Research Governance Protocol for Ely Bridge

Summary of Key Responsibilities of People and Organizations Accountable for the Proper Conduct of a Study.

Please complete every section on this form, failure to do so may result in the delay of the project being approved.

ALL INFORMATION ON THIS DOCUMENT REQUIRES TO BE CHECKED AND SIGNED BY THE PRINCIPAL INVESTIGATOR OR THE SITE STUDY CO-ORDINATOR TO ENSURE THE ACCURACY OF THE DATA.

 

Title of Project (inc acronym)

Proposed start date 

Proposed finish date 

Why the research is needed 

Principal investigator (PI)

Principal investigator's contact details

Multidisciplinary (details of anyone other than the PI) who is involved in the research i.e. research asst etc)

Ethical approval (whether required and obtained)

Medicines Control Agency

Medical Devices Agency

Sponsor

Employing organizations (of all staff involved in the project)

Care organizations (e.g. any other practices involved in the research, all organizations providing health or social care in Wales)

Support required (e.g. if CAPRICORN was the sponsor it may be that you would require some admin support etc)

Support offered ( e.g. any outside grants etc)

Principal research question 

Methodology 

Sample group description (e.g. how many respondents will be recruited? male or female, age groups etc)

Consumer involvement in design, conduct, analysis and reporting of the research (This is an area as you can imagine is not fully exploited and is being looked at closely)

Methods of dissemination 

Literature search (attach) 

Identify any health and safety risks (e.g. if researcher is to interview respondents in their own home or indeed any uncontrolled environment you may wish to have some safety element included, I can provide an example)

Arrangements in place for obtaining patient consent if required (what are they)

Arrangements in place for patient confidentiality and what are they

Details of any deviation from REC approval prior to project start date

The project protocol must be attached to this document

Ensure that any indemnity arrangements are in place for this research

 Additional comments:

The ethical approval form must be attached along with REC number and a copy of the protocol.

The study should in accordance with Research Governance Framework must be audited mid term.