, who are at the concept stage of research development, through the processes required to conduct a research study and to provide tools to assist with the management of a research study.
SOP ID: SOP_2.0.0-StudyMgt
FORMAT: pdf
DATE: 04/06/24
Developing and Maintaining Training Records
This SOP describes how training records should be developed, recorded, maintained and stored for all research personnel of PoCoG supporting and or/undertaking research. Training records should be easily accessible and available on request.
SOP ID: SOP_2.1.0-StudyMgt
FORMAT: pdf
DATE: 05/06/24
This template provides a framework to keep track of and maintain training records. TEMPLATE.
SOP ID: SOP_2.1.1-StudyMgt
FORMAT: MS Word
DATE: 05/06/24
This template is designed to assess the strengths, weaknesses, opportunities and threats in your study - useful when designing the study. TEMPLATE.
SOP ID: SOP_2.3.1-StudyMgt
FORMAT: MS Word
DATE: 05/06/24
SMC roles matrix template - blank
This matrix outlines the key study roles and provides a mechanism by which they can be allocated. BLANK TEMPLATE.
SOP ID: SOP_2.3.2a-DvtSOP
FORMAT: MS Word
DATE: 02/04/24
SMC roles matrix template - with instructions and examples
This matrix outlines the key study roles and provides a mechanism by which they can be allocated. TEMPLATE WITH INSTRUCTIONS AND EXAMPLES.
SOP ID: SOP_2.3.2b-DvtSOP
FORMAT: MS Word
DATE: 02/04/24
The study budget example lists some of the common items that should be budgeted for in grant applications. Though primarily designed for grants submitted to the National Health and Medical Research Council (NHMRC) it should be a useful tool for a range of projects and applications.
SOP ID: SOP_2.3.3-DvtSOP
FORMAT: MS Excel
DATE: 24/04/24
This checklist provides key considerations for the startup of each recruitment site. The checklist should be adapted to contain relevant items for your sites.
SOP ID: SOP_2.3.4-DvtSOP
FORMAT: MS Word
DATE: 04/10/23
This checklist provides key considerations for your study including governance, study materials, sites and study management planning. The checklist should be adapted to contain relevant items for your study.
SOP ID: SOP_2.3.5-DvtSOP
FORMAT: MS Word
DATE: 04/10/23
This checklist has been designed to be completed by the manager or the PI for the study to audit compliance to the SOIPs and in the broader sense, GCP. The checklist should be adapted to contain relevant items.
SOP ID: SOP_2.3.6-DvtSOP
FORMAT: MS Word
DATE: 05/06/24
This is a template to organise and store digital files.
SOP ID: SOP_2.3.7-DvtSOP
FORMAT: MS Word
DATE: 05/06/24